Janssen COVID Vaccine VAERS Reports - Up to March 26, 2021

Vaccine Onset Notes Vaccine Type VAERS ID Adverse Event Description Manufacturer Interval

COVID19 VACCINE JANSSEN 0 days 1070055-1 Severe headache 10/10, nausea, vomiting, temp of 99 degrees F x 24 hours. waning at this time Immediate burning in both arms. Unable to hold a pencil to fill out card after receiving vaccine. Weakness in upper extremities. Tingling, pain and numbness in both arms, red streaks appeared on the left arm going further up on to the COVID19 VACCINE JANSSEN 0 days 1070546-1 shoulder, the were visible and painful for about 90 mins. Sweating. Nausea. Blurred vision. Loss of consciousness. Headache behind the eyes. 15 minutes after vaccine, c/o scratchy throat. RN on site gave benadryl 25mg. BP 134/84, o2sat 98, pulse 90. Lungs clear, COVID19 VACCINE JANSSEN 0 days 1070883-1 no wheezing. No hives. Monitored an hour and 15 minutes. No change in throat, no difficulty swallowing. Released to home, instructed if change in symptoms or develops hives or respiratory symptoms to call 911. Patient was given the vaccination and then waited seated for 15 minutes. At 15 minutes patient started to stand and then fainted. Patient was breathing and had a pulse. Patient was placed on back and feet elevated and 991 was called. COVID19 VACCINE JANSSEN 0 days 1070975-1 Patient was coming too as paramedics arrived. paramedics checked vitals. Eventually patient was able to walk out on her own and did not want to go to hospital. COVID19 VACCINE JANSSEN 0 days 1071786-1 Fever (100) and chills all night, headache, and painful injection site. COVID19 VACCINE JANSSEN 0 days 1073219-1 nausea, headache, lethargic, chills Client received an unknown dosage due to improper vaccine draw. Nurse administered 7 doses in one vial - Janssen vial COVID19 VACCINE JANSSEN 0 days 1073268-1 contains only 5 doses, 6 doses maximum. Other client's dosage verified by myself or other nurse leads. Client received an unknown dosage due to improper vaccine draw. Nurse administered 7 doses in one vial - Janssen vial COVID19 VACCINE JANSSEN 0 days 1073280-1 contains only 5 doses, 6 doses maximum. Other client's dosage verified by myself or other nurse leads. Client received an unknown dosage due to improper vaccine draw. Nurse administered 7 doses in one vial - Janssen vial COVID19 VACCINE JANSSEN 0 days 1073285-1 contains only 5 doses, 6 doses maximum. Other client's dosage verified by myself or other nurse leads. Client received an unknown dosage due to improper vaccine draw. Nurse administered 7 doses in one vial - Janssen vial COVID19 VACCINE JANSSEN 0 days 1073293-1 contains only 5 doses, 6 doses maximum. Other client's dosage verified by myself or other nurse leads. couple of hours after receiving the injection, I had a large hive on my mid chest area. Later I had one on my hip. I was not concerned as I have them on occasion. I felt fine. Went to bed that evening and woke up with extreme burning and itching in my index finger and thumb of my right hand. Also a very large hive on the inside of my arm about 2 1/2 inches COVID19 VACCINE JANSSEN 0 days 1073390-1 from my wrist bend. Intense itching. I took a Benadryl tablet and felt better almost immediately. Later in the day about 6 1/2 hours later, I had more itching on my hip where the high was located. I took another Benadryl. I am fine. I also call my doctor and reported it. GIVEN THE JANSSEN VACCINE. EUA. THE PATIENT STARTED DEVELOPING A RASH IMMEDIATELY AFTER VACCINATION COVID19 VACCINE JANSSEN 0 days 1073418-1 AND SHE STARTED TO FEEL ITCHY. SHE WAS GIVE 25MG OF BENADRYL ORALLY AND WATCHED FOR 30 MINUTES. PT ARRIVED IN OBSERVATION AREA, AND STATED THAT SHE FELT TINGLING AROUND HER LIPS. VS WERE INITIATED. 3:52PM HR 90 BP 126/64 O2 96%. MONITIORED VS EVERY TEN MINUTES. PT WAS ADMINESTERED 25 MG OF COVID19 VACCINE JANSSEN 0 days 1073703-1 DIPHEHYDRAMINE 0.5 ML AT 4:05PM. AT 4:30 PT STATED THAT THEY STILL FELT TINGLING. ANOTHER DOSE OF 25MG OF DIPHENHYDRAMINE WAS ADMINESTERED. MONITORED PATIENT FOR AN ADDITIONAL 30 MINUTES. PT WAS ESCORTED BY SPOUSE STABLE. Patient arrived at observation area after getting vaccine at 5:40 PM. Patient complained of SOB and feeling unwell. V/S COVID19 VACCINE JANSSEN 0 days 1073735-1 taken. Patient feels fine after sitting for 10 minutes. 13 minutes after injection- tongue tingling and numbness for 3 hours. Hot flashes, feeling hot, headache, and extreme COVID19 VACCINE JANSSEN 0 days 1073850-1 fatigue. Started to experience anxiety and dizziness approx 1 hour after receiving vaccine. BP elevated at time of observation (168/102). Obesrvation time extended to 1.5 hours. Provided hydration and light meal. Discharged per team member COVID19 VACCINE JANSSEN 0 days 1073937-1 request after she stated she felt better. Encouraged to take BP meds as directed per PCP. Encouraged to go to ER for symptom return or additional adverse reactions per handout/Agency guidelines. PATIENT RECEIVED THE VACCINE, AND WILL SITTING IN THE RECOVERY ROOM, FELT HOT, DIZZY AND SWEATY AS WELL AS OBTUNDED. BP 90/42, HR 55 SAT 97 RR12 DIAPHORETIC, AROUSABLE, COHERENT CV PULSE DIFFICULT TO PALPATE, COVID19 VACCINE JANSSEN 0 days 1074283-1 BRADYCARDIC PHYSICAL EXAM OTHERWISE UNREMARKABLE PLACED ON STRETCHER. MENTAL STATUS IMPROVED. VS 115/97, 75, 12, SAT 98 TRASNFERRED TO EMERGENCY ROOM FOR EVALUATION Extreme muscle aches and joint pain to the point of barely being able to move Chills Sweats Burning/Irritated Skin COVID19 VACCINE JANSSEN 0 days 1074473-1 Nausea Thirst Severe chills, headache, and body aches starting approximately 5.5 hours post-vaccination. Treated with acetaminophen COVID19 VACCINE JANSSEN 0 days 1074476-1 1g PO. Fatigue, headache, and dizziness beginning the following morning and persisting until approximately 9pm on 3/4/21. Treatment with acetaminophen every 6 hours as needed. After 9pm on 3/4/21, complete resolution of symptoms. within a minute of receiving the vaccine I started feeling dizzy and woozy and like I was floating. Then my blood pressure went up and my heart started beating faster. I had tightness in my chest and I got a tickle like feeling at the top of my COVID19 VACCINE JANSSEN 0 days 1074701-1 chest. I got nauseous. BP was elevated (140/85) normal 107/65. I stayed for an hour. I was very very sleepy the whole time. 3/5/21 I still have the tickle and tightness and pressure on my chest and I am having vertigo attacks. I got a headache and pain and stiffness in my neck where I have had nerve pain injections and ablations. 8 hours after getting the vaccine I started feeling very cold. It came on me all of a sudden. Shaking, shivering, teeth chattering ensued along with generally feeling very unwell. (Similar to how I felt years ago after having surgery) This COVID19 VACCINE JANSSEN 0 days 1074703-1 progressed during the night to fever, chills, extreme body aches, stabbing pains in the head, heart racing, dizziness and nausea. After 12 hours I started to feeling improvement. At the 16 hour mark I am really tired and nauseous but feel like I'm coming back. Probably the worst I've ever felt. We considered going to the ER in the night. Pt received J/J vaccine at location yesterday (3/4/21) at 11am. She noticed a fever at around 3pm. She had a fever to COVID19 VACCINE JANSSEN 0 days 1074773-1 104-105 all during the night, she was 99 this am. COVID19 VACCINE JANSSEN 0 days 1074822-1 Dizziness, lightheadedness, chest pain, increased respiration, gagging Later in the evening after receiving the vaccine, I experienced a very strong and pounding headache. I took some Ibuprofens and went to sleep around 9pm and the headache was resolved around 11:30pm. However, later during the COVID19 VACCINE JANSSEN 0 days 1074845-1 night the headache came back. Also, my body aches all over and just generally uncomfortable feelings. The injection site felt warm to the touch and sore. Janssen COVID-19 Vaccine EUA Injection @ 1130a 1hr after - diarrhea 5hrs after- Rt Arm (opposite arm of shot) tingling sensitive to touch 7hrs after- Skin Crawling painful to touch - low back,thighs, arms, scalp 9hrs after- Freezing and fever sweating 12hrs after- 102 fever, racing BP about 180 high for me, Wrist and Elbows Ached terribly, Lower legs - knee down felt swollen but no sign of swelling. Low back Ached with Pain in Right rear side. Felt like I needed to stretch back and legs tight/anxious. slight Headache 14hrs after- took 2 Tylenol PM & slept COVID19 VACCINE JANSSEN 0 days 1074959-1 restlessly until 8:30 a (12hrs later) 8:30a - Much better with slightly achey back and forearms and occasional headache ting... not constant. Moving slow Had Covid Nov11 2020. Symptoms lasted 6week, each week one symptom would go away and a new would arise- -fever 2days -intensively painful skin crawling 2days -loss of taste and smell -diarrhea (still have loose stools and occasional watery) had diarrhea morning of shot -eyes painfully itchy irritated dry - still occurs most days about 3p -extreme exhaustion in afternoon about 1-3p still COVID19 VACCINE JANSSEN 0 days 1075003-1 Patient vomited 2 min after receiving vaccine. PATIENT FELT LIGHT HEADED A FEW MINUTES AFTER INJECTION. BLOOD PRESSURE WAS CHECKED AND SHOWN TO BE COVID19 VACCINE JANSSEN 0 days 1075074-1 SLIGHTLY ELEVATED. PATIENT DRANK SOME WATER AND AFTER A FEW MINUTES BLOOD PRESSURE WAS CHECKED AGAIN AND WAS IN NORMAL RANGE. (3) syncopal episodes following vaccination, one of which resulted in a fall with direct injury to the base of neck, head, COVID19 VACCINE JANSSEN 0 days 1075246-1 and right flank. Pt reported chest pain prior to syncope. PATIENT RECEIVED VACCINATION AND WAS THEN ASKED TO SIT IN LOBBY. AFTER BEING SEATED PATIENT PASSED OUT AND FELL OUT OF CHAIR, HITTING HIS HEAD AND BITING HIS LIP IN THE PROCESS. 911 WAS CALLED AND EPI PEN WAS RETRIEVED. PATIENT CAME TO AND WAS PALE, SWEATY, AND HAD CLAMMY HANDS. PATIENT REPORTED NO COVID19 VACCINE JANSSEN 0 days 1075378-1 DIFFICULTY IN BREATHING OR FEELING OF THROAT SWELLING SO EPI PEN WAS NOT ADMINISTERED. BP WAS CHECK AND WAS EXTREMELY ELEVATED. AMBULANCE ARRIVED A FEW MOMENTS LATER AND EMTS ASSESSED PATIENT. PATIENTS BP HAD RETURNED TO NORMAL RANGE, COLOR WAS IMPROVED AND HE WAS NO LONGER SWEATING. EMTS ASKED PATIENT IF HE WANTED TO BE TAKEN TO THE ER FOR FURTHER EVALUATION AND PATIENT REFUSED. PATIENT SAT IN THE PHARMACY FOR A FEW MORE MINUTES AND WAS THEN DRIVEN BACK TO WORK. Patient was being monitored for 30 minutes by EMS due to anaphylaxis to Shrimp. About 15 minutes into monitoring, COVID19 VACCINE JANSSEN 0 days 1075569-1 the patient reported to EMS that he was feeling sweaty and had some shortness of breath. EMS reported BP to be 171/89 and pulse of 88. Patient stated that he does take blood pressure medication and reported that BP was elevated for him. EMS contacted ambulance for transport to Emergency room, patient in agreement to transport. 14:59 - RN responded to waiting lot. Pt c/o sensation of facial swelling and heart racing. Denied other complaints. At 1500 BP 110/80, HR 140, R 12. 1503: Pt helt HR slowing down. No further feeling of swelling in face, throat, or elsewhere. 1505: HR 128. 1510: Pt talking, breathing without difficulty. Advised to seek medical attention if s/sx COVID19 VACCINE JANSSEN 0 days 1075575-1 worsen. 3/5/21 @ 1040: Another RN followed up with ph call. Pt reported that after leaving site, she felt HR beginning to speed up. Went to ED and was monitored x 2 hrs. Systolic pressure there was 161. HR was in 140's. No interventions. After 2 hrs VS stabilized and pt was discharged home. Is fine today. COVID19 VACCINE JANSSEN 0 days 1075958-1 Dizziness felt like fainting 15 minutes after injection, customer complained about metallic taste, tongue slightly swollen with small bubbles on each side of tongue. No difficulty in breathing. We asked to stay 15 minutes more for observation. Had tightness in the chest 5 COVID19 VACCINE JANSSEN 0 days 1076091-1 minutes later. Called 911. Operator asks not to give water/benadryl/epipen. EMT arrived 5 minutes later and assessed. Watch 15-20 minutes later walked her out to car. We checked 6:45 pm still have metallic taste and just little swollen on tongue. Called 3/5/21 @ 2:30pm no more symptoms., only from the JNJ shot. tiredness COVID19 VACCINE JANSSEN 0 days 1076118-1 Fast heart rate. Thought it was going to shock me from defibrillator. Client stated her lips felt tingly and her throat felt itchy. Airway clear, respirations even and unlabored, heart rate COVID19 VACCINE JANSSEN 0 days 1076282-1 within normal limit. Patient in no acute distress. No angioedema noted. Patient was administed Benadryl 25mg PO X 1 dose. 65m received J&J vaccine, 10 minutes after admit c/o a gripping pain mid sternum, a 2 on scale of 1-10. Pt brought ot observation area, pain non changing after 15 minutes, eval'd by on site EMS. Transferred to ED for eval. Pt notified his COVID19 VACCINE JANSSEN 0 days 1076306-1 daughter prior to leaving vaccine clinic. He had no complaints of other symptoms. Per electronic health records, pt drove himself to ED. COVID19 VACCINE JANSSEN 0 days 1076316-1 Pt feels dizzy, hot, headache. VS BP 122/80, HR 75, RR 18, Osat 98% Left arm numb from elbow down. blood pressue 96/42. patient sweating. feeling dizzie like he was about to pass out. provided food/water and constant COVID19 VACCINE JANSSEN 0 days 1076318-1 monitoring until symptoms resolved Pt was released after 15 min of monitoring. As soon as pt got in her car 9Parking lot is 3 minutes away from vaccination COVID19 VACCINE JANSSEN 0 days 1076762-1 site) Pt developed palpitations (HR:156/min) Pt drove to the ER (3 blocks away from parking lot) Pt is currently in the ER, HR between 107-119. The patient has had no problems with the vaccine. We were finishing vials of both Janssen and Pfizer at the same time at COVID19 VACCINE JANSSEN 0 days 1076823-1 the end of the evening. He received a dose of Janssen when he should have received Pfizer since he will not be 18 years old for 4 months. COVID19 VACCINE JANSSEN 0 days 1076869-1 patient c/o chest pain with EKG changes 90 min. after vaccine administered. When I got the vaccine I got an instant pain in my arm and into my neck, then an intense headache between my eyes COVID19 VACCINE JANSSEN 0 days 1076897-1 above my nose, I was flush and sweaty, nauseous. Then had a bad headache on the top of my head, then soon I had left side facial numbness . Light sensitivity Fever onset (100F) along with chills uncontrollable shivering and teeth chattering around 8 PM. Around 5 Am, fever had hit 103F and body temperature (measured by an Oura ring) recorded average body temperature increase of +5.6F while COVID19 VACCINE JANSSEN 0 days 1077055-1 sleeping compared to baseline. Fever remained intermittently throughout the next day, as well as headache, sore throat, chills. Slight headache mid afternoon. Chills about 6pm. Fever of 100.8 around 7:30pm. Unsure whet OTC med to take. At 9pm, COVID19 VACCINE JANSSEN 0 days 1077226-1 fever 101.6. Took ibuprofen with PowerAde around 9:15pm. What should I take and how much? Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, COVID19 VACCINE JANSSEN 0 days 1077239-1 Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: Patient recovered after surpine positing for 15 minutes and water About 6 hours after shot, began having chills. Chills lasted 12 plus hours. Fever followed chills. Couldn?t get warm enough but fever was high. Mouth thermometer indicated fever of 101.5* for several hours (24 plus); non oral COVID19 VACCINE JANSSEN 0 days 1077253-1 thermometer indicate parts of body were 105.0*. Despite chills. Terrible headache and aches so bad I couldn?t sleep. Finally took some Advil PM so I could finally sleep. Next day, still have fever, aches, and headache. COVID19 VACCINE JANSSEN 0 days 1077321-1 Temp of 99.6 Muscle aches Chills Rigors Uncontrolled shaking Body feels heavy like lead Very tired Minimal pain at injection site 2:18pm hands twitching and my right eye feels like it's swollen and burning closer to my cheek and then started twitching uncontrollably. Very dry mouth. Moments later body tremors and vomiting. Ended up being taken to the emergency room will elaborate later. Drink Sprite on the COVID19 VACCINE JANSSEN 0 days 1077369-1 way home vomited it up as soon as I walked in the door. Not the feeling of nausea just the vomiting is coming. Took temperature have a fever of 101.0 DAY 2 Tremors while walking Headache Body aches Minimal taste Tingling around eye No real desire to eat Managed to keep some noodles down Today is Day 3 5:00am Still unsteady on feet when walking Still have headache and body aches day 1 severe hot and cold flashes bad headache and severe arm pain today could not stand up sat down felt Like I was COVID19 VACCINE JANSSEN 0 days 1077385-1 going to pass out sat on floor bad cold sweats feeling nauseous bad diarrhea Starting approx 7 hours after injection I started to feel run down. I then played tennis for about 45 minutes. I got home around 8:30 and started to experience extreme chills, fever of 100.4, joint aches in feet, hands, neck, wrists, shoulders, COVID19 VACCINE JANSSEN 0 days 1077387-1 hips. Headache. I did not take any additional medication - toughed it out. This morning is approx 22 hours after vaccine. I could not sleep more than an hour or so, I was very chilled and achy. I am currently feeling a little better but still have aches in my back and wrists and ankles, have a headache Started shaking inside my body 8 hours after the shot plus a fever of 100. Shaking then turned violent on outside of my COVID19 VACCINE JANSSEN 0 days 1077420-1 body. Took 2 Motrin (225) each. Shaking stopped after 30 minutes, fever disappeared overnight. Started with fever of 99.4 which rose to 101.4 at about 2:30 am. I ended up taking tylenol at about 2:30 am and my COVID19 VACCINE JANSSEN 0 days 1077425-1 fever broke by time I woke up at 6:30 am COVID19 VACCINE JANSSEN 0 days 1077529-1 severe headache, chills for about 6 hours; flushed cheeks; body aches 6 hours in: feeling cold, muscle aches 7 hours in: extreme chills and nausea 8 hours in: extreme chills, muscle aches, COVID19 VACCINE JANSSEN 0 days 1077536-1 feverish 13-14 hours: chills subside, muscle aches, hot/feverish 20 hours: muscle aches, fatigue Muscle aches in armpits began a few hours after receiving the dose. Within 8 hours of dose, a mild fever and chills began (around 100 degrees F). I attempted to take a bath to soothe aches but it did not help, and instead tried to go to sleep at 8:30 pm. A slight red rash appeared on chest and arms around this time. I was woken up at 10:30 pm feeling disoriented and hot, with a fever of 104.5 degrees F. My wife noticed slurring of words and that I seemed unstable and confused, and COVID19 VACCINE JANSSEN 0 days 1077558-1 symptoms were severe enough we considered going to the emergency room. I experienced ringing in my ears and a severe headache. I took 2 extra strength Tylenol, put a cold cloth on forehead, and drank fluids to fall back asleep. Fever dropped to around 102 but continued throughout the night. I woke up at 6:30 am and took two more Tylenol. The severe headache continued and I vomited twice. I attempted to take a shower and rinse off, and continue to rest. Fever is reduced to 99 degrees F with help of Tylenol. Went to bed around 10 pm. Woke up at 11:30 with moderate to severe chills and 100 degree fever. Added blankets and COVID19 VACCINE JANSSEN 0 days 1077619-1 clothes. Took Tylenol. Drank water. Chills subsided. At 12:45am temp was 100.4 degrees F. Woke up at 6am. Temp was 98.2. Took Advil at 6am to help with muscle aches from the chills. Left arm was mildly sore, as expected. Around 10 pm Thursday, I started feeling chills. During the night I felt fevers and chills alternating. Around 3 am, I was nauseous and vomited, although there wasn't much actual vomit. I vomited again COVID19 VACCINE JANSSEN 0 days 1077657-1 around 9 am the next morning, with even less vomit, since I hadn't eaten any breakfast. I rested most of Friday and ate sparingly. Today (Saturday) I feel better. Flu-like symptoms. Body aches, fever, chills, headache, nausea. Started around 8 hours after vaccination and lasted over COVID19 VACCINE JANSSEN 0 days 1077658-1 10 hours COVID19 VACCINE JANSSEN 0 days 1077756-1 Headache, body ache, fever, tiredness COVID19 VACCINE JANSSEN 0 days 1077796-1 Chills, fever, headache; took 400 mg ibuprofen COVID19 VACCINE JANSSEN 0 days 1077812-1 Mild fever (99.8, normal resting body temp 97.1) Patient experienced dizziness, elevated blood pressure and increased heart rate. Diphenhydramine 50mg IM was COVID19 VACCINE JANSSEN 0 days 1077855-1 administered into right deltoid. COVID19 VACCINE JANSSEN 0 days 1077868-1 Head ache, extreme chills, fatigue, slight nausea. COVID19 VACCINE JANSSEN 0 days 1077874-1 JANSSEN COVID-19 VACCINE EUA Chills, body aches, fever Dizziness, headache, nauseousness to the point of having to sit still. Home treatment with Ibuprofen reduced symptoms COVID19 VACCINE JANSSEN 0 days 1077879-1 that lasted approximately 24 hours. Janssen COVID-19 Vaccine EUA Body aches and pains (specifically on left side of body and in lower back), lasted for ~14 COVID19 VACCINE JANSSEN 0 days 1077902-1 hours. Migraine-like headache, currently ongoing but started 11 hours ago. Unable to sleep due to these moderate- severe amounts of pain (woke up at 3am unable to go back to sleep). Mega headache (I get headaches so I know it was bad) about 3 hours afterwards. Really cold and falling asleep about 5 COVID19 VACCINE JANSSEN 0 days 1077967-1 hours after. Next day generally just cold and body tired. No arm pain. lymph nodes started swelling in a few hours. Woke up in middle of night with 100.3 degree fever, aches, chills, COVID19 VACCINE JANSSEN 0 days 1077976-1 congestion, and congestion related headache COVID19 VACCINE JANSSEN 0 days 1077998-1 Hives all day & night controlled by using benedryl Janssen COVID-19 Vaccine EAU Headache, dizziness, and nausea starting around 2 and a half hours after vaccination. Left COVID19 VACCINE JANSSEN 0 days 1078001-1 work early due to not feeling well enough to continue. COVID19 VACCINE JANSSEN 0 days 1078033-1 Janssen COVID-19 Vaccine EUA. Chills, headache, body aches, mentally fogginess, slight nausea. 5-6 hours after the shot I got chills and could not get warm. I went to bed and had mild aches and had to wear a jacket to COVID19 VACCINE JANSSEN 0 days 1078035-1 keep warm. Woke up 4am because could not sleep and was ok with only mild aches Friday night at about 10ish I suddenly got a terrible migraine, shaking uncontrollably, and my body have stiff. I tried going to bed at 11pm, but couldn't fall asleep. I got up sometime around 2am and I still had all of these along with extreme nausea. Check my temperature, it was 101.4 F. Got more blankets and tried to get some sleep, but took a while COVID19 VACCINE JANSSEN 0 days 1078067-1 due to the migraine. At 7:30am, the shaking was gone and the migraine was not as bad, but I still had a temperature of 99.1 F and nausea. After calling my boss and mother, I went back to sleep. Stayed in bed until about 1:45pm Saturday. By then, the migraine was manageable and nausea was not as bad, though still had a temperature of 99.9 F. Took a shower and took 2 pills of ibuprofen. COVID19 VACCINE JANSSEN 0 days 1078095-1 Extreme dizziness, red face, high blood pressure, tingling tongue COVID19 VACCINE JANSSEN 0 days 1078109-1 COUGH, TINGLING THROAT AND TONGUE WITH SLIGHT SWELLING OF THROAT AND TONGUE Patient c/o throat closing, SOB, and chest pain within minutes after receiving the vaccine. Her vital signs showed tachycardia, increased respirations, and elevated blood pressure. She had a hard time speaking in full sentences. She COVID19 VACCINE JANSSEN 0 days 1078117-1 does have a history of anaphylaxis to certain medications. She was administered epinephrine auto injector IM and brought to the emergency department by rapid response team. Immediately tasted a metallic taste and numbness in my cheeks. When I got home I had a rapid heart rate and slight COVID19 VACCINE JANSSEN 0 days 1078121-1 shortness of breath. That night I ran a fever of 102 and had horrible chills and nausea. The next day these were gone but I had a horrible headache that even Tylenol wouldn?t get rid of. The second day these symptoms had stopped. COVID19 VACCINE JANSSEN 0 days 1078122-1 Vasovagal response, dizziness, blood pressure drop, irregular heart beat

COVID19 VACCINE JANSSEN 0 days 1078197-1 Headache - moderate. Facial numbness - started at the nose, across the bridge of the nose and upper cheeks, then spread to entirety of face. Face is still somewhat numb 55 minutes after symptoms began. Headache also still present. COVID19 VACCINE JANSSEN 0 days 1078200-1 Mouth and throat tingling and slight swelling, dizziness, rapid heart beat, shaking, difficulty breathing. About 10 min after the vaccine was administered, the patient suddenly felt hot, dizzy, and his vision became blurred. COVID19 VACCINE JANSSEN 0 days 1078218-1 Resolved after about 2 minutes after removing glasses and drinking water mid grade fever, headache, fatigue, mild discomfort at injection site. Fever began approximately 8 hours after injection. COVID19 VACCINE JANSSEN 0 days 1078231-1 Headache persisted for approximately 20 hours after injection. ITC Tylenol alleviated most symptoms Chills at 5 pm, rapid breathing followed by nasea arouns 10 pm, vomited once around midnight, naseau until morning, COVID19 VACCINE JANSSEN 0 days 1078241-1 symptoms revealed in morning Body chills 8 hours after receiving vaccine. 2 hours after that, fever of 103 F and severe headache. Took 1000mg of COVID19 VACCINE JANSSEN 0 days 1078273-1 ibuprofen. The next day fever was about 100F, headache was mild, slight nausea, tired feeling. COVID19 VACCINE JANSSEN 0 days 1078292-1 Low grade fever99.0, chills, headache, body aches

COVID19 VACCINE JANSSEN 0 days 1078313-1 03/05/21 - 6 p.m. - severe throbbing headache lasting all night, cold (no fever) 03/06/21 - 8 a.m. - weakness , sense that blackout very possible 03/06/21 - 9 a.m. - severe lower back pain lasting entire day and into evening, difficultly moving Pt was held for 15 minutes. Past 15 minutes, patient was ready to leave but complained of nausea. Asked pt to stick around. Took blood pressure. It was low ~90/55. Asked again how he was doing, stated okay but feeling chills/cold. COVID19 VACCINE JANSSEN 0 days 1078314-1 Started to shake uncontrollably. Ask pt if he thought a hospital visit was necessary; he stated no at that time. Decision was made to call squad; BP was elevated now and still shaking. Transported at that time.

COVID19 VACCINE JANSSEN 0 days 1078324-1 Severe chills after 7 hours, terrible headache, ?brain zaps,? nausea, fever of 103.5 around 12am, after 2 hours of sleep. Took tylenol and ibuprofen, drank lots of water, felt better by 10am. The pain was intense and I feared a bad reaction. fever, chills, achiness, dizziness, diarrhea, fast heartbeat Side effects began about 8:00 pm, about 9 hours after receiving COVID19 VACCINE JANSSEN 0 days 1078344-1 the injection. Symptoms treated with ibuprofen and rest at home. Symptoms improved the next day. By 5:00 pm on 3/6/21, just fatigue remains. After roughly 4 hours I started to get chills and body aches. I went to bed but could not get warm and writhed in COVID19 VACCINE JANSSEN 0 days 1078389-1 considerable distress for at least an hour. (This was the most uncomfortable I've been since induced labor before the anesthesiologist arrived for an Epidural 28+ years ago.) My temperature fell to 95 before I took acetaminophen and was able to fall asleep.. Now, at 7 hours it's 101.2 and I'm just getting the side effects I expected: weakness, a little nausea. Janssen COVID-19 Vaccine EUA About 8 hours after the injection, I started having strong chills. About 10 hours after, I started having an incredibly fast heartbeat that lasted for about 10 hours. I tried some breathing exercises to bring it COVID19 VACCINE JANSSEN 0 days 1078418-1 down, but that did not work. I did not seek medical care as it went back to normal throughout the morning of the following day. But kind of scary. Also had a low temperature of 98 on the scanner thermometer. Normal is 96 something. COVID19 VACCINE JANSSEN 0 days 1078424-1 fever, chills, headache for 12 hours. Fatigue continues. Patient presented about 5 minutes post vaccination with dizziness and nausea. Patient maintained consciousness and did COVID19 VACCINE JANSSEN 0 days 1078440-1 vomit slightly. After about 15 minutes the patient did feel better and left the pharmacy. COVID19 VACCINE JANSSEN 0 days 1078505-1 Chills and 101.7 fever Developed fever several hours after injection and high fever at night (103.1 degrees). This is second night and still has a COVID19 VACCINE JANSSEN 0 days 1078511-1 fever of (101.7 degrees). Body aches, sweats, and soreness. COVID19 VACCINE JANSSEN 0 days 1078570-1 High moderate myalgia, fatigue, fever COVID19 VACCINE JANSSEN 0 days 1078576-1 Fever, chills, headache, vomiting, cramps COVID19 VACCINE JANSSEN 0 days 1078588-1 Headache, nausea, chills, fever, hives, (within 5 hours) facial swelling ( right side) itching (1 day later) Violent muscle aches that were not settled by medication, far beyond normal muscle aches from illness. Began exactly 6 COVID19 VACCINE JANSSEN 0 days 1078592-1 hours following vaccine and continued for approximately 12 hours. Fever for 24 hours. Fatigue, black outs. Chills Fever/flush Periods of being cold then being incredibly hot Weakness/soreness of muscles Dizziness COVID19 VACCINE JANSSEN 0 days 1078602-1 Headache/sinus pressure COVID19 VACCINE JANSSEN 0 days 1078609-1 Needle was missing from syringe. Not sure if it retracted back into syringe or in patients arm COVID19 VACCINE JANSSEN 0 days 1078645-1 Tiredness, muscle pain, fever (101.8), elevated heart rate (110bpm) COVID19 VACCINE JANSSEN 0 days 1078647-1 Headaches for 2 days at the time of this submission COVID19 VACCINE JANSSEN 0 days 1078680-1 pt had elevated blood pressure that persisted. bp 20/114 and repeat 5 min later 232/126 COVID19 VACCINE JANSSEN 0 days 1078688-1 Itchiness and redness on face , neck, chest. COVID19 VACCINE JANSSEN 0 days 1078690-1 Chills, muscle pain and low fever Pt developed a rash on her finger that spread to her wrist. Benadryl 25mg was given.. the rash improved. Pt blood COVID19 VACCINE JANSSEN 0 days 1078696-1 pressure elevated 195/113, repeat 207/117. Pt developed nausea and abdominal pain. Pt was transported to the ER COVID19 VACCINE JANSSEN 0 days 1078714-1 Fever, arm pain. Tylenol Extreme Chills took 2 Advil at 9:00 pm and 2 more at 11:00 pm on 03/06/2021. Fever 101.5 took 2 Advil at 1:30 am on COVID19 VACCINE JANSSEN 0 days 1078716-1 03/07/2021 - current. Flu like aches started at about 9:00 pm on 03/06/2021 - current. COVID19 VACCINE JANSSEN 0 days 1078726-1 Headache, chills, body aches COVID19 VACCINE JANSSEN 0 days 1078735-1 WHEN I ADMNISTERED THE VACCINE, 2 DROPLETS CAME BACK AND DRIP OFF THE ARM . COVID19 VACCINE JANSSEN 0 days 1078744-1 body aches, back pain, vomiting COVID19 VACCINE JANSSEN 0 days 1078745-1 Chills, and fever that spiked as high as 102.7 Degrees F.... tingling, left side (still exists two days post shot) Chills (severe night of shot, ended early next morning) Body aches COVID19 VACCINE JANSSEN 0 days 1078759-1 (severe night of shot, ended early next morning) Mild body sore Headache (still exists two days post shot) COVID19 VACCINE JANSSEN 0 days 1078763-1 Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium Systemic: Fainting / Unresponsive-Mild, Systemic: Patient passed out and recovery after 40 seconds of chest compression- Mild, Additional Details: Patient was seen rocking back and forth in his chair according to 3 observers in the room, then fell back hit his head after observed his face turned pale. 3 Observers rushed over to him, patient was not breathing, COVID19 VACCINE JANSSEN 0 days 1078765-1 unconscious and not responsive, eye ball stiff, sweating but cold. Eyelid peeled back and the eye is responsive to light. Started chest compression immediately and after 40 seconds of chest compression at third round, patient came back. no hx of preexisting condition or allergies note Systemic: Nausea-Mild, Systemic: Vomiting-Medium, Additional Details: Pt was uneasy about needles and vomited about COVID19 VACCINE JANSSEN 0 days 1078769-1 2 minutes after administration. Pt also had some mild nausea. Pt was monitored for 30-45 minutes before leaving pharmacy when she felt normal and fine. Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating- Medium, Systemic: Hyperventilation-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Additional Details: COVID19 VACCINE JANSSEN 0 days 1078772-1 Patient felt faint immediately upon receiving the vaccination. received instruction to sit down. upon sitting down patient passed out/fainted/ muscle contractions in both hands were observed. 911 emergency services were contacted. patient then taken into ambulance for further evaluation. Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, COVID19 VACCINE JANSSEN 0 days 1078775-1 Additional Details: Patient fained a few minuies after injection. Felt hot then tried to get up and fell to the ground. She was not injured. EMS was called and evaluated her. No signs of anaphylaxis. Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: While sitting for 15 minute observation period, patient was experiencing lightheadedness and sweating. He was instructed to take deep COVID19 VACCINE JANSSEN 0 days 1078776-1 breaths and take oral fluids, to which he stated that he started to feel better immediately. He was instructed to sit for a 30 minute observation period at the end of which he stated that he felt completely fine. He was given instructions on what to do if he experiences any other adverse effects and also given a pharmacy business card with phone number. Systemic: Fainting / Unresponsive-Medium, Systemic: Fainted but seems responsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient fainted from sitting after vaccination. No difficulty breathing/swallow, thus gave water and gatorade. He was responsive to my questions. He has history of anxiety to needles and he did not COVID19 VACCINE JANSSEN 0 days 1078777-1 eat lunch before vaccine. He stayed seated for 1 hour to monitor. Then, walked an aisle before driving home. Asked him to eat first before driving home. Called him twice and he is home and feeling okay. Counseled to call pharmacy if any symptoms of allergic reaction to vaccine. COVID19 VACCINE JANSSEN 0 days 1078778-1 Marked soreness and aches of all major muscles. Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: COVID19 VACCINE JANSSEN 0 days 1078780-1 TOOK PATIENT'S VITALS TWICE, FIRST WAS BP 100/74 HR 64, SECOND BP 105/76 HR 71, FOLLOWED UP WITH PHONE CALL TO PATIENT AFTER 2 HOURS AND SHE WAS FEELING BETTER COVID19 VACCINE JANSSEN 0 days 1078782-1 Fever, chills, headache, body aches, numbness and tingly feeling in all finger tips mild itching, headache, and very tired. I di not take an antihistamine or pain med for the headache. I di sleep about 10 COVID19 VACCINE JANSSEN 0 days 1078786-1 hours. Severe chills, low fever and racing heart. The heart rate almost got me to the hospital. 112 BPM. Symptoms lasted COVID19 VACCINE JANSSEN 0 days 1078795-1 until early morning but then went away. In addition to the muscle ache, headache & fatigue I had extreme chills with shakes and fever of 37.7c. Fever didn't COVID19 VACCINE JANSSEN 0 days 1078801-1 respond to Tylenol but it did to Advil. As morning came fever has returned and has responded to Tylenol so far. COVID19 VACCINE JANSSEN 0 days 1078812-1 Frequent urination Insomnia ( unrelated to frequent urination) Feelings of severe dehydration Muscle ache Headache Chills, back ache, elevated pulse(115) started about 12 hours after vaccination. Lasted about 8 hours. Called cardiologist COVID19 VACCINE JANSSEN 0 days 1078813-1 and he said it was probably a reaction to the vaccine. Took some ibuprofen. Did not do anything else. Felt better the next morning and pulse was fluctuating between 80 and 90. COVID19 VACCINE JANSSEN 0 days 1078816-1 Headache, tired and exhausted, feeling weak, muscles ache, left arm feels sore. Night time the chills. COVID19 VACCINE JANSSEN 0 days 1078820-1 Fever, chills, migraine, increased heart rate for an extended period of time, body aches Muscle ache, headache, fatigue -- essentially severe flu-like symptoms beginning at approximately 10 hours after the COVID19 VACCINE JANSSEN 0 days 1078856-1 injection and lasting for 10 hours. Janssen COVID-19 Vaccine EUA Chills and fever of 103.1 degrees F, elevated heart rate (average 91 bpm) during the COVID19 VACCINE JANSSEN 0 days 1078859-1 night of 3/6/21; Sneezing, runny nose. Treated with Ibuprofen and symptoms resolved by morning of 3/7/21. Fever of 101.7, muscle aches, headache, scratchy and sore throat, very tired. I'm 31 weeks pregnant, pregnancy has COVID19 VACCINE JANSSEN 0 days 1078867-1 been normal, estimated date of delivery is May 6th 2021. High fever, weakness, chills, nauseous. Started at 10am. Was hyperventilating trying to vomit but couldn't took Pepto- COVID19 VACCINE JANSSEN 0 days 1078871-1 Bismol. Fell asleep about 3pm woke up at 630pm soaked from fever breaking. took temperature then was 101.7. Still have fever of 100.7 at 10am 3.7.21 COVID19 VACCINE JANSSEN 0 days 1078878-1 Back pain, leg pin, arm pain(both arms) a headache and weakness and sleepiness COVID19 VACCINE JANSSEN 0 days 1078893-1 headache, dizziness, nausea COVID19 VACCINE JANSSEN 0 days 1078909-1 headache, fatigue, myalgia, chills, muscle weakness (legs gave out while walking) COVID19 VACCINE JANSSEN 0 days 1078918-1 Body aches Fatigue Headache Running nose Chills Fever began around 11pm 3/6/21 and went to 102.3 at about 2:00 am 3/7/21. She had chills for several hours during this COVID19 VACCINE JANSSEN 0 days 1078921-1 time. She felt nauseous, had skin sensitivity, a dry mouth and muscle pain, and felt exhausted. No fever this morning but still some skin sensitivity, nausea and feeling tired, muscle pain, dry mouth, and hot/cold back and forth. Minor chills 36 hours after shot with sever chills 6-8 pm evening of shot. Fatigue and joint aches 36 hours after shot. COVID19 VACCINE JANSSEN 0 days 1078929-1 Slept much more then normal 12-36 hours after shot. COVID19 VACCINE JANSSEN 0 days 1078932-1 Severe chills x 6 hours, fever (up to 102.5)x 18 hours, headache x 24 hours, body aches x 30 hours headache, body/muscle aches, chills around 1130pm, about 12 hours after the shot. there was some arm pain about an COVID19 VACCINE JANSSEN 0 days 1078970-1 hour after the injection. Severe muscle and joint pain, cold chills, extreme fatigue, headache, weakness dizziness. Started one hour after injection. COVID19 VACCINE JANSSEN 0 days 1078979-1 Has not yet resolved, 2 days after injection. Pounding headache about 10-11 hours after vaccine administration. Took 1000mg Tylenol Extra Strength which did not help. Chills about 12-13 hours after vaccine administration, lasting several hours. High fever (102.8) about 17 hours after COVID19 VACCINE JANSSEN 0 days 1078983-1 vaccine administration (took additional 1000mg Tylenol at 2am) and fever was gone by 8am. Muscle/shoulder extreme tightness on right side (same arm receiving vaccine). Dizzy & light-headed 24 hours after vaccine administration (almost passed out). Headache remains 12+ hours since it began despite the multiple doses of Tylenol described. I had my vaccine at 12:15 pm. Five hours after vaccine, at 5 pm, I started to get chills. I took Advil and they went away. Once Advil wore off 5 hours later at 10 pm , I had a fever, very thirsty, shivers, and small headache. I took two more COVID19 VACCINE JANSSEN 0 days 1078989-1 Advil at 11 pm and my shivers disappeared by midnight. By morning time my fever broke and I?m left with a small headache. Fever of 100.3 and severe chills at 8pm on the same day I had the shot. Took 3 Advil (200mg/each) and was feeling a COVID19 VACCINE JANSSEN 0 days 1079005-1 little better by 10pm. Woke up at 7am feeling fine but with a slight headache. -Muscles Spasms (lasted about 15 minutes) -Fever -Chills (including chattering teeth) -Diarrhea -Vomiting -Sore Throat - COVID19 VACCINE JANSSEN 0 days 1079025-1 Headache -Fatigue -Stomachache -Loss of appetite -Shortness of breath Swelling of face; tightness in chest and shortness of breath and difficulty talking (with the exception of the swelling of the COVID19 VACCINE JANSSEN 0 days 1079028-1 face, these are typical of my reactive airway) Treatment: Benedryl, albuteral, Outcome: Swelling has gone down, breathing is somewhat better 3/6/2021 9:30 pm - nausea 10:00 pm - chills and muscle spasms in stomach and legs and headache 10:30 pm - body aches and 99.2 fever and headache 3/7/2021 5:30 am - 100.1 fever and intense muscle soreness in neck, shoulders, arms, and COVID19 VACCINE JANSSEN 0 days 1079044-1 lower back and headache 8:30 am - 98.9 fever and intense headache 10:30 am - intense headache and muscle soreness near injection sit COVID19 VACCINE JANSSEN 0 days 1079080-1 fever, chills, muscles weakness, running nose Immediate post vaccine: injection site soreness (mild), still present at time of event reporting (42hrs post vaccine) Approx 6hrs post vaccine: uncontrollable, full-body muscle tremors and chills. Came in waves lasting 15-45 seconds each, with rest periods of 30 seconds-2min. Overall, this event lasted approximately 1 hour. 9hrs post vaccine: patient was awoken around 3am with an increased resting heart rate of 100 bpm. Patient's normal resting heart rate is approx 76. Increased heart rate persisted until 18hrs post vaccine, at which point heart rate began to gradually return to normal. COVID19 VACCINE JANSSEN 0 days 1079081-1 Normal resting heart rate returned about 26hrs post vaccine 9hrs post vaccine: acute joint discomfort, primarily in hips. Resolved around 17hrs post vaccine after patient took ibuprofen Unknown start time: Fever of 101.4. Patient took temperature 16hrs post vaccine and took ibuprofen at this time. Body temp went down gradually, returning to normal approx 20hrs post vaccine 16hrs post vaccine: general fatigue. Unknown if reason is solely vaccine or combination of vaccine and lack of sleep due to adverse events. Continued until patient slept from 28-40hrs post vaccine. Janssen COVID-19 Vaccine EUA Headache (mild) starting at 1:45 pm 3/6/21, became moderate at 7:00 pm, lasting until COVID19 VACCINE JANSSEN 0 days 1079104-1 ~11:30 pm Chills (severe) starting around 7:00 pm, lasting until 10 pm Palpitations starting around 9 pm, lasting until 11:45 pm Mild injection site pain starting 1:30 pm, still occuring (12:15 pm on 3/7/21) I couldn't sleep, I was very tired but I couldn't sleep. My head was throbbing , felt like it would burst. My blood COVID19 VACCINE JANSSEN 0 days 1079116-1 pressure went up to 170/93. Ached all over rest of body. Adverse reaction came on rather suddenly around 6 PM, eight hours after injection and progressed rapidly lasting almost 48 hrs. Started with mild bodyaches that within an our became moderate, followed by moderate chills, mild headache COVID19 VACCINE JANSSEN 0 days 1079127-1 that came and went over the 48 hours, moderate fatigue, and extremely sore at injection site but no visible redness or bruising. I did have a fever with the onset of the other symptoms. It started at 99.8 and then over the next 48 hours would fluctuate as high as 100.9 but never dropping below 99.8. Person received the Covid vaccine at 9:50 am and within 1 minute after the injections, patient appeared confused and was shanking, had a 2 convulsions while sitting in the chair that lasted 1 second each. Patient stated "" I don't know where I am"". Patient lowered to the ground, face mask removed. Patient systolic blood pressure was 110 during the COVID19 VACCINE JANSSEN 0 days 1079129-1 episode with HR 56, pulse O2 98% room air. After approximately 4-5 minutes patients stated ""I'm feeling ok now"" is alert and oriented to self, place and time. Dr. assisted the patient, orange juice given to the patient. At 10:30am patient back to her baseline, no distress noted and discharged home, no distress at the discharge time."" I had a 101 fever by 3:00 p.m. that would not go down with fever reducing meds. I had aching joints and lethargy. I had COVID19 VACCINE JANSSEN 0 days 1079131-1 chills and headache. My fever broke around 8:00 p.m. and as of this morning I'm better. It's totally worth it but I was told to report if we have any side effects so that data can be collected Fever of 104, heart rate in 160's, rigor, severe back pain. 911 called and ambulance brought to Hospital at 1am. Took 3 COVID19 VACCINE JANSSEN 0 days 1079139-1 bags of fluids, Ativan, Tylenol and Toradol to get the heart to the 110's over the 3 hours there. It is now 12:30 on the following day (3/7) and the fever, shakes, and elevated heart is starting up again but not to the extreme of last night COVID19 VACCINE JANSSEN 0 days 1079150-1 Headache, nausea, bodyaches, chills. Tylenol At least 24 hours Vaccine administered 10:15am. Got a headache and mild nausea 12:15pm (2 hours later). 5:15pm (7 hours later) started to shake violently. Couldn't walk was shaking so much. Speaking was difficult. Breath was labored. It was so scary my husband called the doctor. Shook violently with teeth chattering for 45 minutes then would break for a few minutes COVID19 VACCINE JANSSEN 0 days 1079175-1 before shaking again. The shaking was probably 60 minutes total. Then fever set in. Fever hit 102.4 at 6:15pm. 102.9 at 6:40pm. 103.8 at 8:15pm. Fever ranged between 102.3 and 103.8 for 8 hours after starting then finally broke 1:45am (8 1/2 hours after the shaking started). Was able to get out of bed 8:00am today. Massive headache for the morning but no fever today. 26 1/2 hours post vaccine new and I just feel very tired and drained. COVID19 VACCINE JANSSEN 0 days 1079203-1 Headache,muscle ache,fatigue, chills Body aches, chills, 101 fever overnight. Treated with Tylenol. The next day a lump appeared under the vaccinated arm (in COVID19 VACCINE JANSSEN 0 days 1079204-1 the armpit), which is tender. Vaccine site is very sore when arm is moved. Now it?s day 3 and the vaccine site is still sore and the lump in armpit is still there. COVID19 VACCINE JANSSEN 0 days 1079211-1 102 degree fever Chills Headache Took three doses of Tylenol over 16 hrs; symptoms subsided with Tylenol and time COVID19 VACCINE JANSSEN 0 days 1079220-1 Facial numbness on right side Extremely sore joints in the neck, arms, hands, legs, feet Headache Fever I got severe chills where after a warm shower put on pajamas pants and a long sleeved top, got under my cotton COVID19 VACCINE JANSSEN 0 days 1079228-1 blanket, level 4 down blanket, and heating pad on high and I was still shivering. my daughter brought me socks and i put on a cashmere sweater. my other daughter brought me two fleece blankets. Also, I had a severe headache. COVID19 VACCINE JANSSEN 0 days 1079238-1 nuseau, dizziness, red blotch on right side of face pain in the injection site, fever 103 (started at about 3 PM 03/06/2021 from 99F, then increased to 100, 102, 103 by COVID19 VACCINE JANSSEN 0 days 1079239-1 midnight, decreased to 99 at 2 AM on 03/7/2021), chills, headache, weakness COVID19 VACCINE JANSSEN 0 days 1079305-1 Fever 102 degrees 12 hrs after injection lasting 8 or so hrs. 34 hrs later dizziness and fainting lasting a short while. Patient reports bad chills, shaking, headache, but no fever starting 7 hours post administration of COVID-19 vaccine. COVID19 VACCINE JANSSEN 0 days 1079309-1 Symptoms resolved within 36 hours. Patient had new onset of nausea/diarrhea 48 hours post administration. Patient advised to hydrate and monitor GI symptoms, and call provider if symptoms last more than 24 hours. Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Loss of feeling COVID19 VACCINE JANSSEN 0 days 1079319-1 on finger for 30 minutes-Medium, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild COVID19 VACCINE JANSSEN 0 days 1079351-1 headache, stiff muscles and joints, chills, high fever, nausea, exhaustion Mild to moderate body aches begin approximately 6 hours after injection. At around 12 hours chills, headache, and body COVID19 VACCINE JANSSEN 0 days 1079353-1 aches severe in nature with fever of 100.8. Bed ridden from the 12 hour mark until 27 hour mark. Symptoms gradually subside until gone the morning of 03/07/21. Extreme fatigue starting around 2/3pm Upon waking from sleep around 7pm extreme chills and muscle aches had set in. Fever reached 102 around 10pm. Terrible sleep through the night, jittery and painful Woke to less severe chills, body COVID19 VACCINE JANSSEN 0 days 1079371-1 aches and migraine. Lymph node tenderness. Fever of 100 Symptoms have not improved as of 1:30pm the next day following my injection.

COVID19 VACCINE JANSSEN 0 days 1079380-1 I noticed aching in my legs and 3 hours later I woke up and it was worse. I also had chills and shaking, a slight headache, and mild nausea. This continued into the next day (March 7, 2021). It was significantly better by mid-afternoon. Janssen COVID-19 Vaccine EUA. Gradual headache late afternoon, followed by neck ache, then muscle aches, Horrible chills and shakes, nausea and throwing up. Muscle aches continued throughout the night and into the morning. Left with COVID19 VACCINE JANSSEN 0 days 1079410-1 some muscle aches, stuffy head today. Tylenol did not help in the evening, so switched to Advil at midnight and that started to help. Individual responded to waiting parking lot. Patient c/o sensation of facial swelling and heart racing. Denied other complaints. 1500 B/P 110/80. HR 140 Resp 12. 1503 Pt states she felt heart rate slowing down. No further feeling of swelling in face, throat, or elsewhere. 1505 HR 128. 1510 Patient talking and breathing without difficulty. Advised to COVID19 VACCINE JANSSEN 0 days 1079411-1 seek medical attention if s/s worsen. 3/5/2021 @ 1040 employee f/u with patient with phone call. Patient reported that after leaving the site, she felt HR increasing. Went to ED and was monitored for two hours. Systolic pressure there was 161. HR was in 140s. No interventions by ED after monitor. States is fine today. I received the vaccine at a Department of Health vaccine clinic at the Hospital. About 25 minutes after receiving the Janssen vaccine, my face became flushed (red) and I felt weak. We were in the hospital parking lot and drove to that COVID19 VACCINE JANSSEN 0 days 1079425-1 hospital's emergency room, where I was evaluated. After several tests (item 18) I was declared okay and left after 3 hours with no further intervention. I probably should have taken a Benadryl (diphenhydramine) after the shot to prevent such a reaction. COVID19 VACCINE JANSSEN 0 days 1079466-1 Fever, chills, headache, body aches, tiredness COVID19 VACCINE JANSSEN 0 days 1079487-1 lightheaded, blackout, overheating, fever, chills, headache, stiff neck, muscle soreness, fatigue COVID19 VACCINE JANSSEN 0 days 1079500-1 itching, hives, redness, dizzy Dull lingering headache lasted approximately 30 hours. fatigue; slept for over 12 hours. Severe body / joint pain that started in mid back and spread to rest of body. Worst pain was focused in lower back, hips, knees and ankles. Climbing COVID19 VACCINE JANSSEN 0 days 1079512-1 stairs was difficult. Facility nurse said my face was flushed but I had no fever. Symptoms were 90% gone shortly after headache subsided. I did need to call off of work on 03/07/2021. I had an cold burning sensation on the top of my left fingers around 7:15pm. Around 7:50 I had uncontrollable chills that lasted throughout the night along with a fever of 102.7. On 3/6/2021 I was exhausted and had muscle soreness. I had no COVID19 VACCINE JANSSEN 0 days 1079525-1 appetite and my food tasted funny. I could only work for half my shift. I slept most of the day . On 3/7/2021 I am still very tired and achy. Fever (99.3), nausea, diarrhea, fatigue, body aches. Symptoms other than fever began around 12:30pm on 3/7/21. Fever COVID19 VACCINE JANSSEN 0 days 1079532-1 began at 3:30 pm on 3/7/21. 1:30pm Slight Headache started and slowly got worse 2:30pm Muscle Aches started. Especially in my lower back. COVID19 VACCINE JANSSEN 0 days 1079579-1 3:00pmTook temperature-100 There is no swelling on my arm, just a little achey Took 2 xtra strength Acetaminophen @3:30pm 500 mg each It is now 4:30 and I still feel symptoms but they are not as bad. - severe body aches - high fever (102.6 peak before taking Tylenol) - headaches - tingly sensation in skin - muscle COVID19 VACCINE JANSSEN 0 days 1079595-1 soreness COVID19 VACCINE JANSSEN 0 days 1079605-1 Within 5 minutes felt dizzy, got very hot, face went pale, and had a fast heart beat Foggy/dizzy almost immediately following vaccination, sever chills that lasted for hours overnight, fever of 102.1 COVID19 VACCINE JANSSEN 0 days 1079606-1 (brought down with Tylenol, it remained at or a over 100 for 8 more hours), nausea, headache All symptoms started about 7 hours after injection: Severe chills and shaking (lasted approximately 3 hrs) Bad headache COVID19 VACCINE JANSSEN 0 days 1079614-1 (lasted 24 hrs) Exhaustion (lasted 24 hrs) All adverse symptoms gone after 36 Hours from injection. 7:30pm unusual restlessness in both legs; by 8:30pm dull constant pain increased, legs were weak, knees wobbly, hands shaking. Pain in legs became intense; I could not sit on the toilet. Went to emergency room of Hospital at 9pm; no COVID19 VACCINE JANSSEN 0 days 1079633-1 medications given. Pain calmed by 10pm, but sensation in legs returned at 11pm and continued until discharge at 1:15am on 3/6. Took Tylenol PM at home for moderate pain in legs and went to bed. Awakened next morning to no pain, had breakfast and went back to bed until noon. Feeling fine since that time. COVID19 VACCINE JANSSEN 0 days 1079655-1 Face, neck, and ears became flushed within 5 minutes of the injection. Remained red for approximately one hour. COVID19 VACCINE JANSSEN 0 days 1079666-1 Headache, extreme fatigue, diarhea have been extremely fatigued, headaches, muscle aches, swelling in my fingers (joints), weak, dizzy, weird feeling in my COVID19 VACCINE JANSSEN 0 days 1079708-1 chest Immediately began to feel a headache, dizzy and nauseated. The doctor on site had me lie down on the floor. Was starting to feel better so was able to sit up in a chair for about 15 minutes. Another wave of dizziness and nausea came over and was lying on the floor again. It was hard to breathe, but oxygen and HR were good. The doctor tried to give me juice to see if it was my blood sugar going low, but afterward, I still felt dizzy and nauseated. It was still hard to breathe. COVID19 VACCINE JANSSEN 0 days 1079710-1 It felt like something was sitting on my chest. BP was elevated, oxygen levels were good, HR was good but I started to get a cold chill where my teeth were chattering. At that point (about 45 min to an hour) the symptoms had not gone away and the ambulance was called. Was transported to the local hospital where I received a liter of saline and Zofran for nausea. BP was high, but oxygen levels and HR were good. The heart monitor showed no signs of arrhythmia or tachycardia so I was discharged. The doctor believes it was a side effect and not an allergic reaction. COVID19 VACCINE JANSSEN 0 days 1079763-1 Very bad pain in the tailbone, unsure if muscle or joint pain COVID19 VACCINE JANSSEN 0 days 1079787-1 Fever Body aches Chills Lasted for 24 hours following vaccine

COVID19 VACCINE JANSSEN 0 days 1079789-1 Fever: 102.3 last night Aches: all over Headache Fever 101.1 this evening and continued headache and general malaise. Within 4 hours: extreme fatigue, headache, loose stools continued until 8am 3/7/2021. Itching all over body, without COVID19 VACCINE JANSSEN 0 days 1079796-1 hives, from 2pm 3/7/2021 until 6:45pm 3/7/2021 - unsure itching is over. COVID19 VACCINE JANSSEN 0 days 1079797-1 Face swelling Face and lip tingling Dizziness and weakness My eyes swelled shut for two days is extremely painful now the inside of my eye is so red you can't tell what color my COVID19 VACCINE JANSSEN 0 days 1079802-1 eyes are and they are painful and super sensitive to any light Fast heartbeat and moderate to severe dizziness began at 3:30 PM on March 6. Fast heartbeat slowed considerably COVID19 VACCINE JANSSEN 0 days 1079821-1 after 10:30 pm. Dizziness is mild to moderate as of 5:00 pm March 7. I am reporting this simply because it said we should make you aware of adverse events with the vaccine. After she got the vaccine, she felt dizzy, nauseated and about to faint, her finger was rigid and unable to extend on her COVID19 VACCINE JANSSEN 0 days 1079851-1 left hand (where she got her vaccines on) Jansen COVID-19 Vaccine EUA I got strange sensations in the back of my neck, then later on in the day I have numbness in the back of my neck and some fin the upper back and shoulders. Don't know how much more will go numb and how COVID19 VACCINE JANSSEN 0 days 1079878-1 bad it will get. But I can feel the back of my neck and shoulders and upper back, but it is like there is a layer in between that is numb. COVID19 VACCINE JANSSEN 0 days 1079914-1 Janssen COVID-19 Vaccine EUA. Joint and muscle soreness for approximately six hours. Fever, chills, dry sore throat, headache, body and joint pain, nausea starting 5 hours after vaccination and lasting at COVID19 VACCINE JANSSEN 0 days 1079917-1 least 12 hours Female 50y/o Drove (4 hour drive) with her husband and son. She only ate breakfast and some snacks. Received vaccine at approx. 3:30 pm. She did have a fear of injections but said she was extremely happy because she hardly felt any pain from the injection. Shortly after sitting down for observation she began to feel extremely dizzy. observed her condition and immediately attended to her. Fanning her to give her air and allowing her to lay her head back. informed of the COVID19 VACCINE JANSSEN 0 days 1079930-1 need for someone to assist. After 15 minutes of the woman still not feeling better we decided to call for paramedics. Paramedics arrived in 10 minute took vitals. Glucose 132. O2 sat 100%. BP 120/80. Vitals were all good but patient still extremely nauseous and dizzy. Emt's administered oxygen and ice pack to neck. Woman began to become more alert and was responding better to questions. Due to her positive vitals the emts felt comfortable about leaving her after 15 minutes of oxygen treatment. Her husband and son walked her out. Slight fever began around 4:30pm and I took Tylenol Had chills for about a half hour Around 5pm, I noticed my heart rate was elevated (avg. of 110) and I could feel palpitations while resting Felt well enough to eat dinner at 6pm I kept tracking heart rate and it continued to increase while at rest for prolonged period (120+) When it got into the 130s, COVID19 VACCINE JANSSEN 0 days 1079934-1 went to the ER (around 7:45pm) to check for atrial fibrillation as I was still feeling palpitations Upon arrival, my heart rate was in the 150's. Was given IV fluids and IV metoprolol tartrate Heart rate came down to 120's While at the ER, I began to feel much worse Extremely nauseous and had chills Was barely Temperature reached 104.5 (rectal) around 10:00pm Given acetaminophen at 10:19pm Temperature came down Chills went away I was discharged around 12:00am During 15-minute observation period, patient said he was thirsty and want to get a bottle of water. Atfer getting water, patient felt dizziness and was about to faint. We called 911 and monitored him until EMT team came. Patient was still COVID19 VACCINE JANSSEN 0 days 1079977-1 conscious and said he felt dizzy, sweating due to potential low blood sugar and asked for a sip of gatorade. Then he started felling better after that and he said it happened before during his MRI and other procedure. EMT team accessed his vital signs and symptoms inside their vehicle and finally released him home. His family took him home Onset approximately 12 hours p vaccination. Low grade temp. 99.4 ¶ (normal baseline 97.3) Chills (mild to moderate) COVID19 VACCINE JANSSEN 0 days 1079994-1 Headache (mild to moderate) Neuralgia (mild to moderate) Tinnitus (moderate) Muscle aches (moderate) Site tenderness (mild) Cough (intermittent) Low grade fever and fatigue started around 7:30pm followed by severe chills. Woke up the next morning around 8am COVID19 VACCINE JANSSEN 0 days 1080050-1 with headache that went away after a couple hours. Felt great the rest of the day with slight soreness at the injection site. COVID19 VACCINE JANSSEN 0 days 1080056-1 Severe shivering, muscle and joint pain, head ache, fever of 103.4 F Janssen COVID-19 Vaccine EUA 101 degree Fahrenheit fever, shaking from chills, nauseous, headache. Injection occurred COVID19 VACCINE JANSSEN 0 days 1080074-1 9:40am. Symptoms began 6 hours after injection (4:00 pm). Got better with some Tylenol. Symptoms came back just as bad 5 hours later (9:00pm). Took more Tylenol at 9:30 pm. Dizzy, run down two hours after injection. Woke up 4 am then off and on with extreme body pain, sore neck , lower back, right hand and arm. Headache and fatigue at 6:45 am got up with two children (2 yrs and 10 months) ate small breakfast by 9 am I couldn?t get off the couch or stay awake. My head started aching and my eyes hurt, I felt extreme chills two thick blankets weren?t enough to warm me. Extreme fatigue, stomach pain and loss of appetite. I fell asleep and didnt have the energy to walk to my bed until 2:30 pm. It set off my stomach and I was vomiting off and on until around 9 pm. COVID19 VACCINE JANSSEN 0 days 1080231-1 By then I could keep little bits of fluid and food down. Then I was hot. I felt flushed but had no fever. My usual heart rate is 52-54 bpm via Watch while laying down. My heart rate during this hot period laying in bed was 102 -101 bpm. Which is consistent for my workout heart rate. I went to sleep and woke up 7 am with my kids and was well enough to take care of them but not do all my usual chores. I couldn?t bend down or put my head lower than chest or the extreme throbbing headache was back. Still had body aches and fatigue but nowhere near yesterday. It is 11:22 pm Sunday and I feel spent. 5 hours after injection I came down with intense chills and a high fever (between 102 and 105) which lasted all night and COVID19 VACCINE JANSSEN 0 days 1080244-1 all day the following day. Fever did not break all through the night, despite taking multiple ibuprofen. COVID19 VACCINE JANSSEN 0 days 1080249-1 Chills, fever, whole body aches, headache, nausea COVID19 VACCINE JANSSEN 0 days 1080267-1 Itching of tongue Vaccinated at approx 1300 hrs. I began feeling chilled 6 hours later. Chills continued for hours. I developed a significant headache. Also experienced some body aches. Took my temperature via oral thermometer at 10:00 PM and it was COVID19 VACCINE JANSSEN 0 days 1080268-1 101.5. Went to bed at approx 11:00 PM wearing all my clothes and under a quilt and two wool blankets. Chills continued, but then I also began sweating profusely. I did not rest well and was up approx every hour drinking water and urinating. I noticed an elevated heart rate for several hours through the night. cont'd below Chills hit me suddenly 6hrs after getting the shot. I was freezing. Two hours later, extremely tired and sore. I feel groggy. COVID19 VACCINE JANSSEN 0 days 1080280-1 3hrs later, I cannot sleep although I am so tired. Chugged water and took a hot bath but was so tired had to get out of bath. Zero appetite.

COVID19 VACCINE JANSSEN 0 days 1080281-1 8 hours after vaccination I got headache, fever (101), fatigue and body aches. Woke up in the middle of the night with headache and slight nausea. The next morning and through the day/ night had some joint pain and extremely tired. COVID19 VACCINE JANSSEN 0 days 1080291-1 Soreness, shivering/shaking and fever of nearly 103 degrees began around 7:30 pm , followed by significant sweating. I first noticed that I was extremely cold and could not get warm at about 11 pm on the evening of my vaccine. I then realized it was getting worse, and I was shivering uncontrollably despite sitting in front of a space heater in warm clothing and wrapped in a blanket. I checked for a fever, but my temp was only 99. I fell asleep around 1 am, and woke COVID19 VACCINE JANSSEN 0 days 1080315-1 up at 5 am (3/8/21) to a splitting headache, extreme thirst, slight nasal congestion, muscle soreness, fatigue, and nausea. These symptoms feel almost identical to the symptoms I experienced when I contracted COVID-19 in September 2020 at my university. 5 hours after the vaccine, I started having a sore arm at the injection sight and a low grade fever of 100.0 with chills and I was uncontrollably shaking. I took ibuprofen at 8:00pm. That night at about 9:00 my fever was 100.8 and I felt extreme fatigue. I woke up at 3:30am feeling both extremely hot and cold with a bad headache and my temperature was 101.5. I COVID19 VACCINE JANSSEN 0 days 1080316-1 took ibuprofen again at 3:30am. I then woke up at 5:15 am with a horrible headache and was very hot and sweating. I put cold compresses on my forehead and back of my neck which helped. The entire night, my arm with the injection site was very painful and stiff to move. I took the vaccine around 8:15 am at Hospital. They had a special event for Employees. After I was home I felt extremely tired and that improved after i laid down for a bit. However, around 7 PM I became very cold and had a temperature of COVID19 VACCINE JANSSEN 0 days 1080359-1 100.3 with chills/shakes. It has lasted into the next day with chills being on and off. I experienced muscle cramps as well has some chest discomfort. about 7 hours after receiving the vaccine, I developed strong muscle and joint pain, fatigue, and a fever. Overnight the COVID19 VACCINE JANSSEN 0 days 1080360-1 fever got worse and I developed a headache. I also felt tired. A hot shower and some Advil about 24 hours after the vaccine helped. Within 24 hours of symptom onset, they were better/gone. COVID19 VACCINE JANSSEN 0 days 1080361-1 Extreme fatigue, chills but not a fever, joints very achy, headache, nausea Patient had a syncopal episode post vaccination with brief unresponsiveness lasting about 5-10 seconds . At time of episode pallor and diaphoresis was noted and right after brief LOC he became AXOx3. The patient was placed in the Trendelenburg position while being evaluated by EMS:- Vitals: B/P 99/58 HR: 60 RR20 O2sat 98%. Blood glucose 132. COVID19 VACCINE JANSSEN 0 days 1080362-1 Hospital transfer was recommended but the patient refused. Oral fluids were administered and repeat vitals showed improvement in BP to 104/68. Patient ambulated without assistance and reported a return to baseline. Signed to go home against medical advise. Encouraged to seek medical attention if symptoms returned and see PCP. Left in the company of his spouse mild fever and headache starting approximately 6 hours after injection. 100.4F by digital no-touch thermometer COVID19 VACCINE JANSSEN 0 days 1080370-1 acquired in ear. Fever gone after 12 hours. Headache gone after 18hours with 400mg Advil taken 18 hours after start of fever.

COVID19 VACCINE JANSSEN 0 days 1080389-1 Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild Fever, chills, headache, body aches came on on suddenly at 11pm. Took ibuprofen at 5 a.m. Fever and chills gone by COVID19 VACCINE JANSSEN 0 days 1080391-1 7a.m. Then felt low energy, tired on 3/6 fine by 6 p.m. Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Additional COVID19 VACCINE JANSSEN 0 days 1080393-1 Details: patient bp was recorded as 85/75mmhg at the time patient felt light headednes. rechecked again after 15 minutes and pt felt better and bp recorded-120/79mmhg Started with a fever - that began about 6 hrs after the injection. That lasted a little more than 24 hours, then went COVID19 VACCINE JANSSEN 0 days 1080394-1 away. Last night - about 55 hrs after that vaccine, I have developed an itching rash over most of my body - I still have it as of this morning. Also, slight swelling of my lips COVID19 VACCINE JANSSEN 0 days 1080396-1 Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe Site: Swelling at Injection Site-Mild, Additional Details: After giving the vaccination, patient developed immediate reaction at injection site: warmth, swelling at the site. He did bleed a little and after putting on the bandaid, I went to COVID19 VACCINE JANSSEN 0 days 1080398-1 grab an ice pack and I started applying the icepack to the site. Checked on patient every 5 minutes. Even did a follow up call to him an hour later and he told me he was doing okay. No more warmth in the area, some pain but the swelling had gone down substantially. I suggested to continue to monitor, apply icepack Overnight on the 6th - muscle aches, chills, fever, headache, weakness. Starting on Sunday morning the 7th - bad nausea COVID19 VACCINE JANSSEN 0 days 1080399-1 all day with vomiting for 12 hours. Barely able to have an ice chip. Janssen COVID-19 Vaccine EUA Headache and body aches 10pm. High fever to 102 by 1pm with severe head and body aches, shivering, dizziness, unsteadiness. Tried drinking water, resting. Rapid heart beat at 120bpm. Couldn't sleep, so COVID19 VACCINE JANSSEN 0 days 1080401-1 woke parent at 5:45a. Tylenol acquired from pharmacy and given at 6:30am. By 7:30a, fever under 101, HR 107 bpm. Severe headache and body aches persist. Injection site soreness and generally feeling awful. Continuing to hydrate with electrolyte water and plain water. Slight nausea about 4 hours after dose Fever with chills about 8 hours after dose. Very thirsty. Lasted 12 hours General COVID19 VACCINE JANSSEN 0 days 1080408-1 unwell feeling from about 12 to 36 hours after dose I received my shot at 3:30 pm on Friday 3/5/21. Around 9 pm I started experiencing extreme body aches all over that felt like my body was ""fighting"" against itself. I also experienced chills. I had a hard time sleeping from the pain. The next morning a headache started and progressed into a migraine. I could not get up or open my eyes from how bad the COVID19 VACCINE JANSSEN 0 days 1080410-1 migraine was. I took extra strength Tylenol for the pain with little relief. On Saturday evening the symptoms started to get better and turned more into a headache. I still had the headache on Sunday but it was better after taking the Tylenol. On Monday my arm is now sore (it wasn't sore prior)."" COVID19 VACCINE JANSSEN 0 days 1080414-1 Difficulty breathing High level anxiety Chills then sweats COVID19 VACCINE JANSSEN 0 days 1080419-1 101fever Chills Severe headache Vomiting COVID19 VACCINE JANSSEN 0 days 1080420-1 Chills, Cold Sweat, Nausea, Headache, Body Aches, Body/Skin burning, Thirst Approximately 8 hours later, sudden onset of extreme chills accompanied by aches and fatigue; subsided after taking COVID19 VACCINE JANSSEN 0 days 1080457-1 Tylenol. Next day, approximately 24 hours of fatigue, minor aches, headache, and fever. At 11pm I started feeling chills and was having cold sweats. Around 1 am I went to the next room to check my temperature and almost fainted. I sat on the floor and started vomiting. I kept gagging nonstop for several minutes. COVID19 VACCINE JANSSEN 0 days 1080459-1 During that time I urinated on myself, I felt strong stomach aches, headache, and my body felt extremely fatigued. I was dizzy and sweating. All these symptoms came back again a few minutes later. I do not remember how long everything lasted. I woke up the next day with a slightly upset stomach and headache. A few hours after I got the shot I had flu-like symptoms. Headache, fever, nausea, chills, and vomiting. About 12 hours later my flu-like symptoms went away but my headache turned into a migraine. I have no history of migraines. I have COVID19 VACCINE JANSSEN 0 days 1080463-1 been taking ibuprofen and tylenol but it has not been working. I currently still have the Migraine 48 hours after the shot. COVID19 VACCINE JANSSEN 0 days 1080464-1 Tingling started at fingertips felt it go thru my whole body to my toes. Severe headache, fever, chills, body/joint aches Day of shot Chills, shivering, muscle aches (back, neck), headache Next day - muscle aches and headache, fatigue- COVID19 VACCINE JANSSEN 0 days 1080476-1 responded to Tylenol and Ibuprofen Following day - shoulder and neck aches; chest tightness- using albuterol COVID19 VACCINE JANSSEN 0 days 1080479-1 Chills, pressure headache, body aches, low grade temp 8:00 p.m. symptoms came on suddenly; sore arm (still sore - three days now) low grade fever(two days) uncontrollable COVID19 VACCINE JANSSEN 0 days 1080484-1 shivers body aches headache (two days) fatigue (two days) heart racing Day 1: Chills, full body aches and cramps, headache, loss of apatite, nausea, dizziness, fatigue. Day 2: Full body aches, COVID19 VACCINE JANSSEN 0 days 1080493-1 headache, loss of appetite, fatigue, dizziness. Day 3: Fatigue, Localized aches. Started with chills at 8 pm on 03/06/21 that lasted until 4 pm on 03/07/21 even with staying in bed underneath two comforters. Temp got up to 102.3 at 230 pm on 03/07/21. Was alternating Tylenol with Advil every 4 hours starting at 8 COVID19 VACCINE JANSSEN 0 days 1080503-1 pm 03/06/21. Fever finally broke, temp down to 99 around 830 pm with sweats that resulted in a bed linen change. Temp at 7 am on 03/08/21 was 99.1. Severe chills, sweating, low grade fever, intense headache, and pain in the back of my neck. Vaccination was at 10am COVID19 VACCINE JANSSEN 0 days 1080517-1 and symptoms started at 7pm and lasted through the night. By 9am (23 hours later) all symptoms seem to be cleared leaving me very tired from lack of sleep. Headache, vomiting, body aches, muscle spasms, sweating, chills, extreme fatigue cannot stay awake more than an hour COVID19 VACCINE JANSSEN 0 days 1080519-1 all started about 7 hours after vaccine and are continuing still... almost 48 hrs post vaccine Janssen COVID-19 Vaccine EUA Severe headache, body aches, fatigue for more than 24 hours after vaccine. Feels COVID19 VACCINE JANSSEN 0 days 1080531-1 debilitating. Symptoms barely changed after taking 2 Advil pills. Janssen COVID-19 Vaccine EUA Uncontrollable Shakes, fever spiking between 100 and 104, throwing up, pounding COVID19 VACCINE JANSSEN 0 days 1080572-1 headache, aches throughout body I started getting fatigued and achy around 5 pm. By 6 pm I started to feel chilled and a fever began to form. By 6:30 or so I was shaking intensely and my fever was climbing quickly. By 8 pm I had a fever of 102.7 F. I took two Advil around 7 pm. My fever stayed that high for less than an hour, but it stayed at around 101.5 throughout the night. When I wok up at 6:30 it was still over 101. It took until early afternoon to go all the way back down to my normal temperature of 97.6 COVID19 VACCINE JANSSEN 0 days 1080608-1 (that has been my normal temperature throughout the pandemic). I had a pounding headache throughout the night (with a fever) and for most of the next day. Today, on the 3/8, I will have some joint and muscle achiness. The most intense aching was in my hips and low back. FYI, I am marking that I have recovered from my adverse reaction in the field below because I am considering the high fever and intense headache and bod aches to have been the adverse reaction. My mild aching right now would not have been worth reporting. Johnson and Johnson Janssen COVID-19 EUA vaccine At the time of the injection, the vaccine burned as it entered my arm. (I have never felt that burning sensation with any other vaccination that I have had in the past. Twenty minutes after the vaccination, I became lightheaded and dizzy. I could walk but I was wobbly. At one hour after the vaccination, I felt a sharp stabbing pain in the left side of my tongue and then the left side and only the left side of my tongue began to go numb. Within a couple of minutes, I realized that my left jaw was going numb, too. The numbness slowly but surely began to move up the left side of my face all the way to the top of my head. I had a sharp but brief headache on the left side of my head that subsided quickly but the numbness remained. I went home and talked to two people on the phone COVID19 VACCINE JANSSEN 0 days 1080627-1 for several hours because they wanted to be sure that I was OK. At two hours after the vaccination, my face was still numb but I could think and talk clearly, but I was clearing my throat and coughing a lot. At that point, I also realized that my whole left arm was a little numb and my fingers on my left hand were tingling. That numbness lasted about 20 minutes and then subsided. The facial numbness lasted for hours. I wasn't scared and I wasn't in pain but it was very strange. It felt a little bit like the after affects of dental anesthesia but it wasn't just in my mouth it was the whole left side of my face. I believe that this must have been an allergic reaction to one of the chemicals in the vaccine but I don't know which one. If you can tell me which chemical it might have been, I will avoid it in the future. "Janssen COVID-19 Vaccine EUA"" Joint pain, including shoulders, hips knees and ankles. Chills. Sweating during sleep. COVID19 VACCINE JANSSEN 0 days 1080634-1 Low grade fever. General body aches. Symptoms began approx 12 hours after dose was given and still persist approx 36 hours later. No doctor or hospital visit is required at this time."" COVID19 VACCINE JANSSEN 0 days 1080636-1 Severe pain, fever, hallucinations, dizziness, spasms loss of balance lasting until now ( 3/8) About 6 1/2 hours after receiving the vaccine, I began to feel really cold and began to have uncontrollable shivering and COVID19 VACCINE JANSSEN 0 days 1080675-1 shaking for 4 hours straight. A heating pad helped but continued after removing it. I also had a slight stomach ache. The next day, I felt i had less energy than normal, lethargic. COVID19 VACCINE JANSSEN 0 days 1080684-1 Fever, chills, headache, muscle and joint aches, fatigue COVID19 VACCINE JANSSEN 0 days 1080712-1 fever, headache, muscle aches, and feeling tired for 15 hours Friday , March 5 - Received shot at approx. 9:30am. 10:00 am feeling very tired. By 3:00pm feeling achy and feverish, 6pm full chills, headache, and fever and very achy. At 7:00pm took my temp. It was 100.4 degrees. I took 3 -200mg COVID19 VACCINE JANSSEN 0 days 1080738-1 Advil and went to bed. Saturday, March 6 - woke at 6:30am feeling washed out. By 8:00am was feeling a bit achy, took 3- 200mg Advil and by 10:00am was feeling much better. Symptoms were completely gone by noon and have not recurred since. COVID19 VACCINE JANSSEN 0 days 1080781-1 Heart rate over 100 bpm for 24 hours, dizziness, weakness headache started at approx 3pm, debilitating chills with uncontrolled shaking started at 4pm with low grade fever that COVID19 VACCINE JANSSEN 0 days 1080806-1 began to climb. Fever peaked at 104.8 and stayed there for approx 6 hours. Vomiting started around 7pm. Rapid hear rate for approx 4 hours. Pulse was over 120 beats for approx 2 hours with chest pain. Starting about 5 hours after injection, fatigue, followed by extreme headache, followed by chills and aches. Lasting about 24 hours, treated with extra strength tylenol. I couldn't sleep due to the chills, and muscle aches during the night so I COVID19 VACCINE JANSSEN 0 days 1080813-1 slept most of the next day until late afternoon. Kept taking Tylenol through the day and evening. Felt ok the following day. COVID19 VACCINE JANSSEN 0 days 1080843-1 Lanssen COVID-19 Vaccine EUA Headaches, muscle aches and fever COVID19 VACCINE JANSSEN 0 days 1080877-1 Severe flu like symptoms, Chills, fever, rapid beathing, body aches, headache, fatique for 1.5 days Very rapid heartbeat and ringing in ears. Heartbeat was elevated for approximately 8 hours. It has come back COVID19 VACCINE JANSSEN 0 days 1080891-1 periodically over the past 36 hours with ear ringing. Anxiety. Half hour after injection my throat felt tight and my OPPOSITE arm hurt. About 1:00 am I got so chilled I couldn't get warm, I did not take my temperature because my thermometer goes under my tongue and I was afraid I would break it COVID19 VACCINE JANSSEN 0 days 1080906-1 cause my teeth were chattering so bad. The next day I felt very weak and nauseous. Then I discovered I had a rash at the top of my legs. My left breast was very sore I felt like someone punched me. Today is Monday and I still have diarrhea. COVID19 VACCINE JANSSEN 0 days 1080925-1 Experienced light headedness and felt shaky few minutes after receiving the vaccine. BP 142/70 O2 sat - 100% COVID19 VACCINE JANSSEN 0 days 1080930-1 FEVER, CHILLS, HEADACE, FLU-LIKE SYMPTOMS FOR 18 HOURS AFTER VACCINATION Janssen COVID-19 Vaccine EUA fever of over 101¶F, dry cough, shortness of breath, chills, muscle aches, weakness, COVID19 VACCINE JANSSEN 0 days 1080951-1 headache Eight hours after the shot, I quickly became very chilled with total body aches and pains and extremely tired. My mouth became very dry. This lasted most of the night. The next morning approaching 24 hours after the shot, the initial side COVID19 VACCINE JANSSEN 0 days 1080963-1 effects were gone but I then had a headache and a bit of nausea. Again was extremely tired and pretty much rested all day. All side effects were gone the next day. I felt no need to call my healthcare provider and did not take any over the counter pain medication. COVID19 VACCINE JANSSEN 0 days 1080967-1 Fever onset approx 4 hours and have had high grade and low grade fevers since. Taking tylenol every 4-6 hours. COVID19 VACCINE JANSSEN 0 days 1080968-1 Feel cold, head ache, body ache COVID19 VACCINE JANSSEN 0 days 1080977-1 Rapid heart rate for several hours (about 10). Bad headache which is now a sinus headache on the right side. Chills, sweating, loss of appetite Slept for about 10-11 hours cold sweats throughout out the night and lingering feeling COVID19 VACCINE JANSSEN 0 days 1080980-1 afterwards COVID19 VACCINE JANSSEN 0 days 1080993-1 Severe shaking started at 11 PM and continued for over an hour. Including teeth shattering. Had a low grade fever also. Approximately 6 hours after vaccine, I had a headache, chills and body aches. These continued all night and got better the next morning when I took Ibuprofen. On Sunday morning, a little less than 48 hours after vaccine, I notice certain COVID19 VACCINE JANSSEN 0 days 1081050-1 parts of both arms were itchy. This morning, a little less than 72 hours after vaccine, I am experiencing an itchy rash in several places on my body including torso , knees and arms and legs. COVID19 VACCINE JANSSEN 0 days 1081060-1 Achy knees. sore arm, tired COVID19 VACCINE JANSSEN 0 days 1081067-1 Fever of 102, violent chills, aches, nausea fatigue. Minor chills Muscle aches tightness Throbbing joint pain in multiple areas. Exacerbated in areas where I already have COVID19 VACCINE JANSSEN 0 days 1081079-1 chronic joint/muscle pain Mid grade fever Severe headache All lasted for 36 hours Started with chills. I was freezing for almost three hours. I could not get warm-with tons of blankets, heater, heat cranked up. Then I was seating. I had a fever and am still fighting this fever. It was at 103 on Sat. It was 101 this COVID19 VACCINE JANSSEN 0 days 1081109-1 morning. I feel fluish-body aches, headache, eye sockets hurt, exhausted. On sat, after the chills, my legs hurt and felt like they were 100 pounds. COVID19 VACCINE JANSSEN 0 days 1081111-1 injection sight pain, fever, chills, body aches, exhaustion, migraine. Severe chills/uncontrollable shaking for 4 hours beginning 10 hours after the shot After chills ended - headache for 1 COVID19 VACCINE JANSSEN 0 days 1081122-1 hour, body fatigue for 6 hours Fatigue, chills, fever, body aches, nausea. Lasted approximately 12 hours. Treated with advil, fluids, and rest. Onset of COVID19 VACCINE JANSSEN 0 days 1081123-1 body aches and fever for second time about 36 hours after injection. Treated with advil. Severe chills, body ,muscle, joint aches, fever and sweats. Some stomach cramping . These all lasted 7 hours. Next day COVID19 VACCINE JANSSEN 0 days 1081133-1 still body aches, headache and fatigue. COVID19 VACCINE JANSSEN 0 days 1081142-1 tired, slight headache (back of the neck area) lasted about 36 hours Fever (100.2), lack of balance, body aches (mainly in legs), mild nausea, mild headache, brief period of incontinence, COVID19 VACCINE JANSSEN 0 days 1081144-1 fatigue COVID19 VACCINE JANSSEN 0 days 1081154-1 chills, fever, sweats, body aches, headache, injection site soreness - lasted about 24 hours COVID19 VACCINE JANSSEN 0 days 1081158-1 Chills, fever, achy legs, exhaustion Fever, chills, and vomiting the evening of the vaccine administration. Symptoms continued into the following evening. COVID19 VACCINE JANSSEN 0 days 1081160-1 Fever broke early morning of 3/8/2021 COVID19 VACCINE JANSSEN 0 days 1081228-1 Body aches, joint pain, fatigue, chills, throbbing, starting at 6:30pm and continuing into the following day Patient complaint of fatigue/(sleepy) and sensitive to light immediately 15 minutes after getting Janssen & Janssen COVID19 VACCINE JANSSEN 0 days 1081235-1 vaccine COVID19 VACCINE JANSSEN 0 days 1081238-1 Chills, fever, headache. Fever lasted until Monday, March 8th COVID19 VACCINE JANSSEN 0 days 1081245-1 fatigue 6 hours no treatment COVID19 VACCINE JANSSEN 0 days 1081249-1 Fever Night sweats Extreme chills and shaking Body aches Fatigue COVID19 VACCINE JANSSEN 0 days 1081295-1 Sore arm at sight of injection Nausea Headache Body aches Weakness Panic attacks No adverse side effects until 10:00 PM- chills began, fever until 2:30 AM, fever broke, then whole body aches with COVID19 VACCINE JANSSEN 0 days 1081301-1 intense headache, high level of fatigue- with advil and mucinex- symptoms subsided- unknown if they will return once medication wears off I got the COVID-19 vaccine on Saturday (janssen). I just wanted to let you know that I experience mid back pain after the covid vaccine was administer on my left arm. it felt like a sharp pain but only in my mid back area. by the evening i got chills and also a fever which i took tylenol, i felt nauseous, my head felt like it was not attached to my body, i havent COVID19 VACCINE JANSSEN 0 days 1081312-1 sleep anything in 2 days. I had a severe migraine and also vomiting but most of all is the spinning of y head like when people have vertigo. I havent been able to eat food because it comes out both ways, either i vomit or constant diarrhea. i made a call to my doctor waiting for her response. this symptos started around 6pm on 03/06/21 and still until today 03/08/21 Around 3:00pm on 3/7/21 I began to feel a little tired. But 3:45pm I was experiencing muscle pain through my body at only continued to get worse. At 4:30pm I took 400mg of ibuprofen since sitting, walking, and lying down were all painful. Relief came around 5:30pm and I was able to nap for an hour. At 6:30pm I awoke and attempted to eat, as I was beginning to feel nauseous. At 8:30pm I laid down again, my symptoms returning and worsening. I was now experiencing chills with my muscle pain and a headache. Pain was located throughout my body and my skin was sensitive to the touch. COVID19 VACCINE JANSSEN 0 days 1081321-1 At 10:30pm I began shaking violently and struggled to feel warm, despite my skill feeling hot. My temperature was not taken. Another 400mg of ibuprofen was taken and one 350mg chewable of Tums anti-acid was eaten. It was not until 12:30am that I was able to sleep again. The morning of 3/8/21 I was still fatigued and sore. Moving was difficult and painful and nausea was still present, and my headache returned. I was unable to eat despite trying. At 10:00am I took two tablets of Excedrin Migrain and napped for almost two hours. Currently, my muscle aches are minimal and my headache has improved. This may however be due to the medication. COVID19 VACCINE JANSSEN 0 days 1081412-1 Headache, body aches, chi.lls, fever, excessive tiredness, loss of appetite, injection site soreness COVID19 VACCINE JANSSEN 0 days 1081427-1 Chills, muscle aches, low grade fever, headache 45 minutes after receiving vaccine, patient experienced numbness of her upper posterior palate and down her throat. COVID19 VACCINE JANSSEN 0 days 1081432-1 This lasted about 4 hours and resolved without further treatment. No shortness of breath, rash or swelling noted per patient report. COVID19 VACCINE JANSSEN 0 days 1081509-1 Head aches, fever, fatigue, chills Sore arm immediately. Fatigue, headache, chills and sweats started the next day and into day 3 after the vaccine was COVID19 VACCINE JANSSEN 0 days 1081513-1 received. COVID19 VACCINE JANSSEN 0 days 1081518-1 Body aches and fatigue that evening, around 6pm. Symptoms still present next morning. COVID19 VACCINE JANSSEN 0 days 1081521-1 Chills, Injection site soreness, fatigue, (possible fever) did not record temperature, dizziness and headache. COVID19 VACCINE JANSSEN 0 days 1081529-1 horrendous headache. lasted the night of injection and 1/2 the following day. no treatment. COVID19 VACCINE JANSSEN 0 days 1081546-1 fever, chills, aches, lethargic, shortness of breath Got J&J vaccine Sunday and have experienced every side effect listed. Had 103 degree fever, took tylenol, drank water. COVID19 VACCINE JANSSEN 0 days 1081576-1 Fever broke @ 4am, still have excruciating headache, eyes hurt from the light, body aches, can't move right arm more than 90 degrees . Fever is now at 2pm 3/8 inching up, is 99.5. COVID19 VACCINE JANSSEN 0 days 1081607-1 Fatigue, back and muscle pain, low grade fever, chills, teeth chatter Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, COVID19 VACCINE JANSSEN 0 days 1081616-1 Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Severe COVID19 VACCINE JANSSEN 0 days 1081618-1 No adverse events reported, was instructed to complete VAERS form due to age 16 at time of vaccination. Symptoms included: Body aches Fatigue Chills Fever Headache Nausea Some diarrhea (mostly clear liquid) Runny nose COVID19 VACCINE JANSSEN 0 days 1081621-1 clear Some congestion Difficulty breathing - arrhythmia from 11pm to 4am night after vaccine administered Patient seemed to pass out. Reported fear of needles. Happened about 13 minutes after vaccine was administered. She wasn't responsive to voice for short time period with a blank stare. Once she snapped out of it, she jerked and then we COVID19 VACCINE JANSSEN 0 days 1081625-1 tried to make her more comfortable. EMS was contacted to verify patient was okay. Patient did not want to go to hospital or ER. Janssen COVID-19 Vaccine EUA Approximately six hours after administration of the vaccine, patient experienced sever chills and dizziness. Unable to stop shaking, patient took temperature which registered at 95.4F and then 95.1F at 15 minutes. Patient donned flannel pants, thermal shirt, and oversized hooded sweatshirt and got in bed under flannel sheets, two doubled-over blankets, a bedspread, and quilt. A down-filled king-size pillow was placed on top of patient's COVID19 VACCINE JANSSEN 0 days 1081937-1 torso and a space heater was turned on to highest setting. Patient reports heart seemed to be racing, but did not take BP. Unable to quell the chills, the patient continued to shake, developing very stiff shoulders, neck and back as a result. This continued until approximately 2 am. The next morning, patient's temperature was registering at 99.4F and pulse was 96, but patient did not report chills. General muscle aches and mild headache were noted. At time of this report, patient's temperature and pulse are normal (97.6F and 76 pulse). patient experienced racing heartbeat, heart pounding sound in ears, chest tightness without shortness of breath., and insomnia. She stated that the symptoms subsided by morning except her heartbeat was still a little elevated in the COVID19 VACCINE JANSSEN 0 days 1081981-1 morning. She did not do anything to treat the symptoms and did not seek medical advice. She contacted me to report her symptoms. COVID19 VACCINE JANSSEN 0 days 1081983-1 Fever, aches Saturday night: bad headache which started around 7pm and lasted the wholel night Sunday: headache persisted, then COVID19 VACCINE JANSSEN 0 days 1082003-1 ended around noon. Around noon became bloated and then by 5pm I had the runs and was using the bathroom for about 6 hours Patient stated she received her vaccine around 9:50 am and started having symptoms of fever, body aches, HA, chills and nausea around 3:50 pm that afternoon. States fever went as high as 106 degrees. She took tylenol initially for COVID19 VACCINE JANSSEN 0 days 1082068-1 symptoms. As fever continued to increase she called her PCP who told her to take tylenol and motrin at the same time and if temperature did not drop below 103 to report to her local hospital. States her temperature decreased to 102 the next morning on 3/6/21 and then all symptoms resided by afternoon on the 6th. COVID19 VACCINE JANSSEN 0 days 1082091-1 Complained facial redness five minutes after getting vaccine I received the vaccine at 9am on Saturday, March 6th. My arm was immediately very sore throughout the day. Around 9:30pm that night I began to feel nauseous. As the night progressed my symptoms got worse. I experienced intense chills and by 11pm had a 100 degree fever. Sunday, March 7th my fever had decreased, but I continued to feel nauseous and COVID19 VACCINE JANSSEN 0 days 1082095-1 have chills throughout the day. Additionally I felt extremely fatigued, weak, and had a throbbing headache. Completing simple tasks were difficult and exhausting. Monday, March 8th I continue to experience significant fatigue, headache, and muscle weakness, but at less intensity. Also, my right arm where I received the injection is very sore. I have also been somewhat dizzy today. I have been taking Advil, drinking fluids, using an ice pack, and resting as much as I can as part of the treatment. COVID19 VACCINE JANSSEN 0 days 1082099-1 REDDENED RASH/ITCHINESS TO FACE Janssen covid19 vaccine EUA. Beginning 8 hours after shot, experienced severe chills, head ache, body ache, nauseas and COVID19 VACCINE JANSSEN 0 days 1082122-1 fever which lasted about 18 hours. 7 hours post administration, patient had an anaphylactic reaction. she took liquid Benadryl, administered herself an EpiPen, used an albuterol inhaler and went to the er. Patient recovered while in the er and returned home. At pharmacy COVID19 VACCINE JANSSEN 0 days 1082127-1 on the day of the vaccination clinic, patient stayed in a waiting area 15 mins after getting the vaccine. The way our set up was in the store, patient was sitting next to a kiwi plant in the garden and plant area. she is allergic to kiwi. patient is not certain what caused the reaction. I got the vaccine on 3/6 around 2:45pm. My arm was sore immediately. Around 8:00pm I was cold and then that progressed to chills all night. By the morning of 3/7, I had a headache and my body was achy. At 7:00am, I had a 102 COVID19 VACCINE JANSSEN 0 days 1082139-1 degree fever which lasted all day. Body aches, headache and chills lasted all day 3/6. At 10:00pm 3/7 my fever was down to 99.9. I still had a dull headache and felt dizzy on the morning of 3/8. Fatigue through the afternoon of 3/8. Janssen COVID-19 Vaccine EUA I experienced headaches and body aches during the evening of the day I received my shot. COVID19 VACCINE JANSSEN 0 days 1082208-1 The body aches went away during the night, but the headaches have continued into today COVID19 VACCINE JANSSEN 0 days 1082251-1 Headache in the occipital area

Patient reported a tingling sensation in her throat/tongue within 5 mins of receiving vaccine. This lasted for less than 15 COVID19 VACCINE JANSSEN 0 days 1082256-1 minutes. Patient was still able to drink water normally and talk normally. She didn't feel her breathing was affected, although she noted she felt her heart was racing as she was becoming more anxious. No treatment was administered. Patient stayed approx 45 minutes after shot and reported she felt fine at the 45 minute mark and was able to leave. Severe chills and fever beginning approximately 8 hours after injection and lasting for 8 hours. The next day extreme COVID19 VACCINE JANSSEN 0 days 1082302-1 fatigue. Day after that moderate fatigue. Third day still fatigued. Mild headache all three days. Soreness at injection site. Diminished appetite. Facial swelling, Diffuse facial rash- 24 hours after vaccine administation Extreme fatigue- immediately following vaccine COVID19 VACCINE JANSSEN 0 days 1082310-1 x2 days Evaluated by PCP and given IM Benadryl and Decadron

COVID19 VACCINE JANSSEN 0 days 1082336-1 It was the Johnson and Johnson shot. Both my husband and I felt mild flu-like symptoms on the same day and yesterday. Today the site where the shot was on my arm is very red, puffy and hot. My flu like symptoms are still here, very mild 'AT APPROX 1007AM, PT C/O LIGHTHEADEDNESS AND DIZZINESS. PT WAS COLD, CLAMMY, PALE AND DIAPHORETIC. NURSE TOOK HER VITALS: B/P100/70, P 38 02 92% RA. PT STATES SHE DOES HAVE A 'PHOBIA OFNEEDLESAND WAS VERY NERVOUS ABOUT COMING TODAY' PT WAS BROUGHT INTO THE NURSERY ROOM WITH ASSISTANCE TO A COUCH. PT WAS INSTRUCTEDTO LAY FLAT. A MAKE SHIFT PILLOW WAS PLACED UNDERHER FEET TO ELEVATE HER LEGS. PT WAS ALERT AND ORIENTED X3. PT DENIES SHORTNESS OF BREATH, CHEST PAIN,OR HEADACHE. SITE OF INJECTIONWAS ASSESSED AS PT C/O A SORE ARM. ARM WAS W/O BRUISING OR SWELLING. PT WAS GIVEN WATER TO DRINK AND COVID19 VACCINE JANSSEN 0 days 1082357-1 STATED SHE WAS 'STARTING TO FEEL BETTER'. PT CONTINUED TO LAY FLAT FOR APPROX 40 MINUTES. PT VITALS WERE RETAKEN: 110/78 P68 PO2 98%RA. PT MOTEHR WAS CONTACTED BY A HOSPITAL VOLUNTEER TO INFORM HER OF WHAT OCCURED. PT STATED SHE FELT WELL ENOUGH TO LEAVE. PT INSTRUCTED IF CONDITION RETURNS ORSHE EXPERIENCES ANY SHORTNESS OF BREATH ORDIFFICULTYBREATHING TO CALL 911. pT WASABLE TO SIT UP WITHOUT DIFFICULTY OR ANY COMPLAINT OF DIZZINESS. PT AMBULATED TO HER VEHICLE WITH 2 PERSON FOR SAFETY. PT WAS DRIVENHOME BY A FRIEND/VOLUNTEER AT THE VACCINE CENTER. 1222: VOLUNTEER CALLED TO CHECK ON PATIENT STATUS, NO ADDITIONAL ISSUES REPORTED - 3/8/21 @ 1253 COVID19 VACCINE JANSSEN 0 days 1082367-1 Vaccine received at 12:30 Physical shakes/chills from 7-9 pm Woke up next morning with a splitting headache Adverse event: Vasovagal syncope , nausea 2 minutes after injection , treatment - supine leg elevation -- ice - water , COVID19 VACCINE JANSSEN 0 days 1082421-1 outcome : patient felt better after 15 minutes , left pharmacy observation after 30 minutes after injection About 7 hours after receiving the vaccination I had severe chills with shivering and could not get warm. I did not need COVID19 VACCINE JANSSEN 0 days 1082477-1 medical attention and was fine within 2 hours. COVID19 VACCINE JANSSEN 0 days 1082487-1 Fever, nausea, terrible headache Adverse Event: Vasovagal syncope 2- 3 minutes after injection , treatment: supine , legs raise, ice back of head , water COVID19 VACCINE JANSSEN 0 days 1082496-1 Outcomes: after 911 evaluation by EMT patient left the pharmacy COVID19 VACCINE JANSSEN 0 days 1082520-1 Reports slight muscle spasm on injection site My headache and nausea started around 10;00pm. By 11:00 I had chills and abdominal cramps as well. I had the headache and nausea throughout the night and into the morning, the chills and cramps stopped sometime during the COVID19 VACCINE JANSSEN 0 days 1082531-1 night. I took Tylenol at 11am. It helped the headache a little but the nausea continued. I took Tylenol again at 3:30pm and 9:30pm. Went to bed at 9:30 and slept until 5:00 am this morning. I still have a slight headache and a little nausea but feel much better today. COVID19 VACCINE JANSSEN 0 days 1082549-1 jaw start feeling tight , along tingling around lip areas, patient begin to have a wheezing cough COVID19 VACCINE JANSSEN 0 days 1082557-1 reports flushing and chills Seen and cleared by EMS Severe Chills, headache from 4:00 pm until 10:00. After that sweating, I was in bed from 4 until midnight. Today COVID19 VACCINE JANSSEN 0 days 1082583-1 03/08/2021 I feel much better, just a slight headache and a little nauseous. Complained of chills 10 minutes after vaccine administration. EMS checked blood sugar but machine could not read. It COVID19 VACCINE JANSSEN 0 days 1082586-1 was either too low or too high.. BP 219/89, EKG was unremarkable. Patient was advised by EMS and NP to be transported to ER but decline. Preferred to be transported to by the husband to PCP. Immediately after the shot was given on Saturday 3/6/21, I felt very nauseas. The nausea continued for the next two days. Body aches, headache, and chills set in same day, in the afternoon. I took Tylenol every 6-8 hours until Monday COVID19 VACCINE JANSSEN 0 days 1082601-1 3/8/21. Exhaustion, dizziness, and some shortness of breath occurred on Monday 3/8/21. Nausea, headache, and exhaustion is still ongoing but not as intense. feeling very tired (within 25 min), headache (within 3 hrs) worsened over the next several hours, muscle aches (within 8 hrs) worsened in time, fever (@100 dgs) with chills (within 8hrs), runny nose, watery eyes and dry mouth (within 8hrs), COVID19 VACCINE JANSSEN 0 days 1082606-1 sinus pain (dry) and loss of appetite Called advice line @ 7am on 3/7/21 to see if I could take Ibuprophen (yes) and that helped. All side effects subsided in @ 36 hours. COVID19 VACCINE JANSSEN 0 days 1082622-1 Dizziness, nausea, and light sensitivity chills, shaking, delirium I got progressively more cold and then i started shaking. when i got into bed i was thrashing COVID19 VACCINE JANSSEN 0 days 1082624-1 around for hours. COVID19 VACCINE JANSSEN 0 days 1082631-1 Abdominal cramping Vaginal bleeding COVID19 VACCINE JANSSEN 0 days 1082657-1 nausea, emesis, muscle aches, chills Had immunization at 11AM on 3/5/21. At 11PM chills started, by 11:30PM worst chills and teeth chattering. On 3/6/21 COVID19 VACCINE JANSSEN 0 days 1082713-1 at 3AM fever of 101.2, extremely hot. She felt tired and achy all day. In the evening on3/6/21 she had nausea and vomiting for a short time. On 3/7/21 she remained tired, sore and achy. Feeling better today on 3/8/21. Began having chills, fever spiked up to 100.7, muscle aches and pain, headache, night sweats. These symptoms lasted approximately 36 hours. Felt lethargic and fatigue for approximately 48 hours after the vaccine. Also had some menstrual COVID19 VACCINE JANSSEN 0 days 1082729-1 bleeding which was brief on 3/5/21, which was the date of the vaccine, and this was not expected. Alternated Tylenol and Ibuprofen after vaccine to help lower fever, and drank fluids. (Janssen COVID-19 vaccine EUA) Day of vaccine - soreness in shoulder at the site of the injection. Day 2 - continuing soreness of shoulder, along with general aches, chills, and sleepiness. Day 3 - continuing soreness in shoulder, but no COVID19 VACCINE JANSSEN 0 days 1082731-1 aches, chills, or sleepiness. Began feeling nauseous, but still had appetite. Day 4 - continuing soreness in shoulder, as well as nausea, but both are somewhat diminished. COVID19 VACCINE JANSSEN 0 days 1082746-1 10 minutes after injection, dizzy spell and vasovagal reaction. Diaphoretic, pulse rate 48, BP 107/71. COVID19 VACCINE JANSSEN 0 days 1082748-1 Fever, chills, aches, headache, exhaustion SOB, Lightheaded Ipratropium Bromide 0.5mg/2.5ml nebs treatment given on site by EMS Patient transported to ER COVID19 VACCINE JANSSEN 0 days 1082777-1 after treatment due to c/o SOB COVID19 VACCINE JANSSEN 0 days 1082798-1 Numbness and Tingling COVID19 VACCINE JANSSEN 0 days 1082805-1 Janssen COVID-19 Vaccine EUA - fatigue, body aches, fever (100.6), headache, chills COVID19 VACCINE JANSSEN 0 days 1082822-1 Severe cold and shivering. Severe light-headedness, fainted, body aches, headache COVID19 VACCINE JANSSEN 0 days 1082823-1 Heart palpitations and feeling flush, extreme feeling of being tired and slight chest discomfort COVID19 VACCINE JANSSEN 0 days 1082851-1 Fever, fatigue, nausea, muscle aches Reports he fainted for few minutes. History of same symptom to injection or venipuncture Refused to go to ER, refusal COVID19 VACCINE JANSSEN 0 days 1082989-1 form signed Approximately ten minutes following vaccination patient decided to check his blood pressure at the automated machine because he didn't feel well. Patient passed out sitting at the machine and lost control of his bladder. Patient's eyes were COVID19 VACCINE JANSSEN 0 days 1082997-1 open and he was making snoring noises. Upon checking pulse, it was faint. Patient was breathing. Team moved patient to lying position on the floor. Pulse became more prominent and patient woke up. EMS arrived and took patient to local hospital for precautionary testing. Patient discharge home 2 hours later. COVID19 VACCINE JANSSEN 0 days 1083005-1 Nausea seen and cleared by EMS COVID19 VACCINE JANSSEN 0 days 1083020-1 Tingling/numbness two middle fingers of same arm. Later had rash in same arm. 8 hours after getting the vaccine I started to get the chills and couldn't get warm. I took my temperature and it was 99.7. I wait a another hour and I still had the chills and started to have terrible body aches. I took my temperature again COVID19 VACCINE JANSSEN 0 days 1083022-1 and it was at 101.3. This stayed the same until the follow day (03/07/2021) My fever finally went down around 2pm. And the body aches stopped around 4pm. Patient received the Janssen Vaccine Covid-19 injection and immediately afterwards asked for a trash can. She COVID19 VACCINE JANSSEN 0 days 1083071-1 immediately passed out and fell forward. She hit her head on the wall and received a cut. We called the paramedics and she was transported to the emergency room at the local hospital. Fever of 101¶f. Joint pain, Fatigue, Muscle aches. Beginning about 10 hours after vaccination. Lasting about 16 hours. COVID19 VACCINE JANSSEN 0 days 1083099-1 Vomiting and diarrhea with fever of 99¶f about 60 hours after vaccination. On 3/7/2021 after I returned home, I ate broiled, skinless chicken, salad and small amount of corn at 5:00pm. I started having diarrhea about 5:30pm. Later in the evening around 8:30pm, I had more diarrhea. Around the same time I became very, very sleepy and had extreme fatigue. My right arm where I received the shot did not hurt and still does not hurt. Around 6:00pm, my left arm starting hurting in the same spot where I received the vaccine in the right arm. COVID19 VACCINE JANSSEN 0 days 1083129-1 On the morning of 3/8/2021, I ate breakfast consisting of whole wheat bread and peanut butter and weak coffee (my usual breakfast) and had diarrhea again soon after eating. At 3:30pm, I ate broiled, skinless chicken, green beans and small amount of instant mashed potatoes. Around 5:00pm, I had diarrhea again. I have been drinking a great deal of water on both 3/7/2021 and 3/8/2021 as I normally do every day. At 6:30pm, I had more diarrhea. Soon after, I took two imodium gelcaps and hoping they will help the diarrhea. My left arm has become increasingly more sore and hurts in the muscle. No other symptoms. COVID19 VACCINE JANSSEN 0 days 1083140-1 Redness and itching at injection site Severe joint pain in neck, shoulder, hipd, knees, ankles for 36 hours Janssen COVID-19 Vaccine EUA Chills, Bodyaches, Fever (102.6), Headache, Sweating, Dizzy, Nauseated, very tired. Fever started 4 hours after vaccine and broke the following day around 2pm. I continued to be nauseated, dizzy and have a COVID19 VACCINE JANSSEN 0 days 1083143-1 headache through Sunday March 7th and Monday ( today) I am still tired and have dizzy spells and nauseated off and on. I do feel like it is improving though. The first night was really rough. Full body aches, 101¶ Fever, severe headache by 2am 3/6/21; all symptoms continuing through the end of 3/7/21 COVID19 VACCINE JANSSEN 0 days 1083146-1 Resolving by 3/8/21 COVID19 VACCINE JANSSEN 0 days 1083148-1 Chills, severe headache, tired I received my vaccine this morning at 6:12AM and felt fine after. Around 7:45AM I started to feel slightly short of breathe, but figured it was just from the cold outside and my Asthma. The shortness of breathe feeling goes away. Later in the day sometime after 3 PM, I start to feel as if I am getting stuffy. I take a nap on the buss on my way home, and COVID19 VACCINE JANSSEN 0 days 1083158-1 when I wake up I suddenly feel like I am freezing and have chills all throughout my body. I get home and jump in a hot shower to warm up, but it did not help. I then heat up some food to eat dinner, and I go to drink some soda, and I notice I have no taste. I figured the soda was flat, but even flat soda has some taste to it. I then drink a Cherry Gatorade, and still no taste. Now I check my temperature and it is at 101.4, and I have a slight cough. patient stated she was fine after vaccine, then after a few minutes she stated she felt dizzy. before pharmacist could get back around counter to patient, she fainted and slid out of her chair. patient was alert moments after landing on the COVID19 VACCINE JANSSEN 0 days 1083182-1 floor. patient was laid out on floor and vitals monitored. once vitals returned to normal and patient felt better, she was given water and a banana. EMT arrived and evaluated patient. patient was taken to hospital per EMT suggestion. time frame: 17:26-17:52 The injection site is swollen with redness, very painful to touch and painful to move. There is also lingering pain after any COVID19 VACCINE JANSSEN 0 days 1083192-1 moment of the arm or anything touches the injection site. I also have some itchiness on the injection. The pain has gotten wores today (Monday 3/8) which is more than 72 hours after I received the vaccine Friday (3/5) morning. Extreme muscle aches, low grade temperature of 94¶, highest temp up to 99.7¶, extremely low energy. Next morning, COVID19 VACCINE JANSSEN 0 days 1083193-1 sore ears and throat. Temperature down to 95¶ on second day. Craving salt. Still extremely low energy, but aches are more mild. I first had chills and a low-grade fever with a migraine. That was around 5 PM that night. At around 9:00 PM I had chills, migraine, bodyaches, burning sensation in my joints, neck pain, and a low-grade fever. I took some Tylenol at around 7 PM. But the pain did not subside and I was able to use the bathroom the next day at around 4 AM and was still in severe COVID19 VACCINE JANSSEN 0 days 1083215-1 pain. That day at around 1 PM I was able to set up and felt 30% better. On day two I am feeling better but I still have minor body aches I do get fatigue while doing light work around the house and no appetite and loss of taste is the newest symptom. I am not 100 percent better but close to it. High Blood Pressure, Jaw Pain !0/10, headache, nausea, involuntary leg movement We are deeply concerned about COVID19 VACCINE JANSSEN 0 days 1083232-1 getting patient the care she needs. There is a lack of urgency on the part of the hospital staff in acknowledging a connection to her receipt of vaccine and onset of adverse symptoms. COVID19 VACCINE JANSSEN 0 days 1083246-1 Experienced burning sensation on her throat 10 minutes after receiving the vaccine COVID19 VACCINE JANSSEN 0 days 1083268-1 Chills, disoriented, nausea, extreme fatigue, fever nightmares, head ache, teeth ache, muscle ache started sore arm soon after, arm pain persisted, heart racing, dry mouth, sore swollen throat, severe headache, spasm in COVID19 VACCINE JANSSEN 0 days 1083296-1 arm Vaso Vagal Syncope. Felt warm and dizzy. Previous episodes after vaccines, blood draws, family events. No itching, hives, SOB, tongue or mouth swelling, palpitations. Supine on floor for several minutes and symptoms resolved. Walked around COVID19 VACCINE JANSSEN 0 days 1083314-1 with no return of symptoms. Released to go home. Advised to seek treatment if symptoms return. Lungs CTAB, no hives. BP WNL after resting. COVID19 VACCINE JANSSEN 0 days 1083324-1 Headache - pain scale 3/10 - not worst headache of life. patient took Aleve and drank water with full resolution. 20 minutes after receiving vaccine patient reports paresthesia in bilateral feet traveling up legs to bilateral arms and hands. Patient reports fatigue and headache. Patient able to hydrate with water. After 1 hour of observation, patient reports symptoms improved significantly. Patient informed to take Acetaminophen/Ibuprofen, to consume food/fluids and COVID19 VACCINE JANSSEN 0 days 1083327-1 rest. Advised to follow up with primary care physician. Advised to call 911 if symptoms persist or respiratory distress. Patient declined transportation to hospital for evaluation. Patient reports able to drive home safely which is about 10 minutes away. Patient was ambulatory upon discharge. BP 118/80. HR 82. COVID19 VACCINE JANSSEN 0 days 1083339-1 numb/tingle lip/tongue; no SOB, no CP, HR 67, O2-98; No stridor, no swelling Vasovagal Syncope - seated talking immediately after vaccine. Suddenly stopped and fell off chair onto gym floor. Regained consciousness after 30 - 60 seconds and was light headed and was diaphoretic. No SOB, swelling, itching, hives, COVID19 VACCINE JANSSEN 0 days 1083341-1 difficulty speaking or swallowing, hoarse voice, palpitations, CP, headache. AO x 3. No hives or rash. Ambulance called but patient declined export. Driven home by a friend. Advised to call 911 if further symptoms. COVID19 VACCINE JANSSEN 0 days 1083351-1 5:02p - reaction time; Blood sugar - 169; O2=94; HR 57; BP 110/68; Pt complains dizziness, sweats, no SOB COVID19 VACCINE JANSSEN 0 days 1083360-1 HR-BP; tingling in lips; HR-97- no SOB, no Swelling; O2-97 COVID19 VACCINE JANSSEN 0 days 1083362-1 Headache, sore arm, injection site pain, low grade fever (100 F), fatigue, nausea COVID19 VACCINE JANSSEN 0 days 1083373-1 High fever, weak, inability to stand, soreness, confusion Joint pain began at 10pm followed quickly by chills. At 1 am on 3/8, fever and increased heart rate (120bpm). Those COVID19 VACCINE JANSSEN 0 days 1083375-1 lasted until 5:30 am. Then I experienced dizziness until 8 am and headache until 2 pm. Initial symptoms of chills and heart racing. Initial HR was 119 with slight dizziness. Reassurance, rest, granola bar. Return COVID19 VACCINE JANSSEN 0 days 1083376-1 to normal HR, BP 02 sat normal, normal CV exam 15 minutes after vaccine received, patient reports feeling hot in face and then all over body about 1 minute later. Patient reports left sided headache. Patient denies respiratory distress. Patient advised to follow up with primary care provider and to call 911 if symptoms persist or experience respiratory distress. Patient instructed to take COVID19 VACCINE JANSSEN 0 days 1083382-1 Acetaminophen/Ibuprofen, to have food/fluid, and to rest. Pt able to hydrate with water. Patient ambulatory and reports symptoms resolved after 45 minutes. Patient reports able to return to work. Patient declined transportation to hospital for further evaluation. BP132/84, HR 72. Nothing for the first two hours; malaise and fatigue from hours 2-8 post-vaccination, with a return to vibrancy around 1500 local time. Around 1700, fatigue returned. Took a 3 mile walk between 1700-1800. Consumed two beers @ 7% ABV COVID19 VACCINE JANSSEN 0 days 1083398-1 between 1800-1845. Around 1830 began feeling tingling, chills and muscle and joint pain which continues. The pain is similar to DOMS that occurs after a robust workout; did not have a robust workout today. I'm fully functional, able to eat and able to otherwise function, so the symptoms are manageable. Fever, body chills, muscle spasm, headache Treatment was rest, naproxen, cold pack on neck for fever. Most symptoms COVID19 VACCINE JANSSEN 0 days 1083401-1 subsided by 8 am 3/8/21 except joint pain and flu like muscle ache. 15 minutes after vaccine received, patient reports feeling hot and dizzy. Patient denies respiratory distress. Patient advised to follow up with primary care provider and to call 911 if symptoms persist or experience respiratory distress. COVID19 VACCINE JANSSEN 0 days 1083406-1 Patient instructed to take Acetaminophen/Ibuprofen, to have food/fluid, and to rest. Pt able to hydrate with water. Patient ambulatory and reports symptoms resolved after 30 minutes. Patient reports able to return to work. Patient declined transportation to hospital for further evaluation. BP 118/78, HR 64. COVID19 VACCINE JANSSEN 0 days 1083422-1 Strong headache, mild fever 99.9F, extremely tired, muscle ache Symptoms of feeling of doom and injection site itching after vaccine was received. No throat swelling, urticaria, hives, no COVID19 VACCINE JANSSEN 0 days 1083427-1 progression of symptoms. Vital signs WNL -HR-90's, BP-140/80, 02 Sat-99%. Persistent dizzy and chills. Transported for evaluation to ER. 1 minute after vaccine received, patient reports feeling mild tongue numbness. Patient denies respiratory distress. Patient given Certirizine 10 mg 1 tab oral. Pt able to hydrate with water. Patient advised to follow up with primary care provider and to call 911 if symptoms persist or experience respiratory distress. Patient instructed to take COVID19 VACCINE JANSSEN 0 days 1083428-1 Acetaminophen/Ibuprofen, to have food/fluid, and to rest. Patient ambulatory and reports symptoms resolved after 30 minutes. Patient reports able to return to work. Patient declined transportation to hospital for further evaluation. BP128/82, HR 84. COVID19 VACCINE JANSSEN 0 days 1083447-1 Headache, high fever (102.5 with Tylenol), violent chills/body shaking, difficulty swallowing, extreme fatigue. Mild nausea began at approximately 6:30pm, chills and shivering began at approximately 7:15pm. Shivering subsided by COVID19 VACCINE JANSSEN 0 days 1083455-1 8:30pm, headache and muscle aches persisted. No treatments administered. Janssen COVID-19 Vaccine EUA about 6 hours after Janssen shot I experienced a fever, body aches, chills and nausea COVID19 VACCINE JANSSEN 0 days 1083459-1 throughout the night and through the next day. I started feeling fatigue about 2-3 hours after the shot. Body aches started about 5-6 hours after the shot. I feel feverish COVID19 VACCINE JANSSEN 0 days 1083470-1 and have chills, but thermometer registers normal temperature. I am still experiencing all symptoms 8 hours after injection. COVID19 VACCINE JANSSEN 0 days 1083485-1 Headache, body aches, chills COVID19 VACCINE JANSSEN 0 days 1083487-1 Fever and chills Chills and shivering that resulted in uncontrollable shaking, extreme full body pains especially in lower back that were COVID19 VACCINE JANSSEN 0 days 1083505-1 debilitating, fever, extreme fatigue and weakness, headache, pain and soreness and injection site. All lasted for approx. 32 hrs. Moderate pain at injection site beginning +6 hours from vaccine. Moderate swelling at injection site for 48 hours from vaccine. Fatigue beginning at +6 hours from vaccine requiring additional sleep and continuing for at least 72 hours. COVID19 VACCINE JANSSEN 0 days 1083517-1 Fatigue results in some periods of moderate weakness and general malaise requiring lying down. Stomach cramps and discomfort. Sore at injection site. 5 hours after injection, i had an Increased heart rate, 101 fever, convulsing from the chills, body COVID19 VACCINE JANSSEN 0 days 1083543-1 aches, poor sleep. splitting headache, fatigue, and fever continued to next day. Most symptoms were gone by 48 hours after injection, except soreness around arm. Took ibuprofen to help with symptoms. Bleeding and pain at injection site; Droopy left side of face, pain in upper left jaw, below left eye, upper left arm and left COVID19 VACCINE JANSSEN 0 days 1083549-1 shoulder/neck; Transient headache and pain in left leg with ankle swelling. At the time of injection, it was pretty painful and thus sent my body into a shock less than 5 mins after receiving my dose. My vision went white and I was very light-headed and hot/sweaty. A nurse came with me outside to monitor and I was feeling back to normal in 15 minutes. This is something that happens when I experience a high amount of pain, so just reporting for others who maybe have low blood pressure issues. At about 8pm, other side effects started to set in. I COVID19 VACCINE JANSSEN 0 days 1083819-1 first experienced a headache, then experienced soreness/ache-y-ness in my back. Around 8:30, I started to feel light headed again and soon my whole body felt ache-y. I quickly developed chills where I felt so cold that I was uncontrollably shaking and felt very sore/stiff. I have been laying under a heated blanket for the last hour and a half and am finally feeling better with no more shaking or chills. I still have soreness throughout my body and a headache, but I took ibuprofen around 8:30pm. Got on an airplane that evening, while on plane, Severe sweating, chills, blood pressure drop and feeling faint. Fever of COVID19 VACCINE JANSSEN 0 days 1083822-1 101.9 at 10:15pm. Acetaminophen seems to improve symptoms well. My entire body is shaking. Feels like muscle spasm over my entire body. Slight chills no fever yet. Very sore arm and COVID19 VACCINE JANSSEN 0 days 1083830-1 clenching of stomach, arm, back and shoulders. I took 500 mil of Advil. Shaking starting to stop after 41 min. May be feeling warm I have to check. Janssen COVID-19 Vaccine EUA Six hours after the vaccination I experienced an upset stomach, fever, chills, terrible body aches, headache, and sluggishness. I only had children?s Tylenol so I took that but it did not treat the symptoms. COVID19 VACCINE JANSSEN 0 days 1083845-1 Thirteen hours later I took extra strength Tylenol and that helped with the treatment of most of the symptoms. About eighteen hours later I started to feel better. I had residual hot flashes 48 hours later. COVID19 VACCINE JANSSEN 0 days 1083886-1 Currently have had a 102.1 fever since around 10:00pm on March 8th 2020. COVID19 VACCINE JANSSEN 0 days 1083904-1 feeling very tired started about two hours after injection and lasted for two days 100.9 fever, horrible migraine (can't touch chin to neck), chills, sweats, stomach hurts, shivering, body aches, brain zaps, COVID19 VACCINE JANSSEN 0 days 1083905-1 bad neck pain, nauseous Took Tylenol COVID19 VACCINE JANSSEN 0 days 1083917-1 Fever, chills, aching palms, hands/fingers, shoulders, burning sensation in feet 6 hours after I got the vaccine I started getting a headache, followed quickly by horrible body chills and then horrible body aches. My temperature about an hour later was 105. I took 1000 mg of Tylenol right away and put a cold rag on COVID19 VACCINE JANSSEN 0 days 1083920-1 my head and tried to go to sleep. A couple hours later my fever started breaking, when it was 102.7 I was a sweaty mess and extremely hot and puked a lot. My fever and other symptoms went away within about 7 hours after my fever started breaking. Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Additional Details: Patient fainted 10 minutes after administration of Janssen vaccine. Patient was unconscious for about COVID19 VACCINE JANSSEN 0 days 1083942-1 15 seconds before regaining consciousness. 911 was called and EMT arrived on scene to monitor's patients blood pressure and blood sugar. Patient still reported lightheadedness so was taken to hospital by EMT/ambulance. Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Additional Details: Patient described feeling nauseas about 10- 15 minutes after vaccination then patient fainted. COVID19 VACCINE JANSSEN 0 days 1083945-1 Patient regained alertness a couple minutes after fainting but was still weak and unable to get up. Paramedics came and patient was found to be hypotensive after 15-20 minutes patients blood pressure restored and she was at full alertness and paramedics signed her release. Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances- Medium, Additional Details: Near fainting episode. Pt did not lose consciousness but blacked out (visual disturbances, COVID19 VACCINE JANSSEN 0 days 1083948-1 tinnitus/temporary hearing loss, nausea) occurred within 2-3 minutes of administration. First attempt to read BP was low (~80/60). Pt is an athlete, so I waited until after water was consumed to take BP again. 2nd reading was ~106/65. Pt felt better after drinking water and after sitting for 15 minutes under observation. Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating- Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Severe, COVID19 VACCINE JANSSEN 0 days 1083949-1 Additional Details: Patient complained of nausea/dizziness followed by blurry vision. He felt like he was going to black out. I took his vitals at 11:43 am and his BP measured 78/53 with a pulse of 45. He was also sweating profusely. The paramedics came within a 5 min time frame and patient was stabilized within 10-15 minutes later. Severe body aches fever w/ chills headache dizziness weakness diarrhea. Motrin for aches and pain water to keep COVID19 VACCINE JANSSEN 0 days 1083953-1 hydrated Chills, Sweats, Bad body aches Saturday night through Sunday Morning- Took Tylenol Tiredness- throughout Sunday COVID19 VACCINE JANSSEN 0 days 1083958-1 Chills- Sunday night- Tylenol Monday felt good- Monday night slight temp 99.5 and shortness of breath Took Tylenol Tuesday Feel fine headache and slight shortness of breath. 5pm - body aches and fever began 11pm - fever reached 39 degrees Celsius 4am - fever ended, body aches continued COVID19 VACCINE JANSSEN 0 days 1083960-1 headache and some joint pain continued for another full day COVID19 VACCINE JANSSEN 0 days 1083961-1 Body aches, joint pain, extreme fatigue, fever (102F) Around 8:30p.m. Saturday March 6, 2021 I began to feel chills. I laid down around 9:30p.m to go to sleep. I woke up at 12:25a.m (Sunday March 7th, 2021) with a fever of 104.3 and was experiencing extreme neck and head pain. My hands hurt as if I had arthritis and couldn't make them feel better. I was very short of breath and dry coughing. I took Tylenol and tried to lay back down and was able to go back to sleep around 3:00a.m. I got up at 6:10am and my temp was 101.6. I took Ibuprofen at this point and by 9:30am my temp was 99.8. I was still experiencing a very bad headache and my neck COVID19 VACCINE JANSSEN 0 days 1083974-1 and back were achy. I felt a lot better by about 11:00am, took a hot shower and laid down for a nap around 2:00pm Sunday. When I woke up around 3:15p.m I had spiked yet another fever of 102.0 and was having bad body aches again in my neck and head area and it continued to get worse though my back over the next hour. I was experiencing a dry cough again also but this time it was more constant. It took over 3 hours for my fever to go below 100.0 with alternating Tylenol and Ibuprofen. It finally broke around 7:00p.m. I had a lot of pain in my neck and head the rest of the night. I woke up Monday March 8th, 2021 with a moderate headache but it went away throughout the day. No fever returned Monday. The only time I experienced coughing and shortness of breath was while I had the fever. COVID19 VACCINE JANSSEN 0 days 1083976-1 High fever over 101.5, chills with significant body shaking, headache, muscle pain COVID19 VACCINE JANSSEN 0 days 1083980-1 Extreme tiredness, headache, chills, fever. Lasted from 11:30pm until 7am the following day. He?s feeling better now. Within one hour: headache, some joint pain Within 7-8 hours: severe joint pain and muscle aches (about 9-10 on scale), COVID19 VACCINE JANSSEN 0 days 1083981-1 fever, chills, vomiting Body pain lasted for 12 hours, next morning pain was lessened but still present , about 5/6 on a 10 scale Janssen COVID-19 Vaccine EUA (3/6) Fatigue began 4 hours after vaccine. (3/6) Severe headache, severe fatigue, COVID19 VACCINE JANSSEN 0 days 1084014-1 moderate fever, mild aches, mild nausea beginning the next day (3/7) and lasting until (3/8). Mild headache and mild fatigue all day (3/8) Body ache a little that day, night time - chills, fever, body aches, next day - all body aches, fever, chills, really tired. COVID19 VACCINE JANSSEN 0 days 1084017-1 Monday - slight body aches COVID19 VACCINE JANSSEN 0 days 1084024-1 Fever, dizziness, and weakness COVID19 VACCINE JANSSEN 0 days 1084038-1 Weakness, cold sweat, nausea, metallic/sour taste in mouth, salivation

COVID19 VACCINE JANSSEN 0 days 1084046-1 Fever of 100.4 Degrees F. Muscle Swelling/Inflammation throughout body. Fatigue. Vertigo/Dizziness. 3/9 (31 Hours from Vaccination time) Fatigue and inflammation exist throughout body but temperature has normalized to 98.5 Degrees F. Post vaccination feeling of breath doom, walking to door to get fresh air. Syncope, fell to floor. No head injury. Post COVID19 VACCINE JANSSEN 0 days 1084058-1 vaccination syncope, brief generalized tonic-clonic movement followed by emesis. Blood glucose 114, BP 120/80, HR90, O2 Sat 96%. Janssen COVID-19 Vaccine EUA About 6 hours after receiving the vaccine: - headache - muscle aches - chills - fever The COVID19 VACCINE JANSSEN 0 days 1084063-1 next day, after receiving the vaccine: - mild headache - mild muscle aches - fever and chills have subsided Immediately after receiving the vaccine and continuing the next day: - sore arm in the arm receiving the injection COVID19 VACCINE JANSSEN 0 days 1084065-1 Mother reports same evening patient had 102 fever and body aches. off work/school following day 3/9/21 COVID19 VACCINE JANSSEN 0 days 1084075-1 Mother reports patient experienced chills and headache, never spiked fever COVID19 VACCINE JANSSEN 0 days 1084096-1 fever, chills, body aches, headache, nausea Within minutes, I felt flushed (sweating, light headed), weak, and arm pain. followed by fatigue, fever, continued pain in COVID19 VACCINE JANSSEN 0 days 1084099-1 my arm, overall weakness, and occasional naseau. 7pm chills, fever 102.4, stabbing muscle pain in random places, achey knee joints, rapid heart palpitations, slight headache chills ended around 10pm, fever started to go down at 10:30, palpitations decreased as the fever declined. COVID19 VACCINE JANSSEN 0 days 1084113-1 Tylenol at 7pm, Aleve 10:45pm, Woke the next morning with a headache - drank some water, it has subsided The heart palpitations were concerning COVID19 VACCINE JANSSEN 0 days 1084119-1 Janssen COVID-19 Vaccine EUA Side Effects: - Nausea - Head ache - Body aches - Chills - Very sore arm Immediate rash in chest and face. 20 minutes later entered ER with swollen eye and throat. 14 hours later re-entered COVID19 VACCINE JANSSEN 0 days 1084126-1 ER with rash on chest and face, swollen tongue and throat COVID19 VACCINE JANSSEN 0 days 1084132-1 Nausea, cramping, soreness all over my body, headache, chills and fever. These have lasted so far for 10 hours. 20 minutes after shot felt stinging in middle of forehead and then quickly followed by numbness tingling ( felt like I had novocaine from dentist) down the left side of my face. 30 minutes after that my throat started to swell; breathing COVID19 VACCINE JANSSEN 0 days 1084134-1 remained okay, so I just self monitored. Throat swelling went down about 10: 00 PM; facial tingling/numbness also got better and is just very slight the next morning. Loss of consciousness, irregular heart palpitations, nausea. Loss of consciousness lasted less than one minute, recovery took about twenty minutes to become stable to leave the facility; lingering ?wooziness? throughout the day. This COVID19 VACCINE JANSSEN 0 days 1084135-1 reaction was more likely due to vasovagal syncope than the vaccine. Patient has a history of vasovagal syncope. Arm soreness, fatigue, and headache presented the following day. Unknown vaccine information dose given outside of presenting facility. Facial numbness and droop that began after COVID19 VACCINE JANSSEN 0 days 1084138-1 Janssen COVID vaccine. Patient also with panic attack. COVID19 VACCINE JANSSEN 0 days 1084151-1 About 12 hours after vaccine I had Uncontrollable shivering and mild body aches. Only lasted about 2 hours COVID19 VACCINE JANSSEN 0 days 1084170-1 Headache, chills, fever, muscle aches & pain About 9 hours after the Vaccination (Saturday), I had a low grade fever (101), chills, sweats, lethargy, muscle aches, significant headache. These symptoms lasted through the night. Some symptoms lifted (fever) for 6 hours the next day COVID19 VACCINE JANSSEN 0 days 1084215-1 (Sunday) but all other symptoms still present for a full 24 hours following onset. Fever came back again at night (Sunday into Monday) and extreme lethargy the following day (Monday) with dizziness. Began to feel achey, chills, headache and slight nausea. Symptoms persisted throughout the day and throughout the COVID19 VACCINE JANSSEN 0 days 1084217-1 night. Symptoms resolved by the next day. Within 45 minutes lightheaded, within an hour extreme fatigue and chills, ear ache. Several hour after skin hyper COVID19 VACCINE JANSSEN 0 days 1084226-1 sensitivity, nausea. The next day fatigue , nausea and mild cold symptons, migrane. COVID19 VACCINE JANSSEN 0 days 1084231-1 Patient reports feeling dizzy, lightheadedness, hazzy vision. Declined EMS transport COVID19 VACCINE JANSSEN 0 days 1084233-1 Severe chills, weak, shaky, head pounding and heart racing. Body is sore from the chills COVID19 VACCINE JANSSEN 0 days 1084243-1 Chills, upset stomach, insomnia Patient reports tingling on face and lips, and headache. Felt better after a few minutes, no flushing or dizziness. Cleared COVID19 VACCINE JANSSEN 0 days 1084250-1 by EMS. About 8 hours after getting the shot, I felt tired, then got chills. A couple of hours later, I had diarrhea and nausea with COVID19 VACCINE JANSSEN 0 days 1084293-1 vomiting. This lasted for about 1 hour or so. I became dehydrated and also had a headache. This morning, I seem to be fine - just exhaustion and some headache.

1515-Vaccine administered-Employee was monitored for 15 min and returned to work. 1600- Employee developed hives, COVID19 VACCINE JANSSEN 0 days 1084299-1 reported to occupational health and benadryl administered. APRN present in Occupational Health. Patient stated he felt that his throat was swelling. Epi-Pen was administered while an ambulance was called, employee was transported to ER. COVID19 VACCINE JANSSEN 0 days 1084304-1 Fever, Chills, Extreme Fatigue, Sweats, Severe headache, Joint and muscle pain/aches for 24hrs My body started shaking uncontrollably - lasted for about 30 to 45 minutes. Also developed a mild headache with the COVID19 VACCINE JANSSEN 0 days 1084306-1 shaking. COVID19 VACCINE JANSSEN 0 days 1084314-1 Shakes & Chills,Muscle Aches in legs, 101 Fever Fatigue Days 1-2: fast heart rate, difficulty breathing, asthma attack requiring inhaler, muscle weakness. Days 4+: rash at COVID19 VACCINE JANSSEN 0 days 1084344-1 injection site - size of a dime after leaving facility, while driving home, my left facial cheek began to tingle, then burn. By the time I got home, both my hands and feet also were tingly, like pins and needles falling asleep. The following day, at about 4 PM the tingling, COVID19 VACCINE JANSSEN 0 days 1084348-1 returned to the entire left side of my face, so Monday 03-08-2021 @ 4 PM, from hairline to jaw, tightness, burning and tingling including around my left eye. lasting until roughly 7 PM COVID19 VACCINE JANSSEN 0 days 1084354-1 Elevated heart rate, chills, fever, headache, body ache, COVID19 VACCINE JANSSEN 0 days 1084368-1 Fever, headache, body aches, fatigue ? lasted 6-8 hours. Whole body ache, severe chills, body warm to the touch, nausea/vomiting, headache (lasted from 9 at night to around 3 COVID19 VACCINE JANSSEN 0 days 1084398-1 in the morning) Body ache (for about 3 days) Diarrhea and nausea (lasted about 3 days) Sore arm at injection site (Going on day 4) COVID19 VACCINE JANSSEN 0 days 1084418-1 Chills, fever, aches lasting 48 hrs Patient vaccinated. Shortly after patient complained of itchiness in throat. A focused exam was gone on the patient. No COVID19 VACCINE JANSSEN 0 days 1084420-1 noted swelling in patients oral cavity. Patient able to talk and swallow. Patient given 10mg of cetirizine. Patient states that itchiness resolved during observation period. Patient refused further treatment and decided to return to work. COVID19 VACCINE JANSSEN 0 days 1084421-1 This was an administration error, drawn into syringe and not given. patient had no visible symptoms. COVID19 VACCINE JANSSEN 0 days 1084454-1 headache, nausea, aching, chilling Patient stated that her heart was racing and her feeling shaking in her limbs. Vitals were BP 135/80, HR 90, RR.14. Patient denied any other symptoms. After about 15 minutes patient stated that she felt better, Denies any medical COVID19 VACCINE JANSSEN 0 days 1084462-1 history and instructed to follow up with her PCP. Patient stated that she wanted to return to work and denied any further medical treatment. Janssen COVID-19 Vaccine EUA. Injection site on arm hurt immediately after injection and upper arm is still sore today (3 days later). Approx 7 hours after receiving vaccine I experienced a sudden onset of overall body aches and joint pain specifically in my knees. It was kind of severe- even my skin was hurting when I got goosebumps. A fever came on after COVID19 VACCINE JANSSEN 0 days 1084464-1 that and I was shivering, cold, sweaty. Approx 11 hours after injection I began to experience a severe headache and sleepiness. Symptoms continued overnight and disturbed my sleep, but were relieved somewhat by taking ibuprofen. By the next morning (after sleeping 14 hours) I was only feeling tired, arm soreness, and headache (no more fever, chills, body aches). All symptoms except arm soreness cleared up rather suddenly, approx 24 hours after they came on (which was approx 31 hours after injection). Approximately 10 hours after receiving the injection, I experienced extreme chills, nausea, elevated heart rate. The last time I experienced symptoms like this was on the first day I started chemotherapy and had an allergic reaction to one of COVID19 VACCINE JANSSEN 0 days 1084473-1 the chemo drugs (bleomycin). I had a delayed reaction hours later and went to the ER. It was determined it was an allergy. So I took Claritin D 24 H and saw the symptoms I was experiencing last night dissipate. COVID19 VACCINE JANSSEN 0 days 1084477-1 Fever 101, severe aches, swelling of face, fast heartbeat, bad rash all over body, dizziness and weakness, headache

J&J vaccine around 8:40am Saturday. By 3pm, I was feeling significant fatigue. By 5pm, chills and low fever (99). Chills and fever intensified, and fever rose to 103 by 10pm, with headache and body aches (mainly legs). I had very mild nausea & COVID19 VACCINE JANSSEN 0 days 1084482-1 loss of appetite. Over the course of the night, I tried to stay hydrated with water and apple juice. By about 11pm, I took 200mg of Advil. I took another 200mg Advil several hours later. Throughout the next day, Sunday, my fever subsided gradually, significant fatigue persisted as did loss of appetite. By Monday, I was left feeling mostly weak and worn out, but on the road to recovery. By Tuesday morning (now), I feel that the I will be recovered by tomorrow. Immediate swelling and bruising at injection site, size of golf ball, 09:55 Benadryl administered (50mg/ml) IM to L deltoid, COVID19 VACCINE JANSSEN 0 days 1084489-1 1010 ice pack placed, no report of itching or swelling at any other site. Swelling is reducing at 1030. My Rheumatologist suggested I report this:: I had no side effects other than a sore arm and some tiredness up until approx 6 hours after the injection. At approx 8:30 PM, I was lying in bed and both of my legs from the hips down started to shake violently. It did not feel like the chills as I was not cold and the rest of my body was unaffected. The shakes felt completely involuntary as if my brain was short circuiting. My legs shook so violently that my hip joints began to really COVID19 VACCINE JANSSEN 0 days 1084494-1 hurt. Shaking lasted less than 30 minutes total. I am not sure what stopped the shaking, but I had tried to put my body weight over my legs (body folded in half) to try to stop the shaking and took 1 regular strength tylenol. After the shaking ended, up until I went to sleep (maybe 3-4 hours later) I felt some numbness and tingling in my finger tips and feet. The next day, I felt fine but emailed my Rheumatologist to report the shaking and she directed me to report it here. Fever chills (shivering) started at 11:30 p.m. on May 8, 2021 Temperature was only 99.5 degrees By 1:00 a.m., March 9, COVID19 VACCINE JANSSEN 0 days 1084507-1 fever was 101.5 degrees By 2:30 a.m. May 9, 2021 fever was 102.5 degrees By 4:00 a.m., March 9, 2021fever had reduced to 101.5 degrees By 9:00 a.m., March 9, 2021 fever had reduced to 99.6 degrees COVID19 VACCINE JANSSEN 0 days 1084520-1 Patient complained of dizziness within 5-10 minutes following vaccination Cold chills, shivering, muscle & body soreness, chest congestion, coughing, migraine, sweating, fever, exhaustion.. COVID19 VACCINE JANSSEN 0 days 1084524-1 Treatment: water and pedialyte. Time course: several hours into the next morning COVID19 VACCINE JANSSEN 0 days 1084536-1 Vomiting and Nausea 20 minutes after administration of vaccination Patient complaint of itching and burning sensation on face/cheek area, sporadic itching bilateral upper extremities. Event COVID19 VACCINE JANSSEN 0 days 1084540-1 occurred 15 minutes after J & J Vaccine administration. Symptoms Resolved 15 after the event. Cleared by NP. Janssen COVID-19 Vaccine EUA 19 hours after injection chills, headache, heaviness on chest and dizzy did not feel better COVID19 VACCINE JANSSEN 0 days 1084541-1 until 10 hours later. symptoms gone but still very tired. COVID19 VACCINE JANSSEN 0 days 1084573-1 Light headed first then fever then massive headache and extreme tiredness - lasted for 16 hours COVID19 VACCINE JANSSEN 0 days 1084581-1 Extreme back ache, slight headache, body chills all over Chills Fever of 101.8 Nausea Muscle Aches Fatigue Trouble Breathing Dizziness Symptoms gradually subsided over 24 hours. Used a rescue inhaler for the breathing troubles, took extra strength tylenol for the fever. Slept for 18 solid COVID19 VACCINE JANSSEN 0 days 1084583-1 hours from 9pm on March 7th till 3 pm on March 8th - had been napping most of the day before 9pm.Fever and fatigue were the last symptoms to resolve. Began feeling dizzy and nauseated. Started vomiting at approximately 5:00pm and continued until 6:30 or 7:00pm. I could not open my eyes because of the extreme dizziness. Chills Sweating I was able to sleep for a few hours and woke up COVID19 VACCINE JANSSEN 0 days 1084601-1 at 10:00pm and the symptoms had subsided. I woke up with a headache on Sunday morning. That went away and have not had any symptoms since

High fever, 101.5, chills, upset stomach, headache, body aches, joint aches, fatigue. Onset of symptoms was 7 hours after COVID19 VACCINE JANSSEN 0 days 1084604-1 vaccination, escalated to it's worst by midnight, consistent high fever with all symptoms through 11:00 a.m. next day, then symptoms began to subside and were gone 7 hours later. Sore arm and fatigue lasted through the next day. Patient received Janseen COVID vaccine. The first 1/2 of the vaccine was given easily IM to the left deltoid and then the patient complained of severe arm pain, tensed her muscles, and the last 0.25ml was difficult to inject. Then the patient became hypotensive 90/45, dizzy, and felt like she was going to pass out. She was laid in the supine position, given a cool COVID19 VACCINE JANSSEN 0 days 1084612-1 cloth for her forehead and monitored for approx. 45 minutes. Her blood pressure remained 90/60, 96/56 at discharge. Her heart rate ranged from 55-65, regular. Her son came to take her home as we did not feel comfortable with the patient driving. The patient was continuously monitored by the NPs and APCT. She ambulated without difficulty and was discharged home. She was given information for V-safe to report her reaction and advised to follow up in the ER for any SOB, difficulty breathing, difficulty swallowing, syncope, CP, etc. Severe chills lasting a couple of hours entire body shakes, headache lasting 24 hours, fatigue lasting 24 hours, full body COVID19 VACCINE JANSSEN 0 days 1084619-1 rash still in progress COVID19 VACCINE JANSSEN 0 days 1084624-1 Body chills and Aches for approximately 18 t 24 hours Post vaccination lightheaded, pale. Placed supine, felt better. No local injection site reaction, hives, SOB, tongue swelling, COVID19 VACCINE JANSSEN 0 days 1084628-1 palpatations. Lungs CTAB. Sat up drank water and ate a banana. Fever 102+, chills, aches, headache, nausea, heart rate 135 at rest. Symptoms began 8 hours after injection and lasted COVID19 VACCINE JANSSEN 0 days 1084657-1 for 48 hours. This was a Johnson & Johnson vaccine. No option was given on the website for this. Nausea no vomiting for about 10 hours Fever of about 102 20 hours post shot. She experienced a long bout of a fibrillation along with this fever. She?s COVID19 VACCINE JANSSEN 0 days 1084660-1 experienced an abnormal level of confusion with her Alzheimer?s. This morning about 32 hours post shot her temperature is 95¶. At 48 hours there were still redness and swelling at the injection site. However all the other symptoms had abated. COVID19 VACCINE JANSSEN 0 days 1084695-1 nausea set in that night, sleepless night, pain in joints, nausea and pain in joints is continuing the day after. Significant shaking/trembling, chills yet hot, severs fatigue, muscle aches especially in neck area. No fever. If husband COVID19 VACCINE JANSSEN 0 days 1084712-1 hadn?t been home, I would have gone to the emergency room. Symptoms subsided within 8 hours. Ibuprofen really helped.

Janssen COVID-19 Vaccine EUA. Started feeling very tired two-three hours after the vaccination, got a mild fever approx COVID19 VACCINE JANSSEN 0 days 1084718-1 9 h after the vaccination and high fever (38.5 C) after 11 h. Strong dehydration feeling, nose numbness, chills, sensible skin feeling and dizziness. Fever and side effects approx 6-8 h and disappeared approx 17h after the vaccination COVID19 VACCINE JANSSEN 0 days 1084737-1 Chills Severe Aches Fatigue Upon administering the vaccine, the patient pulled her arm away as the medication was entering her arm. There was 0.1 COVID19 VACCINE JANSSEN 0 days 1084748-1 mL of the vaccine that did not get injected and was lost. The patient was informed and had no immediate adverse reactions. Got vaccine at 5:36 pm and during waiting time afterward, she reported around 5;53 pm having generalized tingling then followed by generalized pruritis. Denied and did not exhibit signs of urticaria, angioedema, cough, dyspnea, wheezing, CP, abdominal pain, nausea, vomiting, abdominal pain, lightheadedness, weakness, pallor, tachycardia. Discussed giving her diphenhydramine and she agreed stating she had no previous adverse reaction to this treatment. At 5:56 pm, I gave diphenhydramine HCL 50 mg/ml 1 ml IM in her right deltoid muscle. Around the time of the injection COVID19 VACCINE JANSSEN 0 days 1084750-1 (approximately 5:59 pm, pulse was 76, oxygen saturation 97%, BP 138/90, lungs clear, heart RRR. Within 20 minutes (6:22 pm) of diphenhydramine injection, she reported that the tingling had largely subsided (only remaining in lower legs) and her pruritis was improving. Her pulse was 77, oxygen saturation 96%, and BP 126/82 at that time. She also reported she had not developed any new symptoms (see above). By 6:28 pm, she reported no further tingling nor pruritis and feeling well. We released her at that time as we deemed her recovered from the symptoms. We advised her to call 9-1-1 if the symptoms returned especially with one or more of the above symptoms she had twice denied experiencing. 3/9/21 11:47 a.m. Called to check on status. No answer. Left message. COVID19 VACCINE JANSSEN 0 days 1084768-1 Chills and fever When administering the vaccine, the patient pulled her arm away as the medication was being injected. Less than 0.1 mL COVID19 VACCINE JANSSEN 0 days 1084788-1 of the vaccine was lost and not injected into her arm. The patient was informed and did not have an immediate adverse reactions. COVID19 VACCINE JANSSEN 0 days 1084796-1 Chills, body aches, headache, & fatigue. I had COVID-19 in early December and these symptoms are very similar. Very dry/sore throat, intermittent lose of voice, low-grade fever, body shivering/chills, pressure/tension headache, hard COVID19 VACCINE JANSSEN 0 days 1084808-1 spot at injection site, joint pain/stiffness, ringing of ears; all for around 40 hours and slowly clearing up. *Tylenol, ibuprofen, cold/flu meds had minimal effect. Freezing Cold, achy starting two hours after getting shot the following day continued with extreme feeling of cold and COVID19 VACCINE JANSSEN 0 days 1084813-1 achy tired and was also nauseous. Began to feel better starting at 36 hours after shot all nausea and freezing seemed to clear up around 48 hours. Arm hurt and still hurts to touch 4 days later COVID19 VACCINE JANSSEN 0 days 1084827-1 Fatigue since the evening of the test COVID19 VACCINE JANSSEN 0 days 1084832-1 Chills, sweats, fever, sleeplessness COVID19 VACCINE JANSSEN 0 days 1084847-1 Fever, headaches, chills Headaches starting in late afternoon increasing in intensity towards evening. Feeling feverish by 8:00 PM. Took Tylenol COVID19 VACCINE JANSSEN 0 days 1084852-1 and went to sleep. Woke up in the middle of the night with a fever of 100. Took two more Tylenol and slept until 9:00 AM. Felt fine and temperature was back to normal. Severe chills - began at 8pm ET 3/7/21 and lasted until approximately 6am 3/8/21 Headache - began at 8pm ET 3/7/21 COVID19 VACCINE JANSSEN 0 days 1084952-1 and lasted until 6pm 3/8/21 Nausea - began at 8pm ET 3/7/21 and lasted until approximately 6am 3/8/21 Severe chills. Moderate body aches. Moderate headache. Fever (peaking at 101.3). Symptoms lasted approximately COVID19 VACCINE JANSSEN 0 days 1084954-1 30 hours. COVID19 VACCINE JANSSEN 0 days 1084960-1 Fever, chills and body aches COVID19 VACCINE JANSSEN 0 days 1084972-1 Chills fever joint aches lasting about 8 hrs Body aches, chills, fatigue, ear blockage; tinnitus; migraine/headache no medical treatment was sought; took Advil for COVID19 VACCINE JANSSEN 0 days 1084976-1 the migraine COVID19 VACCINE JANSSEN 0 days 1084983-1 Cold chills, intense arm pain, heavy sweats, nausea, joint/bone pain, headaches, fatigue I had the most peculiar taste in my mouth. It wasn't entirely a metal taste, but it was strong enough it overwhelmed the taste of everything else for about 6 hours. I could still taste other things, but the primary taste and the one that remained in my mouth was this odd, almost metal taste. The next day (after the taste was gone)- it would have been COVID19 VACCINE JANSSEN 0 days 1084990-1 almost 24 hours from the time of the injection - I was hit with a bad headache and body aches like I haven't had in many years. The body ache was gone the next morning, and the headache lingered another day past that. Today, Tuesday March 9, is the first day I feel like myself again. Started with chills about 12 hours after the shot, headaches, nausea, light-headedness (nearly passed out), dry-heaving, COVID19 VACCINE JANSSEN 0 days 1085023-1 fatigue (slept on and off for 24 hours) Symptoms lasted about 36 hours and then I felt fine again. COVID19 VACCINE JANSSEN 0 days 1085038-1 Chills, shivers, headache, body aches and soreness Severe chills at 11:30 pm night of vaccine. Lasted 1 1/2 hours. Woke up next day with mild fever and slight headache. COVID19 VACCINE JANSSEN 0 days 1085052-1 Both went away shortly thereafter. Felt lethargic all day, little appetite. Felt 100% better next day. Day of vaccine - Throat felt like someone was pushing on either side, numbness in sinuses (nose, cheeks, upper jaw, COVID19 VACCINE JANSSEN 0 days 1085077-1 tongue), bad headache (almost immediately) Next day - congestion, bad headache, body aches, chills, coughing, more throat symptoms, numbness in sinuses COVID19 VACCINE JANSSEN 0 days 1085095-1 Headache, slight fever, body aches, nausea PATIENT RECEIVED VACCINATION AROUND 9:45 AM TODAY, 3-9-21. PATIENT THEN CALLED PHARMACY AT 1:09 TO LET COVID19 VACCINE JANSSEN 0 days 1085098-1 US KNOW THAT AT AROUND 11:00 SHE STARTED GETTING A HEADACHE AND BEGAN VOMITING. PATIENT HAS SINCE VOMITED 4 TIMES AND WAS INSTRUCTED TO SEE HER PRIMARY CARE PROVIDER. COVID19 VACCINE JANSSEN 0 days 1085101-1 Spiked a fever of 101+ still feeling a but drained. Fever is gone COVID19 VACCINE JANSSEN 0 days 1085115-1 felt like his eyes were burning from the inside out and lasted 3 days. Patient did not seek treatment Anaphylactic reaction-flushing, lump throat, cough onset within 10 minutes. InER 2hrs home on medication solumedrol, COVID19 VACCINE JANSSEN 0 days 1085166-1 benadryl,pepcid, IV fluids COVID19 VACCINE JANSSEN 0 days 1085167-1 Error: Improper Storage (temperature) 10 hours after injection began running a fever of 102, chilling, achy, headache. Treated with tylenol and lasted about 5 COVID19 VACCINE JANSSEN 0 days 1085174-1 hours. Felt very tired and achy for the next 12-14 hours. Returned to work two days after feeling fine. COVID19 VACCINE JANSSEN 0 days 1085177-1 shivering, cold, feverish, muscle aches seconds after administration patient started losing consciousness. he stated he previously experienced vasovagal syncope after flu shots. he went in and out consciousness several times over the next 5 minutes. he lost color in face and eyes closed when head dropped. his body was stabilized and kept alert with verbal and physical tests. cold compress was COVID19 VACCINE JANSSEN 0 days 1085250-1 applied behind neck and BP monitor placed on arm. he had normal BP/pulse. skin color gradually improved as well as mental acuity. patient could stand after approx 10m and was observed for additional 30m. his phone was used to call his wife and someone came to assist getting home. said felt fine after full observation time and seemed to have made full recovery. COVID19 VACCINE JANSSEN 0 days 1085261-1 Metallic taste, slight headache and elevated blood glucose numbers (normal 80-120, one hour post no food prior 243) COVID19 VACCINE JANSSEN 0 days 1085263-1 After receiving the vaccine, the patient experienced tickling in the throat. Benadryl was given and patient soon felt fine Headache, chills, fatigue, tiredness, blurry vision, and sleeplessness; was not able to fall asleep the night after the dose. Lots of pain and soreness at injection site. Had a severe headache the next morning (relieved with acetaminophen), and COVID19 VACCINE JANSSEN 0 days 1085282-1 had a difficult time seeing up close for about two hours despite using my corrective lenses, which made the headache worse. COVID19 VACCINE JANSSEN 0 days 1085343-1 flu-like symptoms (i.e., chills, body ache, fatigue, severe headache and slight temperature) for approximately 24 hours COVID19 VACCINE JANSSEN 0 days 1085352-1 Pain at the infection site. Persisted x 3 days. Janssen COVID-19 Vaccine EUA Nasty chills and fever started 10 to 12 hours after vaccination and continued through the night. By 24 hours after the shot, things improved. 24 to 48 hours better -- no chills/fever-- but still general fatigue. COVID19 VACCINE JANSSEN 0 days 1085365-1 ""less than 100%"". 48+ still not fully recovered. Arm muscle still sore at injection site. Suspect will be better largely by tomorrow."" fatigue, muscle and joint pain, chills, fever of 102, headache initial fatigue set in 5 hours after getting the shot chills COVID19 VACCINE JANSSEN 0 days 1085393-1 lasted a few hours muscle and joint pain lasted 12 hours fever lasted a few hours headache lasted 17 hours did not take any medication to help with symptoms Around 10 PM the day of the shot, started experiencing chills, muscle aches, exhaustion and a low grade fever (99.5). COVID19 VACCINE JANSSEN 0 days 1085395-1 Symptoms lasted approximately 36 hours. Treated with tylenol. Patient complained of dizziness following vaccine for about five minutes. Vital signs monitored. Blood pressure was COVID19 VACCINE JANSSEN 0 days 1085445-1 elevated. Advised patient to seek medical care but she declined. She stated she would call her doctor. 12 hours post vaccine injection I had a slight fever. Fever lasted until 20 hours post injection. When measured, my COVID19 VACCINE JANSSEN 0 days 1085498-1 temperature was 100.1. 36 hours post vaccine, I started itching and at 50 hours post vaccine the itching has turned to hives. As of right now, 51.5 hours post vaccine i still have hives. COVID19 VACCINE JANSSEN 0 days 1085499-1 Chills, fever, headache, body aches, fatigue COVID19 VACCINE JANSSEN 0 days 1085526-1 Janssen COVID-19 Vaccine EUA Fever, Muscle Pain,fatigue, hand/arm and foot/leg pain Developed fever and chills approximately 9 hours after being vaccinated. Experienced dizziness, fatigue, and achiness the COVID19 VACCINE JANSSEN 0 days 1085530-1 next day. Fever and other symptoms resolved by Sunday night (March 7). Still experiencing some soreness at injection site. COVID19 VACCINE JANSSEN 0 days 1085546-1 Aches, fever of 100.0 at 3:15 am. Felt better Tuesday morning COVID19 VACCINE JANSSEN 0 days 1085557-1 12 hours of cold chills; 18 hours of excruciating headache; nausea; vomiting. Dull headache the next day. **17 weeks pregnant, Due date 8/11/21, 1st pregnancy** I got the shot at 3am and was feeling fine. When I woke up COVID19 VACCINE JANSSEN 0 days 1085572-1 my arm sore and felt really cold, my temp was 100, I called and they advised me to take Tylenol and rest. I did that and it lasted for about 24 hours. Patient stated that after waiting 15 minutes post injection and leaving, she began to experience throat closing while driving in her car. Patient voiced that she took Benadryl immediately and the reaction began to subside. The patient also COVID19 VACCINE JANSSEN 0 days 1085591-1 stated that he woke up Saturday evening with a large sized knot on her arm where the vaccine was administered. Patient stated that it has since gone down in size but is still fairly large. Double vision about 25 minutes after treatment. Driving home and had to pull off side if road. Lasted 2 to 3 minutes. COVID19 VACCINE JANSSEN 0 days 1085597-1 Continued then on to home. 16 year old patient was inadvertently given Janssen Covid 19 vaccine by PA. This was discovered by Regional Director, COVID19 VACCINE JANSSEN 0 days 1085612-1 who has not been able to reach the patient or guardian, but is awaiting a call back. Patient received vaccine at approximately 10:50 AM. She proceeded to the observation area where she began to feel COVID19 VACCINE JANSSEN 0 days 1085647-1 light-headed. On-site EMS from was summoned. EMS placed the woman on their gurney and began assessment (vitals and EKG). A copy of the PCR has been requested, but may not be available. Severe joint and muscle pain to the point of being unable to get out of bed alone. Difficulty taking deep breaths. Deep breaths cause coughing. Severe headache and nausea to the point of having trouble standing without feeling sick. COVID19 VACCINE JANSSEN 0 days 1085648-1 Started with a few hours of getting that vaccine and is still present. Have missed two days of work so far as a result with no symptom improvement so far. Janssen COVID-19 Vaccine EUA Chills starting at 8pm, began having a fever around 9:30 of about 99.5. Fever worsened COVID19 VACCINE JANSSEN 0 days 1085659-1 during the night to 101. Chills continued through night. Following day fever subsided and no chills but had a horrible headache. Took ibuprofen which helped. "patient is observed in the recovery area pale and diaphorectic. v/s taken hr 71 initially,recheck was 51p. ,o2 sat ra 97%, b/p 100/60, resp 18. comfort provided. 13:00 v/s taken hr 80, resp 18, bp 120/80 o2sat ra 98%. still looking pale. comfort and support is provided. 1315 v/s taken hr 80,resp 20,b/p 130/80 02sat ra 100%. after comfort and support COVID19 VACCINE JANSSEN 0 days 1085674-1 provided pt reports feeling well. 13:30 pt continues to be monitored for possible changes. patient reports feeling well. v/a taken b/p 130/80 resp 20,hr 80,o2 sat ra 100% is oriented, and released accompanied by a family member"", RN - support staff""

COVID19 VACCINE JANSSEN 0 days 1085756-1 Severe body aches. Stiff neck muscles, unable to turn head. Tiredness. All those symptoms started before 10p on 3/8/21. 5am on 3/9 same above symptoms plus temp of 100.2. No change in body aches or stiffness. Temp at 3p was 102 COVID19 VACCINE JANSSEN 0 days 1085764-1 Full body shakes, chills, body aches, brain throbbing, fatigue, nerve zings, lightheaded COVID19 VACCINE JANSSEN 0 days 1085768-1 local reaction on left arm, red, warm and 3"" red circle, increased HR 100-110 BPM (my normal is about70)""

COVID19 VACCINE JANSSEN 0 days 1085794-1 rash all over upper torso and arms noticed within first couple hours after administration, pt called md and was counseled to take benadryl and watch for further symptoms. Pt states she's fine and no further problems beside the rash. Patient was given dose that was higher than recommended dose due to error in measurement. Patient received COVID19 VACCINE JANSSEN 0 days 1085801-1 approximately 0.6 to 0.65ml instead of 0.5ml dose. Patient has not experienced adverse effects due to the increased dose at this time. COVID19 VACCINE JANSSEN 0 days 1085836-1 Patient's entire Left Arm became numb shortly after receiving her vaccination I developed some flu symptoms (chills and aches) around 11 pm the day of the shot, and these symptoms lasted about 36 COVID19 VACCINE JANSSEN 0 days 1085882-1 hours. Janssen COVID-19 Vaccine EUA Chills & fever for 3 hours, 6 hours post shot Entire body aches for 12 hours Headache COVID19 VACCINE JANSSEN 0 days 1085894-1 Tiredness Muscle & joint pain/weakness COVID19 VACCINE JANSSEN 0 days 1085895-1 Covid like symptoms Headache Muscle ache Fatigue 4 hours after vaccine I experienced vasovagal (passed out), for the rest of the day after I experienced fever, chills, fatigue, COVID19 VACCINE JANSSEN 0 days 1085910-1 body aches -severe shaking / chills for 2 hours ...so much so that I could not get warm and my muscles hurt from shaking so much - COVID19 VACCINE JANSSEN 0 days 1085915-1 headache, body ache , both 24 hours -soreness at sight of injection Received vaccine at 8:30am . Just before sleep at 10 pm , Started getting chills and slight nausea. Went to work next day still feeling rundown with muscle fatigue but chills not as bad . Went home after full work day to rest then go to bed COVID19 VACCINE JANSSEN 0 days 1085918-1 early. Next day felt fine . All in all I had a great experience . The people (organizers and others ) at the location that day did a fantastic job. Easy Breezy . COVID19 VACCINE JANSSEN 0 days 1085951-1 Extreme inter cranial pressure, headache COVID19 VACCINE JANSSEN 0 days 1085968-1 Extreme fatigue and nausea 6w6d pregnant at time of vaccine 2 previous healthy full term pregnancies Chills:started on day 1 lasted for 2 days low grade fever, started on day 2, last for 2 days 99.8-100.4 dull headache, 3 COVID19 VACCINE JANSSEN 0 days 1086095-1 days, still a sympton breast/underarm tenderness, started on day 2 sour stomachs started on day 2, still a sympton 10 min. after vaccine - small pang of soreness through left arm, went away after a couple of seconds 7:30 PM the same day - Grade 3 fever (102.9 degrees), intense chills, joint pain, minor headache, loss of taste and smell, coughing fits. Threw on lots of blankets, drank some water, and took two Tylenol pills. 10:30 PM the same day - while on Tylenol, COVID19 VACCINE JANSSEN 0 days 1086098-1 fever dropped to 101.9. Kept taking Tylenol until I went to bed at around 1 AM. 9 AM on Sunday 3/7 - 101.2 w/out Tylenol, no chills or coughing, minor headache. Symptoms faded away over the course of the rest of the day. Back at 100% on Monday 3/8. Vaccine event: higher volume given. Approx 0.6 to 0.65 ml given to patient for Janssen vaccine instead of 0.5 ml. COVID19 VACCINE JANSSEN 0 days 1086124-1 Currently no adverse consequences reported. Vaccine event: higher volume given. Approx 0.6 to 0.65 ml given for Janssen vaccine instead of 0.5 ml. No adverse COVID19 VACCINE JANSSEN 0 days 1086140-1 consequences reported. COVID19 VACCINE JANSSEN 0 days 1086154-1 Janssen COVID-19 Vaccine EUA Awful headache, fever over 102, slow, weak, muscle aches, injection site hurts a lot. Vaccine event: higher volume given. Approx 0.6 to 0.65 ml given for Janssen vaccine instead of 0.5 ml. No adverse COVID19 VACCINE JANSSEN 0 days 1086155-1 consequences reported. The patient is 16, and should have received the Pfizer shot, which is approved for 16 and up. The patient received a COVID19 VACCINE JANSSEN 0 days 1086165-1 Janssen vaccine, which is only approved for 18 and up. COVID19 VACCINE JANSSEN 0 days 1086187-1 Sore arm, fatigue, body aches (like recovering from flu), slight chills COVID19 VACCINE JANSSEN 0 days 1086197-1 At 10:44am, Fainting, drastic drop in blood pressure, blurred vision, numb hands. That evening, chills and vomiting. Patient fainted about 2 minutes after receiving vaccine. She experience nausea, dizziness , and a moment of confusion. Patient stated at pharmacy for 1 hour after episode. She was given water and crackers but refused other medical attention. Patient denied shortness of breath: difficulty breathing. Checked patients blood pressure. It was 144/74. COVID19 VACCINE JANSSEN 0 days 1086219-1 Patient left pharmacy after 1 hour. She called when she make it home. She said she was still a little dizzy and nauseous. She had vomited. I asked patient if she was alone or if someone was there with her. She stated her sister is a nurse and was with her. Will follow up with patient on 3/10/21 5 min after shot became starting feeling unwell became faint had to lay down , was very hot, hearing was impaired , COVID19 VACCINE JANSSEN 0 days 1086228-1 could not sit up for a few minutes.

about two hours after injection, I experienced headache, then mild dizziness, then extreme dizziness, then sudden overwhelming fatigue, then swollen eyes and eyelids, then chills and elevated heart rate, with pounding. I had to cancel the class I was supposed to teach, because I would not have been safe to drive to campus. I slept from approximately 2:30 pm on March 8 until 8:30 am today, March 9, all symptoms continuing, with bathroom breaks, a COVID19 VACCINE JANSSEN 0 days 1086231-1 couple of short reports to family members who were watching out for me, and one 2-hour window during which I ate a small meal, went back to bed, and read part of a book. During bathroom breaks I took more antronex, some milk thistle, and some glutathione, which seemed to at least temporarily reduce dizziness and eye/eyelid swelling. At one point I took some hawthorne tincture because I was concerned about the heart pounding. Today I woke up feeling symptom-free, but by 2 pm I was compelled by sudden fatigue to take a two-hour nap. After that I felt better, and I think I am now fine, at 7:45 pm on 3/9/21. I am happy to have gotten the Janssen vaccine, because it is one and done! 3/6 3:30pm received vaccine. 6pm felt foggy, extreme exhaustion, irritable, nauseated, arm pain. Headache 3/7 12:30am restless in bed with muscle pain in thighs with burning sensation down into calves and up into lower back. 4:30am fever of 102 degrees Fever all day till about 8pm when temperature dropped below 100 degrees. Chills COVID19 VACCINE JANSSEN 0 days 1086248-1 throughout day Extreme fatigue throughout day Headache 3/8 No fever in AM 8pm felt queasy & nauseated continued overnight. Extreme fatigue continued Slight cough Headache 3/9 Temperature over 100 Chills Queasiness and nausea continued throughout remainder of day. 6:30pm lesser sense of taste Headache COVID19 VACCINE JANSSEN 0 days 1086251-1 Fatigue/malaise, body aches, minor arm soreness bilaterally COVID19 VACCINE JANSSEN 0 days 1086256-1 HR 81; BP 148/96; O2-96; pt experiencing some sweats but not in any distress Uncontrollable shaking along with being bone chilling cold for approximately 2-3 hours; vomiting; severely itchy mouth COVID19 VACCINE JANSSEN 0 days 1086293-1 and nostril (on left side); dizziness; intense cramps in thighs; minor headache Patient fainted about 5 minutes after receiving the vaccine. She was in the monitoring area and fell over and hit her head on the ground. I went to her aid and monitored her until the paramedics showed up. She was unconscious for a 10- COVID19 VACCINE JANSSEN 0 days 1086309-1 15 seconds with her eyes open before regaining consciousness. IShe was not having breathing problems or other symptoms of anaphylaxis so i did not administer an epi-pen or benadryl to her. I rolled her on her side in case she became nauseas. Then the paramedics arrived and attended to her. Patient stated after about 15 minutes after receiving vaccine that her face felt numb, she said it feels like it spread from COVID19 VACCINE JANSSEN 0 days 1086316-1 her arm where the shot was given up into her neck and into her face which was numb and tingly Got vaccine at 12:30am, was home asleep by 2:30. Head was insanely stuffy when I woke up around 8:30, my ears hurt on the inside and I couldn?t hear well. My lungs felt kind of funny, as if I?d taken too much asthma medication. By noon COVID19 VACCINE JANSSEN 0 days 1086317-1 my lungs were burning with every breath, my eyes were hot and weepy, the fever and muscle/joint aches had gotten really bad, and I had pain in my neck under my jaw between chin and ears. fever over 102, chills and shakes. chills went away around 4:00 am, fever was gone when I woke up....Slight headache COVID19 VACCINE JANSSEN 0 days 1086323-1 during the day Saturday, headache was gone on Sunday when I woke up.

pt states she had unusual taste sensation at time of injection. She then felt a ""weird feeling"" in her chest area. She COVID19 VACCINE JANSSEN 0 days 1086324-1 desribed it as a pressure (not pain or inflammation). We discussed treatments of ADR. We opted to have her wait longer. She stayed 37 min. During that time the pressure sensation moved lower in chest area and reduced in sensation. She was feeling comfortable at that time and left pharmacy area. RPh followed up 3/9 734 pm and she was doing well."" COVID19 VACCINE JANSSEN 0 days 1086333-1 Patient fainted after receiving vaccine. Regained consciousness shortly after and began throwing up Janssen COVID-19 Vaccine EUA High fever started 9 hours after vaccination, continued until 24 hours after vaccination. Nausea and dizziness started 9 hours after vaccination, continued until 12 hours after vaccination. 5 weeks pregnant- COVID19 VACCINE JANSSEN 0 days 1086358-1 spotting started 25 hours after vaccination. No proven correlation between potential miscarriage and Vaccine. Generalized, spotty red rash, slightly raised, no itch, on the front torso, from top of legs, groin area, up to shoulders, on front torso only (not on arms or back) 33 hrs after vaccination. Spiked a temperature of 102 degrees 4 hours after getting the shot. Had severe chills where my body was shaking. COVID19 VACCINE JANSSEN 0 days 1086360-1 Next day was down to 99.7 but had to stay on the couch all day due to body aches, head ache, etc. On Monday (Got the shot on that Saturday) I felt like myself around 10am. Patient came in for Janssen COVID vaccine that was scheduled electronically online. All appropriate prescreening was done and patient had no previous allergies or issues. Patient was instructed to sit in one of the chairs designated for post vaccine observation for 15 minutes after her vaccine. Within a minute or so patient felt light headed and like she might pass out. She notified the technician who was right there and he notified me. I assisted her to a sitting position on the floor from her chair and I was able to ease her back to a lying down position from there with her head on the floor and feet elevated above heart on a chair. Patient was able to talk the whole time. She told us at that point when she was younger she was scared of shots and had fainted when having them, but thought she was past that and did not COVID19 VACCINE JANSSEN 0 days 1086361-1 mention it during screening. She said she was surprised to feel this way because she was so excited about getting her COVID vaccine. She had not eaten much today (a small snack) and had rushed here for her appointment without getting food. I checked her blood pressure while she was lying down and it was 94/63 and pulse of 75. She said she normally had lower end of normal blood pressure. She was pale when I started checking her, but her color began to return to normal within minutes. After 5 minutes she felt well enough to sit up and we got her a granola bar and water. She remained this way for 5 minutes and felt good, so we moved her to sitting in a chair and got her a pepperoni and cheese snack tray from the cafe. She ate this and waited for 10minutes and felt good. We walked her to her car and she felt fine. I called to verify she got home fine and she did. Patient came in for Janssen COVID vaccine that was scheduled electronically online. All appropriate prescreening was done and patient had no previous allergies or issues. Patient was instructed to sit in one of the chairs designated for post vaccine observation. Within minutes (less than 3), patient was very dizzy, clammy (cold sweats), pale and said he did not feel right. I assisted him to a sitting position on the floor from his chair and we were able to ease him back to a lying down position from there with his head on the floor and feet elevated above heart on a chair. Patient said that the cold floor actually made him feel better instantly. At 4:18pm after lying down for about 3 minutes we checked his blood pressure with him still lying down. It was 110/88 and pulse of 104 (so slightly elevated pulse). He said he was feeling better and we kept him lying down. Patient's wife was also there so she was able to provide information in addition to him doing it also. She did state that he occasionally had panic attacks and she thought this might be one, the patient was adamant that it was not. At 4:24 pm we checked his blood pressure again and it was 100/90 and Pulse of 104. He COVID19 VACCINE JANSSEN 0 days 1086369-1 was feeling quite a bit better so we had him come to a sitting position on the floor and he had not eaten in a while so we got him a granola bar and water. Pt slowly ate these and begin to feel clammy and sweaty again within 3-4 minutes. We checked his blood pressure again and it was 104/90 and pulse of 100. He wanted to stay sitting to see if it would pass. We did continuously observe injection site and screen for any other symptoms of an allergic reaction (nausea, cramping, swelling, and none of these were occurring). Since he was still not feeling well we gave the patient 50mg of benadryl (20 mls of 12.5mg/5ml liquid benadryl) with his approval. After about 10 minutes of sitting total he was still having cold sweats and feeling dizzy so we had him lie back on his back with his feet elevated while the benadryl kicked in. By 4:50pm he was feeling well enough to sit back up and we got him some wraps and a coke from the cafe to eat. Pt continued to consistently improve and was ready to leave about 5:20pm. We advised him and his wife of signs and symptoms of allergic reaction and to have those treated to immediately at urgent care or and ER. We also told him to follow-up with his PCP. I had a manager help walk them to their car. They were very kind and grateful. I will follow-up with a call tomorrow and again on Friday to make sure he continues to do well. Quick onset of fever (peaked at slight above 100 deg F), chest pains, shortness of breath, and severe chills about 11 hours COVID19 VACCINE JANSSEN 0 days 1086380-1 after vaccine was taken. These symptoms were mild the next morning and afternoon and I was able to work fine from home. This evening, my fever once again flared up to 100 deg F. Pt was on his 15 minutes observation period after the covid-19 vaccine. About 10 minutes after receiving the vaccine, he said he had pins and needle feeling on his left arm from his elbow to his ring and pinky fingers. He also had a ""warm COVID19 VACCINE JANSSEN 0 days 1086405-1 feeling"" at the same area. We recommended him staying longer for observation. After about 10-15 minutes he wanted to leave. He now describe it similar to ""numbness on your foot when you sit on it too long"". He said he would be okay and he left."" No symptoms within first 2 hours of vaccination. At about 2 hours, became extremely sensitive to light and sound, severe headache/migraine (pain 7/10) to left side, and heavily fatigued. No discomfort at injection site. Temp 99.1¶F, muscle pain, weakness, stiffness approx 5 hrs after injection. OTC Tylenol (700mg) taken around 7 hrs after injection with no COVID19 VACCINE JANSSEN 0 days 1086421-1 relief of symptoms. Unable to stay awake, slept approx 12 hours from 21:30 on 03/08/2021 until 09:30 on morning of 03/09/2021. All symptoms still active, headache improved slightly (5/10) but muscle stiffness, muscle pain, and fatigue worse. Nausea and mild abdominal pain/cramping around noon. Fever of 101.2¶F at 13:00 on 03/09/2021, 100.0¶F at 16:00, and down to 99.1 at 20:00. COVID19 VACCINE JANSSEN 0 days 1086428-1 start to have fever, chill, and body ache after 8 hours later (99-102) , last for 36 hours COVID19 VACCINE JANSSEN 0 days 1086434-1 Significant body aches and pain all over body, fatigue, headache, injection site pain the night after getting the vaccine COVID19 VACCINE JANSSEN 0 days 1086445-1 Severe headache , chills, fever, sweating, whole body aching. Nausea vomiting and stomach pain COVID19 VACCINE JANSSEN 0 days 1086457-1 Fever. 102.9. Chills. Nauseous. Vomited. COVID19 VACCINE JANSSEN 0 days 1086485-1 chills, aches, nausea, high fever:103.9 and rising. At 5:00pm, March 5th (7.5 hours after the jab) I suddenly got cold chills, nausea, and terrible headache. I eventually COVID19 VACCINE JANSSEN 0 days 1086497-1 threw up. I hade joint aches and I couldn?t seem to get warm. At 1:00am, March 6th after taking aspirin as directed on the label, my headache subsided and I felt famished and I felt like a new person. COVID19 VACCINE JANSSEN 0 days 1086503-1 Hardened and swollen 2inches at injection sight lasting more than 3 days + sore to touch Fever and chills started all of the sudden around 5:15 pm on day of vaccination (3/8). Fever and chills have continued COVID19 VACCINE JANSSEN 0 days 1086505-1 through say and evening of 3/9. vasovagal syncope or seizure? After receiving the drive-through vaccine, we drove into a parking space to sit and make sure I was ok. Within 5-10 minutes, I was sitting in the car and sending a text and with no warning whatsoever mid-text lost consciousness, profuse sweating, wheezing, lost color in my skin, was making unintelligible noises, and eventually woke up about a minute later but couldn't speak or comprehend those speaking to me (according to my wife who was COVID19 VACCINE JANSSEN 0 days 1086511-1 terrified). I was not nervous, stressed, or scared of receiving a vaccine. I regained the ability to speak about a minute later and my wife had summoned the staff on the scene who instructed me to lie back and breathe without a mask. I drank some liquids. A nurse was called over and offered to take my vital signs but I decided I felt ok enough not to. Eventually my normal skin color and came back and sweating stopped after about 5 minutes. We sat for a few extra minutes and once I felt it was past me, my wife drove us home. Patient received Janssen vaccine after denying having a previous COVID-19 vaccine. She then showed her other card which indicated she had Moderna 031L2DA on 1/31/21 but she had allergic reaction of hives. She came on 3/7/21 to COVID19 VACCINE JANSSEN 0 days 1086512-1 Facility and was turned away for already having reaction to previous vaccine. She states she was cleared by allergist and returned on3/9/21 for the Janssen vaccine and showed up with her 3/7/21 ticket. Unfortunately it was not caught in time and she was vaccinated with COVID. She is being observed for over an hour. Experienced extreme chills starting at 4 pm and through the evening/night. At about 3 am I started getting very sore in COVID19 VACCINE JANSSEN 0 days 1086520-1 the left injection arm and throughout my back/shoulders. COVID19 VACCINE JANSSEN 0 days 1086524-1 Dizziness Euphoria feeling Diarrhea Cold sweats Sore throat Injection site pain COVID19 VACCINE JANSSEN 0 days 1086528-1 Nausea, hot and cold, lethargic. After getting it I went home and slept about 3 hours and woke up with fever of 99.3. Had a pounding headache that Tylenol nor ibuprofen could relieve. Body began to ache to the point I was in tears. Checked fever again and was at 99.9. Took more Tylenol and Ibuprophen and went to bed as much as I could. Woke up and took Tylenol the next morning. COVID19 VACCINE JANSSEN 0 days 1087173-1 Checked temperature because I still had a pounding headache and was at 100.2, started sweating and shaking as in cold sweats. No appetite. Spent most of the day resting with most symptoms still accruing. On 3rd day I have no fever. I?m not as weak and I?m able to get around a lot better. Still a little nauseous but definitely feeling better then the previous days.

9 hours after shot - Sudden on set chills. and shaking that lasted for more than hour. Followed by vomiting and COVID19 VACCINE JANSSEN 0 days 1087237-1 headache. Headache continued through night. Next 2 days I had fatigue and nausea. Mid day on March 8, I developed swollen bottom lip and on morning of March 9 had hives under lower lip, chin, neck and itchy feeling on neck and face. Patient developed generalized itchiness and nausea 2 minutes after getting vaccine. She has history of food , sulfa, cipro, fluconazole. No rash/hives. Vital signs BP 134/88, Pulse 108, Resp rate 24. EMS was notified and because one team was out transport 911 had to be called. She received epi pen from POD at 1:10AM in Left lateral thigh. VSS. A few minutes COVID19 VACCINE JANSSEN 0 days 1087243-1 later still reported generalized itching and was given Benadryl 50mg PO tablet. FD paramedics on scene and administered IV benadryl, patient became nauseous and dry heaved. She was transported patient to Hospital in the village. Continued to have Dizziness Followed (15minutes later) Nervousness Confusion Overall body weakness Continued to experience Sore throat with dehydration in my lips and mouth (happening more quickly than I thought possible) Water (16 ounces) did not reduce the dehydration Cold sweats all over (excessive moisture) Diarrhea did decrease quickly COVID19 VACCINE JANSSEN 0 days 1087244-1 (within 2 hours of vaccine) Was released from work (United Supermarket Deli) at 7:00 pm Got home and immediately laying down Called the hospital Hospital said call the Pharmacy that administered the vaccine Pharmacy was already closed Fell asleep a while later feeling very exhausted COVID19 VACCINE JANSSEN 0 days 1087260-1 Fever, chills, tired, headache COVID19 VACCINE JANSSEN 0 days 1087261-1 Fever of 102, chills, aches, minor heart racing, injection site pain, headache After patient was vaccinated, she stood up and had loss of consciousness, falling backwards onto floor and +hit back of COVID19 VACCINE JANSSEN 0 days 1087278-1 her head. She does report history of syncope after injections. BP 96/58, P48, R17, O2=98%. Alert and oriented. No deformity. Moving all extremities. Denies headache, nausea. She was on stretcher and after 15 minutes felt better. COVID19 VACCINE JANSSEN 0 days 1087282-1 Fever of 101.6, chills, body aches, back ache, head ache, diarrhea, ear ache. Chills, body aches and fever about 7 hours after the shot. I took Tylenol and it made the symptoms more mild. I was fever COVID19 VACCINE JANSSEN 0 days 1087283-1 free at about 11am the next day. My injection site and arm still hurts 3 days later and I have a swollen and sore gland in my collar bone on the same side as my shot was given. Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Hyperventilation-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient was extremely anxious when she came in for vaccine COVID19 VACCINE JANSSEN 0 days 1087310-1 informing vaccinator that this was her second appointment because she had cancelled the first appointment due to anxiety of side effects (was worried she \""was going to die\""). She stated that her mouth was slightly numb/itchy and that for a moment it was her whole body. Then stated that her mouth had become dry from being anxious about the vaccine. After giving a dose of diphenhydramine & getting the patient to calm down the rxn subsided"" COVID19 VACCINE JANSSEN 0 days 1087313-1 Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt was escorted to waiting area and sat in chair. Within 5 mins of sitting down, pt's head fell backwards and hit the wall behind her slightly, slipped out of the chair and fell on COVID19 VACCINE JANSSEN 0 days 1087315-1 floor. Pt got up as soon as she was on the floor. The incident transpired in less than one minute and she regained consciousness. Pt was given water and said she felt \"" the blood rushing back\"" and felt \""much better\"". Had pt stay around for > 30 minutes and was picked up by friend. Per pt, she was not hurt"" Roughly 6 hours after the shot I started feeling side effects which included; achy joints, low fever, mild headache, tired and run down like I was getting a cold. The symptoms laster through the night and into this morning when I woke up COVID19 VACCINE JANSSEN 0 days 1087316-1 feeling a bit better. It's been 13 hours since the first side effects and at this point I feel run down but most of the other symptoms have subsided. Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: COVID19 VACCINE JANSSEN 0 days 1087317-1 Weakness-Mild, Additional Details: Patient alerted me that he was feeling unwell, he started hyperventilating, sweating, shaking, experiencing tingling and numbness throughout his body. Patient was dizziness. He received an epinephrine shot in which he then layed on the floor and started calming down. Paramedics came and checked him out and found him to be alert and well. Patient left store fully recoverd and consulted to go to emergency room if he had any symptoms of an analyphylatic reacction. COVID19 VACCINE JANSSEN 0 days 1087318-1 Chills and a 102 degree fever for at least 8 hours COVID19 VACCINE JANSSEN 0 days 1087321-1 Syncope after getting vaccine. BP 95/60, P 100, O2sat 96%. Improved after 2 minutes but monitored for 20 minutes. Janssen COVID-19 Vaccine EUA Six hours after I received the vaccine I began to feel full body muscle aches and shivers. I took 2 Advil. I went to bed at 9:30 p.m. and woke up at 11:30 p.m. feeling as though I had slept 8 hours because I had a 102 fever. My face was burning from the heat and I was shaking. I took two more Advil. About 30 minutes later I threw COVID19 VACCINE JANSSEN 0 days 1087322-1 up. I waited 30 more minutes and threw up again. As a result, of having Addison's disease, I have an emergency steroid injection that I use during crises such as this. I took my shot and immediately began feeling slightly better. I was able to go back to bed and at some point the fever went down overnight. I am currently feeling weak and with no fever. I also have a slight headache. Syncope and fell on her hands and knees. No head trauma. No other injuries. BP 110/77, 85, O2 sat 96%. She was COVID19 VACCINE JANSSEN 0 days 1087332-1 observed for 35 minutes. She felt better and went home. COVID19 VACCINE JANSSEN 0 days 1087340-1 Fever, chills, shivering, whole body aches Muscle soreness and fatigue. Starting at around 6:00 last night and continuing into today. Took Tylenol to reduce pain COVID19 VACCINE JANSSEN 0 days 1087349-1 and soreness. Muscle pain all over body, specifically glutes, lower back back, and arms. Fever above 99¶ F Chills and sweats at the COVID19 VACCINE JANSSEN 0 days 1087351-1 same time Headache with pulsating nerve pain on sides and ears. Dryness in mouth no matter how much water intaked Treatment: tylenol and bed rest In the evening I started to feel aches in my eyes and joints. I was having trouble falling asleep. I woke up every 2 hours. My heart bpm went up to 102 in the middle of the night. I know this because my fit bit was vibrating and encouraging me to keep exercising and I was just laying in bed trying to sleep. I finally got up around 2:30 in the morning and took 1 Aleve. I also took my temperature with a forehead type and it was 98.5, so no high fever. I took another Aleve around COVID19 VACCINE JANSSEN 0 days 1087389-1 7:00 in the morning. Now I am feeling fine. It's now 8:22 a.m. and I am working from home. I just wanted to report that the aches in joints and 102 bpm and unable to fall asleep were my side effects. I feel fine now. I will continue to take Aleve as needed. I have never been tested for Covid. I have never had any symptoms to warrant testing for covid. Since March 13, 2020 I have been fortunate to work for a company that has us all working from home. We are still working from home. i am 63 years old. I shop around 6 a.m. in the morning for groceries to avoid people. I do not go out. I have been very careful. Fever, shakes, severe body aches and sharp pains throughout my body. Nausea and vomiting and constant use of the COVID19 VACCINE JANSSEN 0 days 1087390-1 bathroom. Dizziness, and severe migraine, fatigue and trouble breathing that lasted 2+ hours. COVID19 VACCINE JANSSEN 0 days 1087407-1 Fever, chills, numbness and tingling of face, weakness, headache, sore throat, rapid heart rate. COVID19 VACCINE JANSSEN 0 days 1087409-1 Fever (101 degree), headache, muscle aches, chills. Treated with tylenol and rest. So far it seems to be helping. Janssen COVID-19 Vaccine EUA About 6 hours after receiving vaccine, sudden onset of fever to 101 degrees with chills. About two hours after the fever began, extreme fatigue and muscle and joint pain, and left breast pain began (had the injection in my left arm). The extreme fatigue lasted for about 9 hours, during which time I felt like I could barely walk or COVID19 VACCINE JANSSEN 0 days 1087411-1 move in bed. After the extreme fatigue passed, and for about 24 hours, I continued to experience moderate fatigue, joint and muscle pain, and headaches. A bad headache has bothered me for about 36 hours since the extreme fatigue passed. All symptoms are now clearing up (it is now about 42 hours post vaccination). COVID19 VACCINE JANSSEN 0 days 1087416-1 Janssen COVID-19 Vaccine EUA Nausea, headache, fever, muscle soreness WITHIN 5 MINUTES OF RECEIVING VACCINE PATIENT BEGAN FEELING VERY LIGHTHEADED, SWEATING, AND SPINNING. PATIENT SAID SHE NEEDED TO LAY DOWN. AS WE BEGAN LAYING HER DOWN SHE DID PASS OUT. AFTER LAYING ON COVID19 VACCINE JANSSEN 0 days 1087418-1 THE GROUND WITH ELEVATED LEGS SHE REGAINED CONCIOUSNESS WITHIN ABOUT 30 SECONDS OR SO. PATIENT CONTINUED TO LAY AND THEN SLOWLY SIT UP. AFTER APROX 20 TO 30 MINUTES SHE WAS FEELING OK AND WAS ABLE TO GO HOME

COVID19 VACCINE JANSSEN 0 days 1087423-1 About 9:00 PM got chills. Finally broke around midnight and after that was hot and achy. Today body aches, head ache, and eyes hurt. This is a similar reaction to what I have with the flu vaccine. I no longer get the flu vaccine because of this. COVID19 VACCINE JANSSEN 0 days 1087441-1 headache for ~15hours body aches for ~15 hours fever 100.1 - 7 hours After 7 hours, I started to feel like I had a migraine. Then my whole body ached horribly, I had chills, a fever, difficulty COVID19 VACCINE JANSSEN 0 days 1087450-1 breathing At 5p, started to get a headache and body aches. By 6p, fever was 99.5. At 8p, fever was 101. The rest of the night featured a headache, body aches, chills, fever of 100.5 to 102.5 and nauseated (dry heaved twice) Took tylonel every 6 COVID19 VACCINE JANSSEN 0 days 1087453-1 hours to try and help. Next morning (current as of writing this), felt a little better as fever dropped to 99.5 and nausea significantly lowered. Still have a headache and aches in legs

Fever Chills Sweats Light arm pain Headache Horrible muscle Aches Horrible muscle fatigue Low grade fever while taking COVID19 VACCINE JANSSEN 0 days 1087457-1 extra strength tylenol 99.7 Nauseousness Light headed Tossed and turned all night in such pain and chills and sweats Felt like I was going to pass out on my commute home could barely walk my limbs were so heavy and tired and numb At 4pm I spoke a fever and chills- lasted until 2am. Skin had spots on left arm, left calf and face that felt like a bad COVID19 VACCINE JANSSEN 0 days 1087458-1 sunburn

COVID19 VACCINE JANSSEN 0 days 1087489-1 I had a pretty bad reaction to the shot got the shakes and aches was up and down about every 20 minutes head was pounding felt like my brain was on fire fever finally broke about 6am next morning woke up totally drenched and sweat COVID19 VACCINE JANSSEN 0 days 1087491-1 Chest tightness/pain, headache, body aches, rash, fever and chills Severe joint pain, severe muscle pain, fever 100.5, swelling in joints, and headache started at around 2pm of the same day of vaccination and continued into the night. Took 600mg of ibuprofen every 4 hours to control pain. After second COVID19 VACCINE JANSSEN 0 days 1087494-1 round of ibuprofen pain was tolerable. Day 2: when going off of ibuprofen severe pain returns with limited mobility again. Will continue ibuprofen for day 2. Headache, Fever (100.2), severe chills, severe body aches starting 12 hours after injection. Severe symptoms lasted 8 COVID19 VACCINE JANSSEN 0 days 1087499-1 hours. Ibuprofen lessened symptoms. Symptoms gone 48 hours after injection. Received shot at 2:15 pm and around 9:30 pm, I started to have the chills/shaking. It then went between chills to COVID19 VACCINE JANSSEN 0 days 1087509-1 sweating profusely. I took Advil before going to bed. I have a slight heading now (9:00 am, 3/10/21). COVID19 VACCINE JANSSEN 0 days 1087512-1 Intense body and joint aches all over my body. Fever hovering between 100.3 and 101.2 all over body aches, extreme exhaustion and headache - tiredness noticed late afternoon - gradual progression to COVID19 VACCINE JANSSEN 0 days 1087528-1 exhaustion - fever of 99.2 in the night and a residual head throb in the morning COVID19 VACCINE JANSSEN 0 days 1087536-1 Headache, chills and vomiting twelve hours after my shot. Eight hours later I broke out in hives. body pain immediately following vaccine--left side of body--same side as vaccine: neck, sides, hips, back. That ended within a half an hour. Felt ok for a few hours. Headache starting around 2:30. Neck and back pain around 8. Chills, body COVID19 VACCINE JANSSEN 0 days 1087540-1 aches, fever throughout the night and into the next day. Chills subsided. Body aches continued. Side/rib pain noted for 2 days. Sweats continued on and off. Localized arm pain for 4 days.

I felt no immediate side effects of the shot, but 2 hours later, while sitting calmly, my heart rate suddenly elevated and I began to feel light headed. My home blood pressure monitoring kit provided a reading of 149/99 and a resting heart COVID19 VACCINE JANSSEN 0 days 1087548-1 rate of 108. Normally, my blood pressure is very well maintained with my meds and hovers in the 118/75 range. My resting heart rate is usually below 70. I was going to dial 911 but within 5 minutes, my heart rate began to slow down and I felt better. When I rechecked my numbers at 8 pm, BP was down to 118/80 and resting heart rate was 70. General malaise within 1 hour of injection. Worsening to fever, chills, severe headache, and nausea within 6 hours of COVID19 VACCINE JANSSEN 0 days 1087565-1 injection. No medication taken. Symptoms returned to general malaise 30 hours after injection. COVID19 VACCINE JANSSEN 0 days 1087567-1 Fever up to 102 Severe headache for 24 hours Nausea Chills Severe joint pain - felt like I was in fire High fever, headache, muscle pain, neck pain, dizziness, tremors starting with in 7 hours of injection lasting all night and COVID19 VACCINE JANSSEN 0 days 1087580-1 next day COVID19 VACCINE JANSSEN 0 days 1087591-1 Strong Headache for about 18 hours, and full body muscle ache for about 24-36 hours. Patient experienced a seizure lasting 2-3 minutes approximately 1-2 minutes after receiving the vaccine. patient has a COVID19 VACCINE JANSSEN 0 days 1087595-1 history of seizures/epilepsy. Extreme tiredness, fever over 103 for 2 days, migraine headache day of and 3 days afterwards. Extreme sweating and COVID19 VACCINE JANSSEN 0 days 1087603-1 chills Janssen COVID-19 Vaccine EUA Symptoms started yesterday, March 9th, with muscle aches in my lower back a couple hours after receiving the shot. The muscle aches spread throughout my body as time went on, and joint pain and headaches came as the muscle aches worsened. I took two ibuprofens, though they had no effect. A bit later in the day, I COVID19 VACCINE JANSSEN 0 days 1087646-1 developed a fever and felt very nauseous. When I went to sleep, I had a hard time staying asleep and ended up vomiting when I woke up at around 1:00AM. Today, March 10th, I continue to have muscle aches, joint pain, a headache, and slight nausea. Chills started about 8:30pm. Shaking started about 9:00. Fell asleep and woke up at 11 with sweats and fever of 101.9, COVID19 VACCINE JANSSEN 0 days 1087659-1 terrible headache and muscle aches. Took 2 Tylenol and 2 ibuprofen which brought the fever down but the body aches and headache lasted until well into the afternoon of the 9th of March. Fever, aches, chills, sweats, racing pulse, swollen ears, vomiting. Fever and aches continuing to the next day. Unable to COVID19 VACCINE JANSSEN 0 days 1087671-1 sleep due to pain and getting up several times at night to vomit. COVID19 VACCINE JANSSEN 0 days 1087673-1 chills, headache, muscle aches, severe nausea, slight fever, very tired Fever (no temp taken), chills, nausea, headache, fatigue, no hunger. Symptoms onset Saturday 3/6/2021 at 10:30 PM subsided at 4:00 AM but fatigue and nausea were still present until Monday 3/8/2021. Monday evening 3/8/2021 COVID19 VACCINE JANSSEN 0 days 1087678-1 symptom onset of fatigue and nausea were present again. Tuesday morning 3/9/2021 fatigue and nausea with possible faintness were ever present but subsided about 11:00 AM. Fatigue is still present today (Wednesday) 3/10/2021 with some nausea.

fever Advised caller injection site pain, fatigue, headache, muscle aches, chills, joint pain, and fever can occur following COVID19 VACCINE JANSSEN 0 days 1087679-1 COVID-19 vaccination. Swollen lymph nodes and nausea have also been reported, but not as common. Please seek medical attention if experiencing any shortness of breath, throat swelling, weakness, or diffuse body rash. COVID19 VACCINE JANSSEN 0 days 1087680-1 She experienced headache and fatigue for a couple of days. She took acetaminophen and rested to recover and it helped. Fever of 99-100, plus chills and slight headache that started at about 8pm on 03/08/21. Fever broke around 9am on 03/09/21. I took Tylenol twice, once in the evening and once in the morning. Developed a fever (99.1F) and slight COVID19 VACCINE JANSSEN 0 days 1087694-1 headache again at 7pm 03/09/21. This was not as severe and was lessening by 11:30pm (98.6F). My normal temperature is about 97.6F. I took Excedrin migraine at the onset of the fever and headache. COVID19 VACCINE JANSSEN 0 days 1087700-1 Chills, uncontrolled shaking, headache, body aches COVID19 VACCINE JANSSEN 0 days 1087708-1 Extreme chilling and body aches. Aching lasted about 24 hours. COVID19 VACCINE JANSSEN 0 days 1087711-1 Arm soreness (injection arm), low grade fever COVID19 VACCINE JANSSEN 0 days 1087729-1 Fever 101.4 for about 24hrs with headache and fatigue 12 hours post injection developed severe chills, HA, muscle pain and fever of 101.1 along with moderate injection site COVID19 VACCINE JANSSEN 0 days 1087730-1 tenderness with slight itchy rash on arm. Took 500mg Tylenol and went to bed. Felt better in morning fever down to 98.8 with additional Tylenol taken at 0500 am before arising. Moderate fatigue. pt states that afternoon after she got the covid vax that she developed fever, body aches, chills, loss of appetite, COVID19 VACCINE JANSSEN 0 days 1087752-1 headache. Feels just like she did when she had the Covid Virus. Her urine is dark yellow and she is sweating profusely. Pt still has all of these symptoms and has a phone visit w/ her PCP today 3/10/2021. COVID19 VACCINE JANSSEN 0 days 1087761-1 Got shot at 1:30pm. At 7:30 pm got very tired. Went to be at 8pm. Chills, headaches body aches, very tired After the vaccination, I felt a little dizzy waiting in the parking lot and had a sore arm, but felt fine otherwise. (12:00- 1:00 pm) After returning home, I felt increasingly tired and warm. I laid down and took my temperature after walking the dog around 3:00 pm. My temperature read 99 degrees. I drank a lot of pedialyte to hydrate. Throughout the COVID19 VACCINE JANSSEN 0 days 1087771-1 afternoon, I felt sluggish and the glands seemed to swell up on the side of my neck. I also got a headache. My temperature dropped down to 98.7 before I went to bed, but this morning, my glands under my jawline are a bit more swollen and I still have a slight temperature; 98.9 degrees. My eyelids are puffy and I feel a little feverish, but it is tolerable. COVID19 VACCINE JANSSEN 0 days 1087774-1 Muscle Aches, Body aches, Lethargy, Headache, Lasted 24hours. COVID19 VACCINE JANSSEN 0 days 1087791-1 Fever, chills, nausea, headache i have experienced head ache, fatigue, fever of 101.2, body ache for 24 hours now , i have been taking Tylenol for the COVID19 VACCINE JANSSEN 0 days 1087797-1 past 24 hours but i cant brake the fever Fatigue, body ache, chills, headache. Chills starting Monday night/Tue morning while trying to sleep. Restless through COVID19 VACCINE JANSSEN 0 days 1087798-1 night, then very tired Tue. Took Tue off from work and spent at home. All largely better by Tues evening. Wed morning, left arm still tender at injection site, but nothing serious. Within 30 minutes post vaccine administration, patient started having seizure like symptoms (Altered mental status, COVID19 VACCINE JANSSEN 0 days 1087806-1 clenched jaw, non-verbal, right sided headache) - V/S WNL, Ambulance called and patient was taken to ED for evaluation. Responsive during transport to ED. Patient reported back to baseline after 1.5 hours.

received the vaccination at 0900 and has since developed bluing of the fingertips, chills, fever of 101 and tingling of the COVID19 VACCINE JANSSEN 0 days 1087807-1 fingers. She has taken 2 Tylenol for her fever. Advised would recommend eval to HCF for symptoms. They will go to Medical Center. Followed up with caller who adv that they went to the ED. She was evaluated and discharged home.

Symptoms started around hour 2 with nausea, injection sight was not sore but had some discomfort below injection site. COVID19 VACCINE JANSSEN 0 days 1087814-1 Continued to have nausea. Had chills in the middle of the night, chills started around 1-2 am and was gone by morning. Woke up with body aches and very tired/fatigued. By hour 18 had diarrhea. Still having fatigue and body aches. 6:30 p.m. chills, body aches, fever 99.9 8:30 p.m. nausea, fever 101.4 10:00 p.m. fever 101.9 1:00 a.m. headache 2:15 COVID19 VACCINE JANSSEN 0 days 1087825-1 a.m. headache fever 99.7 - took 2 Advil COVID19 VACCINE JANSSEN 0 days 1087826-1 Chills, fever, heart racing, swollen axial lymph nodes, headache and teeth pain. Symptoms are resolving. COVID19 VACCINE JANSSEN 0 days 1087828-1 Chills, headache behind eyes, fever, muscle pain/aches; now only bad headache and body aches; time now is 10:05; Immediate burning sensation traveled from left side of body: arm, shoulder, neck, back, left ear, and chest. Then COVID19 VACCINE JANSSEN 0 days 1087830-1 traveled across entire face eyebrows, cheeks, and lips felt numb and irritated. COVID19 VACCINE JANSSEN 0 days 1087842-1 nausea, light headedness, chills, fatigue, fever, headache, body aches advil for headache symptoms lasted ~12 hours The patient started having severe chills, and muscle aches on the back and neck at 10:00 PM . Then he took Tylenol for COVID19 VACCINE JANSSEN 0 days 1087847-1 the pain at around 12:00 AM and then started sweating profusely. I tried to get up at 11:50pm and fell. My left side felt partially paralyzed. I was up a couple of hours and was trying to COVID19 VACCINE JANSSEN 0 days 1087854-1 move my leg. I fell asleep and woke in the am and was able to walk COVID19 VACCINE JANSSEN 0 days 1087869-1 fever, violent chills, body aches, nausea Severe headache, very tired, muscle aches,fever, short periods of dizziness, several hours of the feeling of pressure on my COVID19 VACCINE JANSSEN 0 days 1087899-1 chest which then was replaced by significant burning sensation, bottoms of both feet were very painful and a wrist that i broke a couple of years ago and a knee which has caused pain in the past were very, very painful. Sore arm. About 3 hours after getting the shot, I started getting aches, feeling cold, and tired. The next morning my COVID19 VACCINE JANSSEN 0 days 1087908-1 joints ached and I had a sore throat. I took a couple of Ibuprofen (200 mg each) and about an hour later, my aches started going away. By 8 pm the next day, I didn't have many side effects. Developed a fever around 100-101 and headache around 10:30pm (approx 13 hours after vaccination). Fever has COVID19 VACCINE JANSSEN 0 days 1087957-1 persisted until the following day (3/10 as of 11:30am) and headache has worsened. I also have other mild flu like symptoms like some sinus drainage but they have remained mild She got home and did not have any reactions until last night around 10:00 PM when she got a bad headache, fever last night that was 100.1. Her back is killing her, her legs hurt and her left arm hurts as well. Her eyes are also watering. COVID19 VACCINE JANSSEN 0 days 1087960-1 She has not taken anything for the symptoms. She tired to go to work, her husband said that she did not look good. She was sent home from work, she went to the nurses station at work, had a fever of 100.2 who told her to go home, it was a reaction from the vaccine, and to call us.

Patient received J&J vaccine at clinic (lot # 1805022). at approximately 1530, patient has a history of anaphylaxis and was being observed for 30 minutes. Approximately 25 minutes into the observation period the patient was noted to be lethargic, weak, was able to answer questions stated that she felt tingling in throat, numbness, tingling in extremities, back pain. Progressed to feeling itchiness and continued lethargy, was not able to answer what day it was. At that COVID19 VACCINE JANSSEN 0 days 1087968-1 point we assissted patient in wheelchair to get on stretcher behind curtain. Patient given diphenhydramine 50 mg x 1 at 1600, patient became more lethargic and given epinephrine 0.5 mg x 1 at 1603. Vitals after epi were sbp 138, HR ?? reported as elevated, and 02 sats 98. 911 was called. Patient was also nauseous once in wheelchair and on stretcher, wretching when transferred to stretcher patients lower extremities began shaking, lasting a few seconds. Patient motioning towards throat as is if having trouble breathing. Patient remained stable until EMS arrived. I t was reported to me that patient had been cleared by her MD to receive vaccine but to be monitored for 30 minutes. Body aches, muscle pain, fever, headache, fatigue (started 8 hours post dose and lasted ~26 hours). Treated with COVID19 VACCINE JANSSEN 0 days 1087994-1 acetiminophen at first signs and then introduced ibuprofen next day. COVID19 VACCINE JANSSEN 0 days 1088042-1 Patient is 17 years of age

COVID19 VACCINE JANSSEN 0 days 1088048-1 "right after the shot I got really lightheaded, but it went away in a few minutes. then about 2am (3/10) I started having hard chills, my temperature went up to around 102, I have body aches and headache still. missed work today"""" Medication Error NOT ADE COVID vaccine clinic. vaccinator reported to pharmacy that she believes she administered a dose of 0.1ml to a patient as opposed to the necessary 0.5ml that is required. Patient had left building by the time error was discovered. We were able to identify who the patient was who received the underdose. We contacted Janssen for recommendation on either administering the additional 0.4 mL dose or a full 0.5 mL dose. Janssen had no recommendations for partial dosing, split dosing and we were instructed to follow up as we felt most appropriate. We ultimately administered the additional 0.4 mL partial dose to the patient. In reviewing incident with involved COVID19 VACCINE JANSSEN 0 days 1088049-1 Pharmacy staff, it appears that unintentionally a 1 mL syringe was given to this vaccinator amongst the standard 3 mL syringes used to administer the 0.5 mL dose. It was reported to me that the vaccinator self reported that when she was drawing up the intended dose of 0.5 mL she did not recognize that she was using a 1 mL syringe. Vaccinator drew the dose back to the first major marking on the syringe (0.1mL). On the 3 mL syringes the first major marking is 0.5 mL. The Pharmacy staff reported that the 1 mL syringe packaging and the 3 mL syringe packaging are nearly identical. After this incident Pharmacy staff segregated all 1 mL syringes to ensure 1 mL syringes were no longer supplied to any vaccinator. Going forward Pharmacy, whenever possible, will work to prevent any 1 mL syringes from being sent to a Moderna or J&J clinic were the doses are 0.5 mL. Throughout the night and into the next morning, my heart has been racing and I?ve been having some palpitations. I COVID19 VACCINE JANSSEN 0 days 1088086-1 haven?t had a fever so it?s not related to that. About five hours after vaccination received 3/8, chills and fever started, then severe headache, followed by projectile vomiting off and on all night. Heart was racing/pounding. Unable to keep anything down and became dehydrated. Contacted pharmacy in morning on 3/9 and started taking Pedialyte late morning. Also took liquid children's Tylenol COVID19 VACCINE JANSSEN 0 days 1088089-1 every four hours. Also talked with doctor's office (GP); advised to go to Urgent Care if could not keep anything down for extended period. Stayed in bed and continued regimen until went to bed 3/9. Today, 3/10, symptoms substantially better although I am weak and have some stomach uneasiness. Urination back to normal. Woke at 11:30pm with chills and fever. Kept me up the entire night with chills, headache, naurseaous. Vomited next COVID19 VACCINE JANSSEN 0 days 1088126-1 day around 5pm but felt fine with in 24 hours. No other symptoms. Covid-19 Vaccine EUA -drowsiness (begin at 545) -101+ fever (7pm, got first fever, continually on and off every 45 mins COVID19 VACCINE JANSSEN 0 days 1088132-1 since then) -uncontrollable vomiting (3:02 am- 3:34 am) -extreme muscle aches (all night) -dizziness (all night) COVID19 VACCINE JANSSEN 0 days 1088151-1 Body/muscle aches, fever 99.5-101.5, headache Chest pain, shortness of breath, fever, chills, headache, body aches, canker sores, and exhaustion within 12 hours of short. COVID19 VACCINE JANSSEN 0 days 1088162-1 Within 24 hours, spotting, continued fever, body aches, sore throat and sinus congestion. Exhaustion, chills, canker sores and sinus pain have continued. Bruising and sore arm COVID19 VACCINE JANSSEN 0 days 1088168-1 None COVID19 VACCINE JANSSEN 0 days 1088169-1 immediate low blood pressure. not allergic in nature COVID19 VACCINE JANSSEN 0 days 1088170-1 She was having headaches and dizziness the night after getting the shot. She also experienced pain at the injection site. 5 hours after being given the shot, uncontrollable tremors began. Muscles began tensing up, tunnel vision started, extreme dizziness, vomiting, severe weakness in muscles, and fainting. These lasted for about 2 hours before decreasing COVID19 VACCINE JANSSEN 0 days 1088173-1 in severity but continued to be present until about 10:30pm, 13 and a half hours after receiving the shot. Nothing was done to treat the symptoms. As of 12:30pm on 3/10, some minor symptoms are still present, such as muscle weakness and pain, severe migraine, and dizziness. COVID19 VACCINE JANSSEN 0 days 1088191-1 low blood pressure immediately after vaccine with no evidence for allergic reaction COVID19 VACCINE JANSSEN 0 days 1088220-1 immediate low blood pressure after vaccine COVID19 VACCINE JANSSEN 0 days 1088223-1 4 hours later, fever of 101, chills , muscle aches, nausea, continues 24 hours + later Shaking fever and chills all night, waking up every two hours freezing cold despite lots of clothing and blankets. Woke up COVID19 VACCINE JANSSEN 0 days 1088230-1 today feeling slightly better but still have a slight fever today, chills, and naesuea. Super lethargic and monitoring my condition daily. COVID19 VACCINE JANSSEN 0 days 1088243-1 COVID-19 Vaccine EUA Slight consistent dizziness COVID19 VACCINE JANSSEN 0 days 1088244-1 Chills, fatigue, nausea Three hours after shot: clear runny nose- constant drip. Around 11pm same evening: woke up clammy 6:30 next day: Headache. Very Sore . Felt like I?d been tubing on the lake all day. Took ibuprofen and felt better. Very tired. 9:00 pm: COVID19 VACCINE JANSSEN 0 days 1088253-1 very bad stomach cramps. Diarrhea started around 11pm. Many times. 7:30am next morning (3/10): faster heart rate. Stomach hurt but not as bad. Little headache. Hot and clammy. shivers/chills/fatigue 10-12 hours after vaccine, spent 36 hours in bed with fatigue, headache, muscle aches, nausea, COVID19 VACCINE JANSSEN 0 days 1088343-1 didn't eat or drink anything for past 24 hours, lost 5 lbs in the last 2 days, today I'm partially improved Received the vaccine at 3 am on March 8 2021. Symptoms began at 10am. Severe flu like symptoms (9 out of 10 on a pain scale, 10 being extremely painful): body aches and pains and low fever. Took both acetaminophen and ibuprofen to COVID19 VACCINE JANSSEN 0 days 1088345-1 counteract the pains (did not help much). These symptoms lasted through March 9, 2021. Today is March 10, 2021 and my symptoms are feeling moderately faint and lethargic. around 7pm I had had a cup of coffee and a brownie and I suddenly felt tight in the chest and abdomen. tums did not help COVID19 VACCINE JANSSEN 0 days 1088347-1 but didnt resolve. the next day I still had issues and was light headed. It did go away eventually. I have a history of indigestion/gas issues. Left arm went numb about 4 hours after injection and remained numb for 12 hours. Severe muscle aches began 4 hours after injection. Extreme dizziness and nausea. Fever, chills, vomiting started 10 hours post injection. Fainting upon COVID19 VACCINE JANSSEN 0 days 1088353-1 standing. Severe chest pain started 12 hours post injection. All symptoms are continuing except for the numbness in the left arm. COVID19 VACCINE JANSSEN 0 days 1088364-1 Headaches, body aches, fever, chills, sweating, fatigue. 30 hours time course. COVID19 VACCINE JANSSEN 0 days 1088374-1 Copious vomiting Headache moderate Body aches COVID19 VACCINE JANSSEN 0 days 1088375-1 Janssen COVID-19 Vaccine EAU I had a terrible headache for 2 days, chills for 2 days but slight chills for 3 days, terribly achy body, dizzy, nauseous, a little trouble focusing my eyes, diarrhea for 2 days the 3rd and 4th days, slightly sore arm. Body/Joint aches, headache, sinus pain, fever. Started about 6 hours after vaccination, took ibuprofen about 12 hours COVID19 VACCINE JANSSEN 0 days 1088403-1 after vaccination COVID19 VACCINE JANSSEN 0 days 1088406-1 fever (highest 102.3) lightheadedness took Tylenol (x2) COVID19 VACCINE JANSSEN 0 days 1088417-1 Chills unable to get warm, loss of appetite, headache and congestion, fever of 101, fatigue Patient received her vaccine with 2 family members in the room who also got the vaccine. Moments after (less than 2 minutes) giving her the vaccine, I was giving another family member the injection and patient asked if she could take her mask off. I turned around and she was very pale. She took her mask off and started slumping in her seat. She was taking COVID19 VACCINE JANSSEN 0 days 1088448-1 deep breaths and reported no difficulties breathing. She then became ill and began gagging, at which point I gave her the trash receptacle to vomit in. I had a technician grab the patient a water and packet of crackers. After half an hour of resting in the chair, monitoring her breathing, blood pressure, heart rate, and getting some food and water into her system, she appeared and reported to feel back to normal. Patient's family member mentioned she had a similar reaction a few weeks ago when getting blood drawn at her doctor's office. Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient remembered sitting down in a chair for COVID19 VACCINE JANSSEN 0 days 1088460-1 observation, then slumped forward while on his phone. He did not remember falling over and was alert and oriented right away. Emergency services were called as he sustained an injury during his fall. COVID19 VACCINE JANSSEN 0 days 1088469-1 pt became flush and had trouble breathing and fainted At 9:30 am felt warm, lower lip started to itch/burn, and scratchy throat. Flushed in face, ears, neck, upper chest, and COVID19 VACCINE JANSSEN 0 days 1088473-1 shoulders. Was given .3mg Epinephrine IM with immediate results. Flushing and itchiness went away. COVID19 VACCINE JANSSEN 0 days 1088515-1 Muscle aches and pains, fever, headache Vaccine at 11:30, at 12:30 he started feeling faint, light headed, heavy legs, little nausea. Monitored blood pressure COVID19 VACCINE JANSSEN 0 days 1088520-1 from 12:40 to 1:50, ranged 142/93 to 163/113. Pt has high blood pressure. Had he sit and recline until he felt better. Pt reported that approximately five hours after vaccination, she experienced uncontrollable tremors, fainting, vomiting, chest pain and tightness. Today, extremely fatigued and has some chest tightness. She has a history of chest tightness. COVID19 VACCINE JANSSEN 0 days 1088523-1 Did not seek emergency care last night, but called physician this morning who was not in office and referred to local health dept. Advised that it would be best to consult with local emergency facility and if anything worsens she needs emergency care. Itchy throat/tongue, skin 11AM- Treated with oral antihistamine and nasal spray Headache, Nausea, Fatigue 2PM COVID19 VACCINE JANSSEN 0 days 1088576-1 Muscle aches. low grade fever, chills- 5PM Treated with Tylenol All symptoms above continued for 24-36 hours. Muscle Aches & Fatigue Muscle Aches = Approximately 1 hour after taking the vaccine, I started to feel a little crook in my side (like I had been running). As time went on, the pain spread. My entire stomach muscles tighten up (feels like I'm recovering from abdominal surgery) and then spread to the rest of my body. Couldn't move without feeling pain. COVID19 VACCINE JANSSEN 0 days 1088587-1 Fatigue = I dozed off around 7 pm and slept like I was in a coma. Woke up around 2 am and was very confused. Muscle Fatigue = March 9th - The pain has subsided considerably Muscle Fatigue - March 10th - Still just a little sore - Can't laugh or cough without feeling pain and my back is killing me COVID19 VACCINE JANSSEN 0 days 1088642-1 I had a fever that went up to 102.4F by midnight, severe chills, and muscle pain. I took some medicines. Body aches - 1800 hrs Chills - 2000 hrs Recorded body temp, oral, of 102.4 F at 2125 hrs Extra Strength Tylenol, 1000 mg, at 2130 hrs Recorded body temp, oral, of 103.2 F at 2245 hrs Recorded body temp, oral, of 104.2 F at 2315 hrs, Pulse 110 BPM Ibuprofen, 1200 mg, at 2316 hrs, immediate cold shower for 15 - 20 mins Recorded body temp, oral, of 102.3 F at COVID19 VACCINE JANSSEN 0 days 1088672-1 2350 hrs Monday March 8th Recorded body temp, oral, of 101.5 F at 0015 hrs Recorded body temp, oral, of 96.4 F at 0700 hrs Body felt sore until Wed 10th Breathing - can take full breaths, however, discomfort felt when breathing in and out. Feeling similar to minor burns, chemical or thermal, in upper respiratory tract. Pulse Ox - consistently 98 - 99 percent Pulse has returned to normal levels with RBPM at 68 Headache Bodyaches Very weak Chills (not sure if feverish - I didn?t take my temp.) Sore muscles (back of legs) COVID19 VACCINE JANSSEN 0 days 1088679-1 Hazy/Foggy mindset Stuffy nose on morning of second day COVID19 VACCINE JANSSEN 0 days 1088680-1 Chills, body aches, fever, headache The patient reported to the pharmacist that she was feeling sweaty and nauseous after receiving the vaccine today. She COVID19 VACCINE JANSSEN 0 days 1088691-1 stated she got sweaty immediately after administration and experienced nausea during her 15 minute observation period. The pharmacist requested patient to stay for observation for another 15 minutes which she did. At the end of that period, the patient stated she felt fine and was ready to go home and sweating and nausea had gone away. AE: numbness of both arms, fingers, legs and toes Fatigue, dizziness, sweating, skin turned pale, difficulty breathing, numbness on tongue -- 1:20 pm about 5 mins after receiving vaccine Treatment: checked Blood pressure: 117/79 and HR COVID19 VACCINE JANSSEN 0 days 1088726-1 69. Gave 20ml children benadryl (50mg), water and chocolate bar. 1:30 pm Outcomes: pt stated symptoms gone away around 1:45. numbness on arms and legs gone, dizziness and sweating stopped. pt was able to stand up and walked around and went home COVID19 VACCINE JANSSEN 0 days 1088730-1 Patient experiencing hives and rash on center of chest and face (cheek bone area) patient denies any difficulty breathing COVID19 VACCINE JANSSEN 0 days 1088739-1 Dizziness, Nausea with vomiting, hot flashes and increased heart rate. Received Janssen vaccine dose, complained of feeling dizzy and lightheaded. Vital signs taken twice, normal both times. COVID19 VACCINE JANSSEN 0 days 1088740-1 Patient lay down for a short time and then reported feeling better. Refused further treatment or transport. Shot was at 7:20 am 3/9. Started feeling very cold and shaky about 1PM, took an Advil and that helped for a couple hours. By 4:30PM uncontrollable shakes, felt electric zaps, and very, very cold. Temperature around 100.9F. For a couple hours continued shaking and couldn't get warm. Finally stopped shaking and then very hot around 8pm, COVID19 VACCINE JANSSEN 0 days 1088742-1 Temperature was 103.5F. Took Advil and tried to cool down. Heart rate was around 120bpm and pounding hard for a number of hours. Couldn't sleep due to pounding heart. Finally around 3am the next morning heart rate back to normal and temperature back to 100.9. Achy throughout the afternoon and night yesterday and this morning. Feeling much improved at 3pm on 3/10. Temperature 99.5F. Patient stated ""I am going to pass out."" Patient received the Johnson and Johnson vaccine about 10 mintues prior to onset. Patient was located at the recovery station with her son. Patient began to hyperventilate and states she felt like COVID19 VACCINE JANSSEN 0 days 1088770-1 passing out. Patient then went unresponsive and blood pressure was unable to be red. Epi pen was given in right thigh and EMS was called. Patient was transported via EMS to Hospital for evaluation with family members."" On 3-10-2021, Covid Vaccine administered IM L deltoid at 12:15 PM. At 12:25 PM Pharmacist was notified patient symptoms of head and face tingling and throat swelling. BP 165/90 pulse 68 at 12:28PM. Patient described s/sx rapidly developing and described severity as 10/10 with difficulty breathing. Epinephrine (Epipen) administered in R thigh at COVID19 VACCINE JANSSEN 0 days 1088771-1 12:30PM. By 12:34 patient described symptoms as already decreasing to a 7/10 severity. EMS arrived, assessed patient. Continued improvement with no residual effects. EMS dismissed patient to care of her husband without further follow up needed. Janssen eua Very slight dizziness afterwards, and then very heavy feeling in chest, hard to breathe about 45 minutes later, and then hives about an hour later. Next day very slight feeling in the injection area, muscle aches, still have heavy chest and breathing issues, but not as bad as yesterday. I took a Zyrtec tablet around 6:00 p.m. on 3/9/21. Also COVID19 VACCINE JANSSEN 0 days 1088777-1 used CPAP during the night. Oops, forgot to add CPAP and Zyrtec to medication list, I use CPAP nightly and Zyrtec 1xd at night time. I also had a resting pulse of 111 with fast heartbeat. My blood pressure was 136/84, my oxygen was down to 93. Patient was given the Janssen vaccine and within 3 minutes the pt complained that she was lightheaded and dizzy. As I walked out of the pharmacy to see what her reaction was her muscles tensed up and she became completely rigid and stared sliding out of her chair. By appearances it looked like she was shaving a mild seizure, with a blank stare. By the COVID19 VACCINE JANSSEN 0 days 1088806-1 time I got her down on the floor and got her coat off to see if there was an allergic reaction to the site the patient came too and asked me why she was in the floor. At that time she was clamy but knew who she was and where she was. Paramedics were called and while they were here she stated that she was dizzy and nauseous so they ended up taking her to a location hospital to be seen. While there they drew blood as a precaution. Injection site: pain, redness of the skin and swelling. In general: headache, feeling very tired, muscle aches, fever and COVID19 VACCINE JANSSEN 0 days 1088844-1 chills. Duration: approx. 24 hrs PATIENT FELT NAUSEAUS, WAS SWEATING, FELT DIZZY AND HOT, AND ALSO THIRSTY APPROXIMATELY 5 MINUTES COVID19 VACCINE JANSSEN 0 days 1088848-1 AFTER ADMINISTRATION OF VACCINE. PATIENT WAS GIVEN 25MG OF DIPHENHYDRAMINE BY MOUTH APPROXIMATELY 10 MINUTES AFTER ADMINISTRATION OF VACCINE, AND COLD WATER TO SIP. PATIENT'S SYMPTOMS IMPROVED WITHIN 5 MINUTES AND CONTINUED TO IMPROVE OVER THE COURSE OF A 30 MINUTE OBSERVATION PERIOD. wife's report ""He said he was nauseated all night. at 5am this morning (3/10) he was vomiting and said his stomach felt COVID19 VACCINE JANSSEN 0 days 1088880-1 bloated like it 'needed to pop'. He had a 100.8 temp this am, back pain. he took tylenol at 12:30p and now his temp is at 100."""" - severe chills - lasted about 4 hrs - severe headache - lasted about 24hs - body ache - joint pain - nausea - lasted about COVID19 VACCINE JANSSEN 0 days 1088899-1 18hrs COVID19 VACCINE JANSSEN 0 days 1088920-1 Pain at injection sight Fatigue Body aches Headache Fever of 102 6 hrs after shot, went into uncontrollable full body rigid tremors for about 30 minutes. Only relieved by weight of COVID19 VACCINE JANSSEN 0 days 1088927-1 heavy, confining blankets and a Tylenol. No chills or fever, just horrific tremors. extreme feeling of being cold and moderate feeling of nausea for approximately 7 hours, followed by headache for about COVID19 VACCINE JANSSEN 0 days 1088942-1 6 hours (treated with ibuprofen), fatigue for about 24 hours. Bad headache, nausea - threw up numerous times until there was no more to throw up. These conditions lasted for COVID19 VACCINE JANSSEN 0 days 1088949-1 about 30 hours, followed by body aches and weakness. Now feeling mostly better two days after receiving vaccine. High fever up to 103, taking Tylenol to lower but goes right back up, headache, body aches and terrible chills the first COVID19 VACCINE JANSSEN 0 days 1088961-1 few hours. Unable to function normally or go to work. APPROXIMATELY 10 MINUTES AFTER THE VACCINE WAS ADMINISTERED TO THE PATIENT, THE PATIENT BEGAN SWEATING AND FEELING LIGHTHEADED/DIZZY AND WAS THIRSTY AND APPEARED PALE IN COLOR. THE PATIENT WAS COVID19 VACCINE JANSSEN 0 days 1089019-1 GIVEN 50MG OF LIQUID DIPHENHYDRAMINE BY MOUTH AND BEGAN TO HAVE IMPROVEMENT IN SYMPTOMS APPROXIMATELY 5 MINUTES LATER. THE PATIENT WAS OBSERVED FOR 30 MINUTES AFTER, AND WAS GIVEN WATER TO SIP. Having numbness in right arm from fingertips to shoulder. Also numbness in right ear and cheek. Patient was advised to COVID19 VACCINE JANSSEN 0 days 1089030-1 contact his PCP or go to the ER. Started feeling very tired as the evening went on. Went to bed around 10pm and woke up at 11pm with extreme chills and violently shaking, that shortly turned into feeling very warm showing sines of a fever along with nausea. COVID19 VACCINE JANSSEN 0 days 1089037-1 Temperature seemed to normalize around 4 am and then a severe headache followed and has lasted all day. Slight chills started again approximately 24 hours after receiving the shot. 6pm - Fever & chills started and continued to become wores as the night went on 10pm - Fever and extrem chills 1am- dizzy, Fever was about 101 at the highest, elevated HR (80-130bpm) chills with sweats, having trouble getting enough air 3am -was able to finally sleep 6am- Fever 100, swollen lymph nodes, body aches, headache, and dizzy (HR was under COVID19 VACCINE JANSSEN 0 days 1089046-1 control) still having trouble getting enough air. 4pm-Fever 99.5 swollen lymph nodes, body aches, headache, and dizzy (HR was under control) still having trouble getting enough air. 10pm-Fever 99.1 swollen lymph nodes, body aches, headache, and dizzy (HR was under control) still having trouble getting enough air. 5:30am-No fever, felt almost normal 5:30am -next day dizzy and poops COVID19 VACCINE JANSSEN 0 days 1089097-1 Flu like symptoms, muscle aches, fever, headache, pain at injection site Immediate headache, pains in legs/feet after 5 hours, low grade fever after 8 hours, pain in hands and fingers after 10 hours, skin felt bruised and sensitive to touch starting 10 hours after vaccination and skin sensitivity/pain remained until 30 hours after vaccination, fever rose to 104.5F as measured at 2AM overnight (17 hours after vaccination), day after COVID19 VACCINE JANSSEN 0 days 1089112-1 vaccination fever never dropped below 102.0F, day after vaccination all but unable to eat due to nausea, total loss of appetite, mind foggy with difficulty concentrating, difficulty in forming detailed sentences. Pain in feet was agonizing, especially while attempting to walk. Husband?s assistance required to walk to and from bathroom, unable to walk by self most of day of vaccination, and entire day following vaccination. Two days after vaccination fever still present, 99.5- 100.0F, appetite returning, mental fog clearing, Still ?really exhausted.? 21 hours after injection, lethargy and tired. Approximately 40 hours after injection, loss of motor function on left side, specifically, could not lift left leg to climb stairs, combined with soreness in left hip and shoulder. Hip pain is mild to severe, and deep, mostly around the top of the femur. Approximately 8 hours later had sharp, shooting pains deep in COVID19 VACCINE JANSSEN 0 days 1089118-1 the left leg/. Felt like it was in the femur, paint started at the top of the leg and shot down to the knee. Pain duration approximately 1 second, with multiple, sporadic occurrences over the next several days. Approximately 3.5 days after injection, numbness in left hand - small (pinky) finger and radiating along side of hand to wrist. Loss of motor function on left side resolved after approximately 8 hours, pain in hip, pain in shoulder and shooting pain in leg and hand numbness continue. Shooting pain is intermittent, shoulder pain is intermittent, hip pain and numbness in hand are constant. It started about 11 hours after the shot: malaise, then severe shivering (almost locking my jaw). Fever got to 101.8 COVID19 VACCINE JANSSEN 0 days 1089128-1 after a few hours and would not go down with ibuprofen or aspirin. It got down to 100 by morning. Then it hovered around 99 the next day after taking Aleve. mild fever (101), chills, muscle aches, headache, fatigue, nausea. Tylenol to reduce fever, and rest. Symptoms gradually COVID19 VACCINE JANSSEN 0 days 1089131-1 improving after 24 hours seizure about 2 hours after event, per mother also with increase in salivation and groaning. Benadryl has helped, is COVID19 VACCINE JANSSEN 0 days 1089144-1 being monitored At around 8 pm on 3/5/2021 started with a severe headache, around 10 fatigue and muscle aches. Unable to get to sleep, around 12am 3/6/2021 fell asleep but kept wake up very hot, No fever but did have sweats. Around 2 am COVID19 VACCINE JANSSEN 0 days 1089190-1 3/6/2021 headache so severe had to get up and take Aleve. Had throbbing behind eyes and sensitive to light. This lasted till around 9pm 3/6/2021. Had fatigue most of the day also. All symptoms gone on 3/7/2021 except I have had a couple of small headaches on and off till 3/9/2021. COVID19 VACCINE JANSSEN 0 days 1089199-1 weakness, sweating, fever, dry heaves COVID19 VACCINE JANSSEN 0 days 1089206-1 Fever 99.7, chills, weakness, trouble focusing, HR 116, BP 165/72 COVID19 VACCINE JANSSEN 0 days 1089209-1 Fatigue, nausea, and dizziness. Headache, chills, nausea, body aches starting about 7 hours after the vaccination. The side effects lasted about 36 hours COVID19 VACCINE JANSSEN 0 days 1089223-1 and improved with ibuprofen. COVID19 VACCINE JANSSEN 0 days 1089262-1 Tightness in throat after 30 minutes, rash across chest. No previous adverse events to vaccinations previously. Janssen COVID-19 Vaccine EUA. After the shot, at 11:55am, I felt a bit lightheaded but was fine overall. At about 7pm I stated feeling weak and developed a headache, body aches. Had dinner, took Tylenol (2 pills, about 325mg each) and went to bed. Woke up at 1:40am with a terrible body ache, headache, my feet and hands were warm but my torso felt COVID19 VACCINE JANSSEN 0 days 1089265-1 as if I had an ice pack wrapped around it, and a fever was 99.5. I took Tylenol 3 pills (975mg), started sweating and felt better in about 20 min but couldn't sleep for about an hour. Woke up at 7am felt tired, went back to sleep bc of the body achs and headache, woke up at 2pm with fever 98.96F. Took 2 pills of Tylenol 500mg. Its 3:07 and I just feel weak and sore. Felt chills, started shivering/shaking, temperature rose to 100 in 30 minutes. Went to 102 through the night even with aspirin at appropriate intervals. Next morning light headedness and low grade fever and nausea and a partial loss of COVID19 VACCINE JANSSEN 0 days 1089269-1 taste and appetite. Continued into 48 hours. Third day nausea, loss of taste, appetite. Fourth day loss of appetite, nausea. Normal again day five. Day 1 - received injectionwithin a fe minutes of administration I noticed a slight lightheadness and feeling ""off"" within half hour slight nausea began and headache began within hour muscles aches began with joint pain. Above symptoms progressively worsened by midnight was in pain and could not sleep. no fever. took tylenol and only had moderate relief. COVID19 VACCINE JANSSEN 0 days 1089270-1 Day 2 -entire day severe muscle and joint pain - worst headache of my life, severe nausea and chills - no fever. double vision and dizzy Day 3 - same as day 2 - in evening - around 7 pm headache lessened so that it was tolerable with tylenol - muscle aches jopint pain the same Day 4 - headache tolerable, was able to eat. muscle pain better but joint pain still sharp Day 5 - headache sporadic and better - fatigue and muscle pain would come and go, joint pain not as sharp, extreme fatigue Day 6 - extreme fatigue - other symptoms much better"" COVID19 VACCINE JANSSEN 0 days 1089276-1 Patient fainted in and out three times due to anxiety of needles COVID19 VACCINE JANSSEN 0 days 1089281-1 not able to control bladder fever body ache diarrhea light headed High fever, extreme shaking and chills, nausea. I was pretty much immobile from 11pm-3am (until I was able to fall asleep) on the day of vaccination (3/8/21). This happened immediately after I showered with hot water. The next day (3/9/21) until around 8pm I had a high fever, chills (not as bad but still pretty bad), headache, nausea, fatigue, and COVID19 VACCINE JANSSEN 0 days 1089282-1 extreme muscle/joint pain particularly in my back and arms. I was unable to work, go to school, or do homework the entire day. After 8pm, I was down to a 100.4 fever and slight chills with mild nausea and fatigue. Today (3/10/21), I have mild muscle pain in my back and near the injection site. I took 400mg of ibuprofen every 6-8 hours from 3:00pm 3/8/21 (day of injection) to present with mild effects on pain and fever levels. I?m an infrequent user of ibuprofen. If I didn?t have someone with me the first night after the vaccination (3/8/21) I would have gone to the hospital. Headache and overwhelming exhaustion of 1.5 days duration starting approximately 1 hour after vaccination. Lethargy COVID19 VACCINE JANSSEN 0 days 1089288-1 and mental fog of >2 days post vaccination starting 1 hour after vaccination Pt was given shot at 404 PM. At 415pm pt felt dizzy and warm. Pt was given benadryl liquid at 424pm by mouth. Epi- COVID19 VACCINE JANSSEN 0 days 1089306-1 pen was on hand but never used. Pt went home with mother at 435pm and said she was feeling better. Pt stated that they have benadryl at home and pt would be monitored through the night. Pt contact initiated. On scene to for a 25 y/o female pt with a chief complaint of syncope. Pt was sitting upright in chair in no apparent distress. Pt demeanor is calm. GCS 15, Aox4. Pt stated she felt dizzy and had a syncopal episode. Pt fell on floor from sitting position. Pt found on floor prone. Pt rolled over to right lateral recumbent position. Pt hit head and has approximately 1 cm abrasion on right anterior face. Controlled bleeding with gauze and bandage. Airway is patent. COVID19 VACCINE JANSSEN 0 days 1089308-1 Speech is clear and even with no noted slur or abnormality. Breathing is non labored and regular with adequate chest rise. Radial pulses with steady rate and rhythm. Skin is intact, warm, and dry. Eyes PERRL. No JVD, tracheal deviation, or peripheral edema. Negative DCAPBTLS other than noted. Pt is able to ambulate. Gait is steady. Pt denies headache or blurred vision, shortness of breath or difficulty breathing, nausea or vomiting, chest pain, dizziness, tingling or numbness in extremities, or any other complaints at this time other than noted. Low-grade fever and fatigue, followed by increased fever and chills. Nausea & diarrhea. Severe headache. All symptoms COVID19 VACCINE JANSSEN 0 days 1089309-1 continued throughout the night. Severe headache persisted until following day. Ibuprofen taken to relieve headache. All symptoms were diminished by that time. COVID19 VACCINE JANSSEN 0 days 1089318-1 flu-like, fever, exhaustion, increased peristalsis within an hour, it my head felt like a had sinus pressure and had foggy ""mind"". Arm was sore but no more than any other vaccine. close to 4 hours later, headache started, felt hot and cold. Hard to sleep, sweating a lot during the night. Headache was so bad it felt like a combination of a bad flu with a hangover. felt very thirty. In the morning I was dizzy, COVID19 VACCINE JANSSEN 0 days 1089324-1 hot, cold, temp 99.8, sick to my stomach, coudn't taste food very well, just like when you have the flu, nothing taste good. I spend the following day in and out of sleep, very tired, hard to focus. The sensation for being hot and cold continued. Took Imitrex to alleviate the headache/migraine . I did help, but not much. Hard to eat due to an upset stomach. Today is the first full day. I hope I'm better tomorrow"" Shot at 2:00 pm. Chills at 7:00 pm. Violent shaking from the chills that hurt my back & chest. Headache sore throat, COVID19 VACCINE JANSSEN 0 days 1089328-1 dizzy

patient received Janssen Covid 19 vaccine at our clinic inside store. pt was waiting in waiting area for 15 minutes and she informed us she was not feeling well and felt like passing out. She had been waiting less than 10 minutes. I went to COVID19 VACCINE JANSSEN 0 days 1089336-1 her and she said she was feeling very strange and was nauseous. I tried to get her up but she couldn't walk so I let her sit back down. She was not able to communicate with me but was conscious. She said her vision was distorted. her lips started to turn blue and I continued to monitor her. I called 911 and she said she was having difficulty catching her breath so I went for the epipen and gave her 0.3 mg in the outer thigh of her right leg. her color started to improve and she was able to comunicate better. I followed EMS instructions and continued to monitor her until they arrived. Started feeling sick with flu like symptoms 12 hours after the shot. Over 4 days later I am still having gripping chills, COVID19 VACCINE JANSSEN 0 days 1089342-1 major fatigue, dizziness, nausea, vomiting Substantial rise in blood pressure to 205/110. This was recorded 20 minutes after injection. The dizziness associated COVID19 VACCINE JANSSEN 0 days 1089346-1 with the high blood pressure started within 5 minutes of the injection. Fever between of 99 degrees starting 10hrs after vaccination, peaking at 102.1 degrees 16hrs after vaccination, then COVID19 VACCINE JANSSEN 0 days 1089354-1 down to intermittent low fever of 99-100 until 36hrs after vaccination. Accompanied by chills and exhaustion. No symptoms after 48hrs. Patient fainted 5 minutes after immunization. Patient hit head upon falling out of chair. Pt regained consciousness COVID19 VACCINE JANSSEN 0 days 1089360-1 immediately. Ambulance was called due to hitting head. Patient refused treatment by ambulance. Patient felt passing out was due to low blood sugar. She drank 7-up and was helped cleaning up blood and given band aid. Chills lasting 4 hours Extreme Fatigue lasting 24 hours All over body aches lasting 30 hours Treated with over the COVID19 VACCINE JANSSEN 0 days 1089376-1 counter acetaminophen which helped relieve symptoms Face flushing within 1/2 hour that then subsided within another 1/2 hour. 6 1/2 hours after inoculation, at 7pm, I began to feel unwell. I felt a burning all over my body (especially my back), and body aches, and began a fever which grew from 97.3 (my normal) to a high of 100.1 (+2.8 degrees) within 2.5 more hours (by 9:30pm). Very bad chills and fever. By 9:30 COVID19 VACCINE JANSSEN 0 days 1089386-1 took 1 500mg Tylenol. Little sleep that night. Felt very unwell next day (3/9) including headache. At noon I could get up and get some food. By 1pm fever subsided completely, but temporarily. Fever came back by 4pm, but only to 98.6 (+1.3 above normal). Took another 500mg Tylenol. Night 2 slept well. Woke up 3/10 no fever, headache gone, but balance still peculiar. I noticed the first night that my sense of balance was off. Received vaccine at 9:00am, 9:15am light headache 10:30am felt light headed when walking. 12:00pm headache slightly COVID19 VACCINE JANSSEN 0 days 1089387-1 stronger and discomfort in knees. 4:00pm joint aches specially in the knees, ankles and finger joints. 6:00pm tingling sensation on cheeks and headache persist. Walking uncomfortably because of joint aches. patient received vaccination, then immediately said they felt lightheaded and this always happens when they get injections or blood drawn. They requested and were given a bottle of water. They asked to lay down, and laid on the COVID19 VACCINE JANSSEN 0 days 1089391-1 floor for about 10 minutes then said they felt better, sat the remainder of their wait time, then grabbed something to eat in the store, re-established they felt fine now, then proceeded to leave COVID19 VACCINE JANSSEN 0 days 1089397-1 nausea chills throwing up dry heat lasted for four hours COVID19 VACCINE JANSSEN 0 days 1089426-1 100-102 fever 10 hours after vaccination. Diarrhea, vomiting, chills, headache, muscle aches COVID19 VACCINE JANSSEN 0 days 1089430-1 Has a fever. Extreme fatigue. Slept most of the time for two days. Got shot at 10:40 AM. Left Arm immediately felt odd---sore, heavy, tingly all the way down to my wrist. By noon, I was asleep. Slept for about 3 hours. Up for 3 hours. Slept for 3. Up for 3. Then slept all night. I had a headache and slept most of the next day. Definitely felt like my body was fighting COVID19 VACCINE JANSSEN 0 days 1089432-1 something. I have an approximately 3 inch diameter circle around injection site that is a red, swollen, hard, lump, It is hot to the touch and extremely sore---at times it itches. I am shocked how big and hard the knot is. Its crazy! I cannot put weight on that arm. Extremely sore. It is now 4 days after the vaccine and the knot does not seem to be getting smaller. In fact, it may be bigger. Patient received Janssen vaccine at 4pm and began having itchiness and redness at injection site at 4:10pm. At 4:23 patient was given an ice pack to apply to the area and 50mg of benadryl PO. Patient did not have SOB. At 4:28pm rash was still spreading to underarm and chest. Discussed possible future use of epinephrine due to history of anaphylaxis to COVID19 VACCINE JANSSEN 0 days 1089436-1 spider bite, but patient had no SOB and emergency services was called at 4:34pm to assess patient. EMS arrived at 4:50pm and determined patient to be stable. Patient was given another 50mg Benadryl dose to take with him and instructions to call EMS if symptoms worsened. COVID19 VACCINE JANSSEN 0 days 1089446-1 Fever and chills COVID19 VACCINE JANSSEN 0 days 1089448-1 Post vaccine side effects. Flu like symptoms. Headache, fever, chills, fatigue Had bad headache and slight fever from 6pm-1am starting March 6 after vaccination. I was very fatigued. I had to take COVID19 VACCINE JANSSEN 0 days 1089464-1 an Advil as I had no Tylenol. On March 9, I had a slight cough and shortness of breath. On March felt a shortness of breath and cough still. Received Janssen covid 19 vaccine 3/8/21 at 3PM. Twenty minutes after shot, felt skin flush pass over me and was directed to private area where paramedic took blood pressure and checked for hives. No hives but bumpy skin. Blood COVID19 VACCINE JANSSEN 0 days 1089471-1 pressure spiked to 186/75. No history of such high blood pressure. Waited a while and blood pressure went down, flush and skin bumps subsided, and I went home. Blood pressure erratic in evening but never as high. Next day pulse higher than normal. Took homeopathic remedy. Pulse slowed down a bit. Better by next day. COVID19 VACCINE JANSSEN 0 days 1089472-1 janssen COVID-19 Vaccine EUA Fever and chills

COVID19 VACCINE JANSSEN 0 days 1089550-1 developed chills, then slight fever, then nausea which progressed to vomiting, followed by fatigue and mild body aches. Side effects began approximately 6 hours post vaccination and resolved by approximately 32 hours post vaccination. COVID19 VACCINE JANSSEN 0 days 1089629-1 High Fever, headache, nausea Janssen COVID-19 Vaccine EUA Dull headache increasing over time to a raging headache, Tylenol not helping much. 24 COVID19 VACCINE JANSSEN 0 days 1089630-1 hours later, still have the raging headache. Body aches, intermittent soaking in hot bath tub to relieve pain. COVID19 VACCINE JANSSEN 0 days 1089703-1 PT STARTED TO BLACK OUT AND FAINT A FEW MINUTES AFTER SHOT Numbness and tingles immediately after shot. Tingly feeling up left side of neck and into left eye. As days go by more COVID19 VACCINE JANSSEN 0 days 1090303-1 numbness and tingling under my arm pit and down my hand into fingers. Feels like I hit my funny bone from the elbow down when using arm repetitively. Soreness of left side of neck. COVID19 VACCINE JANSSEN 0 days 1090306-1 Temp of 102.5. Aches Chills Short breath (spouse opinion) I became lightheaded/dizzy within the first few minutes. Symptom subsided but came back in a mild way. When I came COVID19 VACCINE JANSSEN 0 days 1090314-1 home and after Seventeen (17) hours, I am still lightheaded, I have body aches and chills. I have no fever. COVID19 VACCINE JANSSEN 0 days 1090316-1 Dizzy, near syncopal. BP 108/71 (pulse 110), O2 sat 99%. First day of menstrual cycle with painful cramps. PATIENT HAD DIZZINESS AND BLURRED VISION 1 HOUR AFTER ADMINISTRATION. SHE SAID SHE DID NOT EAT BREAKFAST AND IT HAD HAPPENED TO HER BEFORE WHEN SHE WAS HUNGRY. SHE WAS GIVEN FOOD TO EAT WHILE COVID19 VACCINE JANSSEN 0 days 1090321-1 SITTING DOWN. HER INITIAL BP WAS AROUND 150/90 BUT WENT DOWN TO 127/80 AFTER A FEW MINUTES. HER BLURRED VISION WENT AWAY AFTER SHE ATE ALTHOUGH SHE STILL HAD SOME DIZZINESS. SHE WAS WELL ENOUGH TO WALK AND DRIVE. COVID19 VACCINE JANSSEN 0 days 1090326-1 Pain, muscle aches, hot flashes, chills. extreme cramping in middle lower back lasting less than an hour. Muscle aches all over in upper torso moderate COVID19 VACCINE JANSSEN 0 days 1090330-1 headache , cold all over .relieved with ibuprofin and tylenol every 6 hours .all ending about 24 hours later with a warm mild fever like sensation and 2 hours of sleep. COVID19 VACCINE JANSSEN 0 days 1090361-1 Flu like symptoms evening after receipt of vaccine. COVID19 VACCINE JANSSEN 0 days 1090384-1 Body ache fever chills sore throat headache Mild Headache -15 mins. after injection Nausea- evening 3/9/21 Tummy ache- 3/10/21 @11 am Low grade fever-3/10/21 COVID19 VACCINE JANSSEN 0 days 1090388-1 @ 5 pm Chills-3/10/21 COVID19 VACCINE JANSSEN 0 days 1090393-1 Mild headache, sustained nasal dripping, fatigue. COVID19 VACCINE JANSSEN 0 days 1090427-1 After 8 hours of administration, experienced Fever for 8 hours (102.4F-101); frontal headaches; joint pain; chills Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Chills-Medium, Systemic: COVID19 VACCINE JANSSEN 0 days 1090430-1 Dizziness / Lightheadness-Medium, Systemic: Fever-Medium, Systemic: Sweating-Medium Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: COVID19 VACCINE JANSSEN 0 days 1090435-1 Nausea-Mild, Additional Details: Paramedics and Firefighters came out. Gave him 1 liter of normal saline. His heart rate was in the 30's. They stablizied the patient and took him to hospital. Pt. received vaccine then felt faint approximately 10 minutes later. Pt was sweating profusely. Vital signs were obtained and were normal. Pt denied trouble breathing, chest tightening, throat closing or any itching or hives. Pt lay COVID19 VACCINE JANSSEN 0 days 1090437-1 down for about 10 minutes then slowly sat up. VS taken every 5 minutes remained normal. Pt was feeling fine and able to leave facility after 30 minutes. About 7 hours after vaccine, I suddenly felt very tired & achy in my shoulders & upper back. These aches eventually spread over my entire body. The tiredness got worse as evening progressed. Finally went to bed, & could not fall asleep COVID19 VACCINE JANSSEN 0 days 1090448-1 for approximately 1 1/2 hrs. During this time, I experienced chills along with the body ache. After 6 hrs of sleep, I woke this AM feeeling achy & exhausted. COVID19 VACCINE JANSSEN 0 days 1090463-1 No appetite, sore at the vaccine site, light headed about 8 to 10 hours after the vaccination started with extreme fatigue, then turned into sweating then chills accompanied by severe joint pain and the injection site was very painful, that last until Monday morning once those COVID19 VACCINE JANSSEN 0 days 1090467-1 symptoms cleared I developed a genital ulcer. I do not have a history of having genital issues and I had no clue you could even get an ulcer in that area. COVID19 VACCINE JANSSEN 0 days 1090495-1 Chills, fatigue, body aches; pain, warmth, and swelling at injection site Headache, muscle ache (not just at the injection site, shoulders, neck, and knees hurt), stomach is lightly upset, and COVID19 VACCINE JANSSEN 0 days 1090510-1 fatigue. COVID19 VACCINE JANSSEN 0 days 1090515-1 flu like symptoms; malaise in muscles throughout body; chills; headache; tiredness; loss of taste; pain in midsection About 830 Pm on night of injection I got chills until about 3 am and in the morning i had a headache and was very COVID19 VACCINE JANSSEN 0 days 1090525-1 unsteady but by that afternoon all that went away. On Wednesday morning when I took the bandaid off the injection site was red and itchy which it is today at injection, arm was not opperable, too weak to pick up coat or purse. After about 15 minutes the full use of arm was back. The muscle is still affected and strained after 6 days. I waited a half hour at the site and got into my car at 3:45. On the drive home within 30 minutes my face started to itch and turn red, then my mouth inside started to itch, then my COVID19 VACCINE JANSSEN 0 days 1090527-1 eyes started to itch. After that my throat started to feel gravely, so I took 75 mgs of gel cap benedryl. This is what I feel and take upon getting stung by a bee. I also took my albuterol inhaller two puffs which I also always have on me because of my asthma. I was sleepy but had dinner and went to be. I did not feel that I had to take more benedryl during the night. pt stated that he got flu like symptoms including tight muscles, headache, body aches, chills, he was nauseated. He COVID19 VACCINE JANSSEN 0 days 1090528-1 woke up feeling a little better but still has head ache, body aches and some nausea. COVID19 VACCINE JANSSEN 0 days 1090545-1 Flu-like symptoms: headache, fatigue, muscle aches, chills, and fever. COVID19 VACCINE JANSSEN 0 days 1090549-1 Extreme chills and headache lasting 14 hours Fever, chills, sore achy joints, night sweats, excessive urination, insomnia. Got some temporary relief with COVID19 VACCINE JANSSEN 0 days 1090551-1 Acetaminophen. Symptoms lasted about 14 hours. Report body aches, fever, chills, GI upset. Treatment: Ibuprofen, Outcome: Mild improvement does not interfere with COVID19 VACCINE JANSSEN 0 days 1090553-1 ADLs. Low grade fever, headache, chills, sweating, dizziness, severe muscle aches, weakness, nausea, exhaustions, flu like symptoms, Severe itching and burning whole body by 6pm the day of injection -took 50 mg of Benadryl. Tightness in COVID19 VACCINE JANSSEN 0 days 1090565-1 chest and throat but could still breath. Symptoms ran their course over 5 days. Still struggling with muscle aches and nausea. Nine hours after receiving vaccine I started ""trembling, shaking."" Not convulsing, more like really cold. My temperature read 97.2 degrees. My normal temperature is 98.6 degrees. Shaking stopped around 11:30 p.m. I woke up COVID19 VACCINE JANSSEN 0 days 1090569-1 at 3:15 a.m. very hot with my heartbeat racing. I did not measure heartbeat rate. I woke up this morning at 5:30 a.m. with no side effects."" COVID19 VACCINE JANSSEN 0 days 1090600-1 Severe body aches, fever, shortness of breath, and fatigue.

On Monday March 8th I went to the Pharmacy to get the Johnson & Johnson Covid vaccine under the new 1b guidelines. I am a 62 year old white male with type 1 diabetes, insulin dependent for the past 49 years. I filled out the question form I was presented by the staff and then was given a dose of the J&J vaccine. This vaccine was administered at approx. 1:30 p.m. I was asked to wait 15 minutes to see if I had and acute reaction, following none, I was told I could leave. There rest of the day I was fine. I went to bed at 11:00 p.m. and within 15 minutes I was cold, shaking and sick on my stomach. I took my temp and it was 100.2 F My O2 sat was 95% and heart rate was 120 with feelings of palpitations from time to time. I went to the bathroom and stayed there the rest of the night with frequent vomiting and loose stool. Stomach cramps all night long. Several BGL were taken and even with an insulin pump I was not able to lower my 299 level for COVID19 VACCINE JANSSEN 0 days 1090608-1 over the next 24 hours of repeated bolus. I was finally able to stop dry heaves and fall asleep for moments at a time around 5:00 a.m. My temp finally broke around 11:00 a.m. the next day Tuesday. I had a headache this entire time. I called hospital ( Ask a Nurse ) on Tuesday morning around 8:00 a.m.and enquired about side effects for this vaccine and effects on a type 1, they basically told me to go to the ER or Clinic and be seen by a Physician. I choose not to do either, but to monitor myself and see how the rest of the day went. The first time, other than a headache and complete body soreness my vitals and BGL, were WNL, was late Tuesday evening around 7:00 p.m. This was a horrible set of side effects. Onset was within 11 hours from injection. No warning for type 1 people to be careful for the possibilities of increased BGL. Today is Wednesday March 10th, and my vitals have remained WNL, but I still have a mild headache and body soreness, some maybe from the vaccine but I believe mostly from the throwing up. Today is March 11th, my vitals are still WNL and BGL is in target. BGL control is responsive to pump therapy now. The past 2 nights I have awoken in a cold soaking sweat that cannot be tied to a low BGL. My body is somewhat still soreness. COVID19 VACCINE JANSSEN 0 days 1090612-1 Fever, chills, shakes approximately 13 hours after shot. Lasted for an hour until asleep. No issues in the morning. COVID19 VACCINE JANSSEN 0 days 1090629-1 1. Tingling of lips and tongue 2. Productive cough with post nasal drip and green mucous 3. High pitched ringing in ears COVID19 VACCINE JANSSEN 0 days 1090637-1 chills, body sore, fever - took Tylenol around 6 hours after start of side effects, kicked in around an hour later COVID19 VACCINE JANSSEN 0 days 1090638-1 Tail bone pain COVID19 VACCINE JANSSEN 0 days 1090641-1 fever, chills, headache, nausea Pt describes feeling severe chills, fever of 101.4, inability to walk overnight, and delirium yesterday afternoon and COVID19 VACCINE JANSSEN 0 days 1090663-1 overnight last night. She reports chills causing contortions, inability to walk, she stool up and fell down immediately, and hallucinations. She describes thinking she was using a computer when she was not. Report chills and fever. Treatment: Tylenol, Outcome: Chills resolved, moderate improvement, does not interfere with COVID19 VACCINE JANSSEN 0 days 1090667-1 ADLs. COVID19 VACCINE JANSSEN 0 days 1090701-1 Fever,headache,chills,body aches,nausea with vomiting. pt presented with drowsiness & delayed response / speech. On-site medics present. BP: 119/81, HR: 81, SPO2: 98.1; RR: COVID19 VACCINE JANSSEN 0 days 1090725-1 16. patient transported to the ER vial EMS Started feeling feverish at 8:30pm - roughly 10 hours after vaccination. Recorded fever as high as 102.4 at 3:00am. COVID19 VACCINE JANSSEN 0 days 1090726-1 Fever ultimately broke and temp was normal when I woke up this morning. Just tired and head-achy now likely from poor nights sleep. Temps were taken with an oral, digital read thermometer. I will follow up if fever continues. nausea without emesis; drank water; emotional support: fresh air symptoms resolved within 3 -5 mins. Let lot after 10 COVID19 VACCINE JANSSEN 0 days 1090745-1 mins of first report of symptom. Has n/o cancer w/ chemo TX. On 3/10/2021 at approximately 2035, a female patient notified vaccine observation staff that she was feeling light headed, queasy and anxious. As staff began to assess the patient she began to pass out loosing consciousness. Staff were able to hold patient before any falls and lower her to the floor. The paramedic on scene began her emergency assessment of the patient. Staff paramedic was able to arouse the patient with a sternal rub. The patient was not fully COVID19 VACCINE JANSSEN 0 days 1090746-1 aware of the event that had occurred. The paramedic place the patient on oxygen via nasal cannula. The patient?s level of consciousness began to improve. The patient stated she has a history of syncopal episode after any immunizations. The patient also relayed that she has a history of anxiety and is complaint with her medication. After secondary assessment of the patient, it was noted that the patient had an extended recovery time from the sycopal episode. She was unable to stand on her own and she still felt nauseous after vomiting. The staff at the clinic notified county EMS at 2055 and care of the patient was transferred. COVID19 VACCINE JANSSEN 0 days 1090750-1 soreness in injection site (mild), overall body aches, mild chills, fatigue Severe chills for several hours, then high temps for several hours, then racing heart rate for 3-4 hours, tightening of COVID19 VACCINE JANSSEN 0 days 1090798-1 chest, inability to sleep . Onset took 6 hours from shot. Conditions lasted about 18 hours. c/o headache- IDDM- ate breakfast 0930 other and nothing since. Denies any of adverse symptoms. does self report. high anxiety R/T being here, getting vaccine & ""emtional"" as has not seen spouse who underwent liver transplant 2 COVID19 VACCINE JANSSEN 0 days 1090799-1 months ago & contracted meningitis. 173/94- 72 given water & banana. Rested & relaxed w/ fresh air flow x 15 additional mins. w/ resolution of symptoms."" Migraine, neck pain, muscle aches, fever of 100.8, fatigue. I noticed that the combination of Gabapentin and tylenol COVID19 VACCINE JANSSEN 0 days 1090804-1 relieved most of the discomfort. pt. experiencing pin and needle on the L arm the vaccine was administered. pt. not in any distress and states that the COVID19 VACCINE JANSSEN 0 days 1090807-1 pins and needles are fading. COVID19 VACCINE JANSSEN 0 days 1090809-1 Client ""fell"" outside after receiving dose. Stated chest felt tight. EMS on site"" Vaccine was not administered on 3/8/21. Provider realized error and patient was contacted on 3/9/21 to come in for COVID19 VACCINE JANSSEN 0 days 1090819-1 vaccine. He returned to clinic and received correct dose of vaccine. No harm to patient COVID19 VACCINE JANSSEN 0 days 1090822-1 Body aches starting 2pm day of shot along with a headache. Around 11pm extreme chills and aches continuing COVID19 VACCINE JANSSEN 0 days 1090831-1 Severe chills, severe headache, aching all over, dry mouth, loss of appetite COVID19 VACCINE JANSSEN 0 days 1090834-1 Fever. Chills. Headache. Fatigue. Tylenol and sleep. Over in 48 hours. At 5:30 pm, I started to have a headache, so I took some Tylenol. I started to feel a little better. From about 7:00 pm to about midnight, I felt awful. I couldn't walk down a short hall without assistance. I was so sore and achy I couldn't really sleep. I felt insanely hot, yet had chills and I had a terrible headache. I am type 1 diabetic, and my blood sugar spiked to COVID19 VACCINE JANSSEN 0 days 1090837-1 over 200, where it hovered between 200 & 300 most of the night, despite the fact that I used insulin to try and lower it. From 10 pm to midnight, I felt nauseous. Overnight was ok. I still had some of those symptoms, but could sleep off and on. I probably woke up every couple of hours. I was till very sore and hot, but not as hot, and still had a headache. Today, I took Tylenol this morning. I still have a mild headache, sore body, tired and a little slow, but significantly better than last night. COVID19 VACCINE JANSSEN 0 days 1090842-1 Joint pain, fever, and headache COVID19 VACCINE JANSSEN 0 days 1090848-1 headache, fatigue, chills, body aches, fever Vaccine was not administered on 3/8/21. Provider realized error and patient was contacted on 3/9/21 to come in for COVID19 VACCINE JANSSEN 0 days 1090854-1 vaccine. He returned to clinic and received correct dose of vaccine. No harm to patient Bad headache, fever (not sure of my temp - no thermometer), body chills and fatigue - basically the same symptoms when COVID19 VACCINE JANSSEN 0 days 1090860-1 I had Covid 10/31/2020 - 11/6/2020. Vaccine was not administered on 3/8/21. Provider realized error and patient was contacted on 3/9/21 to come in for COVID19 VACCINE JANSSEN 0 days 1090880-1 vaccine. He returned to clinic and received correct dose of vaccine. No harm to patient Mild reactions including breathing heavy, throat felt swollen while trying to sleep, slight dizziness, some rashes(similar COVID19 VACCINE JANSSEN 0 days 1090895-1 to big mosquito bites). All reactions are mild. Vaccine was not administered on 3/8/21. Provider realized error and patient was contacted on 3/9/21 to come in for COVID19 VACCINE JANSSEN 0 days 1090906-1 vaccine. He returned to clinic and received correct dose of vaccine. No harm to patient Vaccine was not administered on 3/8/21. Provider realized error and patient was contacted on 3/9/21 to come in for COVID19 VACCINE JANSSEN 0 days 1090931-1 vaccine. He returned to clinic and received correct dose of vaccine. No harm to patient I felt dizzy, nauseous, massive headache, it felt like my brain was swelling. hips and joints where so sore. dehydrated. i COVID19 VACCINE JANSSEN 0 days 1090942-1 was exhausted all day and night. these symptoms lasted up untill today. 102.7 Fever, felt completely freezing, significant body aches, so tired it was hard to open my eyes. Took Tylenol Extra Strength and put ice on forhead Hour later fever came down to 101.7 Body kept switching between sweating and COVID19 VACCINE JANSSEN 0 days 1090951-1 freezing entire night 24 hours later at 7:30AM the next day, i was still very tired, sweating, but fever was gone. 48 hours later - i'm still a bit foggy and have a light cough COVID19 VACCINE JANSSEN 0 days 1090953-1 Approximately 2 hours afterwards?intense sweating Later that evening?Nausea, body aches, fever, headache Pt went vasovagal after dose of Johnson and Johnson vaccine. This has happened before. She did nit lose consciousness. We slowly moves pt from seated position to lying on the floor. She denied use of a cot and a juice box. We had a cold COVID19 VACCINE JANSSEN 0 days 1090962-1 pack on the back of her neck. Eventually she was able to transfer from the floor to the chair and felt better. We started pts 15 minute observation time after she was stable in a chair. Pt felt better before she left. COVID19 VACCINE JANSSEN 0 days 1090976-1 Chills Achy Severe headache Overall feeling very bad . Vaccine was not administered on 3/8/21. Provider realized error and patient was contacted on 3/9/21 to come in for COVID19 VACCINE JANSSEN 0 days 1090987-1 vaccine. He returned to clinic and received correct dose of vaccine. No harm to patient 12 hours post vaccine - muscle pain, difficulty moving, headache. A few hours later - chills, sweats, fever of 101.0, COVID19 VACCINE JANSSEN 0 days 1091005-1 continued muscle pain and headache, throbbing pains COVID19 VACCINE JANSSEN 0 days 1091014-1 Cold rush in arm , chills, fever, pain in arm where shot administrated , arm swollen and body pain. COVID19 VACCINE JANSSEN 0 days 1091015-1 FEVER, NAUSEA, SHAKES, CHILLS, BODY ACHES Immediately after immunization administered, pt became unresponsive. Remained conscious entire time, but very light headed. Pt was warm, sweating, clammy. After 5min, epinephrine was administered. Pt became more conscious after COVID19 VACCINE JANSSEN 0 days 1091025-1 5-10min of epinephrine dose. Pt. stayed in immunization area for approximately 70min after event. Wife contacted. Wife arrived 60min later. Pt left under wife care. Pt did not drive home. Pt was given water, and a soft drink after 30min. Contacted pt early evening. Pt reported feeling fine. No further symptoms. Began feeling tired on way home at 3 pm, rested in chair until 9 pm, in bed was so cold and shivering even with two heavy blankets. Headache developed, heart was pounding (97 pulse rate), headache was the worst ever. Could not COVID19 VACCINE JANSSEN 0 days 1091029-1 sleep, then got up all night until 4 am , finally got back into bed, slept a little, then got extremely hot and sweaty. Finally slept until 9:45 am, still have headache but not as bad. Heart more normal, pulse 75. My temperature stayed a little below normal, 96.6 degrees. Vaccine was not administered on 3/8/21. Provider realized error and patient was contacted on 3/9/21 to come in for COVID19 VACCINE JANSSEN 0 days 1091033-1 vaccine. He returned to clinic and received correct dose of vaccine. No harm to patient Dizziness, itchy, tightness to inj site on arm, tingles. Symptoms resolved about 15 after observation. Pt was released COVID19 VACCINE JANSSEN 0 days 1091037-1 back to observation area and pt checked out. Pt received the Johnson and Johnson vaccine. COVID19 VACCINE JANSSEN 0 days 1091040-1 Moderate pain at site of injection, low-grade fever several hours after injection, 100.2¶, moderate sharp pain in left leg. COVID19 VACCINE JANSSEN 0 days 1091046-1 syringe used to administer vaccine was empty, no vaccine administered Patient got up from chair to pick up his phone and collapsed, diaphoretic. There was no loss of consciousness. Initial BP = 80/60 and HR =84. He had no symptoms other than sweating and dizzyness. He stated he felt dizzy after the vaccine COVID19 VACCINE JANSSEN 0 days 1091051-1 but had not eaten since the night before. He also said sometimes gets dizzy after shots. Repeat BP was 110/60 EKG by EMS demonstrated ST wave changes and patient was sent to Medical Center by EMS. COVID19 VACCINE JANSSEN 0 days 1091052-1 Developed a lisp in speech that has continued since the evening of receiving vaccine. pt had difficulty breathing, was was coughing and feeling abnormal. She vomited and lost consciousness and epipen was COVID19 VACCINE JANSSEN 0 days 1091057-1 administered. She was feeling much better by the time the paramedics arived Vaccine was not administered on 3/8/21. Provider realized error and patient was contacted on 3/9/21 to come in for COVID19 VACCINE JANSSEN 0 days 1091064-1 vaccine. He returned to clinic and received correct dose of vaccine. No harm to patient COVID19 VACCINE JANSSEN 0 days 1091075-1 EMPTY SYRINGE USED TO GIVE THE VACCINE, NO VACCINE WAS ADMINISTERED Chills, fever, headache, muscle aches, severe joint pain and swelling in knees, random acute pains in ear and abdomen, some mild nausea for about an hour after fever spiked. Fever went to 103 before I took fever reducing medication COVID19 VACCINE JANSSEN 0 days 1091082-1 (ibuprofen). Temperature reduced to 101 after lukewarm shower and ibuprofen. Now 24 hours after vaccine, temperature is elevated slightly from my norm (hovering around 100), head ache and joint pain is persisting. COVID19 VACCINE JANSSEN 0 days 1091110-1 Chills, fever, nausea Vasovagal syncope a few minutes after vaccination. Fever of 101.8F 24h after vaccination (3/10/2021). Fever is continuing today (3/11/2021), but is lower at 100.4F. Tingling fingers on hand from vaccination arm (left), swelling from COVID19 VACCINE JANSSEN 0 days 1091139-1 vaccination injection site, headache, and neck pain all developed on 3/10/2021. Headache and neck pain could be due to head trauma from vasovagal syncope. Tingling fingers were not observed on 3/11/2021. *I have had vasovagal syncope in the past, but never with vaccines. It always occurs when I see my own blood. Report of fever, nausea, body aches, HA and mild congestion with lying down, but no congestion with sitting and COVID19 VACCINE JANSSEN 0 days 1091163-1 standing day 1 post vaccination. Treatment: Ibuprofen. Outcome: Mild improvement , no interference with ADLs.

Flushed and sweaty after 20 minutes. Heart started beating fast and irregular. Went by ambulance to ER where given complete smattering of tests, 2 EKG's Chest xrays, Chest CAT scan, blood work and observation. Heart and BP continued COVID19 VACCINE JANSSEN 0 days 1091170-1 to be elevated during stay. PB 168/85 down to 148/74. Heart rate 110 to 85 ish. Discharged from hospital. Bed at 10:15 feeling ok. During the night fever, chills, swollen glands, nausea, severe body aches, headache. fast heart rate, heavy breathing, general malaise, sleeplessness, painful injection site. Took tylenol at 5:00 AM and slept a few hours. Woke at 10 AM with body aches, but heart rate was down to 76 and BP down to 112/74. Continuing the tylenol and wiped out. COVID19 VACCINE JANSSEN 0 days 1091172-1 Chills, low grade fever, fatigue COVID19 VACCINE JANSSEN 0 days 1091183-1 Sever Headache, Fever, Congestion, Muscle ache, and chills. COVID19 VACCINE JANSSEN 0 days 1091204-1 I experienced a high fever of 103 that was not lowered with fever reducer.

Patient passed out after receiving janssen covid-19 vaccine. There was no injection site reaction, no wheezing, or rash/hives. Patient had vision loss, dilated pupils, sweaty, unable focus or respond to use questions being asked, and was COVID19 VACCINE JANSSEN 0 days 1091227-1 having trouble hearing-said he had ringing in his ears. We were able to lay him on the floor without injuries-he did not fall. I was fanning him and we were talking to him. He got a little worse but then got better. When he was better, he said that he had passed out before when having blood taken. He did not mention this to me before the vaccine was administered. I do not feel that the Janssen COVID shot was the cause, I think he just passes out from injections or needles. We did call 911 when he was getting worse. By the time they got here, he was better but they did check him. COVID19 VACCINE JANSSEN 0 days 1091235-1 Fever (102), chills, sweats, body aches, headache, nausea Pharmacy knew that patient was experiencing symptoms (chest tightening) at 3:50pm. Unknown the exact time of outset of symptoms. Patient progressed to coughing and shortness of breath. Patient remained responsive. Pharmacist COVID19 VACCINE JANSSEN 0 days 1091243-1 asked patient if she could administered epi-pen. Patient said yes. Pharmacist administered epi pen and call 911 at 3:58pm, pharmacist stayed with patient till paramedics arrived. Symptoms somewhat improved and patient left with paramedics. COVID19 VACCINE JANSSEN 0 days 1091261-1 sever flu like symptoms. Then chest tightening and inability to breathe. Spouse called 911. COVID19 VACCINE JANSSEN 0 days 1091270-1 headache, back ache & chills COVID19 VACCINE JANSSEN 0 days 1091276-1 Passed out, confused, loopy like they Drunk. Client contacted NJCRI on 3/11/21 complaining that on 3/10/21 at 10 pm he began feeling tire, achy throat and this COVID19 VACCINE JANSSEN 0 days 1091285-1 morning 3/11/21 at 8 am began with profuse diarrhea, shortness of breath and heart palpitations. BP taken by patient at home 164/90 and pulse of 140 bpm while nurse triaged on the phone. Headache, body aches, chills started approximately 6 hours post vaccine. Treated only with Advil and Tylenol . COVID19 VACCINE JANSSEN 0 days 1091288-1 Symptoms, including tiredness, were prominent for first 24 hours; less but still apparent for next 24 hours ( same treatment used). Symptoms resolved by 3 days post vaccine. COVID19 VACCINE JANSSEN 0 days 1091291-1 Severe muscle pain all over body Janssen COVID-19 Vaccine EUA At 11 PM the night of the vaccine (Saturday), extremely bad chills, fever and weakness set in almost immediately. I could not get my body to warm up and was borderline too weak to walk. Very bad headache and nausea set in as well. After several hours the chills turned to intermittent sweating/cold and I could not keep a consistent body temp, nor sleep that night. The next morning (Sunday) I had very bad aches and soreness, along COVID19 VACCINE JANSSEN 0 days 1091293-1 with chills/fever and headaches that could be managed fine with around the clock acetaminophen. Around 8 PM that night, most of these flu like symptoms subsided. The following morning (Monday), still very exhausted despite a full 10 hours sleep. Tiredness and weakness lasted through the day. Tuesday morning until around 3 PM i still experienced drowsiness and was unable to gain strength for anything more than typical day to day tasks (could not workout). Wednesday morning, felt normal but while exercising experienced shortness of breath almost immediately as well as chest/lung pain easily. Come Thursday I feel 90% normal. Severe chills started at 10:30 PM and lasted for 3 1/2 hours. At 2:00 AM they were gone and then just hot. But the chills COVID19 VACCINE JANSSEN 0 days 1091295-1 were crippling. Severe! No pain in arm at injection spot. Within approximately 2 minutes of receiving vaccine, anaphylactic reaction began. Patient's cheeks became very flush/red, & her throat became itchy and tingly. Within the next minute or 2 she started vomiting. She then felt tightness in her chest, and shortness of breath. Complained of lips feeling numb and ""heavy"". Dr was present and COVID19 VACCINE JANSSEN 0 days 1091297-1 ordered an IV to be started, and placed patient on oxygen and a cardiopulmonary monitor with pulse oxmeter after she used a ProAir inhaler. Patient was given IV steroid SoluCortef, IV Zofran for the vomiting, IV Pepsid, and IV Benedryl all for the allergic reaction. She also received 500 ml IV fluids. Symptoms lessoned within one hour, and she was observed for another hour and a half on cardiac monitor and pulse ox by nursing staff as well as Dr. Vitals stable throughout event."" Chills, fever over 102.1 for 5 hours, extreme burning sensation in stomach, cramps in stomach for over 24 hours. Extreme COVID19 VACCINE JANSSEN 0 days 1091298-1 fatigue for over 24 hours. Pain, soreness, and raised area at injection site. COVID19 VACCINE JANSSEN 0 days 1091306-1 Janssen COVID-19 Vaccine EUA Major body aching, chills, fever. Still at 24+ hours after vaccine. Patient received the Janssen COVID 19 vaccine at approximately 3:10 pm. After her vaccination, she walked to the observation area and sat down in a chair. Within 5 minutes, she had a vasovagal response, lost consciousness, fell to the floor. Nurses in the observation area assessed her. She was responsive within a few seconds. Patient was transferred to COVID19 VACCINE JANSSEN 0 days 1091313-1 a cot by nurses where she continued to be observed. She stated she remembered ""everything going dark."" Patient denied any pain, had no obvious injuries. It was unknown if patient hit her head so EMS was called to evaluate her. EMS arrived within 5 minutes of the call and assessed patient. She was medically cleared. Her husband picked her up and stated he would drive her home."" COVID19 VACCINE JANSSEN 0 days 1091318-1 Nauseated and body aches and chills Starting at 10:30 p.m. I experienced severe, shaking chills, fever, random tingling, some joint aches and a headache. I COVID19 VACCINE JANSSEN 0 days 1091326-1 took advil p.m. and tried to sleep, but really couldn't sleep much. By 7 a.m. the symptoms subsided accept for a mild headache. I went to my teaching job that afternoon and felt pretty good. Now two days later, I feel completely fine. COVID19 VACCINE JANSSEN 0 days 1091365-1 heavy chills lasting 6 to 8 hours, nausea, headache, skin sensitivity, lethargy. 3/09/21 - Took 2 regular strength Ibuprofen at 4:00 PM, as a precaution of swelling/inflammation or other adverse effects. At approximately 11:00 PM, severe chills set in. No fever at that time. Took 2 regular strength Tylenol. Started running fever at approximately midnight (approximately 100 F). 3/10/21 - By 1:00 AM, fever had spiked to COVID19 VACCINE JANSSEN 0 days 1091374-1 101.7F. Chills still ongoing. Headache and joint aches/pains as well. Fever reduced to around 100F by approximately 2:00 AM. Fever completed subsided by 4:00 AM. Took 2 regular strength Ibuprofen around 3:00 AM. Aches /soreness/pain lasted until around noon on 3/10/21. Continued alternating Ibuprofen and Tylenol throughout 3/10/21, stopped at approximately 10:00 PM. Extreme fatigue persisted all day on 3/10/21. 3/11/21 - Upon waking, all adverse effects subsided. Energy levels normal. Scratchy throat, redness on tongue ~25 minutes post-vaccination. Assessed by medical director, given Zyrtec. ~90 COVID19 VACCINE JANSSEN 0 days 1091404-1 minutes after vaccination, developed rash on chest. Patient state she felt light headed and dizziness and ""weird"". Patient was sitting at the time and I had the patient lay on the ground to prevent any injury in the event she were to pass out. Due to her stating she felt so hot and ""bad"" 911 COVID19 VACCINE JANSSEN 0 days 1091419-1 was called and dispatched. Upon arrival the patient was seated. and stated she felt weird to the EMS. She stated she did not want to go to the hospital but was unsure if she could stand without passing out. Vaccine was given around 11:40 am and around 11:50 to 11:54am patient started complaining of not feeling well. EMS arrived within 10 minutes of calling 911. Patient stated she did not want to go to the hospital but would go to the ambulance to be evaluated. EMS stated they could exam her in the ambulance and decide from there if she wanted to go to the hospital."" 3/9- 1pm vaccine, injection site discomfort 9pm-chills 10pm-fever (reaching 103.8), body/muscle aches, headache through COVID19 VACCINE JANSSEN 0 days 1091430-1 night and into morning 3/10- 12pm-fever, body aches gone, slight headache remained and tired the next day but continued to improve 3/11- No symptom but arm still sore 10 hours after vaccination I got very tired. Went to bed at 9:30. Had chills. and slight head ache. Woke up around 12:30 with rapid heart beat. My normal resting heart rate is 61(per activity tracker) It was 98 ish. and somewhat eractic. (but COVID19 VACCINE JANSSEN 0 days 1091431-1 not a lot). Also had nausea and diarrhea. Finally got some sleep. Woke up at 7:00am and took 2 aspirin. Today I'm feeling fine. Maybe a little tired. COVID19 VACCINE JANSSEN 0 days 1091435-1 Chills, sweat, tiredness, LOSS OF TASTE (6/10) From 6pm-5am I experienced a terrible migraine, horrible body aches (every joint and muscle was throbbing), upset COVID19 VACCINE JANSSEN 0 days 1091445-1 stomach, uncontrollable shaking/chills, and light headedness. Could only sleep short spurts after taking 400 mg of Ibuprofen. 24 hours after the vaccination, my body is still achey, sore at injection site, and uneasy stomach. COVID19 VACCINE JANSSEN 0 days 1091454-1 Chills, fatigue, achy muscles COVID19 VACCINE JANSSEN 0 days 1091461-1 COVID vaccine was administered within 14 days of receiving influenza vaccine (3/04/2021). Dizziness, passed out and fell backwards onto tile floor. (FIRST TIME EVER) Stopped bleeding from cut on back of head. COVID19 VACCINE JANSSEN 0 days 1091486-1 Severe headache for 3 days. Occasional nausea and lightheadedness. COVID19 VACCINE JANSSEN 0 days 1091494-1 Pain at injection site radiating to arms, shoulder and neck. Aches, chills, hot/cold sweats Shot was at 11:35 am. Symptoms began at about 5pm. Started with moderate headache and muscle aches. A few hours COVID19 VACCINE JANSSEN 0 days 1091501-1 later, chills, shaking, significant achiness and fever of 102. Symptoms persisted into the morning and began to subside about 24 hours after shot. COVID19 VACCINE JANSSEN 0 days 1091509-1 Headache, body aches, chills, alternating hot/cold, fatigue Approximately 5-10 after vaccination, pt began to feel lightheaded, became diaphoretic and pale and felt like he was going to pass out. Pt was lowered to the floor and placed in trendelenburg position. Vitals stable. Pt reported fingers COVID19 VACCINE JANSSEN 0 days 1091556-1 feeling number. EMS was called and pt was evaluated and released. Pt remained at clinic being monitored until he was completely back to baseline. Janssen COVID-19 Vaccine EUA I had a slight headache the evening I received the shot. I woke up feeling extremely COVID19 VACCINE JANSSEN 0 days 1091559-1 tired, groggy. Fog like and woozy, dizzy for several hours on March 9th, the day after I received the vaccine. My side effects went away after about 36 hours. COVID19 VACCINE JANSSEN 0 days 1091596-1 Low Grade Fever (100-101 degrees) for 24 hours. Fatigue for 24 Hours. My tongue started feeling itchy, I have a metal taste in my mouth. It has been this way since about an hour after I got COVID19 VACCINE JANSSEN 0 days 1091600-1 the shot. Itchy has turned into like a tingling but also the feeling it you ""burn"" your tongue. It is not uncomfortable but a symptom that was not listed on the affects"" Flu like symptoms 8 hours after injection, bad headache, body chills and shaking, felt both cold and hot, couldn't untense COVID19 VACCINE JANSSEN 0 days 1091696-1 legs or relax, body aches. Lasted around 4 hours until falling asleep. Mild headache the next day. COVID19 VACCINE JANSSEN 0 days 1091707-1 None as of today 9 hours after the vaccine, the patient was extremely fatigued, experiencing hot flashes, muscle aches, and a fever. COVID19 VACCINE JANSSEN 0 days 1091731-1 Treated with 1000 mg Tylenol. The patient felt relief at hour 26 after vaccination Itching all over the body, random red patches, hives around injection site that are persistent, pain at injection site, COVID19 VACCINE JANSSEN 0 days 1091757-1 consistent nausea over the past 4 days. Per client: As vaccine went in arm went numb, then felt light headed as walking to chair, while sitting vision went blurry and hearing went muffled; feels a little shaky; EMT checked BP 95/66; At 1427 vision and hearing better; BP range 101/68; Client reports her usually BP is ""average""; at 1433 BP per EMT 102/72 while sitting; at 1436 BP per EMT COVID19 VACCINE JANSSEN 0 days 1091766-1 while 93/68 standing; client continues to feel lightheaded; EMT discussed treatment options with client to transport her to the free standing emergency department (FSED) or call husband to pick her up. Client decided to call husband to come and pick her up; EMT recommends her to go to FSED.""

COVID19 VACCINE JANSSEN 0 days 1091774-1 Patient Mom called stating patient started having chills, aches/pains on the evening of the vaccine. She further stated patient had severe nightmares through the night. She reports the patient is taking Tylenol and is feeling better today. COVID19 VACCINE JANSSEN 0 days 1091778-1 Fatigue, mild fever (99.2-99.7), muscle aches, headache I felt ok when I left but overnight I developed a fever and a headache. Temp 101. Advil made the fever go away but the COVID19 VACCINE JANSSEN 0 days 1091788-1 headache is still there. Patient arrived to the outpatient vaccine clinic for her scheduled appointment. Immediately after receiving the vaccine, the patient felt chest pain, dizziness, and passed out. She had swelling of the tongue, lips, eyes, and throat. Patient was COVID19 VACCINE JANSSEN 0 days 1091813-1 admitted to the hospital and treated for anaphylaxis with epinephrine, benadryl, famotidine, methylprednisolone, Duoneb and tylenol. Patient is currently still in the hospital but her condition is stable. Patient was observed in observation area. Patient was sitting in a chair and fainted to the ground. Patient did not notify COVID19 VACCINE JANSSEN 0 days 1091822-1 RN?s in observation that she was feeling faint, lightheaded or had any symptoms. Code was called for EMS to patient side and safety measures were taken. About 9 hours after receiving the vaccine I began developing flu-like symptoms, which quickly escalated. Within a couple of hours I developed a very high fever (which peaked at 104.1 and hovered around 102-103), body-wracking cold chills, extreme lethargy and body aches. The only thing that kept my fever down was 1,000mg of Tylenol every 6 hours, with a cold compress on my head. The symptoms were less severe but still substantial by the following day. On the second night COVID19 VACCINE JANSSEN 0 days 1091860-1 after receiving the vaccine (Monday the 8th) I had nightsweats, but then woke up on the morning of Tuesday the 9th feeling almost completely back to normal. The only other strange thing to happen was waking up today on Thursday the 11th with a giant fever blister on my lip, which I suppose could be attributed to an immune system in temporary disarray or overdrive. I am still very grateful for the vaccine and would do it again, but it was very scary that first night on Sunday the 7th. I don't remember the last time I felt that sick. fatigue starting 7 PM and continuing to present (1 PM following day) headache, fever and chills 8 PM to 8 AM muscle COVID19 VACCINE JANSSEN 0 days 1091863-1 ache 2 hours after injection and continuing to present treated with ice packs, tylenol, rest

COVID19 VACCINE JANSSEN 0 days 1091880-1 6 hours after shot, severe headache and chills. 10 hours after shot vomiting every 1/2 hour for over two hours. 12 hours after shot went to ER . could not hold down fluids. was given IV and anti-nausha medicine. headache lasted two days. Patient became anxious and upon assessment patient described as ?room is black.? Paramedics over to access at 1112. COVID19 VACCINE JANSSEN 0 days 1091888-1 1114 vital signs 82/47 BP, 75 HR, 98 on RA. Blood glucose 113. Paramedics gave 500ml Bolus of NS, BP now 112/74. Patient declined transport to ER, will have wife take him. Day 1 within 20 minutes difficulty swallowing water felt like my throat was closing up. Subsided after an hour. at COVID19 VACCINE JANSSEN 0 days 1091900-1 2:00am woke up with sever abdominal pains, diarrhea, body aches, chills and hot flashes. Continued till am of day 3 woke up with just headache and stiff neck. Brain fog was really bad and a litter better today. Eyes are a little fuzzy. COVID19 VACCINE JANSSEN 0 days 1091903-1 Airway began shrinking took Albuterol. 2 Puffs. Better in 20 minutes COVID19 VACCINE JANSSEN 0 days 1091905-1 Heart rate 120 bpm, Blood pressure 170/110, lightheaded, feeling faint, tingling, anxiety Pt was given the vaccine in her left arm. pt went unresponsive and began to have seizure like activity . Pt was in a COVID19 VACCINE JANSSEN 0 days 1091912-1 chair and lowered to the floor with the assistance of the nurse on her right side. 911 was called. 02 at 2L was administered. pt then became responsive. EMTs arrived and transported pt to hospital. COVID19 VACCINE JANSSEN 0 days 1091961-1 Sore injection site for 2+ days. Chills and fatigue onset 8 hours post injection COVID19 VACCINE JANSSEN 0 days 1091995-1 Administered to 17 years old person whereas the recommended age group was >18- administrative error 61 y.o. right handed male who the Program is consulted for possible stroke. Patient reports that he got his COVID vaccination (Johnson & Johnson) today (3/11/2021) at about 10:30 AM. While waiting after the vaccination, at about 11 COVID19 VACCINE JANSSEN 0 days 1091996-1 AM he became dizzy and felt like he was ""loaded"" (""stoned from smoking weed"") and the started shaking ""as though he has a fever but without a fever."" and left side sensory loss which is non-disabling. He was taking to a CT scan which was negative for stroke and was discharged home."" swelled immediately after the shot and was given 2 benadryl before leaving the drive through. Experiened chills, fever COVID19 VACCINE JANSSEN 0 days 1091999-1 and was vomiting all night. Feeling tired and dizzy afterwards and ever since. Mild headache began approximately 4:00 pm Very severe headache began approximately 6:30 pm Chills, body aches, and shivering began by 7:30 pm Fever at approximately 9:00 pm was 102 and Tylonel was taken at that time. Fever was COVID19 VACCINE JANSSEN 0 days 1092039-1 reduced by the Tylonel but headache remained. After approximately 12 hours the headache was reduced to mild/moderate with the use of Tylonel. Headache was resolved within 48 hours. Body aches still remain after 3 days. COVID19 VACCINE JANSSEN 0 days 1092043-1 Flu-like symptoms, moderate, chills No adverse reaction. Patient was eligible for their Moderna Dose 2, but received Janssen by accident. This is considered COVID19 VACCINE JANSSEN 0 days 1092054-1 full series and patient is aware, and will not seek additional vaccination at this time. The 46yo patient came in to get his covid vaccine. His parents reported he has a medical condition/disability that requires him to receive services in their home. After receiving the vaccine the patient reported feeling lightheaded, dizzy, hot, and that his blood pressure felt abnormal. He requested an ambulance and some water. I called 911 and COVID19 VACCINE JANSSEN 0 days 1092056-1 provided him water, but did not administer any epinephrine or any other medications. The paramedics arrived and talked to him for about 15 minutes. He then left on his own accord with his parents and declined further medical attention. Patient was given Jansen Covid vaccine Lot# 1805029 Exp: 5/25/2021 to Left Deltoid at 10:40AM, by Rn. Fact sheet was given to pt before and consent was signed. Pt was escorted to lobby for monitoring per protocol. At 10:55AM pt begin to show signs of adverse reaction and was transported back to exam room via wheelchair by staff. Pt was lethargic, flushed, warm and dry and had c/o SOB. Pt was being accessed by Dr., vitals signs taken by staff at 10:56AM BP was 157/69 HR 67 R18 O2 98% glucose reading 84. Pt was offered juice and staff was attempting to arouse pt. Per provider COVID19 VACCINE JANSSEN 0 days 1092066-1 order pt was given IM Benadry 50mg to right deltoid lot# 070110 Exp: 7/31/2022 at 11:03AM by staff. Vital signs rechecked at that time BP 137/68 HR 68 R 18 O2% 98. Pt fully alert and oriented at 11:20am and was speaking to her daughter, daughter was explaining to patient the events that happened. Pt vital signs recheck for 3rd time at 11:22AM BP 11:10AM HR 59 R 16 O2 98%. Pt was transported to car via wheelchair by staff and was witnessed getting into car with no assistance. Pt's daughter was contacted at 2:30PM by staff to check on pt and was told pt is feeling fine COVID19 VACCINE JANSSEN 0 days 1092086-1 Fever, chills, muscle aches for approximately 8 hours followed by some fatigue for 16 hours. Vaccine given at 545 PM, pt left the clinic and came back at 623 with complaints of shortness of breath and facial COVID19 VACCINE JANSSEN 0 days 1092095-1 numbness. Vitals were 150/80 97% on RA HR 80 and RR 18. At 630 PM vitals were 115/65 HR 92 100% on RA and RR 18. Pt reported all symptoms had resolved by that time and left the clinic. patient experienced tiredness and fainted for a few seconds after injection, a few seconds of twitching occurred before COVID19 VACCINE JANSSEN 0 days 1092101-1 waking up. Paramedics were called, once arrived, patient was evaluated and denied transport. A few seconds after vaccine was given I had a sensation go up my left jawline that felt similar to a nerve pain. I didn't think much of it and waited the 10 minutes after my vaccine and had no other symptoms. I left the pharmacy and started driving home and had a sudden sensation of a heaviness in my chest and trouble taking a deep breath. I also felt like my tongue and throat were swelling slightly. I had a warm sensation throughout the middle of my back that felt like a heating pad was on it. I felt light-headed and called my husband. As I continued to drive my symptoms worsened and I called 911. I made it home in my car and the ambulance met me there. My husband called the pharmacy to ask COVID19 VACCINE JANSSEN 0 days 1092114-1 them what we should do and they said that it would be ok for him to give me Benadryl. I took 15mL of liquid Benadryl shortly before the ambulance arrived. Within 15-20 minutes, I felt like I was able to swallow better. In the ER, I received IV Benadryl and Famotidine. I was also given 800mg of Ibuprofen for a bad headache I developed. My oxygen level remained in the high 90's and my symptoms were much improved after the IV medication. I was instructed to continue taking Benadryl capsules for the next few days along with Pepcid to keep my symptoms from flaring back up. I noticed this morning when waking up that the left side of my face as well as my throat felt odd so I took the Pepcid and Benadryl and symptoms were relieved in 30 mins or so. Around 8 pm (about 6 hours after receiving the vaccine) I started to feel typical flu symptoms such as chills and aches, and I had some body shaking as well. I was in bed that night and the symptoms kept getting stronger, and around 11 pm I started to feel tingling throughout my body, mostly in my hands and feet. It was very uncomfortable to lay still and I felt I'd never be able to fall asleep if I couldn't lay still. I took 10mg of Z-Quil around 11:30 pm. My body and skin was also starting to get very hot, I never took my body temperature but I probably had a fever. I put a cold compress on my forehead. I also took 1000 mg acetaminophen and 400 mg Advil. I got up to use the bathroom and I could walk but my COVID19 VACCINE JANSSEN 0 days 1092128-1 balance was off and I felt tingling up my legs. I laid back in bed with the cold compress again and the tingling in my hands and feet increased. I tried walking around again and again felt tingling up my legs. I sat on the edge of my bed moving my feet around which helped the tingling, but when I laid down again the tingling kept coming back. I took another 10mg of Z-Quil and 0.25mg xanax (prescription for anxiety). I finally decided to move to a chair with lots of pillows so I could sit upright since that helped reduce the tingling. I finally fell asleep sometime after 12:30 am. I woke up in the chair around 2 am and was feeling better - no tingling, no body shaking, chills and aches were reduced and body temperature didn't feel as high. I was then able to sleep in bed for the rest of the night. The next day I still had aches and chills and a fever but it was manageable with Advil or acetaminophen, and by Monday (March 8) I was able to go to work. Dizziness within one hour of injection. approximately six hours after Injection fever, chills, body aches, headache and COVID19 VACCINE JANSSEN 0 days 1092152-1 shakes. Relief from symptoms occurred approximately 26 hours after injection. At the time of submission 29 hours after injection patient continues to have symptoms but not as severe Sweating, light headed, dizzy, nausea, emesis , pale in his car . After emesis he felt better and his color came back. COVID19 VACCINE JANSSEN 0 days 1092163-1 Ambulance came to reassess. He felt fine. Parents came to pick him up and take his car home At the time of the injection neck and arm were painful-fingers tingled. At about 60 minutes became dizzy, headache, COVID19 VACCINE JANSSEN 0 days 1092164-1 About 2 hours after injection body aches, nausea, feeling very tired, teeth began to ache, all over joint pain About 9 hours after injection - low grade fever (~100* F.) and chills 3/10 4pm: headache 5pm: took 2 Advil and drank a lot of water 6pm: worsened headache, nausea, body aches 6:30pm: took 1 more Advil, continued to drink a lot of water, ate peanut butter toast 7pm: all of the above became worse, COVID19 VACCINE JANSSEN 0 days 1092177-1 difficulty breathing, feverish, chills, fatigue 11pm: vomited 3/11 9am: symptoms improved, lingering headache, ongoing nausea, body felt very weak and drained, fatigue 12pm: symptoms continue to slowly improve

Janssen COVID-19 Vaccine EUA Experienced strong muscular back pain, mostly lumbar but pain felt across entire back. Normal existing body pains also felt amplified. Strong fatigue as if I had engaged in arduous physical activity but had not. COVID19 VACCINE JANSSEN 0 days 1092179-1 Took Advil PM night of vaccine and woke up feeling no pain but slight headache. Took excedrin extra strength in anticipation for headache escalating and felt no further pain until 4:30 pm the day after vaccine. Pain more intense, took 800mg of ibuprofen at 6pm and pain was alleviated by 8pm. Took Advil PM again night 2, and woke up with no pain again. Now 4:45pm of day 3 and not feeling pain but it could return when effects of Excedrin wear off. COVID19 VACCINE JANSSEN 0 days 1092209-1 Itchy in left ear then throat COVID19 VACCINE JANSSEN 0 days 1092238-1 Pt fainted and remained dizzy. possible mild reaction. Pt was eating chicken while waiting the 15 minutes post vaccination. She started choking and pharmacist was called over. After ensuring pt could breath the pharmacist checked the pt with a pulse ox. Reading was COVID19 VACCINE JANSSEN 0 days 1092244-1 93bmp and 98% sat. Pt refused epinephrine and used a rescue inhaler she had. Continued to wait for 30 minutes post vaccination and all symptoms had subsided by then.

At around 9:30 I began getting chills. Body temperature through mouth thermometer: 97.9 degrees F. Developed COVID19 VACCINE JANSSEN 0 days 1092249-1 headache and fatigue over next half hour to an hour. Took my temperature again and it read 101.3. Took ibuprofen and rested. At around 2:30 am, my temperature was 100.0 F and my headache and fatigue felt better. I went to sleep. Normal amount of tenderness at injection site. After about 9-10 hours, I started feeling fatigue and body aches. Several COVID19 VACCINE JANSSEN 0 days 1092256-1 hours later, the body aches turned into a full fever and headache. Fever did not break until 6am the next morning, and body aches and fatigued continued through the full next day. THIS PATIENT PRESENTED TO OUR ED AFTER RECEIVING THE J&J COVID-19 VACCINE AT AN OUTSIDE CLINIC. SHE REPORTED RECEIVING THE VACCINE AROUND 1100. AROUND 1200, SHE REPORTS THAT SHE STARTED DEVELOPING HIVES AND FELT LIKE HER THROAT WAS CLOSING. SHE REPORTED TAKING 1 DOSE OF BENADRYL WHICH DID NOT COVID19 VACCINE JANSSEN 0 days 1092268-1 ALLEVIATE SYMPTOMS, SHE REPORTED CALLING HER PCP AROUND 1400 WHO ADVISED HER TO TAKE ANOTHER DOSE OF BENADRYL. SHE REPORTS THAT SHE DID NOT FEEL IMPROVEMENT IN SYMPTOMS SO SHE ARRIVED TO THE ED AROUND 1500. Chills, body aches, skin sensitivity (clothing and blankets felt scratchy and painful), restlessness (could not get COVID19 VACCINE JANSSEN 0 days 1092280-1 comfortable), nausea, vomiting, insomnia. Side effects began 7 hours after vaccine and lasted for 12-18 hours. Side effects had subsided 24 hours after vaccination. I am currently pregnant. This is my first pregnancy. My due date is August 29, 2021. My pregnancy has thus far been really easy with no complications. I had a low grade fever that I took Tylenol to treat. I had pretty bad muscle and joint pain, chills, and could not stop shaking. I just felt freezing. Once my fever broke I felt extremely hot all night. The next COVID19 VACCINE JANSSEN 0 days 1092284-1 morning I was exhausted and had a lot of the muscle and joint pain still. I marked on my report that it would've stopped me from going about my normal daily activities, as I could not have gone to work and spent most of the day resting. For the next few days I was tired and my eyes ached. On Monday and Tuesday I had a headache in the afternoon. Yesterday afternoon my eyes finally stopped aching and everything seems to be back to normal. I had my J&J COVID vaccine on Monday 3.8.21 On Monday night I developed a fever of 103 which lasted all night despite Advil and Tylenol. I had diarrhea, injection site pain and severe shaking. On 3.11.21 I have developed a very red COVID19 VACCINE JANSSEN 0 days 1092302-1 swollen injection site which is large and extremely painful to the touch. My fever did go away at around 3AM on 3.11.21 but still have the body aches. This was not listed in my possible side effects this far out and some side effects were not even listed in my hand out COVID19 VACCINE JANSSEN 0 days 1092303-1 Patient had headache after receiving the vaccination. burning and hot arm lt side, metal taste in mouth, headache, dizziness, nausea, high blood pressure, Tylenol for COVID19 VACCINE JANSSEN 0 days 1092312-1 headache, Benadryl, tongue started to burn, lt earache, unwell, weak, chest hurting, can't concentrate, rash on right side of face COVID19 VACCINE JANSSEN 0 days 1092314-1 Lightheaded (syncope). 25 weeks pregnant. BPs 92/66 (pulse 72), 95/68 (pulse 75). Given apple juice. After getting vaccinated and escorted to waiting area patient fainted out of chair and hit head on floor. She was briefly COVID19 VACCINE JANSSEN 0 days 1092339-1 unconscious and pale for a few minutes after coming back to consciousness. She remained on the floor feeling dizzy, shaky, and nauseous until she was taken to the hospital by paramedics. Shortly after receiving the Janssen vaccine, Patient began feeling ""a rush going down her body, dizziness, and felt the medicine in her arm."" She became pale and diaphoretic. She rested 30 minutes, attempted to stand to transfer to a COVID19 VACCINE JANSSEN 0 days 1092346-1 wheelchair, felt dizzy again. She laid down again for approximately 10 minutes and slowly sat up and stated she was ""feeling better. Patient's father picked her up and drove her home."" 3/11/21, 5:00 pm started to feel very cold, fingers started to feel numb, by 6:00 pm had severe chills and shivering, fingers were white and fingernails were blue. I became extremely dizzy, so much so that just moving my head or moving from under my blankets or even talking would create a sensation like zaps or electrical jolts inside my head. By this time, COVID19 VACCINE JANSSEN 0 days 1092387-1 I had about four thick blankets on me. This calmed the chills. If I moved even just my hand outside of the blankets, I would immediately start shivering again. I felt my worst at about 9:00 pm. Slowly got better. Drank a lot of water. Dizziness and chills subsided by about 12 midnight and left me with a headache. Tylenol helped reduce that. Slept the rest of the night. Today from about 9:00 am until currently 5:40 pm, I have had slight muscle aches, fatigue, slept on and off all day. Still a bit dizzy but not too bad. Patient was found unconscious laying back in her chair shortly after receiving her Covid-19 vaccine. Patient was awoken with a light shake on the shoulder, but not to noise. The patient stated they had difficulty hearing, along with nausea and light headedness. The patient denied any other symptoms, including difficulty breathing, abdominal pain, and body COVID19 VACCINE JANSSEN 0 days 1092392-1 soreness. Nothing was administered on the pharmacy's end. The paramedics arrived shortly after and took the patient as she was going in and out of consciousness. Patient was contacted after the incident, in which she said that she was told she had vasovagal syncope. The patient is fine now. COVID19 VACCINE JANSSEN 0 days 1092399-1 FOR 24 HOURS POST INJECTION, HAD VIOLENT CHILLS AND SEVERE HEADACHE 4 hours after the vaccine, I started to get body aches and chills and they continued to worsen. I started to develop a low grade fever 8 hours after the shot. 13 hours after the shot, I had a 104.1 fever. Along with the fever, I experienced COVID19 VACCINE JANSSEN 0 days 1092416-1 severe body aches and chills, nausea and a horrible headache. I couldn?t walk as my body was so weak and my vision was blurry. About 15 hours after the vaccine, my fever went down to 102. I was able to get up and walk to my kitchen to take some Advil. My fever broke 20 hours after the vaccine with the medicine. I?m still experiencing severe body aches, headache, nausea and chills and it has been about 30 hours after vaccine. I did have covid 3 months ago, and the symptoms from the vaccine were much worse than the symptoms I had with actual covid.

COVID19 VACCINE JANSSEN 0 days 1092418-1 About 8 hours after the vaccine shot, I started to experience joint aches, then strong chills where I could not get warm, then a splitting headache. Then the injection spot hurt badly, These symptoms lasted for approximately 36 hours Experienced sudden simple onset focal seizure as soon as vaccine was injected into muscle. This was not because of the COVID19 VACCINE JANSSEN 0 days 1092435-1 needle prick but happened afterwards. COVID19 VACCINE JANSSEN 0 days 1092448-1 generalized body aches treat with OTC naproxen and acetaminophen

She got the Johnson & Johnson vaccine at Yankee stadium. Roughly 20 minutes after receiving the vaccine, she started to feel nauseous, develop crampy abdominal pain, and feel lightheaded. She went home and took a shower and lay down in COVID19 VACCINE JANSSEN 0 days 1092461-1 bed. When she got up she again felt nauseous and dizzy. She threw up a total of 6 times, none of which were bloody. She had several episodes of diarrhea throughout the day. Given her ongoing symptoms she presented to the ED. · On arrival, she was febrile to 39.5C, and tachycardic to 145 with BP 98/56 and SpO2 100% on room air. She was given zofran, 1L NS, and tylenol. On repeat, her BP was 75/35 (though no longer tachycardic). She was written for 2 more liters of NS and then endorsed to medicine. Her BP improved w/ SBP in the 90s-110s with continued myalgias, headaches. COVID19 VACCINE JANSSEN 0 days 1092470-1 Tingling in left hand COVID19 VACCINE JANSSEN 0 days 1092478-1 Chills, body aches, headache

COVID19 VACCINE JANSSEN 0 days 1092497-1 Patient passed out for 30-45 seconds shortly after receiving the shot. He recovered with low BP (62/31) shortly after EMS was contacted. After monitoring, patient recovered BP to 112/61 under supervision. He left with parents afterward. COVID19 VACCINE JANSSEN 0 days 1092499-1 Severe chills, fever and body aches Janssen COVID-19 Vaccine EUA woke up with chills, 101 fever, nausea, vomitting, and headache for entire 24 hours after COVID19 VACCINE JANSSEN 0 days 1092502-1 receiving vaccine--took tylenol and symptoms seemed to subside for a bit 36 hours after receiving vaccine a rash appeared on face and neck-appeared as small red speckled dots Vax Clinic note: Approximately 10 minutes after receiving J&J vaccine c/o lips tingling and tongue feeling thick. Medicated with 10 MG cetirizine. VS o2Sat 97%, Pulse 84, BP 146/74. Pt states has had allergic reactions to IV contrast that involved tongue swelling. staets this feels similar but not as bad. o2Sat continues at 97%, Pulse 58, BP 128/68, pt trying to relax, c/o slight headache. Swellig has spread to her lips, and cheeks feeling heavy, O2Sat 97%, Pulse 75, medicated with 50mg benadryl. 911 called to transfer pt to ED for further eval. States throat is feeling tighter. And unable to swallow Epi given 11:18, daughter aware and will meet her at ED. BP 148/82, PUlse 75, O2Stat 97% swelling in tongue decreasing, throat n o longer tight, tongue still feels thick, has some hives between her eyes, and forehead. Pt transported via EMS to ED Intake ED note: 51 y.o. F here after getting J&J vaccine and 10 min. After she c/o her tongue feeling thick and lips tingling Pt given zertec Then 15 min later pt felt lips swelling and had hives around eyes and forehead Pt c/o difficulty swallowing and was rx'd with epi pen Pt has no stridor, or resp issues on arrival, able to speak in full sentences. Pt denies COVID sx 2nd ED note: Pt arrived to ED via EMS from community health center S/P Covid vaccination. About 15 minutes after receiving vaccine - felt nausea and smelled ""medicine"" followed with upper lip swelling and numbness to tongue associated with difficulty swallowing and redness to forehead. Pt alert and oriented at this time. Speaking in full sentence, drinking bottled water without any difficulty. No drooling noted. Denies SOB, chills or fever. Emergency Department Attending Attestation Note See resident/PA/student note for further details of HPI, history, exam, ED course, and diagnoses. Briefly, this is a 51 y.o. female with PMH reviewed in chart and w/ patient notable for insulin dependent diabetes, depression, prothrombin mutation, migraine, p/w concern for allergic reaction. COVID19 VACCINE JANSSEN 0 days 1092507-1 Emesis or change in Covid vaccine today. 10 minutes after receiving the vaccine, patient reports feeling thick in her tongue with tingling in her lips. Patient was given Zertec. The minutes later, her lips began to swell up and was also noted to have new erythematous rash between her eyes and forehead. Patient was given 50 mg of Benadryl. Patient felt like she could not swallow with worsening lip swelling. She was given EpiPen and 911 was called. No stridors. No wheezing. Reports continued tingling and the numbness in her mouth but no lip swelling or tongue swelling. Denies any difficulty swallowing at this time. No wheezing. No abdominal pain or nausea. No rash at this time. Of note, patient also notes left-sided facial, arm, and leg numbness starting about 10 minutes prior to arrival to the emergency department. She reports that she has had recurrent numbness on the left side in the past, which was thought to be due to migraine versus TIA. She has had extensive work-up and multiple hospitalization for this symptom. She reports that she is allergic to iodine and gadolinium containing contrast. Denies any headache at this time though she had a mild headache after receiving the vaccine. Denies any blurry vision. Denies any weakness in her bilateral upper and lower extremities. Assessment and Plan: Vital signs notable for O2 sat of 96 to 98% on room air without tachypnea. Patient is mildly hypertensive. Patient is well-appearing speaking full sentences without any dysarthria. Pupils are equal and reactive to light. Extraocular movement intact. She notes diminished sensation to her left face, left upper extremity, and left lower extremity. Tongue is midline. Hearing is intact bilaterally. No facial droop. She has 5 out of 5 strength in bilateral upper and lower extremities. No pronator drift. Normal gait. No tongue swelling or lip swelling. No stridors. No uvula swelling. No pharyngeal or erythema. Lungs are clear to auscultation bilaterally without wheezing or rhonchi. Cardiac exam without murmurs rubs or gallops. Regular rhythm. No abdominal distention or tenderness on palpation. COVID19 VACCINE JANSSEN 0 days 1092516-1 Feverish, strong headache, frequent urination, lethargy, heartburn Patient received the vaccine at 1500 and at 1510 she began complaining of numbness to tongue and throat. No shortness of breath, O2 saturation 100%, BP 126/84. Paramedics were on scene assessing another patient she they assessed this COVID19 VACCINE JANSSEN 0 days 1092523-1 patient. She was medically cleared and stable. Patient was released to the care of her mother. She ambulated without difficulty to her car. Her mother drove her home. COVID19 VACCINE JANSSEN 0 days 1092527-1 fainting, pale , sweating Extremely weak, extremely tired, slight headache, nausea, chills, pain on the inside of my face, sore joints (shoulders, COVID19 VACCINE JANSSEN 0 days 1092538-1 knees, ankles, feet and toes), sore muscles, minor soreness on injection site, eye pain/soreness 5min following administration of vaccine, pt c/o itching/tingling around mouth. Benadryl was administered. Pt remained COVID19 VACCINE JANSSEN 0 days 1092568-1 onsite for additional 20min w/o complaints. next day phoned pt for f/u, pt states he remained w/o itching/tingling, however pt states he developed a temp of 101.9 this a.m. and has been managed with Tylenol. start with arm hurt, and then headache, dizziness. and these symptoms getting worse along with time. I start to feel cold at night time, but the room temp was 70 which is not cold for me. I started to shiver with cold. my hands and feet COVID19 VACCINE JANSSEN 0 days 1092589-1 were freezing cold. at the same time feel my body is so hot but cold. I started to sweat. after I feel less dizzy, I use an oral thermometer, it was showing 38.5 degrees. I was still boiling hot this morning. and then I took some Tylenol for my body ache and fever. and then i went back to sleep for 6hrs. Sunday night, my heart started pounding really hard. I went to ER - Medical Center. They did an EKG and took my vitals. I had a fever (slight) and chills and was nauseous. Put ONDANSETRON -4 mg. The nausea didn't go away and I couldn't eat or drink without vomiting until today. I couldn't eat or drink or was very tired and groggy and miserable. Today I COVID19 VACCINE JANSSEN 0 days 1092594-1 had another trip to the ER Medical, I got on an antibiotic and anti-nausea medication (GETHALEXIN - 500 mg for the GI) (METOCLOPRAMIGE HCL - 5 mg- for nausea) from the hospital and I had a shot that went into my immune system. They also found a UTI today.

10 minutes after receiving the vaccine, the patient claimed he was feeling light headed and needed to lay down. After speaking, his eyes then went closed, and he clenched his fists and he started coughing up liquid. He was not responsive. COVID19 VACCINE JANSSEN 0 days 1092606-1 He was moved to the ground and turned on his side. He became alert about 3 minutes after becoming unresponsive. He claimed this happens to him when he is at doctor's offices or receiving vaccines/procedures. He claimed it was ""normal."" He said he felt fine/normal, and this has happened in the past, though he did not mention this to the pharmacist prior to administration. 911 was called and examined him. He was allowed to go home on his own, did not go to the hospital."" COVID19 VACCINE JANSSEN 0 days 1092622-1 Light headed, fatigue, numbness on lips - felt like swelling at first then had the numbness 4 pm injection 10 pm mind racing unable to sleep 10 pm body ache 2 (scale 0=none 10=worst pain) 11 pm body ache shine bone pain 4 2 am body pain 7 2 am chills 7 3 am uncontrollable leg twitching 10 4 am body pain, fever now COVID19 VACCINE JANSSEN 0 days 1092629-1 twitching 10 7 am body pain, fever, twitching 10 (Still no sleep) 10 am body pain, fever 10 10 am leg twitching 7 12 (Noon) body pain, fever 8 12 leg twitching 4 3 pm body pain, fever 5 3 pm leg twitching 0 6 pm body pain, fever 2 10 pm body pain 1, fever 0 5min following administration of vaccine pt passed out. Within moments pt became responsive. Pt was pale and COVID19 VACCINE JANSSEN 0 days 1092630-1 diaphoretic. Bp 76/54. HR 84. Pt was taken to hospital by ambulance. Pt was d/c from hospital 2hrs later. Pt states he received iv fluids and ekg wnl. Pt states he feels much better. At 9:15 pm. he took three steps and he started shaking. Got home and went to sleep, woke up every couple hours with COVID19 VACCINE JANSSEN 0 days 1092633-1 a stabbing chest pain, chills and sweating. About 10:30 a.m. the next day, he took 800mg of Ibuprofen and slept for a while and feels better. COVID19 VACCINE JANSSEN 0 days 1092641-1 Fatigue suddenly and chills COVID19 VACCINE JANSSEN 0 days 1092643-1 IM injection given in left thigh due to patient having bilateral Eversense glucose monitors embedded in upper arms IM injection given in right thigh due to bilateral mastectomy, and prior significant swelling of right arm with flu vaccine COVID19 VACCINE JANSSEN 0 days 1092646-1 in 10/2019, with small mass remaining. Patient developed rash on arm and chest, called pharmacy to report, within two hours of vaccination. No respiratory COVID19 VACCINE JANSSEN 0 days 1092647-1 involvement. We recommended benadryl and a trip to emergency room if the allergic reaction became severe. She is not alone.

Came down with a 100.2 degree F fever the night I got it, which went away after one dose of tylenol. The following COVID19 VACCINE JANSSEN 0 days 1092692-1 night I did have a low grade fever of 99.3, which also went away after one dose of tylenol. I have had muscular soreness, and am now developing a small, itchy, red patch at the injection site. I will fill out another adverse form if it gets worse. COVID19 VACCINE JANSSEN 0 days 1092696-1 PATIENT'S HUSBAND REPORTED CHILLS AND MUSCLE ACHES I was fine after my shot, but at 3:00pm I started having chills muscle aches and severe nausea. I also have a headache COVID19 VACCINE JANSSEN 0 days 1092701-1 and fever. While driving home my muscles seem to shut down. My face was numb I couldn?t move my hands or my legs to drive. I had to pull over on the highway for 20min until my hands legs and face regained mobility. Side effects started with in 7 hours starting with tiredness. Headache within 8 hours. Muscle aches, fever and small COVID19 VACCINE JANSSEN 0 days 1092715-1 bouts of nausea within 11 hours. All side effects lasted about 24 hours after injection of the vaccine. Needle became detached from syringe during injection. Participant stated she she felt some vaccine leak down her arm, and a couple of drops of vaccine were visible on the table. Participant was worried that she did not receive full dose. COVID19 VACCINE JANSSEN 0 days 1092717-1 Participant was informed that the amount she received was more than plenty to elicit the appropriate immune response, and that protocol was to not administer additional vaccine in this instance. Participant stated understanding, although still uneasy. Participant information was collected for VAERS report. Around 7pm I started with chills, body aches, diarrhea, nauseas, I was throwing up & headaches. I took extra strength COVID19 VACCINE JANSSEN 0 days 1092733-1 Tylenol & the symptoms lasted for a little under 24 hrs. Body aches, hot and cold sweats, pounding headache, fatigue and upset stomach. Symptoms started 6 hours after COVID19 VACCINE JANSSEN 0 days 1092741-1 receiving the shot and last for a total of 24 hours. After 24 hours only symptoms included sore right arm where shot was administered. pt waiting 15min no problem then return to pharmacy 30 minutes later with facial flushing no other symptoms ask pt to wait longer (gave ice pack) took blood pressure which was elevated and bout 45-1 hr later stilled had flushing and arm COVID19 VACCINE JANSSEN 0 days 1092761-1 seemed bit redder gave 10ml benadryl 12.5/5ml and recheck blood pressure which was still elevated. around 5:45 pm pt said she felt fine and decided to go home. to her to keep eye on symptom and follow with er if got worse. pt was feeling tightness in neck and face around eyes about 5 minutes or so after vaccination. She used an epipen and COVID19 VACCINE JANSSEN 0 days 1092768-1 the symptoms improved. ems was called, fire fighters evaluated her upon arrival and then ems arrived and also evaluated her. Patient noted weakness in both hands while finishing 15min post-observation time, felt it was abnormal. EMS onsite support provided 100mg diphenhydramine HCL (40mL) PO. Patient/EMS contacted provider, who recommended he be COVID19 VACCINE JANSSEN 0 days 1092784-1 evaluated at ER. Patient was transported to ER for evaluation. Upon following up with local hospital, P.A. noted symptoms did not reflect a vaccine reaction in her opinion and patient was discharged. Patient stopped by several days later to pick up vaccine card and noted was much recovered. Intense chills began about 9 pm. Lasted till about 10:30 pm. At about 9:30 pm, the aches kicked in in most joints in my COVID19 VACCINE JANSSEN 0 days 1092789-1 body. Back, shoulders, knees, elbows, 30 minutes after vaccination in R deltoid had rash, fine red not raised on right forearm. Given benadryl 25 mg po. within 5 minutes developed subjective tachycardia/ and shortness of breath and felt light headed. Rash on forearm improved COVID19 VACCINE JANSSEN 0 days 1092796-1 some with benadryl. Given one epipen at the time 911 was called. She felt short of breath, she was not audibly wheezing. EMT took her to the local hospital. She was always alert and conversant. COVID19 VACCINE JANSSEN 0 days 1092799-1 There was a syringe malfunction which caused a drop of the Janssen Covid 19 vaccine to spill out. COVID19 VACCINE JANSSEN 0 days 1092800-1 Joint aches, numbness in hands and lips, headache, chills, tiredness I got the vaccine around 12 pm went home and fell asleep at 1 woke up around 4 was felling very tired and my body was beginning to feel very sore fell asleep again and got up at 6 with a fever and awful migraine and chills and laid down COVID19 VACCINE JANSSEN 0 days 1092804-1 until 8 when I stood up I started to feel very nauseous and started to vomit uncontrollably all throughout the night maybe 4 or 5 times and vomited twice the next day I?ve had a continuous migraine and fever soreness muscle aches in head, neck and back. COVID19 VACCINE JANSSEN 0 days 1092806-1 Muscle aches, chills, headache, fatigue Arm felt heavy and sore 1:30pm took Tylenol. Feel very tired. 6pm Shortness of breath. Needed more air. Used an COVID19 VACCINE JANSSEN 0 days 1092826-1 inhaler & it helped. Exhausted 8pm Fever of 101 F and severe body chills throughout the night. Malaise and headache throughout the whole day after COVID19 VACCINE JANSSEN 0 days 1092832-1 vaccination. Have taken Tylenol 500 mg PO q6h for treatment of fever. At this point, fever and chill have seized, but malaise and headache persist. The patient received the IMZ and was waiting in the post vaccination area and noticed that her hands had turned blue. The patient said she had no symptoms and no complaints of any fever, tingling, or chills. As a precaution, the patient received a dose of diphenhydramine to counter the potential reaction. After advising the patient to seek medical COVID19 VACCINE JANSSEN 0 days 1092839-1 attention, the patient mentions she spray lavender on her hands and that could have been it. Janssen was contacted and notified. They stated that that symptom was not a symptom found in their drug trials but that they would note it and to advise the patient to seek medical care, which was my recommendation as well.

Vasovagal response. After receiving the Janssen COVID 19 vaccine, Patient reported she sat down in her chair. She COVID19 VACCINE JANSSEN 0 days 1092843-1 began to feel dizzy, her palms became sweaty, and diaphoretic. She began to lie herself down on the gym floor but lost consciousness before completely lying down on the floor. LOC for for several seconds after which she began to respond to observation nurse. Fall was unwitnessed so EMS was called to evaluate the patient. She was medically cleared by EMS. COVID19 VACCINE JANSSEN 0 days 1092864-1 Chills, sweating, tiredness, queasy stomach, low energy Patient passed out about 5 minutes after vaccine, did not respond to stimulus, 911 called, pt woke up after about 10 seconds, blood pressure 110/58. Pt was awake for about 5 minutes then pass out again, this time was longer with no COVID19 VACCINE JANSSEN 0 days 1092869-1 response to stimulus, patient was moved to the floor from a chair where he woke back up. EMS arrived and monitored patient. COVID19 VACCINE JANSSEN 0 days 1092880-1 11pm - body aches, sweating fever, tired, weak 3/10/21 - aches, tired, and fever - 100.7 COVID19 VACCINE JANSSEN 0 days 1092889-1 Extreme chills/shivering. Subsided after 1 hour with extra clothing for warmth, tylenol, and ibuprofen Headache neausea Pt became SOB and dizzy. Vital signs stable. She was put on O2 and given po benadryl 25 mg; sent to er for persistent COVID19 VACCINE JANSSEN 0 days 1092906-1 sob and later discharged home COVID19 VACCINE JANSSEN 0 days 1092909-1 Pt felt like he was going to pass out - seemed to go in and out of consciousness for a few minutes but then was fine Immediately and for the first 15 or 20 minutes the site of the injection burned, like a bee sting the whole 15 or 20 minutes. Then as that passed, my throat began to itch and inside my ears became itchy, then after about 5 minutes or so my tongue started to tingle on the front end and felt thicker at the back. After a total of 20 minutes or so after this COVID19 VACCINE JANSSEN 0 days 1092912-1 started I was home and took a Benadryl, which helped, however after a few hours my face started itching, no rash just an itch and it is still itching after 5 days. It seems to be getting better every day. It was definitely a similar type of reaction I get from raw pitted fruits. Eight hours after the vaccine, I awoke with moderate chills and tremors. Eleven hours after the vaccine, i awoke with all- COVID19 VACCINE JANSSEN 0 days 1092914-1 over body aches and a mild headache. I slept 3 more hours and woke up with all of the previous symptoms at once. I felt moderate malaise and these symptoms for 24 hours. I had a sore arm for 4 days. Chills beginning around three pm that got progressively worse, a fever starting around eight pm and very heavy feeling COVID19 VACCINE JANSSEN 0 days 1092921-1 arms, feeling of intense dizziness / unable to walk. Fever has started breaking by 9:30 but dizziness is still present as his heavy feeling in arms though I can use them more now. About six or seven hours after the shot I started to feel bad, first some in my chest, then a scratchy throat with swollen glands, then mild body aches. The next day the sore throat was gone, and body aches got worse. All my joints ache. I felt chilled in spite of outdoor temperature of 79, and a hot bath, blankets and sitting in front of a fire. It was 74 inside COVID19 VACCINE JANSSEN 0 days 1092930-1 the house. I started to get a bit of a headache but it never developed into a full headache. At about 6pm (day 2) I started to get hot. Anything touching my skin bothered me. At about 7pm (day 2) I took two Tylenol and the symptoms improved by about 8:30pm. COVID19 VACCINE JANSSEN 0 days 1092934-1 sore throat, fatigue, numbness of face, ear ( side of injection) Dry mouth..bad stomach pains...severe body aches...very sore back of neck...left arm so sore cant move it...flu or covid COVID19 VACCINE JANSSEN 0 days 1092938-1 like symptoms ...all joints very sore...very nauseated...no appetite Janssen Covid-19 Vaccine EUA recieved shot at around 2:15 Pm, around 8:00 pm I started feeling extreme fatigue, dizziness, and sleepiness. About 1 hour later I started getting the cold chills, a headache and shaking. About 1 more COVID19 VACCINE JANSSEN 0 days 1092953-1 hour later I had a fever, achy joints and muscle aches. The symptoms lasted through the night until about 8:30 the next morning when I started sweating. I decided then to take aceteminiphen and Naproxen. This helped me to feel a little better. Side effects were resolved after 24 hours COVID19 VACCINE JANSSEN 0 days 1092958-1 Blurred vision, rapid heart beat, numbness in legs, nausea , severe headaches and body aches. Fever to 101F for about 15 hours, site pain for about 24 hours, headache for about 15 hours, shortness of breath ongoing, COVID19 VACCINE JANSSEN 0 days 1092965-1 took 400mg ibuprofen every four hours COVID19 VACCINE JANSSEN 0 days 1092968-1 Vagal reaction. Fully recovered after laying flat and drinking water. Monitored for 30 minutes after reaction COVID19 VACCINE JANSSEN 0 days 1092974-1 Soreness In Arm VIS given and discussed, no concerns voiced; Pt instructed to stay in clinic area for 30 minutes after receiving vaccine due to history of anaphylaxis to latex. Patient had epi pen in her purse. Patient experienced diaphoresis and light headedness approximately 15 minutes after receiving vaccine. Was able to walk over to exam table and layed down supine position. Patient appeared pale and diaphoretic. Patient agreed to use her own epi pen from her purse. NP gave her 1 mg COVID19 VACCINE JANSSEN 0 days 1092985-1 epinephrine with her own epi pen from her purse in her right thigh. Blood pressure checked immediately after giving epinephrine, which was 118/78. Heart rate 104; oxygen saturation 94%. Ambulance called and arrived approximately 30 minutes after patient receiving vaccine. Patient denied wanting benadryl to be given and stated she felt a lot better, but felt dizzy if she tried to sit up. Stated that she feels that way when she uses her epi pen. Ambulance arrived within 10 minutes of giving epinephrine. IV started and taken to the hospital. Mild headache, mild muscle aches, light headedness. Regular aspirin taken about 11 hrs after onset were effective for COVID19 VACCINE JANSSEN 0 days 1092994-1 the aches. Mild light headedness continued for about 12 more hrs. after administering vaccine patient fainted and was found on the floor of observation area. She was conscious when i ran COVID19 VACCINE JANSSEN 0 days 1092997-1 to her.She said she usually feels nausea after vaccines and feels like this was just her normal reaction. She refused an ambulance and felt like she was ok. We gave her ice water and and ice pack as she bruised her head when she fainted. We continued to monitor her and she kept refusing medical assistance. She had a friend come to drive her home. Began with chills and muscle aches. Got worse over the course of an hour until I was unable to get out of bed. Pain in my muscles all over from hours of full body chills. The chills stopped after two hours at which point an uncontrolled fever set in. Highest temp recorded was 103. Severe full body muscle pain prevented me from getting up or drinking water on my COVID19 VACCINE JANSSEN 0 days 1093006-1 own. Small movements like sitting up or rolling over to relieve muscle pain resulted in sudden and severe nausea. Considered going to a hospital to bring down the fever and hydrate. After two more hours of applying cold compresses, the fever decreased to 100 at which point I slept it off for six hours. Prolonged bouts of dizziness, dehydration and nausea over the following two days. The night of my vaccine date (6 hours after) I was fatigued and started a fever with chills and acheyness which kept me in bed all night. I got up to shower and get some food as I was going upstairs I grew very faint, my vision grew black and my hearing faded. I was able to make it to my bed then ask for some help. After taking Tylenol, my fever began to be COVID19 VACCINE JANSSEN 0 days 1093017-1 very hot instead of chills. I was able to fall asleep until I woke back up to chills again and taking more medicine. The next morning, I was still dizzy when I walked around but the fever was gone. I was still very fatigued which made me unable to go to class or work. Day 3 I was back to my normal self. 5 hours post injection severe chills and severe shaking, numbing at ends of fingers and toes. 11 hours post injection COVID19 VACCINE JANSSEN 0 days 1093035-1 feverish . Fever resolved 24 hours post injection. Over the course of the following few days, head and body aches and constipation . It is currently 3.5 days post injection and most side effects have resolved 9:30 PM- headache, chills 11:30 PM- projectile vomiting, chills, fever, headache 12:00 AM- projectile vomiting 4:30 AM- COVID19 VACCINE JANSSEN 0 days 1093041-1 projectile vomiting, 101 fever, uncontrollable chills, headache 8:30 AM-headache 11:30 AM-present- lethargic, dizzy, soreness at injection sight Patient had a vasovagal response shortly after vaccination, while in the observation area. Reported dizziness and COVID19 VACCINE JANSSEN 0 days 1093366-1 nausea. Patient was given water and asked to lay in supine position in exam room. After 20 minutes, patient felt better and was able to leave the clinic. COVID19 VACCINE JANSSEN 0 days 1093372-1 Fever about 10 hours after injection. Intense muscle pain two days after. Mild shivers, then intense dry heaves for about 10 minutes (?) (was in bed sleeping), complete loss of bladder control COVID19 VACCINE JANSSEN 0 days 1093373-1 (never before) when stood up Slept through much of the morning. Was OK after. At around 4pm I started to feel cold. 30 mins later I started shivering and feeling cold and very sick with muscle aches all over the body with puncture maximum in left flank on a scale from 1-10 probably 9!I wasn't able to get up from the couch COVID19 VACCINE JANSSEN 0 days 1093378-1 and had shivering until 2-3 hours later. I delayed taking Ibuprofen to not reduce the efficiency of the vaccine but couldn't endure the chills and shivering as well as the massive pain all over my body. I started with 200 mg Ibuprofen, which helped with all 3 symptoms at least as far as I was able to sit instead of lie all the time. COVID19 VACCINE JANSSEN 0 days 1093379-1 Difficulty breathing Fast heartbeat Headache Weakness Chills Fever Eye heaviness COVID19 VACCINE JANSSEN 0 days 1093412-1 103.1 fever, chills, severe.body aches, weakness, severe headache. COVID19 VACCINE JANSSEN 0 days 1093415-1 Fever body aches shakes chills muscle cramping and pain headache nausea, awoken from sleep with symptoms. Janssen COVID-19 Vaccine EUA Vaccine received around 11:30 am. Started feeling chills around 6 pm; took temperature COVID19 VACCINE JANSSEN 0 days 1093424-1 later and verified fever (101.6). COVID19 VACCINE JANSSEN 0 days 1093431-1 Fever, chills, body aches. 4:50-11:45 PM-No symptoms or adverse effects 11:45 PM on 3/11/2021: I started to experience extreme chills that woke me up from a rather deep sleep (due to my intake of 2, 10 mg Melatonin over the counter supplements). I had also drank some ginger and lemon tea before bed due to stomach upset (however I believe that may be linked to my history of digestion issues that are currently going under diagnosis linked to lactose intolerance and food sensitivity). 12:00 AM COVID19 VACCINE JANSSEN 0 days 1093445-1 3/12/2021: I started to experience a headache, muscular aches, and chills continuing. I made myself a cup of mint tea for the warmth and the addition of the stomach settling aspect of mint. 12:15 AM 3/12/2021: I had a bowel movement and the nausea and stomach upset and gas has begun to pass (making me think that portion is linked to non-related issues of the vaccine, but wanted to note in case your professional opinion thought otherwise!). Chills, aches, and headache still continuing with little shift in extremity. 12:30 AM 3/12/2021 I received the shot around 11AM on the 11th. By 5PM that evening I was beginning to have a headache and chills. I drove home from work and by 6PM I had severe chills, I was shaking so bad I could barely fill a cup of water and take ibuprofen, the water was sloshing out of the cup. I had a fever of 102 and spend the rest of the evening in bed, shaking. COVID19 VACCINE JANSSEN 0 days 1093492-1 By around 10 PM the severe chills had subsided and my fever was 101. I did not sleep much during the night due to a headache and alternating chills/sweating. This morning it is 7 AM and my temperature is 99.5 and I am beginning to feel more normal. I took advil at first and then tylenol every 4 hours during the night. Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Pt fainted wile COVID19 VACCINE JANSSEN 0 days 1093495-1 seated. emergency services were called. she recovered quickly. we gave some candy and water. her bp was normal and osat was normal. mother drove her home COVID19 VACCINE JANSSEN 0 days 1093500-1 Fever, body ache, nausea, vomiting, eyes feel hot, head hurts, diarrhea, I gave him 500mg Tylenol Patient became lightheaded, diaphoretic and passed out minutes after receiving vaccine. Woke within seconds. Patient COVID19 VACCINE JANSSEN 0 days 1093504-1 was evaluated by medical professional. BP normal and all symptoms resolved with 10minutes. Kept in nurses offices for approx 45 minutes for observation and was released to his care. Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Numbness (specify: facial COVID19 VACCINE JANSSEN 0 days 1093528-1 area, extremities)-Mild, Systemic: Weakness-Mild Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Numbness (specify: facial COVID19 VACCINE JANSSEN 0 days 1093531-1 area, extremities)-Mild Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Additional Details: Patient stated she had only eaten a bagel and a lemon tart today, COVID19 VACCINE JANSSEN 0 days 1093533-1 shortly after giving her 2 apple juice boxes and a few bites of vanilla ice cream paramedics checked her blood glucose and found it to be 88. Because she bumped her head when she fell, she was escorted to an emergency room.

Systemic: Flushed / Sweating-Mild, Additional Details: Patient stated they felt sweaty and thirsty and said they felt like COVID19 VACCINE JANSSEN 0 days 1093535-1 they were going to pass out, then said they felt fine once they took their sweater off and were given some water. EMTs were called and escorted patient out of the pharmacy. She refused epinephrine injection and did not want EMTs called. Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Seizure-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Vomiting-Mild, Additional Details: Within 10mins of vaccine, pt seem to have a mild seizure for less than 30sec. Pt had no COVID19 VACCINE JANSSEN 0 days 1093537-1 hx of seizures, on no current medication. Pt recovered, and within 1-2mins she passed out. She was warm. She woke up within 1min, then started to vomit. Called emergency services. She felt better after throwing up. When ambulance arrived, she started to have tingling sensation on her finger tips. States she felt better. EMT advised her to go to the ER. Pt decided to go to ER to get checked up. Let with ambulance. Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: pt complained of feeling hot, then lost consciousness while seated for approx 10 sec, pt was given cold cloths and ice pack, given water to COVID19 VACCINE JANSSEN 0 days 1093538-1 sip, and monitored for 30 min. when pt felt recovered, she left, and was followed up by phone call approx 1 hr later, experiencing no further adverse effects Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional COVID19 VACCINE JANSSEN 0 days 1093541-1 Details: Pt nearly fainted/passed out. Had some tunnel vision/nausea/loss of hearing. Recovered after water and sitting for 15 minutes. Had some numb/tingling hands/arms. Chills and fever that night, cold sweat, nausea, dizziness throughout night. Some muscle weakness. Fever of 102, likely COVID19 VACCINE JANSSEN 0 days 1093569-1 was higher last night. COVID19 VACCINE JANSSEN 0 days 1093593-1 Fever, muscle aches, joint pain, headache, fatigue Dizziness; drop in blood pressure; severe aches and pains in joints; low grade fever; migraine; nausea; throwing up; COVID19 VACCINE JANSSEN 0 days 1093614-1 weakness COVID19 VACCINE JANSSEN 0 days 1093617-1 Chills, Headache, skin is sensitive to touch, nauseated, fever, aches Starting the night of vaccination and ending in the afternoon the day after: Headache, body/muscle ache, pain at COVID19 VACCINE JANSSEN 0 days 1093620-1 injection site, fatigue, chills, low fever The pharmacist jam the needle into my arm to the bone and my arm is still a little sore. I could feel the fluid running COVID19 VACCINE JANSSEN 0 days 1093624-1 down in my arm. Around 5 hours or so after the shot, I was in bed for 2 days with chills/aches/fever, head pounding, and heart racing. Also I did not have an appetite. I am just getting my strength back and willing to trust myself walking. COVID19 VACCINE JANSSEN 0 days 1093669-1 Pain fever muscle ache, flu like , chills Nothing serious but the roof of my mouth and back of my throat felt numb for about an hour and then was tingly. This COVID19 VACCINE JANSSEN 0 days 1093679-1 happened about 30 minutes after the shot. I also was very nauseous the next morning. At approximately 1607, observes found patient having a syncope episode. The observation team went over to the patient and safely moved the patient to the floor. The patient was placed on 1.5L oxygen via nonrebreather. The staff paramedic was able arouse the patient with a sternal rub. After arousal the patient did not complain of any difficulty COVID19 VACCINE JANSSEN 0 days 1093687-1 breathing or pain any place. The patient was assisted to chair. The patient was able to answer all orientation questions appropriately at 1612. EMS arrived to the location at 1620. The patient was assisted to the ambulance and care was transferred to EMS. COVID19 VACCINE JANSSEN 0 days 1093696-1 Cold chills 8 hours after injection Subsided 8 hours later 16:00 -Patient started running a fever of 102. He c/o chills, fatiigue, severe body aches, vomiting. Pt was admitted to COVID19 VACCINE JANSSEN 0 days 1093701-1 hospital. Treated symptomatically with IV Tylenol, toradol, Zofran, and fluids

COVID19 VACCINE JANSSEN 0 days 1093705-1 Within 10 hours: chills, headache and nausea within 24 hours: chills, headache, nausea, fatigue, body aches, fever within 48 hours: headache, nausea, fatigue, body aches within 72 hours: fatigue, headache within 96 hours: no symptoms Chills, tiredness, body aches and fever of 101.1. Tylenol helped fever but chills, body aches and exhaustion remained for COVID19 VACCINE JANSSEN 0 days 1093708-1 about 24 hours after onset. No symptoms until about 6 hours after injection The patient stated she experienced fatigue, nausea and vomiting hours after receiving the vaccine. She ultimately ended COVID19 VACCINE JANSSEN 0 days 1093716-1 up going to the emergency room and was treated with Zofran. COVID19 VACCINE JANSSEN 0 days 1093722-1 Fever, chills, nausea, vomiting, headache, arm soreness

Fever of 104.3F. Treated with 325mg acetaminophin, repeated 4x dose. Cold compresses and other physical cooling COVID19 VACCINE JANSSEN 0 days 1093727-1 applied. Fever dropped from 104.3 to 102.5 immediately before taking patient to emergency department, so did not transport. Continued dropping so no further treatment sought. By following morning temperature returned to normal. COVID19 VACCINE JANSSEN 0 days 1093740-1 muscle aches, nausea, and fever in lower extremities; was not able to sleep ibuprofen taken within 12 hours of onset Slight fever, chills, shivering, weakness, headache, severe heartburn. Duration from 6:30 in evening to noon the next COVID19 VACCINE JANSSEN 0 days 1093761-1 day. Flu like symptoms without nausea and without tingle in sinuses. More runny nose than usual. About 10 p.m. I started with bad chills, nauseau, and fever. Felt like I couldn't move at all. Then developed bad COVID19 VACCINE JANSSEN 0 days 1093767-1 headache -- couldn't get out of bed for about 12 hours -- almost went to the hospital I felt so bad. Didn't have any breathing issues -- just severe flu symptoms. Patient has a fear of shots, needles, and blood.. She got light headed . We had her lay down and got her a cold compress. We continued to talk to her and observe. She was awake and coherent mainly embarrassed. Approximately after 15 to COVID19 VACCINE JANSSEN 0 days 1093776-1 20 mins we helped her to a chair. We continued to observe and noticed nothing more. She was not having breathing or communication issues, we asked if she would like a water and got her one. COVID19 VACCINE JANSSEN 0 days 1093778-1 Fever, extreme migraine lasting more than 24 hours. The worst pain I have ever felt. severe chills and trembling, body aches, headache and fever of 103.8. All of these are expected but due to the severity of COVID19 VACCINE JANSSEN 0 days 1093780-1 the fever, I felt it important to report. I have not had a fever that high since I was a child. Probably the highest adult fever I have had is 102. about 10-15 minutes after receiving vaccine pt complaine of dizziness, loss of vision, sweating, loss of consciousness, COVID19 VACCINE JANSSEN 0 days 1093785-1 vomiting and of her left hand getting cold. Body aches and chills through the night By 9 am Wednesday- 102 fever Severe headache / migraine through Wednesday COVID19 VACCINE JANSSEN 0 days 1093806-1 Fever broke Wednesday night Still fatigued and sore arm (Friday morning) went to bed, got chills for half the night then got hot and was uncomfortable most of the night with stomach ache and COVID19 VACCINE JANSSEN 0 days 1093840-1 little or no sleep COVID19 VACCINE JANSSEN 0 days 1093850-1 Dizzy, achy Janssen COVID-19 Vaccine EUA. About 8.5-9hrs after receiving the vaccine, I started getting body aches in my legs and hips. I started getting really cold, took my temperature and it was at 100.1. Got a headache, slightly nauseous, body aches got a lot worse (particularly my lower back). I was also feeling a little dizzy and having a hard time comprehending COVID19 VACCINE JANSSEN 0 days 1093856-1 information; this was probably the fever. Around 8pm, I took my temperature again and it had risen to 102. I took some extra strength Tylenol which started helping about 30 minutes later. I woke up 3/12/2021 still with some body aches, slight headache, and slight stomachache. Janssen COVID-19 Vaccine EUA @ 10:30 am 3/11/2021 Begining at 8 pm, I got chills (shivering and shaking uncontrolably) COVID19 VACCINE JANSSEN 0 days 1093858-1 for over an hour, then a fever of 103 less than an hour after the chills started. I took Ibuprophen and was able to fall asleep. Woke to a fever of just 99. Feeling better the next morning. RECIPIENT NOT HAVING ANY ADVERSE REACTIONS AT THIS TIME. REPORTING THIS DUE TO HAVING RECEIVED FIRST COVID19 VACCINE JANSSEN 0 days 1093881-1 DOSE ONLY OF THE MODERNA VACCINE ON 01/06/2021. I was fine but at 5pm Monday 3/8 I felt nauseous. Tuesday I was nauseous really badly with bad chills. I went to bed. no COVID19 VACCINE JANSSEN 0 days 1093885-1 fever. chills all night. wanted to throw up but didn't. Wednesday I had nausea but no chills and by noon Wednesday the nausea was gone and I was fine. COVID19 VACCINE JANSSEN 0 days 1093886-1 soreness at sight of injection, 2 days chills, 24 hrs sweats, 12 hrs muscle aches, 36 hrs Headache (shorty after shot was given), soreness in left arm, tiredness, chills, muscle cramps and spasms, dizziness and COVID19 VACCINE JANSSEN 0 days 1093904-1 fever (day 3 still have nagging headache) Chills throughout Thursday nite 3/4, Fever Friday AM 3/5 102.4F, slept most of day, Fever blisters occurred on top and COVID19 VACCINE JANSSEN 0 days 1093916-1 bottom lips as well as blisters in roof of mouth. Fatigue. Tylenol, topical applications for blisters as well as salt water oral gargle several days. COVID19 VACCINE JANSSEN 0 days 1093930-1 Sevier migraine, chills and fever That night about the time I went to bed I started with cold chills and felt like I may be running a low fever. In the morning about 4 AM I could not sleep I achedall over and just felt generally unwell. I did run a low-grade fever and I COVID19 VACCINE JANSSEN 0 days 1093933-1 could not work because of it.I was a bit foggy lightheaded dizzy at some points. It might be worth noting that I am a redhead and overall we are very sensitive. COVID19 VACCINE JANSSEN 0 days 1093936-1 Body aches/quite severe, nausea, chills, headache beginning 4 hours post-injection and lasting 30 hours Report minor congestion in nasal passage, minor HA and body aches. States it feels like I have a cold. Treatment: COVID19 VACCINE JANSSEN 0 days 1093979-1 Tylenol. Outcome: Moderate improvement does interfere with ADLs continues to work. Vaccine 3/8/21 at 4:00 PM.Headache and fever 3 hours post vaccine. The following day had diarrhea and vomiting. Then COVID19 VACCINE JANSSEN 0 days 1093981-1 presented to ER on 3/10/21 with lactic acidosis, & leukocytosis. Hospitalized for 24 hours 3/10/21 to 3/11/21. About 10-11 hours after receiving the vaccine began to have severe body aches and 102 fever. Fever subsided but extreme fatigue and body aches for two full days following the vaccine. Two days after the vaccine I began to have sharp COVID19 VACCINE JANSSEN 0 days 1093983-1 intermittent pains in my head and lost my balance and had trouble walking for about two hours. I took Advil for the fever and the pains in head and this seemed to help with both. Three days after the vaccine I am feeling less fatigue and body aches have improved. COVID19 VACCINE JANSSEN 0 days 1093993-1 Chills, muscle aches, fever, headache COVID19 VACCINE JANSSEN 0 days 1094011-1 Janssen COVID-19 Vaccine EUA Extreme tiredness, headache, chills, loss of appetite Client got very quiet and lost eye focus immediately after vaccination. She reported feeling dizzy around 2 minutes after vaccination. After reclining client, they lost consciousness about 9 minutes after vaccination for 3 minutes. EMS was COVID19 VACCINE JANSSEN 0 days 1094025-1 activated, upon regaining consciousness, clients mental status was still altered per staff report. Client was then transported via EMS to local ER. Nausea first for 2 hours then fever that reached 101.9 at 12 hours after injection. Fever and aches and shaking all night. COVID19 VACCINE JANSSEN 0 days 1094042-1 Fever broke at 5:30 am-19.5 hours after injection. It?s 24 hours after injection and fever has broke but nausea has returned. Comes in waves. Extra tired and sick feeling just like the flu. Within six hours: fatigue, aches overall of body Six to 24 hours: fatigue, aches overall of the body, especially along the spine, and in joints. 24-48 hours: fatigue, reduced aches overall of the body, but aches in hips and knees remained, COVID19 VACCINE JANSSEN 0 days 1094044-1 especially pronounced on the right side. After 48 hours: some fatigue, much reduced aches overall, some minor aches remain in right leg. At 60 hours: some fatigue, minor achiness. I'd say almost recovered. COVID19 VACCINE JANSSEN 0 days 1094045-1 fever , vomiting and head ache. 8 hours after injection. COVID19 VACCINE JANSSEN 0 days 1094048-1 Soreness in arm at injection site, small bump at site, fatigue, drowsiness Fever 1.5 degrees higher than normal begining approx 6.5 hours after injection and lasting for several hours. Chills COVID19 VACCINE JANSSEN 0 days 1094051-1 begining approx 6.5 hours after injection and lasting for several hours. Headache beginning approximately 20 hours after injection and lasting several hours COVID19 VACCINE JANSSEN 0 days 1094059-1 Fever over 104 degrees, vomiting, body shakes, hallucination, muscle pain Janssen COVID-19 Vaccine EUA G1P0 at 33w5d by LMP, presented to L&D the evening of 3/10/2021 after experiencing fevers, chills, diaphoresis, and muscle aches beginning approximately 8 hours after vaccination. She has chronic headaches which is also present on presentation. She denies any cough, sputum production, nausea, vomiting, diarrhea, dysuria, COVID19 VACCINE JANSSEN 0 days 1094062-1 hematuria, flank pain, abdominal pain, vaginal bleeding, rash or skin changes, no leg swelling or pain. On presentation she was noted to have a fever of almost 103F, was tachycardiac to 160s, BPs 90s/50s, and had fetal tachycardia in the 170s. Her exam was non focal with no evidence of infection. Sepsis workup was initiated which was negative. COVID-19 test was negative Discharged home in stable condition Patient was administered the vaccine, during her 15 min observation she stated ""my lips feel tingly"". Patient appeared pale, her feet were elevated, she reported that she had not eaten since the previous evening. She was able to drink 11.5 oz of orange juice, blood pressure was 175/122, apical pulse was 68, blood glucose was 76. Butterfly IV was started COVID19 VACCINE JANSSEN 0 days 1094095-1 by assistant clinical manager who administered diphenhydramine 25 mg. Clinical director was notified and orders received to continue to monitor the patient until systolic blood pressure had declined to 140-150 then she would be discharged if asymptomatic. The patient rested and was monitored, blood pressure declined to 145/82 and she notified her primary care physician to follow up the same day. She was summarily discharged and was seen by her physician later in the afternoon."" fever, chills, nausea, fatigue, lighthead, lasted for several hours went away by the morning. Took ibuprofen for the arm COVID19 VACCINE JANSSEN 0 days 1094101-1 pain and the fever. Chills, Fever. Fever started about 10 hours after injection. Highest fever was 101.9 lasting through the night and was COVID19 VACCINE JANSSEN 0 days 1094148-1 back to normal by 0800 next day. Took Tylenol at night... COVID19 VACCINE JANSSEN 0 days 1094170-1 Headache, body aches, thirst, fever approx. 15 minutes after vaccine, had left ear fullness, lip swelling and difficulty swallowing. Given EpiPen x1 IM right COVID19 VACCINE JANSSEN 0 days 1094173-1 thigh with improvements in symptoms. 911 called and transferred to hospital. COVID19 VACCINE JANSSEN 0 days 1094178-1 muscle aches, foggy mind, fever, chills, COVID19 VACCINE JANSSEN 0 days 1094230-1 chills and headache COVID19 VACCINE JANSSEN 0 days 1094239-1 experienced body aches maliase and headache Starting at 8 pm on 3/11 I had flu symptoms; fever, aches, headache neck ache. Had fever through night chills and sweats. This morning I noticed around 9 am I started to develop hives on my shoulders/back/neck/face and my ears are COVID19 VACCINE JANSSEN 0 days 1094244-1 red. I took 400 mg Aleve at 1:30 am 3/12, Tylenol 500 mg at 9 am and Benedryl at 11 am all on 3/12. My arms/shoulders/chest/neck feel itchy. COVID19 VACCINE JANSSEN 0 days 1094253-1 body aches, little nausea, and now c/o fever 100.6F. pt will be taking Tylenol for high fever- higher than 100.4¶ F. Senior Living Facility nurse requested patient receive Covid Vaccine from EMT . Patient was just recently admitted to COVID19 VACCINE JANSSEN 0 days 1094255-1 the facility. EMT gave patient a Janssen Covid 19 vaccine as requested and when the information was put into the database it was discovered that patient had had 2 previous Moderna vaccines at a previous facility. 25 yo F with presented for Janssen (Johnson and Johnson) Covid-19 vaccination at the drive up clinic a on 3/10/21. Patient is part of group 3. Patient with no allergy history and no history of previous allergy reactions to vaccinations. Patient given 0.5ml Janssen Covid19 vaccination in left deltoid at 1407 (Lot # 1802070). Patient assigned to be observed COVID19 VACCINE JANSSEN 0 days 1094258-1 for 5 minutes. After observation(?), while moving her car to in the parking area/clinic, the patient stopped at traffic control to tell them they did not feel well. Traffic controller told patient to pull over to the side. Simultaneously the car proceeded to move forward, over the curb and hit the stop sign. Patient was alert but c/o dizziness when staff arrived at vehicle to assess. EMS called. No other information available for further followup. Vasovagal event? No medical records are available for this patient 15 mins after vaccination I began to have a scratchy throat, which gradually got worse and became thick mucus in throat, wheezing, sinus inflammation, fatigue, racing heartbeat. Symptoms became under control after 50mg of Benadryl. COVID19 VACCINE JANSSEN 0 days 1094277-1 Thick mucus lingered until the next day. Increased heart rate leveled off after Benadryl took affect. Fully recovered by the following day. At bedtime, felt chills. Overnight developed muscle aches and a headache. On 3/12 9:45am still feeling headache and COVID19 VACCINE JANSSEN 0 days 1094301-1 body aches. Began with violent shakes and chills. Migraine type headache developed, followed by nausea feeling, all over sore COVID19 VACCINE JANSSEN 0 days 1094323-1 muscles. This lasted about 12 hours, then slowly started to subside. By second day, nausea gone, headache gone, but very light-headed. On third day, still very light-headed. - Started day of vaccination: Fever of 103 that lasted several hours (even when taking Tylenol), strong pain along length COVID19 VACCINE JANSSEN 0 days 1094368-1 of entire spine, intense all over headache, nausea - Insomnia/sleeplessness from day of vaccination that continued for 5 days after injection Client tripped and fell while leaving the site of the POD. He hit his chin, head and wrist on the ground. He did not lose consciousness and had no bleeding. His vital signs were as follows: BP=118/72, Pulse=74bpm. On examination, client was COVID19 VACCINE JANSSEN 0 days 1094375-1 conscious and alert X 3, and was talking coherently. He refused to go to the emergency room and stated that he did not want the EMT to be called. He was observed for 30 minutes and decided he felt well enough to leave. He was asked to call ?911? if he developed any symptoms including a headache or dizziness and he voiced understanding. After receiving the Johnson & Johnson vaccination at approx 0855 the patient told the vaccinating nurse that he was ""feeling dizzy."" Pt then fainted and was lowered to the floor and positioned on his side; he was pale and diaphoretic initially but resolved before he was sat up. He then opened his eyes and stated that he was ""feeling ok."" Patient then COVID19 VACCINE JANSSEN 0 days 1094392-1 confirmed that he has fainted twice before while receiving bloodwork or vaccines. Pt refused emergency services. Pt advised to call 911 or seek medical attention for any concerns after leaving facility. Pt verbalized understanding. Pt vital signs are as follows BP 136/58, R 18, P 84, O2 sats 98% on room air. Pt alert and denies any pain or discomfort. Denies any further concerns. Pt left facility at 0900."" Care facility nurse asked EMS staff to give patient a Covid vaccine. EMT gave vaccine and then it was discovered in our COVID19 VACCINE JANSSEN 0 days 1094440-1 covid vaccine reporting system that patient had already had 2 Moderna covid 19 vaccines . COVID19 VACCINE JANSSEN 0 days 1094507-1 Rapid heart rate. 3/12/21 COVID19 VACCINE JANSSEN 0 days 1094522-1 Fever, body aches, chills, dizziness all the evening and night of receiving the vaccine Immediately had a dull headache. About an hour and a half just didn't feel well and became very tired where he was dozing off. About 7:00 pm started to shake. This continued to get worse with severe jerking along with the uncontrollable shaking. Had a rapid resting heart rate over 142 and a fever at 102.4. Was incoherent, mumbling his COVID19 VACCINE JANSSEN 0 days 1094530-1 words and not making any sense. Went to ER at 8:48 pm they did blood work, urine test and started an IV. They weren't sure what was going on and first accused of doing drugs then wanted to do a spinal tap. His father stopped that and again told them it was from the covid vaccine. They finally gave him a shot of Ketorolac 30mg and LORazepan 1 mg. They sent him home and told him to take tylenol for his fever. spontaneous shaking kept on until late 3/11, along with a fever. Friday 3/12 he is feeling better, fever has broke but not quite 100%. COVID19 VACCINE JANSSEN 0 days 1094544-1 numbness and pain in right arm swelling in throat COVID19 VACCINE JANSSEN 0 days 1094574-1 Underdone Patient reported feeling dizzy while waiting in the car, approximately 5 minutes after receiving the vaccine, stating her vision began to blur. VS BP 100/60, HR 51, O2 sat 93% on room air. Patient appeared lethargic, unable to keep eyes open when instructed by personnel, upper and lower extremities were limp, unable to keep upper extremities up with full strength or cooperation. Encouraged by personnel to practice deep breathing exercises, compliant until she began feeling tired. Able to understand commands provided by personnel. EMS and police department arrived to scene within 5 COVID19 VACCINE JANSSEN 0 days 1094584-1 minutes. Upon assessment from parademic, patient vitals WNL. Encouraged to go to the hospital by paramedic, patient did not want to go despite feeling dizzy. Aquaintance/close relative on the scene, was responsible of taking patient's car. Relative encouraged patient to go to the hospital, patient refused saying she was feeling better. Patient was able to transfer self from driver's seat to the passenger seat, steady gait. Relative was waiting with patient in patient's car, relative behind the wheel, at the parking lot to monitor patient. Wait approximately 20 minutes before heading home. RN provided education on signs and symptoms to monitor once arriving home, and to seek medical help if conditions worsen. On 03/12/21, 39 yo M with No Known Allergies presented to Drive Up Covid Vaccine clinic. At 0922, pt was administered COVID-19 (Janssen) Vaccine 0.5 mL in left deltoid (Lot #1802070; NDC: 59676-580-15; Exp: 5/25/2021). 2 minutes after COVID19 VACCINE JANSSEN 0 days 1094626-1 injection, pt became diaphoretic with tremors and loss of consciousness. Pt placed in reclined position, pulse present and became responsive and verbal within 30 seconds. Ice pack applied and EMS called. Pt was transported to a local hospital for follow up care. No additional information available. The patient did not disclose that she had a vaccine prior to signing up to our clinic. We discovered the information when COVID19 VACCINE JANSSEN 0 days 1094637-1 entering the vaccine information that was given to the patient on 3/11/2021. Contacted our local health department and was instructed to submit a VERS. COVID19 VACCINE JANSSEN 0 days 1094648-1 Site: Pain at Injection Site-Mild, Systemic: heart racing, palpitations-Medium Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Additional Details: a few minutes after vaccination, pt expressed nausea and dizziness and was unable to stand due to dizziness. pharmacist assisted patient to COVID19 VACCINE JANSSEN 0 days 1094658-1 the ground to lay down. she said she felt much better after laying down but symptoms returned after she sat back up. symptoms were on and off for about 30 minutes. pt recovered with no issues after about 30 minutes of rest 10 pm: Severe chills, body aches Midnight: same as above plus vomited on time Following morning: body aches, COVID19 VACCINE JANSSEN 0 days 1094695-1 lethargic, head ache Patient received Janssen vaccine at 9:33am. Approximately 30 minutes post vaccination after patient returned to her work office, she complained of dizziness, and feeling light- headed. Blood pressure taken and was recorded at 191/102. Blood pressure taken every few minutes after initial pressure, and readings were 182/102, 167/105,174/98, 198/123. COVID19 VACCINE JANSSEN 0 days 1094703-1 Complained of feeling nauseated. Vomited. Ambulance was called at around 10:50am. RN stayed with patient and continued to check blood pressure. Blood pressure readings were recorded as follows: 174/114, 169/110, 167/108, 155/106, 165/114. Around 11:30am, ambulance still had not arrived. Patient transported to hospital by co-workers. Reported feeling much better prior to leaving for hospital. COVID19 VACCINE JANSSEN 0 days 1094746-1 Pt. 17 years old, no adverse events, EXTREME body aches and headache. Joint pain. Dizziness. Nausea. Weakness. Fever. All lasted about 8 hours. Woke COVID19 VACCINE JANSSEN 0 days 1094752-1 up the next morning feeling completely normal.

COVID19 VACCINE JANSSEN 0 days 1094757-1 At 1346 pt c/o itching around face and head. Benadryl 25mg administered PO. Referred to pharmacist supervisor. At 1350 BP 142/78 P 82 R 16 O2 98% (room air). At 1400 pt states itching has decreased at this time, At 1415 pt discharged home. Fever on the night of vaccination. Body aches that felt like every bone in my body hurt. Tylenol did not control the fever. Body aches lasted three weeks. Fever lasted about 4 days. No appetite, diarrhea. Sill lack of appetite and run down and COVID19 VACCINE JANSSEN 0 days 1094760-1 nothing tastes good. The fatigue is lingering. The breathing and low oxygen levels are still causing problems since the first dose. COVID19 VACCINE JANSSEN 0 days 1094770-1 fever, headache, muscle soreness After receiving Janssen covid vaccine at 10:45, patient reported feeling lightheaded and weak at 10:47am. Patient lowered to the ground safely, alert and oriented, state has Hx Vasovagal response s/p vaccine injections and blood draws. Patient alert throughout the episode, laying flat on the ground with leg elevated, initial B/P 88/60 HR 50, R 18, COVID19 VACCINE JANSSEN 0 days 1094772-1 O2 sats 98-99% ra. Orange juice and cookies provided to patient, ate and drank and stated felt better. Repeat VS: B/P 92/64 HR 65 R 18 O2 98-99%.Dr at the patient site, patient observed for 30 minute- patient felt he's at his baseline and d/c home, no distress noted. Re-evaluated by Dr, BP on/dc 102/72. approx 10 hours after shot, he felt chills, body aches and then sudden onset of nausea and then woke up next to his desk. COVID19 VACCINE JANSSEN 0 days 1094788-1 uncertain length of time of LOC. next day feeling tired and achy but better

1000 vaccine recieved and pain started after he felt a pop, (instructed him this was the vanish shield needle most likely) followed by numbness and tingling. When he walked to chair become dizzy and light headed. 1005 reported issues to COVID19 VACCINE JANSSEN 0 days 1094801-1 recovery staff. b/p 132/78, p-99, 02 sat 97%ra, r-18. 1019 cont to be dizzy and light headed, tingling wrist down, pain is gone @ this time. 1023 starting to get sleepy per report. 1045 c/o of vision alterations, blurry vision. B/P 152/80, p-99,02 sat 96%ra, r-18. 1100 b/p 140/86, p-99, r-18, 02 sat 97%. Reports cont to feel the same. 1105 Site lead instructed pt to call MD, go to urgent care or we could call EMS. Pt and significant other opted to drive via their car to urgent care. First 24 hours: fever, body chills, muscle weakness and sore First 48 hours: entire face broke out in acne and rash across COVID19 VACCINE JANSSEN 0 days 1094808-1 cheeks, jaw, and neck

After 29 minutes in observation, the client began complainig about lips tingling, chest tightness and feeling like she had heartburn. Client was watched, given Benadryl after she refused Epinephrine. 02 per mask was administered. EMS was COVID19 VACCINE JANSSEN 0 days 1094816-1 called and assessed the client. Blood pressure was elevated, rapid heart beat. Client declined transport to hospital. Vital signs improved 35 minutes after Benadryl was administered. Client left the facility on her own accord 1 hour and 20 minutes after receiving the Janssen covid-19 vaccination. Client has history of previous reaction to FLU vaccine. At 1410 c/o throat itching, Benadryl 25mg PO administered. BP 139/90, P 70, )2 99% (room air), R 26. At 1415 BP 121/84, COVID19 VACCINE JANSSEN 0 days 1094818-1 P 66, O2 99% (RA), R 20. At 1420 BP 128/56 P 62, O2 98% (RA) R 16. At 1430 BP 117/76, P 64, O2 99% (RA), R 16. Patient states he feels better, minimal itchiness present. 1438 pt discharged home. COVID19 VACCINE JANSSEN 0 days 1094834-1 Patient admitted to hospital with fever, shortness of breath. Severe chills, fever of 100.7, vomiting, fatigue, weakness for less than 12 hours Chills, diarrhea, fatigue, weakness for COVID19 VACCINE JANSSEN 0 days 1094844-1 three days COVID19 VACCINE JANSSEN 0 days 1094862-1 102+ fever muscle cramping, joint pain, severe headaches body sorness

S: Patient is a 53 y/o male c/o having dizziness and nausea while he is walking towards his car after 5 minutes of getting vaccine. Reports having high blood pressure. He did take his medication this morning. O: 1st reading vitals BP 150/70 HR COVID19 VACCINE JANSSEN 0 days 1094864-1 64 Oxygen sat 94 pain 0/10 resp. 18 2nd reading 130/80 Hr 68 oxygen saturation 96 Clamy to touch. Negative for shortness of breath, throat swelling, facial swelling, negative for rash. Negative for numbness or tingling of lips or throat. Cardio: Negative for arm pain, back pain, weakness, palpitations Neuro: Alert x4, negative for limb weakness, neg for slurring, neg Medications: losartan 50 mg daily, carveidlol 12.5 mg bid, famotidine 20 mg every other day, simvasta COVID19 VACCINE JANSSEN 0 days 1094873-1 Severe headache, chills, sweats, vomiting, diarrhea 33 yo M with NKA, history of fainting in the past and anxiety about vaccines and needles was in the drive through clinic to receive COVID-19 Janssen vaccine on 3/12. After receiving the vaccine at 0943 (lot # 1802070) in right deltoid, the patient began to feel anxious. He had been or was watching EMS working with another patient who had experienced an COVID19 VACCINE JANSSEN 0 days 1094881-1 ADR. He began to feel ""floaty"" and noted he was blinking uncontrollably. He reported some tunnel vision/blurred vision. He states he recalled a nurse rubbing on his chest and placing a cold pack on his neck and at this point he began to feel better. He states he was trying to ""fight"" the feeling and was tensing up his extremities but denied convulsions or any loss"" headache and fever within 5 hours after injection followed by congestion, loss of appetite and extreme malaise. Fever COVID19 VACCINE JANSSEN 0 days 1094892-1 ranged between 99.0 and 101 degrees and broke after 36 hours. Headache lasted 24 hours, congestion for 48 hours. Fatigue for 48 hours COVID19 VACCINE JANSSEN 0 days 1094900-1 Fever Chills Headache COVID19 VACCINE JANSSEN 0 days 1094913-1 Chills, 101 temperature, severe headache, body aches. Covid vaccine given at 1255, started having tachycardia at 1530 reports heart rate was 143, PCP recommended to wait a COVID19 VACCINE JANSSEN 0 days 1094919-1 couple of hours to see if heart rate would decrease and it didn't so patient went to ER at 1730. Was transferred via ambulance to Hospital at 2213. Diagnosed with Supraventricular Tachycardia on 03-9-21. COVID19 VACCINE JANSSEN 0 days 1094928-1 Quick episode of syncope after injection. Recovered without complication. Patient began feeling dizzy and hot about 10 minutes after receiving vaccination. Notified staff, Dr assisted patient to COVID19 VACCINE JANSSEN 0 days 1094930-1 floor with his feet elevated. VS done, juice and crackers given, Patient stated, ""This happens all the time. I have anxiety about needles."" Left clinic in no distress, no dizziness."" S: Patient is a 19 y/o male c/o odd sensation over his legs and arms lightheaded while he is walking out of the vaccination tent after 5 minutes of getting vaccine. Reports having history of lightheaded none with injections an appendectomy 2 years ago otherwise no other history . He did not eat or drink this morning. He did vape before taking COVID19 VACCINE JANSSEN 0 days 1094963-1 vaccine. Allergies: PCN, anesthesia hives post surgery O: 1st reading 10:53 vitals BP 120/80 HR 92 Oxygen sat 99 pain 0/10 resp. 18 2nd reading 10:56 120/80 Hr 95 oxygen saturation 99 3rd reading standing after 5 minutes 110/80 Pale. Shivering. Weather is cold outside. Negative for shortness of breath, throat swelling, facial swelling, negative for rash. Negative for n Patient states she received J&J COVID19 vaccine today at clinic site at 10:30am. States she noticed facial swelling starting at 11:30am. Patient went out to lunch and returned home and called COVID19 hotline to report symptoms. States when the swelling was at it's worst, it was difficult to see facial structure of cheek bones which she can usually COVID19 VACCINE JANSSEN 0 days 1094988-1 see. States symptoms are improving facial swelling has 'mostly resolved' with mild swelling around eyes persisting. No OTC medications taken. Denies vomiting/itching/nausea/rash/SOB. Talking comfortably on the phone. Denies need to clear throat. Pt is here with c/o diffuse redness and itching rash which started last night; he took the J&J COVID vaccine around noon yesterday from facility; he denies any wheezing, dyspnea or SOB; denies any prior allergic reaction; no h/o anaphylaxis; Pt stated he was not provided with a hotline to call to reports vaccine reactions. Solu-Cortef 100 mg IM x1 given in the COVID19 VACCINE JANSSEN 0 days 1095027-1 office today; will also place him on prednisone taper which he will start tomorrow morning; Zyrtec 10 mg qd also started today; pt is advised to call 911 or go to the nearest ER should he developed wheezing, SOB and difficulty breathing; he agrees with plan and voices understanding. Incident about the vaccine reported to VAERS. COVID19 VACCINE JANSSEN 0 days 1095041-1 Fever, chills, aches, headache, nausea, hot flashes COVID19 VACCINE JANSSEN 0 days 1095042-1 Headache from 10:00pm-5:30am (3/11/21-3/12/21) and 11:00am-4:00pm (3/12/21). Sleeplessness on the night of 3/11/21. COVID19 VACCINE JANSSEN 0 days 1095056-1 Chills and body aches night of. Body aches and nausea next day

Began feeling tired and developed an intense migraine around 6 hours after, went to bed several hours early (8:30 pm). COVID19 VACCINE JANSSEN 0 days 1095061-1 Intense started in early evening in upper arms and neck and spread through entire body. Felt as if bones hurt. In bed 10 hours but got little rest. Chills and sweats. Note that the pain is the exact same I had when I had COVID several months ago, which has flared up on and off since. Next day symptoms are mostly gone, some tiredness and soreness remains. As soon as I started to inject vaccine into arm patient arm started to swell and get a welt at injection sight. I finished injecting vaccine but by the time I finished the welt was about 1.5 inches in diameter and about a 1/4 inch thick. Notified COVID19 VACCINE JANSSEN 0 days 1095089-1 provider and he looked at it and stated it was a local reaction and stated to patient to watch it and put ice on it when he got home. He also told patient if he had any other side effects to come in to clinic or go to ER. COVID19 VACCINE JANSSEN 0 days 1095119-1 Evening: chills fever Morning: fever, Nausea, fainted, Resting comfortably now Lip tingling, swelling and redness. No respiratory distress. No further signs of mucosal swelling. Benadryl 50 mg po given COVID19 VACCINE JANSSEN 0 days 1095129-1 x1. Lips remained same to slightly improved. Normal vitals. No epinephrine given. Discharged after 50 minutes. Patient is a 22 y.o. female who received the Janssen COVID vaccine Lot# 1805020 on 3/12/2021. The patient experienced the following reaction(s) during the immediate 15min of observation: 1050: Pt observed to have syncopal episode. Pt transferred to ground for assessment. Pt regained consciousness within 30sec of episode. Pt reports vasovagal response COVID19 VACCINE JANSSEN 0 days 1095137-1 to needles. Vitals: 1051: Pt alert and verbal BP: 102/72 HR: 63 RR:18 O2: 99% 1100: Pt alert and oriented x3 BP:117/84 HR: 95 RR: 18 O2: 98% Reports feeling better. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted to car accompanied by parents. Patient is a 63 y.o. female who received the Janssen COVID Lot#: 1805020 on 3/12/2021. The patient experienced the following reaction(s) during the immediate 15 of observation: ""tingling around lips and left arm"" Patient was COVID19 VACCINE JANSSEN 0 days 1095151-1 treated/managed as follows: 1120: BP: 162/80 HR:65 RR: 18 O2: 99% 1130: BP: 160/90 HR: 69 RR:18 O2: 98% Pt reports tingling has completely stopped and feels fine. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted to door by RN.""

Jansen COVID-19 Vaccine EUA After waiting 15 min post vaccination, I got in my car to drive home. I started to see arcs of color in the peripheral vision of my left eye. Later this became more prominent. Overnight, I developed a headache COVID19 VACCINE JANSSEN 0 days 1095155-1 and saw wavy colored/blurred lines in my left eye for about 10 min that obstructed my vision. I saw an ophthalmologist as I was very concerned. They suggested that as my eyes looked healthy under examination that it might be an ocular migraine. I still have a painful headache 26 hrs post vaccination. I?ve never had an ocular migraine previously. 6:20pm Chills with uncontrollable shaking, headache, muscle aches. Took 2 ibuprophen. Went to bed. Headache continued. 9:30pm Started having chills again along with headache and muscle aches. Took 2 Tylenol. Fell asleep. Woke COVID19 VACCINE JANSSEN 0 days 1095161-1 around 11:30pm with a pulse of 112bpm (which normally would have been 58bpm) and a headache. Fell asleep. Woke around 6am with a headache. Got up around 11am. Still feel tired. Around 10 minutes after vaccine patient reported feeling dizzy, tired and weak. Patient was still responsive, stated she had eaten breakfast. She then was given water. She then became unresponsive, eyes closed, snoring with head slumped down while sitting. After we realized patient could not be awoken, property manager called 911. While COVID19 VACCINE JANSSEN 0 days 1095167-1 ambulance was on thier way, patient ""woke up"" but was drowsy and could barely communicate. No epinephrine or diphenhydramine was administered. BP was 130/100. After EMS arrived, patient's partner came in from the car and reported this has happened multiple times at doctor appointments/procedures. Patient was unconscious for around 5minutes. Patient reported she went to the ED but was discharged after a short visit."" COVID19 VACCINE JANSSEN 0 days 1095191-1 Whole body aches, fever, headache, extreme chills, fatigue, dizziness, sore throat, not hungry COVID19 VACCINE JANSSEN 0 days 1095215-1 Chills then a few hours later faster heart rate and feeling very hot. Due 6/17. No pregnancy complications. Severe headache started within 6 hrs. of injection. Had a slight rise in temperature to 99.9. Very sleepy and tired. Muscle aches in legs and buttocks. Slight nausea. Took extra strength Tylenol. Slept off and on for next 24 hours. Had COVID19 VACCINE JANSSEN 0 days 1095216-1 severe sweats and chills. All symptoms were just like I had had early December, 2020 when I had COVID, as per verified by a COVID nasal test done at local hospital.

This writer was given a list of clients to visit in the home today to administer the COVID vaccine. This particular client, answered no to having a COVID vaccine before, and to all questions on the questionnaire. This writer then administered the vaccine. While waiting in the home, this writer was walking around the kitchen and saw a note on the fridge that read: ""You had your COVID vaccine on 3/9/21."" I pointed this out to the client who stated she had no recollection of this COVID19 VACCINE JANSSEN 0 days 1095227-1 note. Caregiver made to employee who confirmed pt had the vaccine previously on that date. Vitals- temp 97.8 pulse- 78 resp- 20 O2- 97% RA BP 130/76. Pt denied any symptoms. Caregiver made to pt's Dr. who advised to contact the family. MD also advised family is to monitor pt for 2 weeks for any side effects. Any concerns, they are to contact his office. MD stated ok to give tylenol PRN fever/pain. MD advised pt dx with dementia. Caregiver made to pt's emergency contact family member who is the DIL. Advised her of the situation. Daughter in law stated she will check in on pt and contact MD office with any concerns. Our on call team leader to follow up with client this evening."" Chills, headache, body aches, some stomach ache, slight fever started at 6:00 pm night injection received- lasted through COVID19 VACCINE JANSSEN 0 days 1095243-1 the next day. COVID19 VACCINE JANSSEN 0 days 1095247-1 Moderate fatigue, chills, body aches, nausea. Severe headache and myalgia. 19:30 post injection fever onset - duration 36 hours 36 hours post injection - severe inflammation of injection site --- COVID19 VACCINE JANSSEN 0 days 1095251-1 duration approximately 18 hours until severeness subsided to mild irritation COVID19 VACCINE JANSSEN 0 days 1095252-1 We sent patient to the ED

Within minutes of receiving the Janssen vaccine, patient c/o dizziness, difficulty breathing, and feeling like her throat was closing. Her breathing was labored, shallow and fast RR high 30s, 93% RA, HR 120s. Lungs sounds with poor air entry, no COVID19 VACCINE JANSSEN 0 days 1095272-1 wheezing. No rash, injection site unremarkable. Pt disclosed extensive history of allergies and h/o anaphylaxis needing Epi. States that current symptoms feel like previous anaphylaxis events. Called Code. Administered Epinephrine IM L thigh and within 2 minutes patient felt better, vital signs improved to HR 121, 99% RA, 170/86 speaking in full sentences. Allergy fellow and ED team arrived and patient was transported to ED alert and responsive in NAD. COVID19 VACCINE JANSSEN 0 days 1095275-1 Chills, headache, nausea

The night of 3/9/21 following the vaccination I had fever, chills, sweating, severe body aches and pains (all over) and nightmares Wednesday morning I was unable to go to work and remained in bed sleeping all but approximately 2 hours in the afternoon because I was still in pain and had headache/fever/chills/muscle and joint pain. I also had no appetite. I was awake long enough to eat one bowl of cereal and a small apple sauce cup so that I could take more meds without COVID19 VACCINE JANSSEN 0 days 1095278-1 upsetting my stomach. Wednesday night 3/10 my temperature was still at 99.3. I was still having body soreness and headaches (sinus). Thursday morning 3/11 I still had the headache and body soreness but no more fever. I was still feeling unwell but could at least get out of bed and function. By late Thursday most of the symptoms subsided and I started feeling better. Friday morning I was no longer having symptoms. It was the initial symptoms Tuesday night and Wednesday that concerned me the most because it hit me so severely and fast. The pharmacist warned me of possible side effects that would require over the counter medication, but in my case that did not suffice. I was physically unable to do anything but sleep which is highly unusual for me, and my entire body was in more pain than I?ve ever experienced. Injection was around noon, felt fine until dinnertime At around 5pm I started feeling a little groggy, lack of appetite By 7 pm I was experiencing moderate chills and shakes and tingling fingers and tongue, shakes subsided around 830p 9pm I went to sleep, 11pm woke up disoriented having been tossing and turning, elevated heart rate (approx 120 bpm) and COVID19 VACCINE JANSSEN 0 days 1095289-1 temp (101.5) which lasted until around 12:30 am Resolved with symptoms of pressure headache until mid morning, made it difficult to sleep Treatment was ice and water, cold compress, hot shower, then in the morning two tylenol Day2 only effects seem to be those lingering from the night before (tired from lack of sleep, muscle soreness from shakes) The main fear was the high heart rate which was only listed in my side effects packet as something to look out for shortly after the injection as sign of an allergy, not something that would come on later The vaccine injection was given at 1:15PM. Symptoms started 8 hours later at 9:00PM. After the first bout of vomiting on night #1, symptoms diminished in intensity but continued into the next day until 10:00PM (when the fever finally COVID19 VACCINE JANSSEN 0 days 1095290-1 broke) for a total of 25 hours. Took 200mg Advil/ibuprofen x 1 dose for relief/sleep on night #1. The symptoms included the following: 1. Chills w/ intense body shivering 2. All over body aches 3. Nausea 4. Violent vomiting 5. Fever 100.3F at the onset 6. Fever 99.9F the following day 7. Headache 8. Extreme tiredness (eyelids felt like lead weights) 9. Dizziness 10. Minimal to no pain at the injection site (very mild if pressing on the skin below the site) Subject received a Janssen Covid-19 vaccination at the Education Center vaccination site. After administration of the vaccine, the patient was required to ubdergo medical observation for fifteen minutes. At the end of the observation period, the patient had no medical complaint and left the observation. Approximately five minutes after leaving the COVID19 VACCINE JANSSEN 0 days 1095292-1 observation area, the patient returned with a complaint of chest pain. The patient was assessed and treated , a Paramedic assigned to the vaccination site. EMS was requested through the 911 system and the Fire Department responded (Incident # 2021-019703). The patient was subsequently transported to a loca Patient is a 60 y.o. male who received the Janssen COVID 19 Vaccine lot #1805020 on 3/12/2021. The patient experienced the following reaction(s) during the immediate of observation: 9:05am Patient c/o dizziness during observation period. Patient evaluated in treatment area. Reports PMH of HTN, depression, and anxiety. Patient was COVID19 VACCINE JANSSEN 0 days 1095293-1 treated/managed as follows: 9:05am VS BP 150/92, HR 56, RR 18, 96% on room air. Patient states symptoms are same. 9:15am VS BP 146/86, HR 60, RR 20, O2 sat 97% on room air. Patient reports feeling better. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance.

I started feeling mildly shaky sometime between 10:16 PM and 10:32 PM. I am a diabetic, so I took a blood glucose reading to determine if my blood glucose levels were low (which can cause mild shakiness). They were not (reading was COVID19 VACCINE JANSSEN 0 days 1095302-1 172 mg/dL), but by the time I took that reading at 10:32 my shakiness had increased from onset, and I was so shaky at 10:35 PM that I was not sure if I could take my bedtime injection of Levemir safely. I was only able to do so by injecting myself and then letting the insulin rest on the palm of my hand (rather than hold it firmly as I usually do). Although the shakiness began to subside several minutes later, I was unable to fully control my toothbrush in my mouth when brushing my teeth. I then got in bed, and the shakiness was gone by around 11:00 PM (I didn't record the exact time). Started with some dizziness and lethargy, shortness of breath, then a slight fever that slowly increased to 99.8 at high point over the next 24 hours, some nausea and diarrhea, increase in headache and swollen/dry eyes. Temperature COVID19 VACCINE JANSSEN 0 days 1095317-1 gradually reduce over the next 12 hours and other symptoms faded as well. Used Acetaminophen and Ventolin to treat symptoms. isolated during course of fever. COVID19 VACCINE JANSSEN 0 days 1095319-1 Lightheaded, dizzy post vaccination. PT AMA recorded at ER Janssen COVID-19 Vaccine EUA She has history of seizures and was given the vaccine and then had a seizure. She was transferred to local ER for further COVID19 VACCINE JANSSEN 0 days 1095334-1 evaluation. She was given Ativan and has been discharged. 34-year-old woman with no significant past medical history presents with syncope event after receiving a COVID-19 vaccination prior to arrival. Patient describes lightheadedness and eventually falling forward. She did sustain facial COVID19 VACCINE JANSSEN 0 days 1095342-1 abrasions to her forehead, bridge of the nose, and right zygomatic arch region. Complains of mild headache with without any nausea. Patient is a 32 y.o. female who received the Janssen Covid vaccine Lot# 1805020 on 3/12/2021. The patient experienced the following reaction(s) during the immediate of observation: Shakiness Dizzy Patient was treated/managed as COVID19 VACCINE JANSSEN 0 days 1095343-1 follows: Pt was given gatorade and VS checked: 0928: 120/84 HR:87 O2: 98% on room air 09:38: 116/80 HR: 79 O2: 97% on room air Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt reports feeling better and escorted out by RN: 10-15 min. After shot, throat felt slightly tight, heart beating fast, slight itch in inner right ear. Given Benadryl. After COVID19 VACCINE JANSSEN 0 days 1095359-1 about an hour, felt better to go home and rest. Two days after injection, left foot-big toe goes numb periodically. That?s occurred a couple of times now. Today I?m very fatigue, heart beating fast, at times hard to catch my breath. COVID19 VACCINE JANSSEN 0 days 1095361-1 Tongue felt a little swollen then had trouble with the swallowing motion. Had to force a swallow 34-year-old woman with no significant past medical history presents with syncope event after receiving a COVID-19 vaccination prior to arrival. Patient describes lightheadedness and eventually falling forward. She did sustain facial COVID19 VACCINE JANSSEN 0 days 1095411-1 abrasions to her forehead, bridge of the nose, and right zygomatic arch region. Complains of mild headache with without any nausea. MDM-43-year-old man presents wit syncope versus near-syncope. Differential diagnosis includes vasovagal reaction COVID19 VACCINE JANSSEN 0 days 1095421-1 versus dehydration versus anxiety versus arrhythmia. Patient is a 72 y.o. female who received the Janssen Covid vaccine Lot# 1805020 on 3/12/2021. The patient experienced the following reaction(s) during the immediate of observation: Dizziness Patient was treated/managed as follows: Pt COVID19 VACCINE JANSSEN 0 days 1095445-1 given gatorade and VS taken 0948: BP: 106/82 HR 76 O2: 96% 0958: BP: 122/82 HR: 78 O2: 97% Pt reports feeling better Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted to car by RN. Patient presented to the Emergency Department of our hospital with report of nausea, vomiting, fever and chills after receiving a COVID-19 vaccination at the local Health Center. Specific information regarding the vaccine (lot number, COVID19 VACCINE JANSSEN 0 days 1095452-1 vaccination site, etc.) is not available to me at the time of this report as the vaccination was not administered by our organization. 4 hrs after injection experienced joint pain in wrists and hands, treated with Extra Strength Acetaminophen 10 hrs after injection experienced fever & chills, body aches, headache and continued joint pain in wrists and hands; treated with COVID19 VACCINE JANSSEN 0 days 1095453-1 Extra Strength Acetaminophen throughout night 21 - 28 hrs after injection continued to have headache; treated with Extra Strength Acetaminophen Patient is a 57 y.o. female who received the Janssen COVID vaccine Lot# 1805020 on 3/12/2021. The patient experienced the following reaction(s) during the immediate of observation: Dizziness Patient was treated/managed as follows: Pt COVID19 VACCINE JANSSEN 0 days 1095474-1 given Gatorade Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted to car by staff COVID19 VACCINE JANSSEN 0 days 1095483-1 Severe chills and fever lasting 10 hours with moderate joint pain

6 hours after receiving vaccine, I started to get the chills, then body aches, then very intense shaking to go along with the chills and body aches. I felt terrible and the shivering was uncontrollable. I took one 200 mg of ibuprofen at 9 or COVID19 VACCINE JANSSEN 0 days 1095486-1 10pm, and another one at 11pm. That seemed to help and I fell asleep. When I awoke in the morning, I had a pounding headache. The headache was debilitating and lasted all day. The headache subsided around 6 pm 10/11/21 after taking a 200 mg ibuprofen. All of the above is unlike anything I have ever experienced, even with a fever or flu. It was misery, and I am a good sport, I didn't expect to have any side effects. These events came on vicious and strong. 23 yr old male sat on chair post Janssen vaccine and complained of light headedness approximately 1 minute afterward, patient called for assistance and onsite Paramedic (1) arrived by his side immediately. Patient became pale and clammy and as onsite Paramedic (2) approached patient sustained syncopal episode while seated on chair. Patient remained in COVID19 VACCINE JANSSEN 0 days 1095489-1 seated position. Patient awoke and only recalled feeling ""dizzy and lightheaded."" Patient denied any medical history, allergies or medications. Patient denied shortness of breath, chest pain headache or pain. AOx4 EMS arrived. Care provided."" Vaccination administered 3/12/2021 @ 1213, left deltoid (Johnson and Johnson lot 1805020) While in recovery area at 1243, patient stands from her chair and states that ""I feel funny, and I have to walk"". RN asks patient to elaborate on reasons why she is needing to ambulate and encourages patient to sit for assessment. She states, ""No, I really don't want to sit, I feel like I need to walk. I have a tingling down the back of my neck, it really feels warm actually hot, I think if you take my vitals it will only make it worse"". RN again requests that patient sit and allow for vital signs to be taken, patient refuses, and asks for water. RN provides a bottle of water for patient and she says that she would like to COVID19 VACCINE JANSSEN 0 days 1095508-1 stay in recovery a little longer. Patient ambulates in area for (with RN observation) and verbalizes that she is feeling a little better with walking. Again, upon visual examination no changes noted in patient skin on neck or sholders. At 1248 patient agrees to sit, but again refuses additional assessment. By 1247, patient states that she is feeling better, denies dizziness and states that heat in neck has decreased. Patient reports having similar reaction after taking Compazine. By 1250, patient verbally expresses that she is ready to depart clinic. Advised to seek medical attention after departure if necessary, with increase or significant change in symptoms. Patient verbalizes understanding. Ambulates from clinic alone at 1251."" Janssen COVID-19 Vaccine EUA -Rapid heart 9:30 p.m. ish until approx. 1:00 a.m. (not consistent - on and off) -Body Aches COVID19 VACCINE JANSSEN 0 days 1095510-1 & Chills 9:30 p.m. ish -Fever - maxed at 101.3 (fever through the night - fever broke around 5:30 a.m.) Took Aleve for fever and aches around 10:30 p.m. Patient warned staff that she was not good with shots and had a history of syncope. She also marked this on her VAR form. She was very nervous and crying in the chair. She received the vaccine promptly and remained in the chair for a few minutes before getting up to sit in the auditorium bleachers. after about 20 or more minutes someone shouted that COVID19 VACCINE JANSSEN 0 days 1095521-1 saw her fall in the bleachers, she was face down between the benches. She was conscious and responding, breathing normally, with normal pulse when we examined her. She got up slowly and recovered without needed further medical attention. VanishPoint spring-retractably syringe (Lot G200712) malfunctioned during (R) deltoid IM administration. Unable to depress plunger on administration so nurse pulled out a little and was able to administered. Minimal leakage noted from COVID19 VACCINE JANSSEN 0 days 1095531-1 injection site simultaneously as plunger malfunctioned after being fully depressed. Site lead notified for further assistance. COVID19 VACCINE JANSSEN 0 days 1095546-1 Fainting, sweating, blood sugar dropped, unresponsive. COVID19 VACCINE JANSSEN 0 days 1095549-1 I had headaches, chills, soreness all over my body, and wanted to throw up for 48 hours after the vaccine. Approximately 30 minutes post vaccination, patient complained of not feeling well. BP checked 130/92, P =82. Diabetic. Had not taken meds this morning. Admits to having eaten irregularly throughout the day. Hydrated with water, gave COVID19 VACCINE JANSSEN 0 days 1095554-1 Gatorade and a snack. Continued to monitor. BP rechecked which was recorded at 145/97 and P= 80. Resident on site. Neuro checks done by resident. Left sided weakness with sensory changes on left side were noted. Ambulance called. Patient transported to Hospital for observation.

Patient is a 61 y.o. female who received the Janssen Covid vaccine Lot# 1805020 on 3/12/2021. The patient experienced the following reaction(s) during the immediate of observation: Dizziness Patient was treated/managed as follows: COVID19 VACCINE JANSSEN 0 days 1095559-1 Given Gatorade and VS taken: 12:16pm: BP-180/90 HR: 71 RR:18 O2: 98% 12:26pm: BP: 180/90 HR: 73 RR: 18 O2: 97% Pt states she has not taken BP meds this morning. Pt reports feeling better Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted to car by Site Lead immediate severe arm pain, 102 fever, severe weakness, severe chills, loss of appetite, diarrhea, severe body aches, the COVID19 VACCINE JANSSEN 0 days 1095565-1 worst of which lasted 24 to 36 hours. Symptoms were to the point I could barely take care of myself and needed help. Considered going to ER

I am 6 months pregnant (28 weeks). Approximately 8 hours after the injection, I developed a fever of 103 degrees. Other symptoms were severe body aches, tremors, and chills. I took two 500mg Tylenol pills, but the fever remained at COVID19 VACCINE JANSSEN 0 days 1095570-1 103 degrees for 12 hours. After 12 hours, the fever reduced to 100 degrees for another 6 hours. Body aches, tremors and chills decreased in severity along with the fever. After 18 hours, my temperature returned to normal and tremors and chills subsided completely. I remained very fatigued with some body aches and general soreness for another 24 hours. COVID19 VACCINE JANSSEN 0 days 1095572-1 Fatigue, Achy Joints, Chills, Headache vaccine at 1246. 1248 arm started to hurt, light-headed, nauseated, SOB followed by emesis. B/P 78/42, HR-55, 02 sat 99%, r-18. Pt given crackers and water. Pt reports only eating banana today. 1313 hr-64,02 sat 98% ra, b/p 88/60. Pt COVID19 VACCINE JANSSEN 0 days 1095573-1 states she is starting to feel better. 1329 had pt stand up cont to be slightly dizzy. Instructed to f/u with MD as needed. 1335 escorted to her parents car who came to get her and updated of the situation per pt ok. COVID19 VACCINE JANSSEN 0 days 1095585-1 Fever of 102.3, chills, headache, nausea COVID19 VACCINE JANSSEN 0 days 1095592-1 Fever, flu-like symptoms, injection site soreness and swelling Patient is a 18 y.o. male who received the Janssen Covid vaccine Lot#: 1805020 on 3/12/2021. The patient experienced the following reaction(s) during the immediate of observation: Pt reports nausea and diaphoretic Patient was COVID19 VACCINE JANSSEN 0 days 1095595-1 treated/managed as follows: 1:27pm: BP: 136/88 HR:112 RR: 18 O2: 98% 1:37pm: BP: 144/94 HR: 107 RR: 18 O2: 97% Pt given gatoorade and reports feeling better. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted to car by site lead. During administration of the vaccine, the needle separated from the hub of the syringe partially. Most of the vaccine COVID19 VACCINE JANSSEN 0 days 1095611-1 leaked out onto patient skin. Followed up with patient and Dr. Patient is a 29 y.o. female who received the Janssen COVID Vaccine Lot#: 1805020 on 3/12/2021. The patient experienced the following reaction(s) during the immediate of observation: Dizzines Diaphoretic Patient was COVID19 VACCINE JANSSEN 0 days 1095618-1 treated/managed as follows: Pt was given Gatorade VS are as follows: 10:20: BP 108/76 HR: 76 RR: 18 O2: 98% 1034: BP 116/64 HR: 80 RR: 18 O2: 99% Pt reports feeling better Patient given educational material regarding vaccine and advised to continue to self-monitor. Pt escorted to car COVID19 VACCINE JANSSEN 0 days 1095622-1 Intense nausea and lightheadedness Slept and took Pepto and ginger pills. Patient reported tingling in the throat and slight dizziness about 5 minutes after injection. Vitals stable. 10 mg Zyrtec COVID19 VACCINE JANSSEN 0 days 1095623-1 given as per nurse practitioner order. Throat continued to feel tingly. No shortness of breath/swelling/rash noted. Dizziness resolving, transferred to a doctor's office nearby for further observation. Patient is a 42 y.o. female who received the Janssen Covid Vaccine Lot#: 1805020 on 3/12/2021. The patient experienced the following reaction(s) during the immediate of observation: Nausea Diaphoretic lightheaded Patient was COVID19 VACCINE JANSSEN 0 days 1095629-1 treated/managed as follows: Given a bottle of Gatorade Vital Signs: 1030: BP: 104/72 HR: 95 O2: 97% 1040: BP: 132/78 HR: 85 O2: 96% Pt reports feeling better at this time. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted to car by staff Around 7 hours after receiving the vaccine I started to get a fever. It was 99.6 at 11:30pm, 102.2 at 2:15am, 102.7 at 3:25am. It started going down at 4:00am after taking 1000 mg naproxen and Tylenol. Fever came back around 1:15pm COVID19 VACCINE JANSSEN 0 days 1095649-1 today at 100.7 and has been up to 101.7 as of 5:30pm. The fever has come along with relentless shaking due to the chills. A migraine has also persisted despite taking NSAIDs to help with that as well. COVID19 VACCINE JANSSEN 0 days 1095664-1 Pain in arm, muscle and joint aches, headache, fever, nausea, muscle cramps, fatigue COVID19 VACCINE JANSSEN 0 days 1095673-1 Possibly inadvertently injected patient with empty syringe with J&J vaccine and ml vanish point syringe. COVID19 VACCINE JANSSEN 0 days 1095674-1 Possibly inadvertently injected with empty syringe with J&J vaccine and Ml vanish point syringe COVID19 VACCINE JANSSEN 0 days 1095690-1 Possibly inadvertently injected with empty syringe with vaccine and ml vanish point syringe. COVID19 VACCINE JANSSEN 0 days 1095691-1 Possibly inadvertently injected with empty syringe with vaccine and Ml vanish point syringe COVID19 VACCINE JANSSEN 0 days 1095712-1 Possibly inadvertently injected with empty syringe with J&J vaccine and ml vanish point syringe. COVID19 VACCINE JANSSEN 0 days 1095721-1 Possibly inadvertently injected with empty syringe with J&J vaccine and vanish point syringe COVID19 VACCINE JANSSEN 0 days 1095732-1 Possibly inadvertently injected with empty syringe with J&J vaccine and ml vanish point syringe. Patient noted to be flushed, lightheaded and Diaphoretic. Treated with cold compress, gave water, juice and crackers. COVID19 VACCINE JANSSEN 0 days 1095747-1 Patient observed for 60 minutes. About 3 minutes after the injection, I blacked out and started convulsing. The event I was told lasted approximately 5 minutes in duration in the clinic before I regained consciousness. The clinic called an ambulance and I was transferred to COVID19 VACCINE JANSSEN 0 days 1095753-1 a larger hospital. In route to the hospital my heartrate dropped and I was given atropine to stabilize my heart rate and was taken to the Emergency Room at Hospital. COVID19 VACCINE JANSSEN 0 days 1095767-1 Persistent mild chest pain, stinging in sensation in chest COVID19 VACCINE JANSSEN 0 days 1095769-1 Itching rash swelling in the throat eyes being all watery and goofy,- Treatment three Benadryl, Albuterol tablet Patient is a 61 y.o. female who received the Janssen Covid vaccine Lot# 1805020 on 3/12/2021. The patient experienced the following reaction(s) during the immediate of observation: ""Feeling funny"" ""Cold feet"" Patient was COVID19 VACCINE JANSSEN 0 days 1095782-1 treated/managed as follows: Vital Signs: 1240pm -BP: 140/76 HR: 94 RR:18 1250pm-BP: 133/88 HR: 82 RR: 18 Pt reports feeling better Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted out to car by Site Lead""

Received shot around 2:10 pm. Experienced some stinging at injection site within a few seconds that became uncomfortable for several minutes then disappeared. At 2:40 texted spouse that my face was tingling. Started in cheeks COVID19 VACCINE JANSSEN 0 days 1095788-1 and upper lip and spread to nose. A few minutes after that I started having hot flashes and my face was flushed. Hot flashes lasted for an hour and subsided, tingling has mostly subsided except for area of cheek closest to my nose (it is 6 pm now). Did not formally check into the urgent care facility but did contact them to see if this was normal. Was advised to take antihistamine and, and if symptoms worsened to go to ER. Symptoms did not get worse.

- Low grade fever for 72 hours w/ high of 100.5¶F. Nausea for 36 hours w/ abdominal cramping after eating for 72 hours. Diarrhea one day after vaccination and again 4 days after vaccination. Extreme fatigue for 48 hours. Headache that came COVID19 VACCINE JANSSEN 0 days 1095789-1 and went for 72 hours. Chills/clammy-ness for 96 hours. Muscle/joint aches starting two days after vaccination and continuing until 4 days after vaccination. Chest tightness starting 2 days after vaccination and continuing 5 days after vaccination. Runny nose/sinus inflammation starting day after vaccination and continuing for 5 days after vaccination. - Pain in injection site for 48 hours. - Symptoms were debilitating for 48 hours and were manageable after that point. Patient was flushed, could not hear, was feeling nausea, and fainted for few seconds. I administered Epi 0.3mg and called COVID19 VACCINE JANSSEN 0 days 1095795-1 911. Paramedics arrived and patient was taken to the hospital. COVID19 VACCINE JANSSEN 0 days 1095803-1 experienced chills for 3 hours, roughly 8 1/2 hours after receiving vaccine COVID19 VACCINE JANSSEN 0 days 1095811-1 Chills, vomiting, diarrhea, muscle pain, fever

Patient received Janssen vaccine was told to sit for 15 minutes post observation. He came up shortly after (less than 5 mins post imz) saying he didn't feel well, like he was going to pass out. I immediately came from the pharmacy, my tech sat a chair behind him. I called for optical to call a code white. The patient requested to sit on the ground. At this point, COVID19 VACCINE JANSSEN 0 days 1095830-1 his wife was present. He was sweating. I gave him an ice pack, a water after it was determined he was breathing okay. He was pale, extremely lethargic and sweating. After sitting him on floor I told my tech to call 911. I took his blood pressure, it was 99/73, pulse 75. Very low for him. Hes on blood pressure medicine but been having issues controlling it. He later tells me hes terrified of needles. He also tells his wife he hadn't eaten all day. I stayed with the patient until ems left with him because when standing his heart rate dropped 20 points, after they stuck him again to check his blood sugar. They determined then he should be checked out at the hospital and they took him. Extreme muscle aches, moderate body chills, skin felt really hot, fatigue. Just took some pain relievers and used ice packs COVID19 VACCINE JANSSEN 0 days 1095836-1 for muscles. Mostly gone after 24 hrs COVID19 VACCINE JANSSEN 0 days 1095866-1 patient had vasovagal symptom Skin felt extremely on fire, body chills and sweats , bad headaches, fatigue. Took pain relievers and rested. Over just COVID19 VACCINE JANSSEN 0 days 1095876-1 about 24 hrs after injection. COVID19 VACCINE JANSSEN 0 days 1095889-1 Dizziness, sweating, and lightheadedness COVID19 VACCINE JANSSEN 0 days 1095944-1 Aching muscles, chills, sore arm, headache, nausea COVID19 VACCINE JANSSEN 0 days 1095948-1 11pm woke up with full body chills, fever, body aches, fatigue. Noticed loss of smell/taste/appetite by morning. Fever 103.9, Chills, Migraine, Weakness, Hyper-elevated heart rate. Fever resolved to 99.5 F in 4 hours with COVID19 VACCINE JANSSEN 0 days 1095950-1 Acetaminophen during ER visit. Anti-anxiety meds administered to reduce heart rate. 48 hours later, most symptoms where not present. Symptoms lasting 72 post injection hours included weakness. COVID19 VACCINE JANSSEN 0 days 1095951-1 Injection site swelling and redness, injection site warm to the touch and is painful COVID19 VACCINE JANSSEN 0 days 1095954-1 Pt received vaccine that is recommended for 18 years and older and is only 16 years at time of injection

Patient is a 26 y.o. male who received the Janssen Covid-19 Vaccine, Ad26.COV2.S (PF) 0.5 mL IM Susp, Lot 1805020 on 3/12/2021. Vaccine administered at 1610 and reaction was immediate. The patient experienced the following reaction(s) during the immediate observation: pt presented chills and shivering upon administration of vaccination. Brief altered mental status and decrease in HR. Staff talked pt through symptoms. PT stated ""I pass out after hang a shot."" Also informed staff that he is a runner. 1621 VS- 100/62, P-56, R-99, noted pale, shivers, clammy hands and cold 1627 VS P-61, COVID19 VACCINE JANSSEN 0 days 1095955-1 O2-100% 1629- BP 104/64 and shivers improving 1635- Stood patient up and moved him to chair in post vaccination area 1637 VS 102/64, P-61, O2 sat- 100%, R-22 1652- P-50, O2-99% 1659- P-47-56, O2 sat 100%, BP- 122/62- good color, shivers resolved HR Increased to 56. Pt is now stable and ambulating. Patient was treated/managed as follows: assessed vitals until wnl, wrapped patient and covered, cool damp cloth, offered therapeutic communication, cool water, and stayed with patient until he was able to ambulate. Left vaccination site accompanied by mother @ 1720. Patient given educational material regarding vaccine and advised to continue to self-monitor per the agency guidance. Education patient on how to seek primary provider or additional medical management if symptoms return."" COVID19 VACCINE JANSSEN 0 days 1095961-1 Pt given vaccine at 17 years old and vaccine recommended for 18 years and older. Fever over 103F, intense chills, extreme muscle aches, tingling in hands and feet for 6 hours. Severe headache for 24 COVID19 VACCINE JANSSEN 0 days 1095962-1 hours. Extreme night sweats for 2 night. Fatigue for 24.hours. patient reported feeling of hot flashes and head pounding; patient informed pharmacist about the reaction 2 hours after COVID19 VACCINE JANSSEN 0 days 1095978-1 the vaccination. Pt felt better after taking Tylenol. COVID19 VACCINE JANSSEN 0 days 1095985-1 Fever Nausea Headache Chills Sore arm COVID19 VACCINE JANSSEN 0 days 1096028-1 soreness at the injection site; muscle aches; chills & shivering; mild fever=99.7; low blood sugar; headache Pt received vaccine and was directed to mandatory waiting area by pharmacist, shortly after pt started having COVID19 VACCINE JANSSEN 0 days 1096042-1 lightheadedness due to anxiety. This only lasted 5 minutes in length and after the 15 minutes, pt was back to normal mental status. Fever over 100F about 12 hours after injection, lasting about 12 hours, after subsiding, arms and neck broke out in a hives-like rash (but does not itch). I?ve taken some Excedrine, Ibuprofen, and Benadryl... I occasionally had idiopathic allergic reactions as child, and this seems moderate to me - my breathing is fine, my stomach doesn?t have the rash (my COVID19 VACCINE JANSSEN 0 days 1096047-1 back does a little...) I?m not certain this is cause for concern, but if a handful of other people react similarly, that might be useful information. I don?t feel like I?ve had direct contact with anything that would cause this sort of reaction - & the few environmental allergies I have rarely react this strongly even when I am directly exposed... About 6 hours after receiving vaccine, I got very tired. Soon after, I had a bad headache and uncomfortable temperature issues (feeling hot and cold). My heart rate seems a little elevated and I am experiencing sensitivity and body aches. I COVID19 VACCINE JANSSEN 0 days 1096051-1 have taken naproxen and acetaminophen. It is now 4 hours since symptom onset and I have not gotten much relief, if any. I would describe my symptoms as moderate. COVID19 VACCINE JANSSEN 0 days 1096056-1 Muscle aches and fatigue all day taking Aleve. COVID19 VACCINE JANSSEN 0 days 1096061-1 Patient is under 18 years old. No adverse events during covid clinic. Pt came in for appointment for COVID vaccine, pt was instructed to have a seat in the waiting area. Only a few moments after, pt started to experience 8-10 minutes of nausea and light-headedness. RPH came over to provide care, asked more COVID19 VACCINE JANSSEN 0 days 1096064-1 about past experiences - pt admitted that a long time ago she experienced nervousness and has had this feeling before. She states she has not had such a reaction since she was a child and was also embarrassed for the incident occurring in front of others. COVID19 VACCINE JANSSEN 0 days 1096065-1 PT PASSED OUT FOR LESS THAN 20 SECONDS, EMS CAME. NOT TREATMENT RECOMMENDED BY THE EMS PATIENT FAINTED AND BECAME UNRESPONSIVE BUT BREATHING WITH PULSE, PARAMEDICS ARRIVED WITHIN FEW COVID19 VACCINE JANSSEN 0 days 1096086-1 MINUTES, PATIENT CALLED FEW HOURS LATER TO INFORM US THAT SHE IS OK AND HER ADVERSE REACTION WAS DUE TO HYPOTENSION. By 9 a.m. I was running a temperature of 100.1. Over the next few hours, it rose to 104.1. I had chills, a headache, a COVID19 VACCINE JANSSEN 0 days 1096108-1 ringing in my ears, nausea and body aches. Tylenol reduced the fever, somewhat. I still ran a fever on Tuesday. Since Wednesday, it has been between 99.8 and 100.1 and feel mostly better. COVID19 VACCINE JANSSEN 0 days 1096128-1 Shaking, temperature, headache, difficulty breathing, chest pains, leg pains Pt complaint of numbness and tingling to upper lip area 30minutes after vaccine given. Pt did complete 15+ minutes of observation in the waiting area at the vaccine site. Pt did go to her car then came back into the vaccine site to report COVID19 VACCINE JANSSEN 0 days 1096131-1 her symptoms. O2 @ 2L/min applied. Deep breathing encouraged. No s/s of anaphylaxis occurred. Respirations easy, skin warm and dry. Pt did present with increased anxiety prior to receiving the injection. No worsening of symptoms. Family on site to transport patient home. EMS was on site. No transport to local ER needed. COVID19 VACCINE JANSSEN 0 days 1096141-1 Moderate Headache Shaking Chills Fever Sweating Hot Flashes Injection Site Soreness Fatigue Patient reported prior to administration of vaccine significant history of syncope episodes with previous vaccine injections. Placed in wheelchair prior to administration of vaccine. After vaccine given patient experienced COVID19 VACCINE JANSSEN 0 days 1096144-1 lightheadedness and feeling hot within 1 to 2 minutes placed on cot no respiratory distress or anaphylaxis occurred symptoms persisted EMS on site now feeling better EMS recalled back to site and transported to local hospital. The patient presents with a complaint of palpitation while in observation area. Began feeling nauseated with lightheadedness and seen black spots no emesis. No chest pain. No respiratory distress. EMS on site. Patient agreeable COVID19 VACCINE JANSSEN 0 days 1096149-1 to transfer to ED. Family on site. Supination PO fluids given and tolerated relaxation and deep breathing encourage throughout. COVID19 VACCINE JANSSEN 0 days 1096150-1 puffiness under eyes, tingly lower lip COVID19 VACCINE JANSSEN 0 days 1096164-1 Slight fever (99.0 D) at night of shot. Chills, muscle ache, fatigue, headache. Started pretty immediately with feeling overheated like a wave of heat then started feeling unwell or not right then my right hand went numb that was about five minutes after the shot. Told the nurses they took me back in a room took my vitals at that time I started to feel weak like my arms and legs were Jell-O or jelly. I also felt jittery the nurses gave me apple juice and crackers they put me in a private room they check my vitals again my heart rate was elevated and my blood pressure also went up . 02 That?s normalsats normal My feet are they just started to feel numb as well. A doctor came in and checked me out they felt like my exam was normal but they also felt like I might be having a mild reaction COVID19 VACCINE JANSSEN 0 days 1096167-1 around 1500 I started to get itchy but no hives noted I took a Benadryl 25 mg at 1500 around 1515 my feet were still numb but I definitely felt better still kind of felt like my arms and legs were weak but not as bad so after an hour and a half I was allowed to leave and was told to rest for the rest The day and you call or go to the emergency room if I had trouble some side-effects about four hours after the shot my lips did start tingling at home I did check my oxygen saturations and it was normal I look at my lips to make sure that they weren?t swelling the only thing I noticed was that a scar I have on my lip that usually you can?t see was more prominent and you could actually see it my lower back hurts a lot Pharmacist incorrectly identified patient for vaccination and mistakenly vaccinated the patient with a Shingrix vaccine COVID19 VACCINE JANSSEN 0 days 1096174-1 when the patient was scheduled for a Janssen COVID-19 vaccine. Pharmacist subsequently realized her mistake and then administered the Janssen COVID-19 vaccine as well in the same sitting. COVID19 VACCINE JANSSEN 0 days 1096176-1 Janssen COVID-19 Vaccine EUA Extreme headache Extreme fatigue Nausea Mild fever Mild fever began around 8:00 pm and then spiked to 101.8 degrees Fahrenheit until around 2 am and then came down COVID19 VACCINE JANSSEN 0 days 1096190-1 quickly. Normal by morning with no other issues. I also had an MRI with and without contrast at 4:15 pm on same day as I was vaccinated. High high high fever. exceeded 105 while i was sleeping. I've been taking advil and Tylenol to try to get it under control. COVID19 VACCINE JANSSEN 0 days 1096194-1 I'm also eating ice cream and using an ice pack. I took one preventative Tylenol at 7pm per a friend?s recommendation. I woke up at 11:55p (8 hours post vaccine, two hours after falling asleep) due to full body chills and shaking. I took two Tylenol. This lasted about 45 minutes. I felt cold but didn?t have a fever. I kept waking up throughout the night clammy. I woke up at 5:30a (30 mins earlier than COVID19 VACCINE JANSSEN 0 days 1096195-1 normal) because I couldn?t sleep and had a headache. I felt sore and achy and very fatigued all day. I took the afternoon off work and came home and slept 3 hours. Still felt groggy and sore after. Felt more normal the next morning. My left arm is still sore two days post vaccination. 3/10/21 7pm chills, aches, slight nausea slight headache 3/11/21 all day aches, slight chills, slight fatigue 3/11/21 3pm COVID19 VACCINE JANSSEN 0 days 1096200-1 aches only all other symptoms gone COVID19 VACCINE JANSSEN 0 days 1096211-1 Headache COVID19 VACCINE JANSSEN 0 days 1096215-1 Fever 103.9 chills headache body ache

Fatigue set in early in the evening, around 5:00, accompanied by a mild headache. By around 9:00, I experienced chills COVID19 VACCINE JANSSEN 0 days 1096220-1 and suspected I had a fever. I took my temperature using a digital under-tongue thermometer which registered 100.4. It's currently 1:00 in the morning, and the fever is still present but slightly lower at 99.9 degrees. Although there is no pain or tenderness at the injection site, I feel mild systemic achiness. I have not taken anything for fever or aches. COVID19 VACCINE JANSSEN 0 days 1096233-1 Severe flu like symptoms, body ache, fatigue, hot/cold flashes. Temperature is 102.5 Dizziness Nausea COVID19 VACCINE JANSSEN 0 days 1096245-1 Fever ranging from101.3 to 102.4 without breaking. Still hasn?t. Sever body aches and severe headache. COVID19 VACCINE JANSSEN 0 days 1096248-1 Headache and fever of 102F when I woke up at 3:30 AM. Starting 8 hours after shot: body aches, extreme chills/shivering, headache, exhaustion, Lasted from 9pm on day of COVID19 VACCINE JANSSEN 0 days 1096258-1 vaccine until 7pm next day, so 22 hours. Then I felt totally normal again COVID19 VACCINE JANSSEN 0 days 1096260-1 chills, fever, headache, tired COVID19 VACCINE JANSSEN 0 days 1096262-1 Severe body aches and severe head ache, sore throat and low fever. Same symptoms as when I actually had covid. Received shot at 2:45 pm on 3/12/21. Starting feeling body aches and headache at 10pm. From 10pm to now 7am on COVID19 VACCINE JANSSEN 0 days 1096267-1 3/13/21, she has been up all night with headaches(just gave her a Tylenol)body aches,....slept minimal all night. Her temperature is at 102.9. Within the first 10 minutes of the shot my heart raced and I felt light headed. This came on fast and ended pretty fast, COVID19 VACCINE JANSSEN 0 days 1096294-1 within 5-10 minutes. ALSO About 14 hours after injection my eyes felt very weird like they were stinging and on fire. This lasted about an hour. Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient has history of fainting with IVs but never to COVID19 VACCINE JANSSEN 0 days 1096306-1 vaccinations. He said he gets stomach aches with sugar derivatives. First BP taken was 107/93 with a low pulse. 5 minutes later it was 165/93 pulse 99. We called the paramedics and they came within 5 to 10 minutes. Patient stabilized after. COVID19 VACCINE JANSSEN 0 days 1096308-1 Error: Wrong Patient (documentation in database) COVID19 VACCINE JANSSEN 0 days 1096310-1 Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: Patient became rigid, COVID19 VACCINE JANSSEN 0 days 1096311-1 unresponsive, fixed eyes, dilated pupils, shaking (seizure-like movements), when patient was moved to floor, she became alert and oriented. Dizziness, shakiness, body slower to respond than normal...took some time to get back to normal. EMS called for monitoring and support. 8 hours after vaccine I got severe chills. Shivering. Couldn?t get warm. Mild headache. Overnight severe cold sweats COVID19 VACCINE JANSSEN 0 days 1096312-1 more intense headache. Fatigue that lasted about 24 hours. Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient did experience fainting with Janssen, though COVID19 VACCINE JANSSEN 0 days 1096316-1 important to note that patient said he has fainted before in past with vaccinations. He said he is fearful of them and it is more \""mental\"" and does not attribute it to the vaccine itself."" I still have a lot of swelling and pain at the injection site and it?s been almost a week. I am also very itchy all over, but COVID19 VACCINE JANSSEN 0 days 1096324-1 there is no rash or hives on my skin. Could not sleep for 6 days and nights. The first night I did not sleep at all, the next 5 days and nights I could sleep a few COVID19 VACCINE JANSSEN 0 days 1096340-1 hours at a time but it was quite fitful sleep. COVID19 VACCINE JANSSEN 0 days 1096344-1 Fever of 102, body aches, headache, nausea, resting heart rate 116 COVID19 VACCINE JANSSEN 0 days 1096350-1 Chills severe body aches fever for a day and a half COVID19 VACCINE JANSSEN 0 days 1096368-1 Chills then fever of 102.4 Patient became diaphoretic and passed out within minutes of receiving vaccination. She woke within seconds. Returned COVID19 VACCINE JANSSEN 0 days 1096376-1 to baseline within 15 minutes. Patient stated this has happened before with blood draws and other vaccinations. She was released into the care of her driver/sister after returning to baseline. Got extremely cold and shivering starting around 6:30 pm on Friday 3/12/21. Could not get warm. Took my COVID19 VACCINE JANSSEN 0 days 1096393-1 temperature and it was 97.1 (my temp is usually in the mid 97's). Weak and tired. Took Tylenol about 7:30 pm - it helped a little but still felt freezing cold. Went to bed and next morning felt better but wrung out. A couple of hours following the injection I experienced fatigue. About 6-8 hours after shot had fever onset, which lasted a few hours. Day 2 just some fatigue. On day 3 started experiencing rash/hives and extreme itching all over body, COVID19 VACCINE JANSSEN 0 days 1096403-1 especially throughout the night on 4th night. Took antihistamine which helped alleviate for time being. I?m currently on day 5 and there are still some hives present. I will continue antihistamine if needed. Shot at 9:30 am Chills starting in lower back at 4:00pm by 7:00 pm severe flu symptoms. High temp, chilled with no COVID19 VACCINE JANSSEN 0 days 1096430-1 way to get warm, headache. Arm was not sore. Did not have nausea. From 7-11 was the worst. Did take Tylenol. Symptoms did not completely go away until 5:00pm following day. It was rough. Injection site soreness (lasted 2 days), Significant Weakness with onset about six hours after receiving vaccine lasting for 24 hours, Mild Nausea with onset 26 hours after receiving vaccine and lasting for 12 hours, mild headache with onset COVID19 VACCINE JANSSEN 0 days 1096455-1 about six hours after receiving vaccine and lasting for 15 hours. Took Ibuprophen for 24 hours after first onset of headache and bed rest. Now 48 hours after receiving vaccine and all side effects have ended except minor soreness at injection site. COVID19 VACCINE JANSSEN 0 days 1096457-1 no adverse event. Patient is under the age that is approved for the vaccine. He is 15. Three hours after injection I fell fast asleep. 7 hours after injection I had mild body aches and chills that lasted about an COVID19 VACCINE JANSSEN 0 days 1096462-1 hour. I have had a dull headache for about 15 hours. I ended up sleeping for 14 hours The actual injection itself was so painful that I almost passed out. It hurts so badly while the needle was in my arm and when she took it out it was worse. I was in such pain that I began to sweat profusely and apparently I turned white and began dry heaving. This was all within a minute or so. I really thought I was going to pass out. A woman with a tag that COVID19 VACCINE JANSSEN 0 days 1096465-1 said pharmacist came rushing over. She got a reclining chair with wheels, they help me into it and then took me to a recovery room. After a few more minutes of sweating and dry heaving I began feeling better. The pharmacist got me some paper towels so I could dry myself off as I was drenched in sweat. I asked her for a bottle of water. I waited the 15 minutes and came home. They never checked my vital signs. Once I got home, I laid down and slept for 15 hours. I was fine the next day and my arm was never sore. Could the shot have hit a nerve? I?ve never felt such acute pain. COVID19 VACCINE JANSSEN 0 days 1096480-1 Chills, muscle spasms, fever, high heart rate, sore arm, rash, headache, body aches. 3:30pm Blood pressure/ pulse rate elevated/ low temperature/arm soreness, 4:30pm uncontrollable shivering/ rising temperature/ body aches, 5pm fever 101.4/body aches/took 2 acetaminophen 500mg tablets, 6pm fever reduced, 9pm COVID19 VACCINE JANSSEN 0 days 1096502-1 fever/ took more tylenol, 1am fever/ vomiting/ took more tylenol..... more of the same until fever subsided roughly 28- 29 hours after injection

COVID19 VACCINE JANSSEN 0 days 1096503-1 Client reported feeling dizzy within a few minutes of vaccination. Her face flushed and she had a rash on her arms. Vitals remained stable. EMS was called, however client refused transport. Clients symptoms resolved without treatment. Burning and watery eyes within minutes. (similar to itching of seasonal allergies) Fatigue, headache, upper body (head, COVID19 VACCINE JANSSEN 0 days 1096580-1 neck, chest and back to top of rib cage) stiffness, chills starting at approx. 8:30 pm and lasting about 12 hours. Chills & fever of 101.7 8hrs after shot. Fever rose to 102.1 during night. At daylight or 18hrs after shot, fever began COVID19 VACCINE JANSSEN 0 days 1096592-1 dropping & was totally gone by 22hrs after shot. Just achy & wiped out the remainder of day 24hrs to 34hrs post shot. All gone by 42hrs after shot COVID19 VACCINE JANSSEN 0 days 1096649-1 Pain in right arm, muscle pain through body, fever 102 degrees, chills, nightmares, lethargy, headache, profuse sweating COVID19 VACCINE JANSSEN 0 days 1096661-1 Whole body ached for about 12hrs The symptoms began about 6 hours after administration. Fever, muscle aches, fatigue, headache and nausea. Patient COVID19 VACCINE JANSSEN 0 days 1096688-1 used Tylenol. Symptoms were resolved in about 12 hours Janssen COVID-19 Vaccine EUA 12:15pm (3/10/21)- initial injection 12:20pm- excessive bleeding from arm 6:45pm- chills, COVID19 VACCINE JANSSEN 0 days 1096690-1 inability to get warm, headache 7:45pm- low grade fever (100.3F), took Tylenol Overnight- inability to sleep, constant chills and sweating, muscle aches, felt very horrible 2:30pm (3/11/21)- fever breaks, only arm is still sore COVID19 VACCINE JANSSEN 0 days 1096710-1 Very stiff neck and toes, to the point of being difficult to move them over a 12 hour period. Fever overnight reached 101.8¶ Chills Very mild nausea Body aches all over Slight soreness at site of injection Soreness COVID19 VACCINE JANSSEN 0 days 1096714-1 in armpit and inner upper arm of injection arm Patient experienced dizziness and possible orthostatic hypotension before losing consciousness on the walk to the observation room. EMS was contacted and assessed the patient upon arrival. Blood pressure was approximately 90/60. COVID19 VACCINE JANSSEN 0 days 1096718-1 EMS departed and the patient stayed at the facility. Observation time was extended to 1 hour and the patient was driven home by a third party. On MON evening after the shot, at 11:00pm I experience severe chills that lasted for hours. Tuesday morning I awoke with a bad headache and had body aches all day as well as tendonitis- like pain in both lower arms. I felt somewhat better on WED but I did notice that my compression sleeve on my right arm (lymphedema arm) felt more snug than COVID19 VACCINE JANSSEN 0 days 1096749-1 usual. That night I had severe chills and fever of 101. I slept until 11:45am on THU and felt aches all over. Very fatigued. Went back to sleep from 2:00pm until 6:00pm. Temp was down to 99.8. When I woke and removed my compression garment, my arm was red and swollen, also rash-like bumps, and was very warm to the touch. FRI morning it looked worse, so I contacted my lymphedema specialist and then my PCP. This is NOT a good situation for anyone who has lymphedema and will necessitate months of treatment. 5:50pm to around 8:30pm constant shivering no matter how many layers to heat up body. Fingers and toes tingling and numb from cold. (It was 70 degrees in the house). Fingers under nails discolored bluish. 8:30pm shivering stopped, COVID19 VACCINE JANSSEN 0 days 1096753-1 started getting a fever and headache, vomiting around 9:30pm. Vomiting started and stopped within an hour. 9:30pm to 4:20am (this morning) fever, severe headache. 4:20am to 10:30am severe headache. COVID19 VACCINE JANSSEN 0 days 1096782-1 All symptoms of covid but did not loose taste Received vaccine at 8am. Began feeling achy at 2pm. Fever reached 102F at around 4pm and was hard to control with Tylenol/Advil. 10/10 pain in the form of a full, throbbing headache that also didn?t subside with Tylenol or Advil. My COVID19 VACCINE JANSSEN 0 days 1096784-1 headache is now down to 6/10 pain 28 hours later but is worse when lying down. Fever is down to 100.6 without medication. Arm soreness at site of injection lasting for several days. A tension headache developed by 2pm the day of the shot. Not COVID19 VACCINE JANSSEN 0 days 1096787-1 debilitating, but obvious. It lasted until late the first night, leaving a feeling of lightheadedness afterwards that was gone by late morning the next day. Some tiredness, but not extreme. Patient complained of shortness of breath, general weakness, dizziness, chest pain which she specifically described as COVID19 VACCINE JANSSEN 0 days 1096794-1 ?angina.? Patient stated symptoms lasted for about 30 minutes then resolved. No medications administered in response to event. I developed a few hives on arm and torso within an hour of receiving the vax. Other than minor soreness at injection site, COVID19 VACCINE JANSSEN 0 days 1096801-1 I've had no other adverse reactions. Janssen COVID-19 Vaccine EUA. Mild body aches and chills. Injection site tenderness. Three 200 mg ibuprofen taken COVID19 VACCINE JANSSEN 0 days 1096802-1 around 10 pm relieved symptoms vaccine administration approx. 11:20 AM, at approximately 11:30 AM developed itching to buttocks and bilateral posterior thighs. patient notified nurse of symptoms at approximately 11:40 AM. Nurse assessed area of itching- no COVID19 VACCINE JANSSEN 0 days 1096808-1 redness, rash, or hives noted. Nurse administered 50mg diphenhydramine and 20mg famotidine. At 12:00 AM patient reported the tip of her tongue felt tingly. EPI pen was administered immediately (12:00 PM) and EMS called. Patient denied any shortness of breath or difficulty swallowing. Around 7:00 P.M. on March 12, 2021 approximately 9 hours after receiving the Jansen COVD-19 vaccine in my left arm. I developed extreme fatigue, muscle aches, skin hurt to the touch of anything including clothing, headache, and fever 101.5. I had to go to bed and was very weak. I took ibuprofen and Tylenol for the discomfort. I slept 14 hours and was able to get up at 11:00 A.M. on March 13, 2021. The soreness at the site of the injection is not problematic. There were COVID19 VACCINE JANSSEN 0 days 1096828-1 other odd symptoms overnight I would awake with strange nerve like sensations tingling and itching that occurred on the bottom of the left foot, upper lip, and neck. I also had several episodes of restlessness that was so bad that I had to stand for a few minutes before being able to lay down again. The worst is the skin hurting and headache. I have also had a few dizzy episodes since getting out of bed this morning. It passes if I sit down or hold onto something. None of these symptoms are normal for me and I cannot remember having a reaction to any vaccinations that I have received in the past. I hope this helps with your study. Fever for 40 hours, chills, uncontrollable shaking for more than 3 hours, severe nausea for 36 hours, nausea continues now but at a much less severe amount, swollen glands around head and in right arm pit for more than 40 hours, pain in right eye started within 10 minutes of shot and continues now, pain in ankles started about 8 hours after shot and continues now but is becoming much more bearable, joints of toes and joints of a few fingers were painful for about 24 COVID19 VACCINE JANSSEN 0 days 1096864-1 hours, sore arm started about 3 hours after shot and continues now, overall muscle aches started about 8 hours after shot - became much worse within 12-14 hours after shot and became less severe after 30 hours. Overall I felt as if I had a terrible case of the flu. It was very intense. I was unable to sleep the first night due to the severity of symptoms. The second night I sweated a tremendous amount and my fever broke. I am still not over all of my symptoms but I am feeling better. COVID19 VACCINE JANSSEN 0 days 1096866-1 Syncope 15 minutes following vaccine. Epipen administred. Subsequent ER visit. High heart rate (90- 100+) for several hours approximately 10-11 hours after receiving vaccine. This happened after I COVID19 VACCINE JANSSEN 0 days 1096934-1 went to bed and is not a normal heart rate when I am resting. My heart rate finally went back to a normal rate for me after 10:00 am the day after the injection. Fainted during the mandatory 15 minute evaluation period post vaccination. Sat with patient who returned to and refused medical transport and color returned was with wife who will watch him today. Recommended a meal with rapid, COVID19 VACCINE JANSSEN 0 days 1096937-1 intermediate, and long acting carbohydrates. Reported once started drinking water again he felt better. Monitored patient for additional 20 minutes to observe. Stood up without assistance but was carefully monitored. Then left with wife for lunch since hungry. COVID19 VACCINE JANSSEN 0 days 1096968-1 Janssen COVID 19 Vaccine EUA Intense headache, nausea, muscle aches for ~24hours Patient developed redness at the injection site and arm and complained of generalized itching. Benadryl 25 mg capsule COVID19 VACCINE JANSSEN 0 days 1096981-1 given. Patient watched for 30 minutes and then left. Patient felt better after receiving Benadryl. Client reported shortness of breath with gradual onset within 30 minutes of vaccination. Monitored by paramedics and COVID19 VACCINE JANSSEN 0 days 1096998-1 symptoms resolved without treatment. Sudden jump in heart followed by pounding, rapid heart rate which lasted about 2-3 minutes. Somewhat light feeling COVID19 VACCINE JANSSEN 0 days 1097003-1 throughout body. Chills lasted for about 16 hours Fever in the middle of the night Muscle pain in injection arm (current) Pain in arm pit of COVID19 VACCINE JANSSEN 0 days 1097010-1 injection arm (current) Headache lasted about 24 hours Within 5 minutes of receiving the vaccine, patient stared to feel warm, and clammy. He was assessed by EMS in the COVID19 VACCINE JANSSEN 0 days 1097015-1 Observation Areas. He was assessed by EMS. He did have low BP. Initial was 114/77, and lowest was 58/38. No dizziness or loss of consciousness. she recieved shot without reaction. she stood up and moved over the waiting area to sit for 15 mintues. after 3 to 4 minutes of talking with her mother (mom left to go get water from front of store). she said out loud ""I think I'm going to COVID19 VACCINE JANSSEN 0 days 1097028-1 faint."" I rushe out of the pharmacy to help. Her eyes rolled back and she fainted, the she convulsed for 5 top 10 seconds. she woke up 30 seconds later (mom returned by this time). 9-1-1 was called and ambulance came to check vitals and she left on her own accord."" Rash on chest. Swollen lymph nodes. Swollen lymp nodes particularly worse on injection side and still persistent. Periods COVID19 VACCINE JANSSEN 0 days 1097030-1 of hot and cold chills Headache starting around 5-6 hours after injection and continuing through following day. Fever started around 8 hours COVID19 VACCINE JANSSEN 0 days 1097031-1 after injection and reached 103.1 F. Nausea and vomiting in the middle of the night (around 12 hours after injection). Mild fever the following day. COVID19 VACCINE JANSSEN 0 days 1097033-1 Vaccine given to a patient outside of age range. Patient was 14 years old Vaccine was administered to patient under the age indicated of 18 years and up. Patient was 17 years old and reports no COVID19 VACCINE JANSSEN 0 days 1097034-1 symptoms at this time or any adverse side effects. PATIENT FAINTED ABOUT FIVE MINUTES AFTER GETTING THE VACCINE. HE CAME TO AFTER ABOUT 30 SECONDS . COVID19 VACCINE JANSSEN 0 days 1097061-1 CALLED PARAMEDICS AND HE WAS ATTENDED TO. HE DID NOT HAVE ANY OTHER REACTION. PT MENTIONED THAT HE HAD NOT HAD ANY FOOD SINCE MORNING AND HAS HISTORY OF SYNCOPE AFTER BLOOD DRAW. Fever: onset ~7.5 hours post injection. Peaked at 101.8 ¶F ~13 hours post injection. Overall duration ~24 hours. COVID19 VACCINE JANSSEN 0 days 1097063-1 Headache: accompanied fever Sore arm in vicinity of injection site: roughly same time as fever as well. Made it almost impossible to lie on my left side. COVID19 VACCINE JANSSEN 0 days 1097089-1 Numb tongue and lips COVID19 VACCINE JANSSEN 0 days 1097091-1 Chills, Fever 102.1 F COVID19 VACCINE JANSSEN 0 days 1097100-1 Anaphylaxis. High temp, swollen face, throat, eyes, chills, Required ER visit After my first dose of J&J vaccine performed , I developed a cold, cough, runny nose, my eyes were red and nasal COVID19 VACCINE JANSSEN 0 days 1097105-1 drainage, also had allergies. I called my doctor to get medicine. I also had a Covid test which was negative. I am recovering of my symptoms today. Patient was observed to be sitting in her chair with head down on knees in 15 minute waiting area after receiving Johnson and Johnson Vaccine. Patient reported light headiness and nausea. Patient was AOX4 and vital signs laying at 11:24 am: HR: 79, O2: 96% RA and Temp: 98.1 F, BP not reading. BP retaken at 11:34 am laying down: BP: 50/29 with COVID19 VACCINE JANSSEN 0 days 1097127-1 thready pulse. Patient denies any chest pain, trouble breathing, itchiness, pain. BP retaken laying down at 11:40 am BP: 95/59 and Heart Rate 71. BP retaken sitting at 11:49 am. BP: 83/49. Blood pressure retaken sitting at 12:06 pm : BP 92/57 , HR: 65. Patient reported she normally runs a low blood pressure. Per Patient stated she feels better, had a snack. As precaution called friend to pick her up. ~3PM PATIENT RECEIVED COVID VACCINE AND WAITED AT COUNSEL WINDOW TO ASK RPH A QUESTION. WHILE WAITING PATIENT COLLAPSED TO FLOOR FACE FIRST WHICH WAS WITNESSED BY PHARMACIST. PHARMACIST IMMEDIATELY CALLED 911 AND TECHNICIAN AND TECHNICIAN WENT TO ASSIST THE PATIENT. PHARMACIST COVID19 VACCINE JANSSEN 0 days 1097130-1 MAINTAINED LINE OF SIGHT ON PATIENT DURING 911 CALL. PATIENT REGAINED AWARENESS OF SURROUNDINGS ~1 MINUTE AFTER FALLING AND ASKED HOW HE FELL. PATIENT REMAINED SEATED ON FLOOR FOR ROUGHLY 10 MINUTES WHILE WAITING FOR PARAMEDICS TO ARRIVE AND WAS OBSERVED DURING THE ENTIRE TIME BY PHARMACIST AND TECHNICIANS. PATIENT DRANK SOME WATER DURING THIS TIME FROM A BOTTLE PROVIDED BY TECHNICIAN. PARAMEDICS CARED FOR PATIENT AND LEFT STORE ~15 MINUTES AFTER ARRIVAL. Patient was given the vaccine and seemed fine. He was talking and then just fell out of the chair and fainted. He was unconscious for about 15-20 seconds and came to. He was disoriented and complained of tingling in his hands. EMT was COVID19 VACCINE JANSSEN 0 days 1097134-1 called non-emergency since the patient had regained consciousness. He still appeared disoriented for several minutes. Patient said he hadn't eaten since breakfast. He was given crackers and water. EMT arrived and took vitals. Patient appeared fine, just a bit shaky. During administration of vaccination, pushed the punger of the 1ml 25g 1inch VanishPoint Syringe feeling the plunger push to completion. Pulled the syringe out of the deltoid. Medication did not finish injecting in to the arm and instead sprayed outside of arm, and the needle did not retract. Confirmed the plunger was all the way down at this time. COVID19 VACCINE JANSSEN 0 days 1097169-1 Administered second injection within 15 minutes to ensure patient receives full dose of medication. This was performed without incident to left deltoid. Patient waited full 15 minutes without adverse reaction. Patient advised to monitor for any adverse reaction and report to PCP if experiences any adverse effects. Headache began immediately after shot. Violent chills and shakes, fever started 6 hours after. Fatigue, headache, muscle COVID19 VACCINE JANSSEN 0 days 1097190-1 aches, fever lasted for 24 hours COVID19 VACCINE JANSSEN 0 days 1097195-1 High fever Chills Aches Dizziness Headache For 36 hours COVID19 VACCINE JANSSEN 0 days 1097203-1 patient fainted after vaccination

Injection at 11am on 3/9/21. Typical soreness at injection site. At 6pm, the same day, headache, fatigue, chills begin. COVID19 VACCINE JANSSEN 0 days 1097215-1 Fever reaches 102 overnight. Fever down to 100 on 3/10/21. Today is 3/13/21, 4 days after injection, fever is still at 100. Extreme fatigue. Cannot do any daily activities. Tiredness, headache will not go away. Advil/Tylenol will not lower temp. COVID19 VACCINE JANSSEN 0 days 1097233-1 chills for 5 hours, fever and pounding headache for more than 5 hours; muscle aches and fatigue for more than 10 hours Post-injection patient reported feeling hot, sweaty, dizzy, and flushed. Blood pressure was low. Patient began vomiting. COVID19 VACCINE JANSSEN 0 days 1097240-1 Patient was transferred to a nearby doctor's office for further observation. Patient's symptoms resolved.

COVID19 VACCINE JANSSEN 0 days 1097258-1 8:15 pm - start of shivering and headache, right side tension in shoulder and neck 10:30 pm - 103¶ temp, continued body shakes, muscle aches, headache, (flu like symptoms) 10:00 am on 3/13/21 - low grade temp, sweats, headache, sore arm COVID19 VACCINE JANSSEN 0 days 1097272-1 Vomiting, headache, dehydration, diarrhea, fever, chills Bell's palsy symptoms within an hour after receiving vaccine injection: consisted of right-sided facial numbness, right- sided eyelid droop, right-sided mouth turn, right-sided tightness in neck muscle, pressure behind right eye, headache, loss of balance, difficulty speaking. The injection was at 3:15 pm and started with arm soreness and stinging, a slight headache, and some tingling in my right hand while waiting 15 minutes after the shot, I had also felt a sensation going up the right side of the back of my neck almost immediately after the injection. The Bell's palsy symptoms started by 4:00 pm. I had a low-grade temp that evening of 99.9. I emailed my neurologist who I see for migraines, of my COVID19 VACCINE JANSSEN 0 days 1097281-1 symptoms. The following morning on 03-10-2021 I woke with a severe migraine, fullness in my right ear, more pressure behind my right eye and it is watery, with new ringing in both ears, louder in the right ear. Still residual numbness and drooping of right side of face and eye, tightness in right side neck muscle in front, and speaking better. Woke up on Thursday morning 03-11-2021 with flu symptoms and migraine gone. Eye pressure still there and now having significant pain moving my eye and now more feeling of fullness in my right ear. Eye pain was concerning. Dr advised me at this time if symptoms have continued or gotten worse to go to the emergency room. Today, Saturday 03-13-2021, I am still experiencing moderate eye pain behind/above my right eye with pressure. I am continuing to treat the pain with oxycodone prescribed by ER Physician. 10am vaccine given. No side effects noticed. 630pm developed chills, headaches, ringing in ears, dizzy, eyes fluttering and 102.0 fever. 645pm - Took 3 Tylenol and BP 144/85 HR 83. Bed rest with Gatorade and water. 1100pm - Took 2 Tylenol. COVID19 VACCINE JANSSEN 0 days 1097317-1 Fever reduced to 99.8. Headache and extremely tired. No energy. Bed rest with fluids. 24 hours after vaccination : Fever almost gone, 11am 2 more Tylenol, extremely tired and weak. Low energy. Ringing in ears. Minor headaches. 48 hours after vaccination; No fever, extremely tired and weak. Low energy. Ringing in ears. Symptom Onset 3/12/21 4:30pm - 4am Fever of 101.9, muscle pain, joint pain, numbness in fingers, muscle weakness, COVID19 VACCINE JANSSEN 0 days 1097319-1 difficult to move on my own, skin pain, migraine-like headache . 3/13/21 9 am - muscle fatigue, muscle pain, headache, sensitive skin, joint pain, brain fog. COVID19 VACCINE JANSSEN 0 days 1097322-1 6:00 PM on 3/11/21 began experiencing chills and joint pain which lasted for approximately 18 hours. Flu like symptoms as well as rapid heart beat 12 hours after injection (120 bpm) and significant heart palpitations. 101.6 COVID19 VACCINE JANSSEN 0 days 1097351-1 fever, headache, lymph node shooting pain, and swollen right eye.

Immediately Saturday: spacey and throat feels strange; afternoon: body is cold/tired. Sunday: felt great! lots of energy until during a walk at 3pm started to feel spacey (hands feel weird) and spiked a short term fever. Tired and cold. Monday: tired, bottom of lungs burning like I inhaled campfire smoke for a week straight, stumbling over words. Tues: tired, more burning lungs but sensation moving to mid chest (NOT heartburn), feeling like I needed to cough but nothing in lungs, still tired, still struggling with full sentences, irritable. Weds: felt hot but temp was below normal, lungs COVID19 VACCINE JANSSEN 0 days 1097364-1 burning. Took Covid test (negative), incredibly tired, got the spacey feeling and hands felt weird-lasted 30 mins. Thurs: tired, irritable, left side hurt, started having to clear my throat every 20-30 minutes, cold. Fri: still tired, felt like I needed to cough but didn't reduce the pressure in chest/burnin/aching. Slept 14 hours. Sat: woke up feeling awful. Short of breath, clearing throat all day. Went to urgent clinic. Lab/chest x-ray and EKG all negative. Dr:""Nothing we can do for you. This vaccine is too new and you are likely having a reaction. Come see us if it gets worse."" I almost cried. When he had me take 4-6 deep breaths to check my lungs with his stethoscope I almost passed out. Now I'm home stuck on the couch under an electric blanket feeling like crap with no relief in sight. Hoping no one else has this ever."" Approximately 1 hour after injection I became exhausted with a headache and unable to drive. Then 1.5 hours after COVID19 VACCINE JANSSEN 0 days 1097365-1 injection I began to vomit and had a stiff neck. Used ice packs on head and neck for 12 hours for pain. Body aches and injection site pain continued for 48 hours. Immediately got dizzy, had pins and needles in the arm and hand on the injection side also has swelling of the face on COVID19 VACCINE JANSSEN 0 days 1097387-1 that side and itching at injection site. Layer that evening and the next day I had heart erratic heart rate Six hours of projectile vomiting, uncontrollable chills, excruciating headache, muscle and joint pain primarily in lower COVID19 VACCINE JANSSEN 0 days 1097389-1 extremities, fever, fatigue. It has now been 24 hours since the injection and I am still experiencing extreme head pain, muscle fatigue and weakness, nausea an extreme headache Seven hours after receiving the shot, I started to have severe chills. This carried on for about three hours. During the night, I started to have a fever. The highest I measured the fever was at 101. Into the next day, the fever lingered and I COVID19 VACCINE JANSSEN 0 days 1097395-1 was sore. I had a headache that had extreme sinus pressure by my temples. Into the second day and there are no signs of a fever or chills, but there is a light headache. 5 hr after shot fever 101 chills severe headache body ache. Next day fever came down to 100 but still had headach and COVID19 VACCINE JANSSEN 0 days 1097396-1 took tylenol both days. COVID19 VACCINE JANSSEN 0 days 1097410-1 Trouble focusing right eye I received the Janssen Covid-19 Vaccine EUA on 3-11/21 at 10:15 AM. Starting at 3:30 PM I began having mild body aches; by 5:30 PM the body aches were severe and accompanied by a fever of 100-101 degrees, headache, extreme fatigue and intermittent mild nausea. This lasted throughout the night with body aches severe such that I was awakened COVID19 VACCINE JANSSEN 0 days 1097412-1 by them about once an hour. By the following morning, Friday, 3-12-21, symptoms were still present but less pronounced, and the headache had abated. Slept most of the day and by nightfall had only lasting fatigue, which was still present this morning, 3/13/21. By this afternoon all symptoms had abated. COVID19 VACCINE JANSSEN 0 days 1097418-1 Started to feel facial and arm tingling about 25 min after received JJ vaccine. Given 50mg Benadryl IM First day had major chills, then fever and headache. After two days those symptoms subsided and 72 hours later feeling COVID19 VACCINE JANSSEN 0 days 1097426-1 fatigued and tired. COVID19 VACCINE JANSSEN 0 days 1097446-1 Fatigue, chills, 104.3 fever, body aches COVID19 VACCINE JANSSEN 0 days 1097459-1 100 degree fever for 8-10 hours; started approximately 9 hours after vaccination; treated with Tylenol Tingling/numbness in left arm near injection site and in face and tongue. Began about 20 minutes after vaccine and COVID19 VACCINE JANSSEN 0 days 1097473-1 continued until I took benadryl and the symptoms subsided.

Patient was sitting in the post-vaccination chair, about 10 minutes after her vaccination time. She lost consciousness and COVID19 VACCINE JANSSEN 0 days 1097481-1 fell to the floor. I instructed the technician to call 911 and went to the patient, who quickly regained consciousness. She sat back in the chair, and we gave her some water. She said she was feeling better when the EMT arrived. 10 hrs afterwards I had the worst chills I have ever had for 2 hrs then my body was on fire for 2 hrs. I was drenched in COVID19 VACCINE JANSSEN 0 days 1097486-1 sweat had to change my clothes twice and a severe headache. I felt some mild discomfort in my breathing and I was extremely thirsty. All of this lasted about 5 hrs Administered out of approved age range. Vaccine approved for 18 years and older. Patient was 17 years old at the time COVID19 VACCINE JANSSEN 0 days 1097500-1 of vaccination. COVID19 VACCINE JANSSEN 0 days 1097501-1 diaphragmatic, low bp 95/53, dizziness, lightheartedness, tingling on arms and feet . Pt felt lightheaded/dizzy after receiving the vaccine. She stated that she usually felt that way after receiving all kinds of COVID19 VACCINE JANSSEN 0 days 1097513-1 vaccines. She stated that after consuming some sugary drinks, she felt better. She had the symptoms for about 15 minutes I experienced fever, chills, tiredness, and headache approximately five hours after administration of the vaccine on 3-10- 21. Symptoms became severe within 30 minutes thereafter, at which time I experienced difficulty standing. After five hours with no improvement, I used my home blood pressure monitor to check my BP and HR; BP was high for me, 120/90 COVID19 VACCINE JANSSEN 0 days 1097520-1 sustained, and HR varied between 135 and 150, with 143 being the most consistent value after multiple readings. I seemed to be experiencing a ""severe allergic reaction"" per the instructions I was given and called 9-1-1. I was transported to Hospital, treated in ER, and then admitted to the intermediate care unit. I was discharged to home on 3- 12-21."" Slight chill started about 7:15 p.m. and within minutes my entire body was shaking uncontrollably. After about 1 and COVID19 VACCINE JANSSEN 0 days 1097522-1 1/2 hours extreme shaking stopped. Felt very wiped out the following day with slight headache and legs hurting. Shooting pain in/ around heart for 3 hours. It started about 2 hours after the shot. Sharp shooting pain that was much COVID19 VACCINE JANSSEN 0 days 1097529-1 worse on deep inhales and when stretching chest open. COVID19 VACCINE JANSSEN 0 days 1097530-1 patient was weak and pale . could not sit . low BP 91/44 HR; 43 . sever arm pain on injection site .

Patient reported feeling dizzy. She asked for some water, which was provided. Went to check on patient a minute later and her eyes were fluttering and her breathing altered. She did not respond to me. Her pupils dilated dramatically and COVID19 VACCINE JANSSEN 0 days 1097533-1 she slumped over. I called for a nurse and we lowered her to the floor together. Blood pressure was low (around 100/60) Her pupils started to return to normal and she was able to converse with us. Blood pressure increased slightly but was erratic. Emergency service responders made call to take to hospital because blood pressure would not stabilize I discovered patient on the floor at approx. 3:03pm. She was lying face down on the floor next to the chair she was sitting on during her 15-minute observation post-covid19 vaccine. Unknown person turned patient over face-up, Face was clammy and warm/hot to the touch. Pulse was taken (weak). Sweating. Eyes were closed when EpiPen was injected on COVID19 VACCINE JANSSEN 0 days 1097537-1 left thigh through pants. It was decided to inject patient as we did not know what exactly happened, why she was on the floor, and she was unconscious at the time we initially thought to give epi injection. 1 pen injected. Pharmacist called emergency services at 3:05pm. Patient eventually regained consciousness while waiting for the paramedics. She was able to talk and answer questions. She was taken outside the gym on stretcher, but her son met us at the school to pick her up. She declined going to the hospital for further treatment. Patient started feeling numbness from head down to her legs at 2:56pm, call 911 at 2:59pm, then chest tightness at COVID19 VACCINE JANSSEN 0 days 1097581-1 3:03pm and given Epi pen at 3:04pm. EMS took over care at 3:10pm Fever of 101.4 F, migraine headache. Treated with sleep rest and ibuprofen and hydration of fluids. 17 hours from initial COVID19 VACCINE JANSSEN 0 days 1097584-1 symptoms, fever broke. Temperature normal at 98.6 twelve hours after initial symptoms. Patient began feeling dizzy, warm, and confused shortly after vaccination. The patient was helped to lie down on the floor. The patient remained there for 3 minutes and then pharmacy staff helped patient sit back up. Patient stated she COVID19 VACCINE JANSSEN 0 days 1097585-1 was feeling better and remained in the area for 30 minutes to wait after immunization. I checked in with patient 5 hours after vaccine and she felt fine. pt received vaccine and went to waiting area. 5 minutes after in the waiting area, pt had a self reported panic COVID19 VACCINE JANSSEN 0 days 1097587-1 attack/fainting spell. pt did not fully lose consciousness. pt has a history of panic attacks/fainting spells, especially with needle sticks. Paramedics assisted on scene but pt was not transported to hospital. pt left under his own power ADVERSE EVENTS: racing heartbeat, chest pain, high blood pressure TREATMENT: took prescribed dosages of Eliquis, COVID19 VACCINE JANSSEN 0 days 1097589-1 Carvedilol, Metformin, Diltiazem, Nitrostat, Bayer aspirin 325 mg, and Diphenhydramine HCI 25 mg OUTCOME: after 96 hours, heartbeat still elevated; chest pain reduced; blood pressure reduced but still elevated COVID19 VACCINE JANSSEN 0 days 1097590-1 Abdominal pain, chill, tiredness, body aches, COVID19 VACCINE JANSSEN 0 days 1097591-1 Muscle aches, fatigue, headaches, weakness, chills, fever COVID19 VACCINE JANSSEN 0 days 1097601-1 Fever on 3/11 and 3/12/21; body aches; fatigue. Back to no symptoms by 3/13/21 Shortly after vaccine patient reported feeling dizzy. The patient refused to lie down, just stated she felt dizzy. The patient was given a cold compress and orange juice shortly after, within 5 minutes the patient stated she felt fine. COVID19 VACCINE JANSSEN 0 days 1097605-1 Patient was observed for 30 minutes before leaving clinic site. Patient was followed up with 2 hours after event and stated she felt fine. Vaccine administered at about 9.05am and temp maxed at 101.5 degrees by 7 PM. Vomiting started at 5pm, ended by COVID19 VACCINE JANSSEN 0 days 1097624-1 6pm. All symptoms passed by next day except for redness around injection site and sore arm. No pain at injection site. But 9 hours later I started shivering and was achy. Temperature is 101.3 and holding around COVID19 VACCINE JANSSEN 0 days 1097628-1 100.3. very bad headache. Lukewarm wash cloths for soothing/ cooling. It's 19 hours do far of fever and headache and achy muscles. I haven't taken any pain reliever. Fever of 100 degrees, headache, muscle aches, joint pain, nausea, fatigue. I felt like O had the flu. I had these symptoms COVID19 VACCINE JANSSEN 0 days 1097661-1 from 4:30 pm on 3/10/21 to 7:00 am on 3/12/21. This was a clinic for Covid-19. Janssen vaccine was used. Patient is 17 years old. RpH reviewed the information gave the COVID19 VACCINE JANSSEN 0 days 1097675-1 vaccine to him. The vaccine is for 18 and over. I spoke to mom who check and patient has no side effects thus far is doing fine. Employee at our store translated for mom. The information was given to this store for processing only. When injected, felt the burn of the vaccine. A few minutes later started sweating, dizzy, blurred vision, ears ringing and COVID19 VACCINE JANSSEN 0 days 1097680-1 sound start fading. Patient arrived for COVID vaccine prior to working shift. He stated upon questioning having an anaphylactic reaction to seafood. We requested him to stay in observation for 30 minutes after vaccine administration. He agreed and vaccine was administered. After working approximately 3 hours later he returned to the pharmacy stating he felt out of breath. COVID19 VACCINE JANSSEN 0 days 1097686-1 He didn't know if it was because of vaccine or CHF. Questioning him further, he said he felt a little swollen around neck. He was responsive. Administered 50mg of Benadryl. Instructed him to sit. He had a portable fan. After sitting down, he started to feel better. He remained at the pharmacy and called for transportation home, leaving approximately 1 hour later JANSSEN COVID -19 VACCINE WAS ADMINISTERED TO PATIENT AT 10:20AM TODAY. PATIENT WAS DIRECTED TO WAIT FOR 15MINUTES AS REQUIRED BUT JUST WITHIN 2 MINUTES OF VACCINE ADMINISTRATION SHE COLLAPSED ON THE FLOOR. SHE WAS UNRESPONSSIVE FOR LESS THAN A MINUTE THEN BECAME RESPONSIVE. WHEN ASKED WHAT HAPPENED SHE STATED SHE FELT DIZZY AND SLIPPED TO THE FLOOR. SHE FELT COLD IN HER EXTREMITIES AND SWEATY. COVID19 VACCINE JANSSEN 0 days 1097687-1 SHE WAS KEPT SUPINE, HER FEET WERE ELEVATED AND APPLIED A COLD COMPRESS ON HER FACE AND NECK AREA FOR A FEW MINUTES. SHE WAS KEPT ENGAGED WATCHED OVER FOR ABOUT 20MINUTES. SHE REFUSED US CALLING AMBULANCE. WHEN SHE SAID THAT SHE WAS NO LONGER FEELING SWEATY AND COLD IN HER HANDS SHE WAS ALLOWED TO SIT UP. SHE KEPT AND OBSERVED FOR UP TO ONE MORE HOUR. SHE REQUESTED TO BE ALLOWED TO LEAVE AND WE LET HER GO HOME. SHE CALLED THE PHARMACY LATER AND INFORMED US THTA SHE WAS DOING WELL. COVID19 VACCINE JANSSEN 0 days 1097690-1 Chills, fever, headache COVID19 VACCINE JANSSEN 0 days 1097692-1 Numbess and tingling in pinky finger and ring finger of left hand (shot was given in left arm) Hand tremors 9 hours after injection lasting for one hour. Fever starting approx. 12 hours after injection. Possible COVID19 VACCINE JANSSEN 0 days 1097694-1 contribution to fainting event approx. 15 hours after injection. Muscular aches in neck and shoulders starting approx. 17 hours after injection. Pt developed hematoma at point of vaccine administration, upon removing the needle patient bled more than usual for a vaccine and developed a hematoma. Pt was monitored for approximately one hour, hematoma did not worsen. Pt was COVID19 VACCINE JANSSEN 0 days 1097695-1 advised on care and to seek medical attention should the hematoma worsen. Pt did not complain of pain or any other side effects/symptoms. Temperature peaked at 101.7, chills, little confusion, but the temperature is coming down due to vinegar and water on COVID19 VACCINE JANSSEN 0 days 1097702-1 head. COVID19 VACCINE JANSSEN 0 days 1097704-1 Patient under the age of 18 at time of administration COVID19 VACCINE JANSSEN 0 days 1097710-1 Patient felt extremely dizzy after receiving. Had to lay down on the floor to prevent passing out. Day one 3/12: starting at about 4 pm: 102 fever, chills, muscle aches, headache. Was able to keep fever down with COVID19 VACCINE JANSSEN 0 days 1097716-1 Tylenol and Advil. Day two 3/13: low grade fever, chills, weakness, muscle aches, body pain Bilateral Flushing/swelling of hands, redness on face, hives on neck and back, ears red, no itching. Gave Benadryl 25mg COVID19 VACCINE JANSSEN 0 days 1097717-1 @4:10 at 4:20 stated she was feeling better and redness had diminished at 4:30 patient described feeling jittery dosed another Benadryl 25mg at 4:35 After no improvement sent her with her husband to the ER March 12, 2021. 5:15 pm. began chills. By 8:00 pm fever of 102, body aches, severe headache, joint pain, pulse ox COVID19 VACCINE JANSSEN 0 days 1097719-1 dropped to 92, sore arm (could not lie on it), severe fatigue, nausea Continued through March 13, 2021 until 8:00 pm when fever dropped to 99.2 and all left was somewhat fatigue and slight headache COVID19 VACCINE JANSSEN 0 days 1097727-1 fever, diarrhea, profound fatigue, muscle pains Upset Stomach. Diarrhea. Left side of nose started to hurt and burn (same side of vaccine) immediately after vaccination COVID19 VACCINE JANSSEN 0 days 1097735-1 for 10 minutes following. Patient went into a vasovagal response with sweating about 8 minutes after the shot. patient came back to consciousness after 7 seconds after pharmacist checked pulse made sure the patient was upright and used applied tension technique. Patient was then given fluids and lime soda that helped the patient come back to total consciousness. We COVID19 VACCINE JANSSEN 0 days 1097740-1 continued to monitor patient for an extra 30 minutes and called family to pick him to ensure that he does not drive. Moreover, I recommended that the patient does not go snowboarding as he was thinking of heading to the mountains today. My menstrual cycle is not due to begin until March 17, 2021. I am on birth control and I take it routinely at the same COVID19 VACCINE JANSSEN 0 days 1097741-1 time everyday. I did not miss a dose, my cycle has never been early like this (maybe a day early.) I started spotting hours after I received my shot, on March 8, 2021 and now it is a full blown cycle. This makes my cycle 9 days early. Pt. received 0.5 ML IM L deltoid of J&J COVID19 vaccine and ambulated independently to observation area. While in observation area pt. became lightheaded, dizzy, and flush and slipped out of his chair to his hands and knees. Bystander helped pt to the floor so he did not hit his head. BP immediately was 118/74, no blurry vision, no headache, no nausea, COVID19 VACCINE JANSSEN 0 days 1097755-1 had not eaten since 1300. Pt sat up and vitals were taken: BP 126/82 HR80 RR18 A/Ox4, pupils equal and reactive. Pt was then assisted to the cot where he had a snack and juice and was feeling much better. Pt called a friend to drive him home. COVID19 VACCINE JANSSEN 0 days 1097758-1 16 y/o was given a Janssen COVID19 vaccine shot, the product was only studied/approved for 18+ y/o Patient has prior allergies to other medications, never had to use epinephrine. Past allergies include: Percocet, tramadol, Toradol and latex tape. Patient stated she has some full budding numbing experience but no anaphylaxis. We gave her the J&J covid 19 vaccine and asked her to wait 30 minutes to be monitored due to her past allergies. Around 20 minutes patient let one of the pharmacist know she was feeling very flushed and dizzy. We brought her over to the side to be COVID19 VACCINE JANSSEN 0 days 1097761-1 monitored more closely. We had patient elevate her feet to help with faint feeling and drink some water. Within 5 to 10 minutes her symptoms started worsening. Tingling sensation started going up her side of head and neck. It started moving to the front of her face. Once that happened I asked how her breathing was and she was starting to get short of breath. Soon after patients throat started to close. We administer 0.3 m of epinephrine and called 911. Pt was able to breathe a little better but within 5 minutes she was back to gasping for air, we administered another 0.3 mg of epinephrine and the paramedics arrived. Immediate: intense soreness at injection site 6pm body aches 7pm chills 8pm fever 102.4F 12:30am fever broke, onset of COVID19 VACCINE JANSSEN 0 days 1097769-1 migraine 7am nausea Migraine & nausea intense until 6pm 3/13/21 Mild headache now COVID19 VACCINE JANSSEN 0 days 1097771-1 High Fever, body aches, headache, diarrhea, and vomiting extreme headache and dizziness about 4 hours after the shot at around 4:00 PM. migraine continued to get worse and i COVID19 VACCINE JANSSEN 0 days 1097805-1 was seeing spots, vertigo and loosing balance and that lasted until 7 pm on 3/13 COVID19 VACCINE JANSSEN 0 days 1097812-1 Fever, chills, congestion, nausea COVID19 VACCINE JANSSEN 0 days 1097817-1 48 hrs fever at 101 degrees Vomiting Bodyache Fatigue Chest pain Nausea Mild fever (99.5), slight chills, flush face. Still ongoing after 2 hours with 1000 mg Tylenol taken promptly after COVID19 VACCINE JANSSEN 0 days 1097820-1 symptoms started. COVID19 VACCINE JANSSEN 0 days 1097832-1 Headache, fatigue, dizziness, chills, fever, muscle/joint pain Body Aches, extreme fatigue, increased heart rate, fever (101¶F) starting at 7:15 pm 03/13/2021. Taken 1000mg COVID19 VACCINE JANSSEN 0 days 1097834-1 acetaminophen 10:00 pm - fever increased from 99 to 101 Drop of body temperature even wearing layers of clothes and bedsheets, drop in body temperature caused me to have COVID19 VACCINE JANSSEN 0 days 1097836-1 uncontrollable shaking. The hyperactivity of having the uncontrollable body shaking accelerated my heart palpitations and felt intense pain in my chest. This reaction lasted for about an hour and felt like I needed to go to emergency care. COVID19 VACCINE JANSSEN 0 days 1097838-1 About 12hours after dose fever chills and joint pain with side of headache lasting untill Saturday Mar 13th. Patient had arm tingling shortly after injection. Pt stayed in store for about 4 hours after 2pm injection, no redness or swelling noticed. Pt was quite anxious & nervous (but already has severe anxiety). Pharmacist called patient following afternoon, the 11th and patient noted he was doing marginally better but still sounded anxious. Pharmacist called patient on Fri the 12th 5:16p and this was when the patient explained the following: Muscle stiffness on left side & pain COVID19 VACCINE JANSSEN 0 days 1097839-1 down left leg; cranial pain; shoulder stiffness; nasal congestion; some shortness of breath; soreness & fatigue. Patient called back and said he had partial shortness of breath at 7:34p on the 12th. On Sat the 13th at 11am, pharmacist called to check on pt; found him quite agitated & saying, ""He feels the shot was botched"", noted he had called Janssen to report his issues. At 4:30pm, pt came to pharmacy, looked fine, arm showed no redness, was more subdued in person than on the phone earlier. He said he was feeling better but was not happy with Janssen and wanted the Moderna 2 series shot because he feels Janssen's vaccine wasn't doing what it was supposed to."" COVID19 VACCINE JANSSEN 0 days 1097842-1 Fever, joint pain 10:20a covid vaccine appointment 10:35a Johnson and Johnson vaccine administered 10:49a left pharmacy from getting vaccine. Feel normal. 5:45p - genera achiness- back, legs, feet, headache. Feeling weak. 7:00p - ate dinner at COVID19 VACCINE JANSSEN 0 days 1097844-1 6:45 and started feeling a little more energized but still achey 8:32 - general achiness continued. Temperature: 99.3¶ 9:19p - chills, lower back, butt, and leg soreness. Tightness in head like my head is being squeezed. Very tired and worn down. First pain in whole arm and across my chest. Then chills and all over body aches. I also have fatigue. It began around 9 COVID19 VACCINE JANSSEN 0 days 1097869-1 pm and is getting worse at 11:15pm. Jansen COVID-19 Vaccine EUA I received the vaccination on 3/12/2021, about 8:30AM, at Fairgrounds. I needed the J&J vaccine, one Moderna or Pfizer as I have a history of anaphylaxis. County Public Health received about 200 does of the J&J and 800 of Moderna and Pfizer. I waited at the vaccine site about 40 minutes after the vaccine. I went home, ate, COVID19 VACCINE JANSSEN 0 days 1097880-1 read, and became unusually sleepy so took a nap. I woke up about 2:00PM and noticed my lips and tongue were swollen, and sore. I took 2 Benadryl. The Benadryl seems to have worked as expected. I will take 2 more when I go to bed, about 11:00. I'm unusually sleepy, and my joints ache. Overall, however, I think I am experiencing a very mild reaction and I'm thankful for the vaccine. I sent my doctor a message through the patient portal, telling him of the reaction. His office is closed so he will get the message on Monday. Waves of extreme fatigue, headaches and body aches. Some brain fog. Difficult completing simple activities due to COVID19 VACCINE JANSSEN 0 days 1097882-1 exhaustion. Nausea then headache at 5:00 pm. Progressively worse all night unable to sleep with bossy aches chills and fever all the COVID19 VACCINE JANSSEN 0 days 1097888-1 next day. It almost 9:00 hopefully this stops tomorrow In a few hours after my COVID shot, I had Intense chills that made my entire body ache, then a headache and a rapid COVID19 VACCINE JANSSEN 0 days 1097914-1 heartbeat, with a 101.7 fever. COVID19 VACCINE JANSSEN 0 days 1097956-1 Chills followed by fever. Pain at injection site. Chills and fever were treated with ibuprofen. COVID19 VACCINE JANSSEN 0 days 1097959-1 Headache , fever within 12 hours of vaccine Swollen, painful and redness at site 7 hours after the shot I began to feel very tired and sluggish. I also developed a headache. At the 10 hour mark, I was COVID19 VACCINE JANSSEN 0 days 1097961-1 experiencing body aches, severe headache, fever, chills, and nausea. After 36 hours, I am still experiencing muscle aches, headache, fever, and joint pain. COVID19 VACCINE JANSSEN 0 days 1097987-1 Petechiae/ Soreness at injection site immediately and lasting afterwards at least 24h. About 6 hours after vaccination, general COVID19 VACCINE JANSSEN 0 days 1097989-1 aches, headache, fever (~101 oral reading while taking ibuprofen), chills, insomnia; all of these symptoms lasting (so far) about 16 hours and continuing. ?Janssen COVID-19 Vaccine EUA 8 hours after injection I started getting severe chills that wouldn't go away. I took a shower and felt week and I still had chills. I checked my temp and it was 102.5. I went to bed for about an hour and still had chills. I got up and drank water and checked my temp. It was 103.7. I took two tylenol and my fever broke about 40 COVID19 VACCINE JANSSEN 0 days 1098006-1 minutes later. I was so hot. I checked my temp again and it was 102. I tried to eat and drink but I felt sick. I did drink water. I got chills again and took another tylenol. My temp went to 101. I've had fever and chills all night. I kept taking tylenol and my fever has stayed between 100- 101. I forced myself to eat soup and I took more tylenol. My current temp is 99.6. I have a throbbing headache. It is 7:15AM. COVID19 VACCINE JANSSEN 0 days 1098010-1 Headache, itchy eyes, nasal congestion, nausea within 15 min of administration. COVID19 VACCINE JANSSEN 0 days 1098012-1 Systemic: Dizziness / Lightheadness-Mild COVID19 VACCINE JANSSEN 0 days 1098013-1 Pt complained of lightheadedness after shot administration within 15 minutes COVID19 VACCINE JANSSEN 0 days 1098015-1 Pt dizzy immediately after shot administration. c/o dizziness with any IM shots in the past. Patient complained of feeling nausea and warm ""flushed"" apprx 15 mins post vaccine. VS HR 74, RR 17, O2 95, 100/60, COVID19 VACCINE JANSSEN 0 days 1098016-1 wheeled patient outside for fresh air. Patient improved. Left walking to car with family members."" COVID19 VACCINE JANSSEN 0 days 1098017-1 Pt dizzy after shot administration COVID19 VACCINE JANSSEN 0 days 1098019-1 Patient complained of nausea after receiving vaccine . symptoms resolved and no further issues at this time. Pt dizzy after IM shot @ 1200. Felt hot and tingly in legs. 1215 - Nausea, BP 143/90. 1230 - increasing dizziness and COVID19 VACCINE JANSSEN 0 days 1098020-1 headache. 1300 - vomited x 7. 1309 - pt complained of throat pressure and increased vomiting. 50mg IM benadryl given. EMS called and Pt taken to hospital for evaluation. COVID19 VACCINE JANSSEN 0 days 1098024-1 Dizziness, blacking out, high fever, body aches, sore throat, headache COVID19 VACCINE JANSSEN 0 days 1098031-1 Headache the night of the shot Headache and tiredness the next day. COVID19 VACCINE JANSSEN 0 days 1098042-1 Body aches, slight fever, tiredness COVID19 VACCINE JANSSEN 0 days 1098050-1 couldn't stop shaking uncontrollably, stiff neck, shaking, for 1 hour The evening of the vaccine (I guessed around 6:00 p.m.), my ears felt like they became stopped up, especially the left. I COVID19 VACCINE JANSSEN 0 days 1098053-1 still feel pressure. I feel like I can?t hear quite as well as before. I hear a high pitch sound when everything is quiet. Fatigue that lasted for 15 hours. General muscle and joint aches for about 12 hours. Minor Injection site pain that lasted COVID19 VACCINE JANSSEN 0 days 1098063-1 for 2 days. Dose given at 1415. At approximately 2030 on the same day, patient began experiencing upper extremity myalgias, then generalized myalgias, fevers to 104.3 F and chills. Her oral intake decreased and she vomited multiple times. She COVID19 VACCINE JANSSEN 0 days 1098073-1 subsequently presented to the emergency department where she continued to spike fevers. Her vomiting has subsequently subsided. Extreme chills starting at 11:30pm. Needed to wear layers of clothing and turn up heat to get warm. Wife was hot while I was freezing and shivering uncontrollably, so I know something was wrong with me. The shivering and chills lasted for a couple of hours until about 2:30-3:00am. Then I got really hot. Took my temperature, was at 99.1 degrees. But room COVID19 VACCINE JANSSEN 0 days 1098077-1 was really warm so I turned down the temperature and took off my layers of clothing. Woke up this morning, around 7am, to a headache and aching legs. I took 2 Excederin, but the headache is still there. Legs are feeling better after a couple of hours. This patient was given the vaccine at an off-site clinic event and received the Janssen vaccine which in indicated for COVID19 VACCINE JANSSEN 0 days 1098078-1 patients 18yr and older however patient is 17 years old. Advised father and patient of incident, no reported side effects or adverse events as of time of communication with patient. Patient felt lightheaded and dizzy. He appeared to be pale and pass out for approximately 2 sec and independently came COVID19 VACCINE JANSSEN 0 days 1098110-1 to. VS stable. Headache, body ache, Fever, chills, vomit, GI pain. Started at 5pm the same day I took Vaccine and latest until 3am. Next COVID19 VACCINE JANSSEN 0 days 1098123-1 day it cleared up. Except for body ache and dull head pain. COVID19 VACCINE JANSSEN 0 days 1098124-1 Sore arm at injection, muscle pain, fever, chills Fever resolved itself after 24 hours COVID19 VACCINE JANSSEN 0 days 1098128-1 Muscles and joint pain. Slight fever. Nauseous. Immediately and still on going Fever (99-101 fluctuations), body aches, chills, nausea, headaches Symptoms continued from 6:00pm March 13 into next COVID19 VACCINE JANSSEN 0 days 1098132-1 morning First I felt lightheaded/dizzy, then became nauseous, and my feet and hands were numb and tingling, I felt like my tongue was getting bigger but the primary care dr at the clinic didn't think so. They eventually after monitoring me for awhile sent me down to ER, by then my voice was raspy and scratchy, my lower lip was big, my tongue still felt big. I still felt nauseous. The dr asked me if my eyes are usually swollen and red and I said no. My extremities were still numb and COVID19 VACCINE JANSSEN 0 days 1098162-1 tingling. I got epi and other drugs, zofran, benadryl, pepcid, I think a dose of steroids. The symptoms continued so I ended up getting a 2nd dose of epi. I went home around 5pm. When I woke up that evening to do a neb treatment I was nauseous, my lower lip again big, my tongue felt thick and this time my upper throat felt swollen, I gave myself epi and took myself to ER, they monitored me for 3 hrs the dr was gonna hospitalize me if I got worse, I still felt nauseous and the numbness and tingling feeling in my hands and feet when I left but was not having any airway issues when I left. Not sure if the numbness/tingly is gonna go away in my hands and feet. COVID19 VACCINE JANSSEN 0 days 1098174-1 Flu symptoms, muscle and joints pain, headache, eye pressure, insomnia, fogginess, dizziness. COVID19 VACCINE JANSSEN 0 days 1098186-1 Fever of 101 degrees, chills, muscle aches, and head ache. Patient felt flushed feeling which is sometimes a trigger for seizure. Patient observed for 15 mins, no seizure activity or COVID19 VACCINE JANSSEN 0 days 1098194-1 other sx noted. Patient felt lightheaded, nauseated, hot and sweaty and appeared pale. She states she has a history of fainting with COVID19 VACCINE JANSSEN 0 days 1098213-1 blood draws and vaccines. VS improved over 25 mins, patient left via own car. COVID19 VACCINE JANSSEN 0 days 1098218-1 Janssen COVID-19 Vaccine EUA Chills and intense shivering, nausea, headache, and fever. Had a 102.6 for a couple hours COVID19 VACCINE JANSSEN 0 days 1098232-1 Severe headache, aches, fever, exhaustion for 6 day 9 hours after the shot I became nausea and had the chills. About 11 hours after the shot I had a fever of 101 and then COVID19 VACCINE JANSSEN 0 days 1098235-1 vomited. 18 hours after the shot my fever has gone down but I still have a headache and bodyaches. I?ve been taking Tylenol to treat the symptoms. High fever, chills, nausea, fast heart beat started about 14 hours after the injection and lasted about 8 hours. Very achy COVID19 VACCINE JANSSEN 0 days 1098237-1 and fatigued for an additional 6 hours after the most severe symptoms passed. As soon as I got the vaccine I started with a cough 30 hours later developed a fever chills headache and it one point to it COVID19 VACCINE JANSSEN 0 days 1098256-1 we?re not too three days muscle aches severely cold and now I have so I said my mouth five days later violent diarrhea five days later still sores Injection about 1:20 pm. By 7 pm, developed body aches, then chills, headache, upper jaw ache. Fever 100.2F overnight. COVID19 VACCINE JANSSEN 0 days 1098362-1 Minor stomach queasiness. Treated with acetominophen which gave some but not total relief. 11 am day after injection still experiencing backache and headache, mild queasiness. Injection site mildly sore. COVID19 VACCINE JANSSEN 0 days 1098398-1 Sore arm, chills and fever, severe headache About 9-10 hours after receiving vaccine at 8:15am - chills, body aches, and headache. Fever peaked at 101.4 around 8-9 COVID19 VACCINE JANSSEN 0 days 1098449-1 pm. Tylenol was able to reduce fever. Woke up twice in the middle of the night dripping in sweat. Next morning (3/14) all symptoms were gone. Persistent fever, chills, body aches, headache, fatigue Treated with Advil - symptoms fade and then return several hours COVID19 VACCINE JANSSEN 0 days 1098464-1 later Bad chills/shaking for 2 hours. Headache (took tylenol several times, gone by noon next day) Tired and general achiness COVID19 VACCINE JANSSEN 0 days 1098472-1 through the next day (gone by 3-13-21) Light red rash under arms and across rib cage area (gone by 3-14-21) COVID19 VACCINE JANSSEN 0 days 1098508-1 Body aches Low grade fever Onset of a feeling like I was drunk the afternoon of the vaccine. The evening on 3/9 sleeping was difficult and I was very restless. When I awoke the next day (3/10) the only symptom was pain at the injection site. The afternoon of the 10th I COVID19 VACCINE JANSSEN 0 days 1098536-1 began to experience flu like symptoms and was lethargic. No fever but did have chills. Slight headache. Awake the morning of 3/11 and symptoms had subsided. Janssen COVID-19 Vaccine EUA Chills, shivering and body aches which started around 8:15 p.m. on 3/13. Severe headache COVID19 VACCINE JANSSEN 0 days 1098601-1 through out the night and morning of 3/14. I then took ibuprofen and Tylenol which helped. Sore arm for more than 24 hours, developed low grade fever (99.4) about 8 hours after injection, fever still going after 16 COVID19 VACCINE JANSSEN 0 days 1098625-1 hours. Using ibuprofen for fever and arm pain. COVID19 VACCINE JANSSEN 0 days 1098678-1 Chills, hot flashes, nausea, fever, headache- 24 hours Took Tylenol Symptoms Continued with Tylenol Started with a dull headache that got more severe over time, body aches, chills, diarrhea and a temperature around COVID19 VACCINE JANSSEN 0 days 1098688-1 101. Rest and liquids

Janssen COVID-19 Vaccine EUA 34 y.o. male with GERD who presents with syncope and question of PEA arrest. He went for COVID 19 J&J vaccine on 3/13/2021. A few minutes after getting the vaccine he started feeling nauseated. His lips COVID19 VACCINE JANSSEN 0 days 1098942-1 became gray. He went unresponsive and was taken out of the car. He had agonal respirations. He had 90 seconds of chest compressions and returned to his normal state of health. He was seen in ED where labs were remarkable for mild hyperkalemia (serum potassium 5.5). Given worrisome syncope, chest compression he was admitted for observation. He did well overnight, No arrhythmias of telemetry and was discharged with Holter monitor. 8:30 pm started - very cold/ then very bad body aches and slight headache; then dizziness and 4 hours later started COVID19 VACCINE JANSSEN 0 days 1098951-1 vomiting for about 15 hours; slept all of next day and night/ waves of nausea; dizziness gradually faded after 24 hours, nausea faded after 26 hours 30 weeks pregnant at time of receiving vaccine. Estimated due date May 20, 2021 Had dull headache immediately following vaccine. At 4pm I had chills and then started having contractions every 5 minutes. I called my OBGYN who recommended that I drink fluids and lay on my side to decrease the presumed Braxton Hicks contractions. This did not COVID19 VACCINE JANSSEN 0 days 1099034-1 decrease the contractions. I came to the hospital where I was admitted to labor and delivery with contractions 2-4 minutes apart and a 99.6 degree temperature. I was given an oral medication to stop the contractions, a 2 part series of injections to speed up lung development of my unborn child, and IV fluids were administered. Bad headache, arm and neck pain, dizziness, fatigue body aches, chills, nausea, stomachache. Did not sleep well much Friday night due to these symptoms. Sudden pain in left side of my head about 40 min after the vaccine after I walked to COVID19 VACCINE JANSSEN 0 days 1099103-1 the car and sat down after the 30 min wait. Pain starts as a slow dull ache, increases rather sharply, then goes away quickly. Have this pain several times or so yesterday and today even after taking ibuprofen. Also pain in my neck with what feels like stress headaches with ibuprofen relieving it. COVID19 VACCINE JANSSEN 0 days 1099205-1 Fever, chills, joint/body pain, headache Tylenol relieves temporarily High fever (102), extreme headache, severe body chills, body aches, swollen lymph nodes in neck and groin. Onset at COVID19 VACCINE JANSSEN 0 days 1099354-1 2:00 pm, kept developing rapidly until I took 800 mg of ibuprofen around 6 pm and symptoms lessened within an hour. Symptoms still present but mild with the pain meds. Injection site pain as well. 2 hours after the vaccine, I started to feel very achy, and had terrible chills. That lasted through the night and I woke up with a slight fever, 99.9. The aches were in my joints and muscles. It actually felt like I was having back labor. I took COVID19 VACCINE JANSSEN 0 days 1099412-1 advil, and I was able to sleep and sweat out the fever. These symptoms were similar to one of my worst Lupus flares. These symptoms lasted until Tuesday, 3/9/21, afternoon. The following Sunday, my joints feel extremely stiff and achy. Not sure if it has anything to do with the vaccine. I took Advil and it seemed to help. COVID19 VACCINE JANSSEN 0 days 1100992-1 Diarrhea, vomiting, nausea, dizzy, dehydrated COVID19 VACCINE JANSSEN 0 days 1101020-1 Fever Chills Body ache Feeling cold Sleepiness Chills started at 7:30 the night of the vaccine followed by Fever, Headache, and Body Aches. Nausea & Tiredness through COVID19 VACCINE JANSSEN 0 days 1101472-1 Monday. fever, chills, muscle aches recommended tylenol or ibuprofen to relieve symptoms. If symptoms worsen referred her to COVID19 VACCINE JANSSEN 0 days 1101525-1 see primary provider. Patient received Janssen vaccine by registered nurse and was completing her 15 minute waiting period. She began to feel faint and an employee of our facility caught her as she experienced a near syncopal episode. She was promptly placed in Trendelenburg position and vitals obtained. BP was 90/58 with mild tachycardia to max of 130-140 bpm. Patient COVID19 VACCINE JANSSEN 0 days 1101941-1 was given supportive treatment and monitored. BP improved to 110/70 after 5 minutes and 120/72 after 15 minutes. Patient continued to feel very dizzy and weak, however, and became tachycardic and diaphoretic each time she attempted to move to a seated position. After 1 hour of monitoring and vitals showing continued tachycardia, decision was made to transport the patient to ER for further testing. Patient expressed agreement and understanding of plan to transport to ER via ambulance. COVID19 VACCINE JANSSEN 0 days 1101990-1 Dizziness, sweating, blacked out, blood pressure dropped Lightheadedness and tachycardia noted 20 minutes after administration of Covid Vaccine. Emergency drugs available. COVID19 VACCINE JANSSEN 0 days 1102498-1 Airway assessment done, vital signs obtained, cold, damp cloth placed on patient's head and neck. Husband requested EMS to transport patient to ER for further evaluation. Patient stable when EMS arrived. COVID19 VACCINE JANSSEN 0 days 1102714-1 Janssen COVID-19 Vaccine EUA Anaphylaxis; Severe Angioedema of lips, tongue, eyelids. Hypoxemic Respiratory Distress, O2 88-89% on presentation. Chest pain/tightness. Epi pen, IM, minimally responsive. Epi gtt, IV steroid, dual histamine block. IVF bolus x2L. HF O2 COVID19 VACCINE JANSSEN 0 days 1103680-1 support, via non RB. Pt with slow response to above intervention, but remained hemodynamically stable and with improvement to respiration/oxygenation and angioedema over about 1 hour. while patient prepared for transfer to higher level of care. Muscle soreness, 102.7 fever, tiredness, headache. Started around 4 pm day of shot. Took 2 Tylenol at 9:30 pm that COVID19 VACCINE JANSSEN 0 days 1103695-1 night. COVID19 VACCINE JANSSEN 0 days 1103710-1 Light headed, dizzy, nausea, fever and chills COVID19 VACCINE JANSSEN 0 days 1103712-1 None stated. About 6 hours after vaccination, patient felt immense headache, muscle pain and weakness, chills, sleepiness, lack of COVID19 VACCINE JANSSEN 0 days 1103716-1 appetite to eat and slight nausea. This phenomenon lasted for about 48 hours. Started experiencing mild fatigue and body aches ~5 hours after getting the shot. Over the course of the day these symptoms started increasing and I developed chills and a fever around 100F at about 7 hours. Took an ibuprofen when symptoms persisted and fever kept rising. Fever rose to over 101F while sleeping and woke me up once the ibuprofen COVID19 VACCINE JANSSEN 0 days 1103719-1 ran its course. Did some wet towel compresses but did not help. Took another ibuprofen. Muscle aches and chills persisted into the next day. Developed another mild fever in the second day. Symptoms resolved on day 3. Soreness in arm where the vaccine was administered persists. Vaccine was given on 3/13/21 at 2:50 pm, patient began experiencing head pressure, moderate lightheadedness, with numbness of extremities and lips at 2:55 pm. Metallic taste in mouth, then tongue tingling. At 3 pm, throat felt like it COVID19 VACCINE JANSSEN 0 days 1103720-1 was narrowing so 911 was called, Epi administered. Epi helped resolve airway narrowing within 2 min. Paramedics administered Benedryl IV. BP 158/92, pulse 100, SaO2 100% on room air, resp 20. High fever(103.3), chills, body aches, headache, nausea, general malaise and fatigue had onset 2100 hours 03/07/2021. COVID19 VACCINE JANSSEN 0 days 1103723-1 Fever reduced 03/09/2021 1000 am. Remaining symptoms other than headache resolved 03/11/2021 0600. Headache still present 03/16/2021. Thursday, March 11, 2021 (approximately 8:30 am) Patient experienced blurred vision, unbalance, and slurred speech COVID19 VACCINE JANSSEN 0 days 1105748-1 and had an irregular heartbeat. March 11, 2021 (approximately 11:30 am) Patient was admitted to Hospital administered CT scan, MRI and multiple blood tests. Diagnosis - Ischemic Stroke After she waited 15 minutes after having the injection, she was fine. Starting driving home, she had a light headache. COVID19 VACCINE JANSSEN 0 days 1106400-1 She had itching, tenderness, body rash and fever. She went to ER. Chills and fever lasted for 7 hours, rapid racing heart for 5 hours. Started 12 hours after the vaccine was administered. COVID19 VACCINE JANSSEN 0 days 1106734-1 Took tylenol for fever. Went to er for rapid heart rate after I could t lower it for 2 hours.

High respiratory rate with shallow breaths, Rash on chest, Tachycardia, Altered Mental Status . The Patient that was suspected to have an adverse reaction. EKG displayed no abnormalities, IV was placed in patients L Arm and provided COVID19 VACCINE JANSSEN 0 days 1106904-1 1,000 ML of Normal Saline, and administered supplemental O2 via simple mask. An Epinephrine Auto Injector 0.3mg was also injected into the patients L thigh. Determination to transport to local treatment center was made by provider. Patient arrived at Medical Center approx. at 2245 and further evaluated there. Patient was then transferred to Level 3 Trauma facility to Hospital around 0100, 17 March. Admitted to the ICU for further evaluation. Update- Patient will be admitted until 18 Mar 2021. It was noted by Hospital Patient had a sever anaphylactic reaction. Yesterday I got the Johnson and Johnson vaccine. I was the last appointment, so they observed me for 5 minutes, and I left. After riding in the car for a few minutes, I noticed that I was having a hard time breathing and my throat felt like it was starting to swell. By that time, the clinic was closed, so I went to the emergency room just in case and sat in my car since they didn't allow people to sit in the waiting room because if covid. It started becoming increasingly difficult to breathe, and I was feeling more and more swelling of my throat and tongue. I was having a lot of dizziness, nausea, facial flushing, palpitations, and some mild confusion. I then started getting numbness in the bottom half of my face. Over time, the numbness spread, mostly staying on the left side of my body (face, scalp, lower arms and legs, left side on tongue and inside of mouth). I also started getting a prickling burning pain sensation for brief periods of time where I had numbness. I had decided that if my breathing worsened at all, I would go to the er even though I can't afford it. After about an hour COVID19 VACCINE JANSSEN 0 days 1107324-1 and a half, my breathing started to feel less constricted and like there was less resistance. The swelling in my throat was mostly in the upper throat where I had difficulty swallowing but not as much difficulty breathing. The numbness continued to get worse and was sometimes disappearing and reappearing in the same spot. At 9:30 pm we went to go get some benadryl. I continued feeling less and less swelling and having an easier time breathing. At that point, I went home. Once I was home, my breathing continued to improve and the numbness started to dissipate. In the middle of the night, I started itching and getting widespread hives and getting a sharp burning pricking pain that would last a few seconds in different areas. The numbness also started coming back mostly in my face. I continued to have difficulty swallowing. I am feeling much better today. I still feel some slight swelling in my throat when I swallow, but my breathing is fine. I'm still itchy and occasionally breaking out in hives. Im having mild lower facial numbness. I'm also starting to get the normal side effects of fever, headache, arm soreness, and body aches. I'm taking benadryl every 4 hours. COVID19 VACCINE JANSSEN 0 days 1107326-1 Chills COVID19 VACCINE JANSSEN 0 days 1107345-1 Chills, fever, diarrhea, headache High fever for 2 days -topped out at 104, muscle aches and pain, Chest pain and mild breathing issues, and extremely COVID19 VACCINE JANSSEN 0 days 1107350-1 tired COVID19 VACCINE JANSSEN 0 days 1107352-1 Pulsing in my left foot COVID19 VACCINE JANSSEN 0 days 1107353-1 Headache, fatigue, confusion, fever, body aches COVID19 VACCINE JANSSEN 0 days 1107355-1 Headache, fatigue, fever, body aches, confusion ?Janssen COVID-19 Vaccine EUA? i Headache muscle aches and chills began at 2200 on day of vaccine, by midnight fever was brought down to 100.5 after taking 800mg ibuprofen. Slept ok, next day temp was 100.2 and headache, muscle COVID19 VACCINE JANSSEN 0 days 1107371-1 aches, nausea continued throughout the day despite rest. Today Tuesday fever and headache are gone, mild muscle aches persist. Vaccine site is very sore. COVID19 VACCINE JANSSEN 0 days 1107378-1 101 degree fever, chills, muscle aches, insomnia 3pm- I got the J&J shot 10pm - went to bed ~11pm - woke up freezing, couldn?t get warm Midnight - burning up/freezing/body ache ~ 2 am - felt like I was burning up and I have been switching ice packs on my head all night, I move slowly when I get up to switch out ice pack because I am slightly dizzy when I stand. 4:30 am - 5pm ice packs have help, COVID19 VACCINE JANSSEN 0 days 1107380-1 but now I have an awful headache. My head feels like it is going to explode, it feels like there is so much pressure. 5pm- 10:15am (Current time) - cough, scratchy throat, shortness of breath going up stairs, hot cold flashes, mild headache, still haven't felt hungry. Fever, chills, headache onset 8 hours post vaccination, resolved 12 hours after onset. Tightness in chest with deep COVID19 VACCINE JANSSEN 0 days 1107388-1 breathing and dry cough onset 8 hours post vaccination, still present 6 days post vaccination with no improvement. COVID19 VACCINE JANSSEN 0 days 1107399-1 3:00pm vaccine, 11:15pm chills, 1:50am 100.99 fever/headache/body aches COVID19 VACCINE JANSSEN 0 days 1107400-1 Flue like symptoms, fever, body aches, sore throat. chills, body aches began 8 hours after shot and lasted approximately 6 hours; fever began 10 hours after shot and lasted COVID19 VACCINE JANSSEN 0 days 1107405-1 approximately 4 hours Headache and fatigue lasted for 24 hours Nausea and tightness of chest began 3 days after shot and are continuing Side effects: First experienced fatigue, then body aches and extreme chills overnight. Severe headache upon waking COVID19 VACCINE JANSSEN 0 days 1107427-1 following morning. Administered 2 (500 mg) acetaminophen tablets to counter symptoms, which has lessened the severity of symptoms. At this time (following day after vaccination) still recovering from above side effects. Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: she fainted shortly after administration. when i went back to her..she was conscience and breathing ok. She felt like it was typical to what she COVID19 VACCINE JANSSEN 0 days 1107446-1 experiences with vaccines and did not blame the vaccine at all. She was responsive and did not seek additional help. she refused an ambulance. she had a friend pick her up so she didnt have to drive home. Nausea vomiting diarrhea headache and chest pain that began 15 minutes after vaccination and persisted over the next COVID19 VACCINE JANSSEN 0 days 1107447-1 7 days. COVID19 VACCINE JANSSEN 0 days 1107448-1 Error: Wrong Dose of Vaccine - Too Low COVID19 VACCINE JANSSEN 0 days 1107457-1 pain in the back of the left heel. No trama or activity related I broke out in itchy hives all around the left arm injection site, underarm, and left breast. This occurred one hour after COVID19 VACCINE JANSSEN 0 days 1107479-1 injection and 45 minutes after I left the vaccination site. I took one Claritin OTC antihistamine and within 15 minutes, all reactions went away. No other symptoms occurred, not even soreness at the site. COVID19 VACCINE JANSSEN 0 days 1107527-1 Flu like symptoms. Muscle aches, tiredness, chills, fever for 24 hours high fever, chills and sweats throughout the night; extreme fatigue and weakness the next day in addition to sore COVID19 VACCINE JANSSEN 0 days 1107603-1 injection site Roughly 8 hours later, mild headache that increased, followed by fatigue and sweating. Roughly 20 hours later I have a COVID19 VACCINE JANSSEN 0 days 1107658-1 burning right eye that has continued into the day 3/17/21. COVID19 VACCINE JANSSEN 0 days 1107672-1 Body Chills, then Fever. Subsided with acetaminophen On March 11th at around 10pm I experienced severe shaking, fever, headache and delirium. The next day I improved but had a fever on and off of 99.1. I felt like I was stable, but felt dizziness increasing, and was lethargic through the weekend. Then on Monday the 15th, I had a noticeable cramp in my right abdomen. At around 8pm CST I began feeling COVID19 VACCINE JANSSEN 0 days 1109385-1 like I needed to burp and that I had GI problems. The problems increased that night at around 10pm I had pain where the cramp started. Two hours later I started throwing up because of the pain and feeling of too much air inside of me. I could not stop vomiting after 2 hours so went to the Hospital ED at around 2:30 AM Tuesday the 16th. I was admitted after a CT scan showed and white cell counts confirmed and infection and drastically enlarged appendix. I was diagnosed with an appendicitis and they immediately scheduled me for surgery. I have had severe chills, headaches and body aches. I am having a temperature that spikes and breaks. I have a runny COVID19 VACCINE JANSSEN 0 days 1109969-1 nose and am exhausted High fever approx 8:00pm 102.8 degrees. Severe chills, muscle aches, moderate headache. Fatigue, dizziness and COVID19 VACCINE JANSSEN 0 days 1109996-1 confusion. All side effects approx 6:00pm to 8:00pm when started. Still continuing at current time of 10:12pm times. COVID19 VACCINE JANSSEN 0 days 1110012-1 Fever Received vaccine at 0900. At 2100, chills, body aches. At 2300, itching left elbow that progressed. Seen at 0600 next COVID19 VACCINE JANSSEN 0 days 1110016-1 day and diagnosed with hives. No anaphylaxis. However, as precaution he was given epi, solumedrol iv, and Benadryl po. Patient discharged to room. He is in setting overseas. COVID19 VACCINE JANSSEN 0 days 1110020-1 103.5 fever , sever chills, headache No side effects until 8 hours later. Started feeling dizzy occasionally, especially when I turned my head. Dizziness worsened over the evening to the point where almost any movement made me dizzy. Extreme muscle and body aches COVID19 VACCINE JANSSEN 0 days 1110040-1 around 8pm continuing now. Feeling very weak and had chills throughout the night. These symptoms feel exactly how I felt when I had covid on 12/28/20. Received vaccine at 4pm. Lost appetite by 6pm . Teeth chattering chills and high fever 103 by 9pm. Vomiting by 10pm. COVID19 VACCINE JANSSEN 0 days 1110057-1 Called Primary Dr. at 11pm. Dr. prescribed Ondansetron HCL 8mg tablet for nausea and vomiting. Fever throughout the night and next day. Day 2 Still had fever, vomiting, Day 3 fever was gone. fever, fatigue, nausea, sweating, dizziness, runny nose. Started with a fever and fatigue, took Advil for muscle aches, Through the night I had sweating and nausea. I had dizziness upon standing the next day after the vaccine. About 48 COVID19 VACCINE JANSSEN 0 days 1110108-1 hours after vaccine, I developed a burning sensation in my nose and had a very runny, stuffy nose for one day. By day 3 after vaccine, everything went back to normal. 21 yo male presented to ED Face swelling, hives, facial pruritus, throat tightness starting approx. 30-40 minutes after J&J COVID19 VACCINE JANSSEN 0 days 1110136-1 COVID shot. In ED vitals stable, pt not in distress. Good response w/ Epi pen and adjunct medications. Arm is sore where injection happened. Later in the day after the injection I got chills and feverish. Had nausea and body COVID19 VACCINE JANSSEN 0 days 1110143-1 aches all night and through to the next morning. Also experiencing diarrhea and dry mouth. severe chilling, headache, body aches, fatigue, loss of appetite, started 6pm. 9 hours after vaccine, chilling ended 4 hours COVID19 VACCINE JANSSEN 0 days 1110173-1 later, headache , fatigue and loss of appetite lasted the whole next day. 3rd day feel good. Took no meds like tylenol or ibuprogen to help. COVID19 VACCINE JANSSEN 0 days 1110193-1 chills, Headache, sore arm, tiredness Chills, body aches, fever, nausea, and headache starting roughly five hours after injection on 3/11/2021. Majority of COVID19 VACCINE JANSSEN 0 days 1110202-1 symptoms including the fever lasted three days, ending on Sunday, 3/14/2021. Headache and body ache still occurring a week later on 3/18/2021. Patient experienced significant nausea and vomiting and 103 degree fever. Symptoms started about 4 hours after COVID19 VACCINE JANSSEN 0 days 1110218-1 vaccination and built for the next 3 hours before patient went to the emergency room for treatment. pt stated that she started shaking really bad and her muscles tensed up along w/ fatigue and feeling very hot but no fever. Pt took ibuprofen and that seemed to help. She woke up with another one of these episodes. She feels like she is COVID19 VACCINE JANSSEN 0 days 1110346-1 shaking but her spouse says she was not physically shaking. She also had headache, body aches with pain, nausea, vomiting and can hardly walk. Ibuprofen is not helping with this pain. pt contacted her PCP and was to call us and and take Tylenol or ibuprofen and rest. COVID19 VACCINE JANSSEN 0 days 1110350-1 patient became diaphoretic, had involuntary muscle movement, non verbal for 4-5 seconds. Within about six hours, started having violent spasms. Each lasting 45-60 seconds, from neck down. Everything would COVID19 VACCINE JANSSEN 0 days 1110351-1 seize up including jaw. Felt like I was having a seizure but completely conscious. Happened every 2-3 minutes until about 5:00am. Husband had same reaction the next day after his injection. COVID19 VACCINE JANSSEN 0 days 1110372-1 Pt reporting hives to the underarm and chest with itching The patient was signed up for the Pfizer vaccine which we ran out of doses. The patient said they were fine with Janssen COVID19 VACCINE JANSSEN 0 days 1110375-1 and it was switched at the out window to that vaccine. The patient was 2 months shy of his 18th birthday which Janssen is not indicated for. The patient had no adverse reactions to this point but we wanted it documented. At 10 pm I started to experience some moderate body aches. By 1 am, I was in so much pain I could not sleep and started to develop a fever. I drank a ton of fluids, used OTC treatments (Ibuprofen and Motrin) but nothing alleviated the pain. By 10 am I had a sustained fever over 100 degrees. I was in so much pain I was crying in bed. By 3 pm my fever reached COVID19 VACCINE JANSSEN 0 days 1110377-1 102 degrees. I had to go to the emergency room for IV drip and medication because I couldn't drink enough water to stay hydrated. Once given IV, my temperature plummeted. When the medication they administered wore off, my body started experiencing mild to moderate pains again. Body aches and soreness all over- my muscles feel like they are being squeezed from the inside. I am still feeling a lot of fatigue and pain but it is random and comes and goes along with ""hot flashes""."" Fever, chills, body aches, headache, could not get warm, weak; next day upper back aches, tight chest, left arm pain, sore COVID19 VACCINE JANSSEN 0 days 1110379-1 injection site/very slight bruising Mild Headache - 12 hours Fever followed by a hot flash - 12 hours followed by a 15 minute hot flash Joint Pain - 12 COVID19 VACCINE JANSSEN 0 days 1110435-1 hours Fatigue - 24 hours A few minutes after the vaccine my heart began palpatating and I began sweating profusely. My vitals were checked, I was given water and moved to a cooler area of the facility. HR was still elevated but I wasnt feeling as flushed. By 4pm that evening I began having having chills and a fever of 100-100.4 which lasted about 4hrs. Later that evening my HR COVID19 VACCINE JANSSEN 0 days 1110436-1 elevated to 125 with the feeling of feeling I was having a heart attack. By that Wed. my HR was still at 125 in motion and about 75 still so I went to visit my PCP on Thurs and when I arrived the HR was 77 but during the visit it elevated to 125 and blood work was done resulting in my tyroid level elevated and since getting the vaccine my HR had been up and down. When in motion its elevated and when sitting its around 75. Fatigue and fever of 99.9. Major side effect was muscle aches in lower to mid back to the point that I was doubled over COVID19 VACCINE JANSSEN 0 days 1110466-1 and could not straighten up for several days. Legs were like jelly as well. COVID19 VACCINE JANSSEN 0 days 1110470-1 chills, pain at injection site, muscle aches, headache COVID19 VACCINE JANSSEN 0 days 1110499-1 I've had 2 nosebleeds within 24 hours of receiving the vaccine. I am 66 and have not had a nosebleed since I was 13. Fatigue, fever, chills, headache and arm soreness beginning the same day as the vaccination date through to end of the COVID19 VACCINE JANSSEN 0 days 1110536-1 following day At 2PM, I began to feel a little nauseated and extremely tired. I lied down and began to get the chills. By 5pm my temperature was at 99 degrees F and by 7pm, my temperature was 100 degrees F. My muscles on my back, neck and COVID19 VACCINE JANSSEN 0 days 1110554-1 legs were painful. I had no problems drinking liquids. I refrained from Tylenol until about 7pm, I had 1000mg. I slept for 8 hours and woke up with no fever but the muscle aches have reduced by about 50%. 03/12 flu like symptoms, fever (99.3), headache, vomiting, diarrhea She stated her symptoms are getting better, I COVID19 VACCINE JANSSEN 0 days 1110568-1 recommended she follow up with her doctor just to get a check up to make sure everything is ok has stuffy nose, without sinus congestion and no post nasal drip symptoms associated with : severe fatigue, loss of appetite ( drinking good, eating fair) , severe headache upper posterior headache , severe nausea with out vomiting, COVID19 VACCINE JANSSEN 0 days 1110570-1 mild generalize muscle pain with weakness or joint stiffness 1. mild dizziness with out passing out, worst with movement, use walker I received the vaccine at approximately 4:35 PM. I got a headache around 9:30 PM and took Tylenol at that time. I started getting very cold and shaking around 10:00 PM. My finger nails and lips started getting pale and my temperature started rising. The shaking stopped around 12:15 AM, but my fever continued as high as 101.4 throughout COVID19 VACCINE JANSSEN 0 days 1110573-1 the night and into the morning. I continued taking Tylenol and the fever went away the morning of 3/12/21, but slight chills returned around noon that did not last long. I took more Tylenol that evening for a headache and noticed I had an on and off throbbing pain in my right ear. pt. complains of headache on her right side of the head and seems anxious. pt. out of her car waiting her dogs states COVID19 VACCINE JANSSEN 0 days 1110593-1 that she feels better. H/R 102 COVID19 VACCINE JANSSEN 0 days 1110607-1 Pounding headache, fever, chills, sweats, joint pain, shortness of breath. Immediately after being vaccinated, patient's face and eyes began to swell and became red. Patient denied itching or shortness of breath, itchy throat. Patient given 50mg benadryl at 1900. Patient then complained her throat was itchy COVID19 VACCINE JANSSEN 0 days 1110624-1 and her voice was becoming hoarse. She continued to deny shortness of breath. EMS was called at 1908. EMS arrived at 1920, evaluated patient. Patient found to be stable and was given option to go to the hospital via EMS or go home. Patient decided to go home with her friends.

Monday around 1230pm pain at injection site, Monday night 10pm intense fatigue, Tuesday all day Fatigue, COVID19 VACCINE JANSSEN 0 days 1110625-1 tiredness,body chills, Wednesday 2pm flu like sypmtoms(runny nose, sneezing, mild sore throat) Wednesday 10pm Fatigue, tiredness. Took 2 Aleve 220mg every 12hrs. Thursday no more pain in arm, no more fatigue, mild runny nose. COVID19 VACCINE JANSSEN 0 days 1110635-1 faint rash upper body, between fingers. Increased heartrate. Itching. Female patient waiting in observation area for 15 minutes requested a bottle of water, notes that her throat feels tight and she is not sure of it is from nerves, observed for several minutes and vitals taken within normal limits. Patient continues to complain of throat tightness, lead clinician notified. Decision to administer epi/ Benadryl as per protocol. COVID19 VACCINE JANSSEN 0 days 1110639-1 patient in no active distress, skin warm, dry, respirations without effort, color full. Epinephrine/ Benadryl administered to right deltoid. Vital sign continued to be stable, Emergency Medical Services activated, patient complain of heart pounding, lightheadedness, and shakiness post treatment, but throat and tightness has resolved. vital sign continued to be stable, ems arrived, report and endorsed to crew at 1:58 pm. Patient ambulatory, alert, skin warm, dry when transferred to emergency medical service. Fever 101, chills, nausea, vomiting, dizziness first 24 hours. After 24 hours, ongoing severe nausea and dizziness. Missed COVID19 VACCINE JANSSEN 0 days 1110645-1 four days of work so far and was told symptoms may last up to 8 weeks by doctor. COVID19 VACCINE JANSSEN 0 days 1110689-1 Chills, fever, tired, muscle and body pain Spoke with client onsite. Immediately upon injection, client had swelling occur right at the injection site--her arm swelled up noticeably, about the size of a golf ball. The site was sore, the client describing it as ""it feels like there is a lot of COVID19 VACCINE JANSSEN 0 days 1110704-1 pressure where the vaccine went in"". No other symptoms occurred. After 30 minutes of observation there was some faint bruising at the bottom of the swelling."" 3 hours after vaccine- felt flushed and slight aches/chills By 6 hours after vaccine had body chills/aches and fatigue By 10 hours after vaccine I had a fever of 101c severe chills and aches and a headache. This all last for about 6-8 hours. At that COVID19 VACCINE JANSSEN 0 days 1110715-1 point I took ibuprofen to help with the severe symptoms and it helped a lot and I was able to get relief. 24 hours after vaccine I felt fatigue and a slight headache. The fever and aches/chills were gone. I received the vaccine at 9:45am. Most part of the day I didn't feel any side effects. Around 6pm, I started to feel chills on COVID19 VACCINE JANSSEN 0 days 1110733-1 my body and a headache. The chills started to get worst and around 11pm a fever started that lasted almost all night long. Also I spent the night with a lot of pain in my body and strong headache. Patient reports that as soon as he received he experienced tingling through out the his body - to the tip of his toes; experienced light headedness and slight nausea. Shortly after experienced tightness of throat, though denies having difficulty breathing. Patient described as, ""having a knot in my throat."" Denies experiencing hives, nor itching, no nasal COVID19 VACCINE JANSSEN 0 days 1110896-1 drainage, no cough. States he waited 50 minutes post receipt of vaccine to ensure he could drive. Reports on 03/17/2021 he again experienced tightness of throat; denies difficulty breathing; states it felt like, ""my throat was swollen."" Again patient denies having difficulty breathing, no hives, itching, no cough. Advised should he experience difficulty breathing to please call 911 since that could be a life threatening emergency; or nearest ER. Denies tightness of throat today, no shortness of breath, nor difficulty breathing."" Within 2 hours my wrist & joints in my right hand have become inflamed & very painful. I have MCTD but I also have carpal tunnel in both arms. I had a steroid shot in my Right wrist on 2/12/21 from Dr, which is over a month ago. The COVID19 VACCINE JANSSEN 0 days 1110897-1 only place I that I am having a very significant reaction is in my right wrist & hand ... so I am not sure why I am having an issue but it is significant & happened very quickly as all was fine before I got the shot. COVID19 VACCINE JANSSEN 0 days 1110901-1 After vaccine later I felt very dizzy and exhausted, a bad headache, I fell asleep in the kitchen standing up. I laid down. Since yesterday, March 17, 2021, after receiving the covid 19 vaccine (Janssen and Johnson vaccine) my left arm was sore COVID19 VACCINE JANSSEN 0 days 1110904-1 from the shot. Last night I developed a severe headache. I felt feverish. All bones seem to be aching. I can hardly move like my normal movement without aches. I felt dizzy and felt tired. - Pain in injection site on left arm - redness, swelling (knot), warm to touch (still continuing, worsening) - Mild nausea for COVID19 VACCINE JANSSEN 0 days 1110946-1 over 36 hours (still continuing) - Headache for less than 36 hours - Minor body aches for less than 36 hours - Slight chills on second day 3/8/21: Immediate dizziness lasting all day. Headache, fatigue/lethargy all day. Intermittent chest pain/tightness, throat tightness, gas, fever, chills. 3/9/21: Gas, loose bowls, tired, but otherwise pretty good. 3/10/21: Still tired and mildly dizzy all day. In afternoon, chest pain/pressure with any exertion, even climbing the stairs in my home, Chest discomfort COVID19 VACCINE JANSSEN 0 days 1110950-1 stopped when I stopped the activity. 3/11/21: Chest discomfort, mild dizziness and tiredness continued this day. 3/12/21: Chest pain gone. Sore throat started in evening. 3/13/21: Sore throat all day. Runny nose for about 10 minutes. 3/14/21: mild tiredness in afternoon. COVID19 VACCINE JANSSEN 0 days 1110953-1 30 minutes after shot, experienced sudden dizziness, nausea, and felt like it was hard to breathe. At 15:00 Patient received Janssen vaccines, Lot 1805018 Exp 05/25/2021 At 5:15 Patient started experiencing tingling around the nose. VS: 74 HR , BP 137/101, O2 97 % Room air. Observed patient an additional 15 minutes. Offered patient COVID19 VACCINE JANSSEN 0 days 1110963-1 a bottle of water. 15:35 VS: 62 HR, BP 135/93 Left arm. 98 O2, sat room air. Patient states he feels better and the tingling is gone. Anaphalatic Shock - Rash / Hives / redness / heat / inability to communicate / swelling of the throat. Epi pen , COVID19 VACCINE JANSSEN 0 days 1110966-1 Epinephrane in Ambulance, Steroids and Benedryl, overnight stay COVID19 VACCINE JANSSEN 0 days 1110982-1 Reports bilateral ringing in the ears. Seen and cleared by EMS 07:40 patient reported to mother that he was ""lightheaded and dim vision"" then mother witnessed syncope. Nurse assessed patient LOC but breathing was recorded at approximately 1 minute with pallor, cool, and clammy skin. ED was notified of patient transport. Vitals were obtained BP - unobtainable, HR - 44 faint and thready, Resp -10. Patient regained consciousness and informed nurse that he had ""white coat syndrome and history of fainting with blood drawn and doctor visits"" he apologized for not notifying nurse prior to vaccination. 07:43 patient has second witnessed COVID19 VACCINE JANSSEN 0 days 1111000-1 syncopal episode after reporting ""dim vision"", patient was lowered to floor with assistance from 3 nurses and bystanders. Vitals obtained - BP - 117/76, HR - 46 Resp - 12. LOC lasted 30 seconds, patient was pallor, skin was cool and clammy. Patient regained consciousness and was alert and oriented x 3. 07:48 patient was assisted to sitting position and then assisted to W/C and escorted to the ED with a nurse, CNA and family for examination and further treatment. Upon leaving patient had pink color, skin was warm, but diaphoretic. Pt entered ED at 07:55 VS BP - 141/83 MAP - 102 HR - 66 RR- 20 SPO2- 96% Temp - 97.9. Pt was observed in ED for an hour and was provided food and liquids after report of not eating or drinking since previous night."" COVID19 VACCINE JANSSEN 0 days 1111002-1 lost taste and smell, body aches, headaches, nauseous, throat hurts, diarrhea Patient presented to the pharmacy to report adverse reaction, but had a slurred speech/ difficulty to speak, tingling COVID19 VACCINE JANSSEN 0 days 1111627-1 fingers, numbness in feet, muscle weakness, nausea Extreme shaking and chills to the point of needing assistance to walk, nausea, migraine and headache, low grade fever, COVID19 VACCINE JANSSEN 0 days 1112129-1 numbness in fingertips, extreme muscle pain (body), sleeplessness, fatigue Repeated vomiting over a five or six-hour period, dizziness, aches, feeling unwell. The vomiting stopped by 7:00 AM COVID19 VACCINE JANSSEN 0 days 1112741-1 Saturday, 19 Mar. 2021, but I felt quite sick for a few days. I don't yet feel my normal self. Approximately 7 hours after vaccination, my neck began to ache. Shortly thereafter, I began feeling cold and having chills. This progressed to rigors and fevers (highest temperature measured 102.9 F), which continued through the night. COVID19 VACCINE JANSSEN 0 days 1112752-1 The following day I felt weak. Within 48 hours, the worst of it was over, although I did have mild pain at the injection site for 2-3 days. Approximately 4:30 pm I started feeling leg/calf pain. I was driving at the time. Got home about 6:30pm, got out of the car and felt immediately sore all over. I took our trash can to the street and started feeling very cold and intense body cramps and shaking, also feverish, hot flash. It felt difficult to walk. I went immediately to lay down. Now I felt very COVID19 VACCINE JANSSEN 0 days 1113632-1 cold. I slept on/off until 10pm. Woke a few times with intense leg/hip pain, Woke up around 10pm, vitals 115/77 107 temp 101.5 Took a long hot shower, feel better, but still feel some hip and leg pain, slight fever. I took one Acetaminophen 325mg. COVID19 VACCINE JANSSEN 0 days 1113634-1 Horrible stomach pain first night, extreme nausea going on 4th day . COVID19 VACCINE JANSSEN 0 days 1113692-1 racing heart beat, fever, nausia COVID19 VACCINE JANSSEN 0 days 1113693-1 By 8:30pm, low grade fever, lower back pain, chills, couldn't get hands warm, very tired, heavy legs. No sore arm. The patient presented to the ER after having the vaccine several hours earlier in the day complaining of chills, shortness COVID19 VACCINE JANSSEN 0 days 1113707-1 of breath, chest tightness, abnormal jaw movements and twitching of his eyelids with uncontrollable movements of his eyes as well. Nausea , fatigue, weakness, headache , back and Neck pain, pressure behind eyes, headache, fever, intermittent hot then COVID19 VACCINE JANSSEN 0 days 1113722-1 chills, rapid heart rate 110s, and shortness of breath at rest & w/ exertion. Vaccine @ 9:00am 3/13 ?> symptoms progressing at 4:00pm and lasting until next day 3/14 3:00pm 30 minutes after leaving the site, got a mild reaction where my face got tingly and red but then it subsided but then 4 hours after receiving the vaccine I began getting a low grade fever (100.6) by 5pm that same day, I began having flu like COVID19 VACCINE JANSSEN 0 days 1113723-1 symptoms, body aches, headaches, fatigued, chills, sweating and fever had risen to 101.7. Took ibuprofen to help with the symptoms but fever kept rising. By 8pm., fever was at 102.9, headache worsen, sweats throughout the night and felt dizzy. Next morning 3/18, fever was low grade by 7am (100.4) by 9AM, fever was gone, felt tired, with mild body aches and moderate headache and felt exhausted the rest of the day. Symptoms are getting better with rest. COVID19 VACCINE JANSSEN 0 days 1114073-1 Headache, myalgia, dizzness There was no adverse event, the syringe came from manuf already pulled back to 0.5m. so when filling multiple syringes for a vaccine clinic this one was mistakenly not filled with vaccine and the first dose given to her was only 0.5 ml of air. COVID19 VACCINE JANSSEN 0 days 1114420-1 She was no injured, did not complain of pain and was observed for 15 to 20 minutes after. She was also given the correct dose of Janssen 0.5ml. COVID19 VACCINE JANSSEN 0 days 1114468-1 Flu like symptoms, fever, body aches, migraine, diarrhea. COVID19 VACCINE JANSSEN 0 days 1114478-1 Shakes, chills, body aches , muscle cramps in thighs and hips. Headache, Vomiting , fever The night of the vaccination, I had chills that lead to uncontrollable shivering. Eventually, that turned into full-body COVID19 VACCINE JANSSEN 0 days 1114506-1 aches, a headache, and severe dizziness. The following day I still had the body-aches and I was exhausted, sleeping most of the day. The day after that, I felt fine. Fever and chills, headache, fatigue, slight nausea. Symptoms (except for nausea) were significant and lasted COVID19 VACCINE JANSSEN 0 days 1114531-1 approximately 36 hours. Joint pain 3-11-2021 9:00pm - 3-13-2021 10:00pm Fever 3-12-2021 6:00pm - 9:00pm (Ibuprofen resolved the issue) Feeling COVID19 VACCINE JANSSEN 0 days 1114551-1 hot but no fever 3-12-2021 12:00am - 3-13-2021 10:00pm Fatigue 3-12-2021 8:00am - 3-13-2021 10:00pm Injection site pain 3-11-201 7:00pm - 3-17-2021 10:00pm Patient should have received the second dose of Moderna vaccine instead of the Janssen. Medical records indicated on COVID19 VACCINE JANSSEN 0 days 1114728-1 the first page that the patient should receive Janssen. Patient was monitored for 15 minutes with no ADR. Swelling under the skin at injection site; noticed approximately 30 minutes after injection; swelling persists today (03.19.21). Pain at injection site but only discernable when I lean against that arm, or lie on that side (03.15.21 through COVID19 VACCINE JANSSEN 0 days 1114743-1 today, 03.19.21). Awoke after midnight, 03.16.21 with severe headache; it persisted for about 36 hours. Slight nausea the next day (03.16.21). Slightly elevated temperature two days later (03.17.21). Pt reported to me on 3/18/2021 that a few hours after receiving her Janssen dose she started to have a heart rate of 122 bpm at rest and 144 with exertion that lasted for 2.5 days. (Day 0, 1 and 2). She reported she had severe muscle COVID19 VACCINE JANSSEN 0 days 1114755-1 aches and difficulty breathing. She did not seek medical care and her symptoms were resolved when she called me on March 18th. I instructed her to get medical care if her symptoms began again. Patient should have received the second dose of Moderna vaccine instead of the Janssen. Medical records indicated on COVID19 VACCINE JANSSEN 0 days 1114778-1 the first page that the patient should receive Janssen. Patient was monitored for 15 minutes with no ADR. COVID19 VACCINE JANSSEN 0 days 1114818-1 Aches, Fever 103, and Headache for 6 hours Nausea (next day) Headache and neck stiffness within 15 minutes of vaccine and lasted for a couple days. The days after vaccine I had extreme tiredness and felt like I had a bad cold with a lot of coughing and shortness of breath. I was coughing up a lot of mucus. The cold like symptoms are still ongoing, 2 weeks after the vaccine, but are less extreme. 8 days after the COVID19 VACCINE JANSSEN 0 days 1114826-1 vaccine I started to have pain at the injection site. My upper hurt if I touched it. Twelve days after the vaccine my upper arm hurts if I raise my arm and if I shake my inhalers to use them. This seems like a muscle pain from the injection site to my shoulder. started with drowsiness and no appetite, chills came on but nothing serious but within 1 hour the chills became very intense and I couldnt warm up or take it. I had sweatpants, two sweatshirts, slippers and 2 blankets on to help. Later on I had fallen asleep to wake my husband to uncontrollable laughter and crying, mentally I knew what I was doing was not COVID19 VACCINE JANSSEN 0 days 1115048-1 right but I couldn't control it. I believe my feve may had spiked so high that it was border line hysteria. By morning I woke and the fever had broke however I still had no appetite, terrible headache along with weakness and fatigue....I also tried food but ended up spitting it out because everything tasted strongly of metal. Sunday I was back to tasting to food and more energy. Fever, chills, headache, muscle and joint pain, fatigue, loss of appetite within 7hours after vaccination. Fever overnight. COVID19 VACCINE JANSSEN 0 days 1115061-1 Felt little better in the morning. Experiencing Severe headache. Given Tylenol 6hrs apart. Ibuprofen in the am for headache. "About 1 hour after administration she developed intense itching to her face and scalp, face and neck flushed. Given ice COVID19 VACCINE JANSSEN 0 days 1115071-1 packs, vital signs all normal. Seen by PCP and was given Benadryl and a Prednisone blast."""" VASOVAGAL SYNCOPE- PATIENT FELT FAINT, AND LIGHT HEADED BUT DID NOT PASS OUT. PATIENT FELT WARM COVID19 VACCINE JANSSEN 0 days 1115113-1 FOLLOWED BY A PERIOD OF COLD CHILLS. PATIENT STATED WAS SIMILAR TO A PREVIOUS EPISODE AND IDENTIFIED A VASAVAGAL REACTION IN THE PAST. Swelling in the eye on the bottom, and a little on the face, itchy, red, and is claiming to have tachycardia These COVID19 VACCINE JANSSEN 0 days 1115121-1 symptoms are likely not due to COVID vaccine. Check with cardiologist for tachycardia and make sure eye drops have not expired or have not been contaminated. If symptoms worsen seek medical help. Janssen COVID-19 Vaccine EAU. Side effects in order of occurrence: sudden onset of severe headache, chills, COVID19 VACCINE JANSSEN 0 days 1115127-1 uncontrollable shaking, nausea, muscle aches. Following day - low grade fever, dull headache, fatigue, lethargy. 36 hours following injection feel back to normal. Fatigue, aches, nausea, cotton mouth, headache, wheezing, loosing voice, and arms and legs feel heavy. Called doctor COVID19 VACCINE JANSSEN 0 days 1115147-1 the next day (the 16th) for medical advise, was told to drink coffee and take tylenol due to aspirin allergy. Approximately 10 hours after the injection (about 2 weeks prior to this ER visit) the patient started experience COVID19 VACCINE JANSSEN 0 days 1115152-1 paresthesias of the right arm and face. Evaluation in the ER on today's date did not show objective findings of the paresthesias, nor identified cause, including evaluation for stroke. Initial headache and nausea and headache, slight fever. Felt generally lousy. Over weekend and continuing the COVID19 VACCINE JANSSEN 0 days 1115161-1 headache has gotten worse and my fever has spiked to over 102.5 "About 2 hours after administration she had nausea and vomited x1. She reported having dizziness during the evening COVID19 VACCINE JANSSEN 0 days 1115200-1 and is 100% improved this morning."""" COVID19 VACCINE JANSSEN 0 days 1115210-1 "Called out this shift due to chills and body aches most likely associated with the vaccine. """" Started with a headache, nausea, a fever 106.4, extreme fatigue, very tired, no appetite, I am trying to keep fluids COVID19 VACCINE JANSSEN 0 days 1115221-1 down. Swelling and soreness at the injection site. all muscles are stiff and sore especially my neck.

Starting at 4pm muscle ache starting in my lower back and hips, by 7pm full body muscle and joint aches 7-8 on the pain COVID19 VACCINE JANSSEN 0 days 1115229-1 scale. I felt like I had a high temperature but each check I was never higher than 98 degrees accompanied by chills. No headache at anytime. 3 Tylenol tabs taken every 6 hours but it gave minimal relief from the muscle/joint pain Received vaccine at 3:40pm. Tiredness started around 7pm. Fever started at 11pm and lasted until morning. Terrible COVID19 VACCINE JANSSEN 0 days 1115385-1 body aches, unable to sleep. Painful. Fever broke around 5am but then returned around 1pm. Finally broke fever around 4pm. Body aches lasted the rest of the day. Overall weakness and tiredness for a week. Janssen COVID-19 vaccine EUA Vaccine administered 9:20am 3/18. By 4:30 pm same day onset of chills, followed by fever of 102.6 measured at 7:00pm. Took Tylenol, fever unchanged an hour later. Also experienced joint aches. Symptoms COVID19 VACCINE JANSSEN 0 days 1115386-1 started to subside around 12 midnight that night. Fever completely gone and had no other symptoms by 7am next morning 3/19. Chills, high fever (102) first and second nights. Tylenol helped. Fever broke around 2 am second night. Starting Mar 18, COVID19 VACCINE JANSSEN 0 days 1115388-1 muscle aches in back. starting at 11:00 PM day of vaccine, I started to feel nauseous, chills, aches all over, extreme exhaustion / tired, and headache. The symptoms worsened through the night, unable to sleep. Sometimes the chills would turn to fever and COVID19 VACCINE JANSSEN 0 days 1115405-1 extreme sweating and burning hot sensations. The symptoms were the worst on Thursday and lessened slightly with each passing day. The illness stayed until Sunday morning. Fever, chills, whole body aches, nausea onset 6 hours after injection. Fever reached 102 degrees overnight, came down COVID19 VACCINE JANSSEN 0 days 1115465-1 to 100 by next morning at 9am. Body aches and nausea continue so far, 18h after injection (time of reporting is 18h post injection) COVID19 VACCINE JANSSEN 0 days 1115488-1 Shakes, chills, elevated temperature - lasted 24 hours, forehead pressure, temple pain - lasted 48 hours 6 hours after my shot I had a high fever, and for the next 24 hours I had a fever on and off, muscle aches, no appetite, COVID19 VACCINE JANSSEN 0 days 1115513-1 moderate to severe pain at injection site with redness and swelling, and fatigue. I took generic Tylenol around 6:30 the day after my shot which improved my condition Headache, body ache, chills. Lasted from 7pm on Friday, 3-12 to 10am on Saturday, 3-13. Symptoms faded away after I COVID19 VACCINE JANSSEN 0 days 1115514-1 took a 500mg Tylenol at 9am on Saturday, 3-13. This is the first time I have ever had an adverse reaction to a shot. I also do not get headaches, like ever, and haven't had body ache or chills since I had the flu in 2009. 1 minute after administration of vaccine patient experienced warm ness and lightheaded and a little dizzy. She was COVID19 VACCINE JANSSEN 0 days 1115622-1 extremely anxious about receiving the shot prior to. I asked her to breath and relax and I fanned her. After about 10 minutes she felt better

26 minutes after receiving the vaccination, the patient developed over her left forearm, right shoulder, posterior neck, and left scalp. Upon evaluation, she had no hives or rashes. Lungs were clear on auscultation bilaterally. No shortness of COVID19 VACCINE JANSSEN 0 days 1115632-1 breath, nausea, respiratory distress, anaphylaxis. She was given Allegra 60 mg PO times one. Her blood pressure, taking by machine, was 205/117. No dizziness, chest pain, headaches, or vision changes. Subsequent manual recheck of her blood pressure were in the 160s to 180/ 100s, and after possibly 30 minutes of monitoring with serial your blood pressure checks, her blood pressure was 172/94 manually. Her itching resolved, and she developed no other symptoms. DURING THE 15 MINUTE OBSERVATION PERIOD, ABOUT 5 TO 10 MINUTES POST VACCINE THE PT FAINTED WHILE SITTING IN HER CHAIR AND FELL OUT OF THE CHAIR. I INSTRUCTED A TECH TO 911 WHILE RAN TO THE PT. AS I TOUCHED HER TO FEEL FOR A PULSE SHE REGAINED CONSCIOUSNESS. I EXPLAINED WHAT HAPPENED AND ASKED HER TO STAY COVID19 VACCINE JANSSEN 0 days 1115660-1 WHERE SHE WAS AT UNTIL PARAMEDICS CAME. SHE WAS ALERT AND ABLE TO ANSWER QUESTIONS. THE PARAMEDICS ARRIVED ABOUT 5 MINUTES LATER. THEY GOT HER UP AND SHE HAD A SEIZURE. THE TOOK HER TO AND UNKNOW HOSPITAL COVID19 VACCINE JANSSEN 0 days 1115675-1 Chills, fever, headache, nauseau COVID19 VACCINE JANSSEN 0 days 1115695-1 Chills, body aches, fatigue, headache, diarrhea Pain, swelling, redness at injection sited About 10 minutes after shot patient vomited and felt dizzy Dizziness lasted about half hour Gave patient chips and donut and water Patient admits to eating a very small bowl of cereal and taking metformin previous night at 7pm Also admits to not taking high blood pressure the e medication this day Patient blood glucose was 202 right before eating chips COVID19 VACCINE JANSSEN 0 days 1115705-1 Patient felt much better after about 40 minutes late Was sent home in a car service and confirmed her got home Also we stated if situation worsens to seek medical attention ASAP hr representative called his emergency contact and informed this person of incident and told to monitor patient COVID19 VACCINE JANSSEN 0 days 1115708-1 Severe Chills and shaking Fever maxed out at 99.5 Muscle Aces Severe Headaches Nausea COVID19 VACCINE JANSSEN 0 days 1115716-1 Diarrhea, loose stools a few times a day w/o bloody/melenic stools. Nausea w/o vomiting. Urticarial rash. After vaccinated, arm site felt like it was punched hard & took Tylenol 1 hr later. Felt better later to run errands. My left leg felt achy as I was walking my dog @1pm. Then around 9:20pm, I felt chills & started getting charly horse a few COVID19 VACCINE JANSSEN 0 days 1115736-1 times on my rt calf & felt tired, so I took 500mg ibuprofen & put a portable heater in front & bundled up & fell asleep at 10:30pm. Woke up at 9am, arm site still achy & feel tired. Pain at injection site then by late afternoon/ early evening my entire left arm was achy and I was tired. By morning my neck and shoulders were achy as well as my left arm and I was still a little fatigued. By the next day my only symptom COVID19 VACCINE JANSSEN 0 days 1115764-1 was soreness in my upper arm and especially at the injection site. 5 days after the injection I still have soreness at the injection site. I took a few doses of tylenol and rested. My job has forced a 10 day isolation on me because they said fatigue and achy muscles are signs of COVID-19. So I am getting plenty of rest. The night after receiving the vaccine: Chills, body aches, nausea The day after receiving the vaccine: Chills, body aches, COVID19 VACCINE JANSSEN 0 days 1115780-1 nausea The second and third day after receiving the vaccine: headaches muscle aches, chills, and high fever. Ran a fever of about 103 for about 24 hours. Rested and drank a lot of fluids and was COVID19 VACCINE JANSSEN 0 days 1115784-1 fine about a day and a half after the injection Blotchy arms and itchy legs within 10 minutes, no breathing issues. At night severe chills (legs, arms, seizure like chills), severe body aches and exhaustion. During the night fever of 100.2. Took Tylenol every 4-6 hours after that, it helped. COVID19 VACCINE JANSSEN 0 days 1115785-1 No appetite and stayed in bed the next day. Day 2 (today) fever has subsided, feeling exhaustion and slight back and neck pain. Taking tylenol still, feeling more alert. Still cannot go out of house or drive.

Within 7 hours I was violently shaking with chills. I was shaking so bad my body was in pain. This lasted about 6 hours. COVID19 VACCINE JANSSEN 0 days 1115793-1 The highest fever I ever recorded was 100.6 but it felt much higher. I had nausea, body aches, headache, and exhaustion for a full 24 hours. Within 48 hours, my chills and aches were mostly gone, but a sore throat, cough, and congestion developed. As of this morning, Friday 19 March, I?m still exhausted, but all other symptoms have finally resided. Immediately broke out in a sweat and was very hot. Didn't think much about it. The staff noticed I was in some distress and kept asking if I was okay to which I replied I thought I'd be fine once I got some fresh air. Left the facility to drive home and didn't feel right, Within 30 minutes, developed chest pains, rash and labored breathing. I recognize the COVID19 VACCINE JANSSEN 0 days 1115812-1 symptoms as the same symptoms I get when I've had morphine, which I now must list as an allergy. This lasted 4 hours, then got better. The next day around 1:00, I became ill again with flu-like symptoms and had to leave work. Headache and body aches mostly. I was ill with these symptoms for a 24 hour period. Hopefully all symptoms have passed, except my arm which is red, swollen, itchy and feverish. Symptoms began little after ten hours of receiving vaccine. Symptoms included flu like symptoms of aches , joint pain and fatigue with fever up to 101 lasting 3 1/2 days. Fever broke SUnday night 14th, approx 9:00pm. Awoke Monday the 15th light headed and fatigued but aches and fever gone. Then approximately 5 pm on Monday the 15th started having COVID19 VACCINE JANSSEN 0 days 1115816-1 chest pain, upper right side. By midnight I was being transferred to ER for the chest pains. Released Monday morning the 16th from ER Dx. Possible chest wall inflammation; Followed up with primary care office (not my regular Dr. but with Dr. Have been experiencing internal jittering; agitated cough, upper respiratory issues (but lungs are clear.) ever since I originally had Covid. Chills began around 9:30 pm lasted about 5 hours Headache worsened around 10pm, lasted about 12 hours Nausea began COVID19 VACCINE JANSSEN 0 days 1115820-1 around 1 am, lasted about 2 hours Aches began around 10 pm, lasted about 12 hours

pt stated that after she took the covid vax her arm was red and hurting very badly. Later she felt nauseas, had muscle COVID19 VACCINE JANSSEN 0 days 1115843-1 pain and headache. Temp was 100.4. She took 2 Tylenol and felt some better. By 3/17/2021 she began having more muscle pain in her arms and legs and her arm is still very sore. Pt states she will call her PCP for medical advice. COVID19 VACCINE JANSSEN 0 days 1115873-1 Pt had 1 dose of Moderna @ hospital. Rec'd Moderna 3/5/21. Rec'd J&J 3/16/21 Immediately tasted a metallic taste in my mouth. Within 12 hours experienced body pains (not aches...true pain) just like I had with Covid at Christmas. We are now almost a week later and the body pains have only gotten worse. Tylenol COVID19 VACCINE JANSSEN 0 days 1115890-1 and Motrin have not helped. I don?t have a primary care doctor or insurance so I can?t follow up with a doctor, but I feel terrible. COVID19 VACCINE JANSSEN 0 days 1115897-1 Pt under age at the time of vaccination Patient presented to clinic for Covid-19 vaccine. Patient started complaining of chest pain 5 minutes after vaccination. Patient denied shortness of breath, but states the pain worsened with deep breathing. Patient denies other complaints or symptoms. Vital signs stable and work of breathing normal. RN auscultated lung sounds, upper lobes clear bilaterally. COVID19 VACCINE JANSSEN 0 days 1115904-1 Blood sugar 227. Patient states she has diabetes and hypertension. Patient kept closing her eyes, RN encouraged patient to keep her eyes open, but patient kept stating, ""I'm tired."" RN notified provider, provider in to assess patient. Per provider, patient to go to ED via EMS. Patient's husband notified and arrived to clinic to be with patient. RN contacted EMS and report given."" rapid heart rate and tingling/numb face; low grade fever; extreme fatigue; arm that received injection increasingly COVID19 VACCINE JANSSEN 0 days 1115923-1 tender upon touch began ~15 minutes after injection; all but tingling has continued through today (3/19) at one week; fever and arm pain improving but rapid heart rate upon any exertion and painful arm continuing about 6 hours after injection, i started getting chills and extreme fatigue. this lasted throughout the night with mild COVID19 VACCINE JANSSEN 0 days 1115936-1 fever peaking at 100.8 F. muscle aches, fatigue, and persistent dizziness continued the following day. most symptoms resolved by the 36hr point. About 6 hours after receiving the shot I started experiencing skin sensitivity (common when I feel ill), chills, aches in my legs and a slight headache. The chills subsided after about 2 hours, but then my resting heart rate went up to 110-120 COVID19 VACCINE JANSSEN 0 days 1115945-1 bpm rather than the normal 75-85 for me. It felt like my heart was beating out of my chest even though I was laying down in bed. That lasted through the night and I felt back to normal around mid-morning. Patient experienced brief fainting, and recovered quickly after 30 seconds. Then patient experienced nausea for around COVID19 VACCINE JANSSEN 0 days 1115948-1 10 minutes. Had patient remain in chair and provided supportive care and encouragement. After shot, pain/soreness at injection site lasting up to 1 week after shot. Same night around 11:00pm vaccine symptoms include: fever/chills, headache, diarrhea lasting up to 10hrs. Reduced with aspirin. 9-13 days later increase in nightly symptoms including: Headache, stomach pains (upper stomach) Rashes/hive like bumps itching on body spreading to COVID19 VACCINE JANSSEN 0 days 1115949-1 different parts each night ( 3-17-21, rash/swelling on both feet including white bumps that mostly went away with Benadryl (Diphenhydramine) and aspirin), ( 3-18-21, Rash spread to throat and face over night, numbness in upper lip mostly went away with Benadryl (Diphenhydramine) and aspirin), (3-18-21 rash moved to lower back left side, itchiness and sore throat. About ten hours after my vaccine, I experienced chills, shakiness, sweats but no fever. I felt really tired and my body felt COVID19 VACCINE JANSSEN 0 days 1115964-1 achy as well. I took OTC Tylenol and by the following evening my symptoms went away. I am also currently 39 weeks pregnant. COVID19 VACCINE JANSSEN 0 days 1115968-1 17 year old patient given single dose Janssen COVID-19 vaccination. Underage, but incarcerated as an adult. Metallic taste in mouth - 5 min after injection Ringing ears - 45 min after injection Pain at injection site - immediate after COVID19 VACCINE JANSSEN 0 days 1116040-1 injection Injection site pain, body aches, headache, dizziness, nausea, and tiredness. Injection site pain started immediately after COVID19 VACCINE JANSSEN 0 days 1116072-1 vaccine given and continued until now (approx. 24 hours later) . Body aches, headache, dizziness, nausea, and tiredness started about 8 hours after injection and continued until now (approx. 24 hours later) Shaking and chills 8 hours after shot shortness of breath , painful sensation in lungs. 3/19- lungs still do not feel right. COVID19 VACCINE JANSSEN 0 days 1116076-1 Other symptoms resolved. COVID19 VACCINE JANSSEN 0 days 1116223-1 Fever, chills, nauseous, diarrhea, headache Took Tylenol Lasted 2 1/2 days COVID19 VACCINE JANSSEN 0 days 1116242-1 Fever, chills, sweating, body aches, stiff neck, headache and loss of appetite In the same area as my shingles virus, which is well on its way to healing, I developed a rash about 6 or 7 hours after the vaccine. The rash is small red markings that look like hives and it is unbelievably itchy. I took benadryl which reduced COVID19 VACCINE JANSSEN 0 days 1116282-1 the itching within 4 hours, but did not appear to impact the rash. Today is day 1 after my vaccine, so I am watching the rash to see if and how it progresses over the next 48 hours. Patient was seen in our ER on 3/8. She stated that she had received her Johnson/Johnson COVID Vaccine on Thursday (3/4/21) and since then, had been experiencing body aches, chills, fever, fatigue, headache, n/v/d. She was admitted for treatment with IV fluids and supportive meds for the n/v/d. On 3/9, she was still feeling very ill. Fever and chills had improved but she was still not tolerating PO. BP was also elevated ranging from 142/82 to 206/80. She was also COVID19 VACCINE JANSSEN 0 days 1116322-1 diagnosed with AKI. BUN was 51, Cr 3.26. By 3/11, she was feeling a little better but kidney function continued to deteriorate. BUN was 53, Cr 4.39. The physician decided she should be transferred to a higher level facility for her AKI on CKD. However, there were no beds available. So she remained at our facility awaiting transfer. Around 1900 that night, she experienced a bout of hypotension and decreased urine output. Chest xray was normal. EKG was NSR. She was eventually transferred to another hospital on 3/12 at 1300. I have had Pain and soreness throughout the entire left side of my body.. and very sore left side kidney area pain. the COVID19 VACCINE JANSSEN 0 days 1116346-1 pain runs from the side up through my arm and into my neck COVID19 VACCINE JANSSEN 0 days 1116375-1 Vaccine given to inappropriate age recipient. COVID19 VACCINE JANSSEN 0 days 1116376-1 Vaccine given to incorrect age recipient Patient had a Pfizer vaccination on 2/10/21, then received a Janssen vaccination on 3/11/21. No adverse reactions COVID19 VACCINE JANSSEN 0 days 1116380-1 occurred with the Janssen vaccination. DOSE AT 12:50 PM, ABOUT 5 PM GOT VERY NAUSEAND LAID DOWN IN BED ABOUT 8:00 PM, WITHIN MINUTES BECAME VERY VERY COLD. WAS VIOLENTLY SHAKING FROM CHILLS, THEN VIOLENT SHAKING WITH MUSCLE TENSION FOR COVID19 VACCINE JANSSEN 0 days 1116383-1 SEVERAL SECONDS THEN RELAXED FOR A FEW MINUTES THEN MORE TENSION. ALL OF THIS ALONG WITH THE CHILLS.I DO NOT KNOW HOW LONG THIS HAPPENED BEFORE I FELL ASLEEP. NEXT DAY WAS VERY TIRED, AND ACHED ALL OVER AND WAS WEAK. COVID19 VACCINE JANSSEN 0 days 1116404-1 Vaccine given to age inappropriate recipient. 12:28pm Splotchy red rash on L deltoid ( shot site) and chest traveling up left neck and ear. Patient given Diphenhydramine 25 mg PO. BP:135/84 p:81 Monitored vital signs: 12:35: 125/86 p:83 12:40: 119/83 p:76 12:46: COVID19 VACCINE JANSSEN 0 days 1116479-1 133/91 p: 92 Rash fading 12:50: 125/80 p:92 Rash much more diminished and patient denies any shortness of breath, scratchy throat, itchy ness or other symptoms. Ate a granola bar and them dismissed with instructions to call 911 if scratchy throat or difficulty breathing occur. COVID19 VACCINE JANSSEN 0 days 1116483-1 Hospitalized due to 101 Temp, Weakness and shakiness. 15 mins after receiving the vaccine, I began feeling nauseous. One hour after receiving the vaccine, I began throwing up. I COVID19 VACCINE JANSSEN 0 days 1116507-1 could not keep anything down until 2 PM the next day. I was also extremely tired and slept most of the next day. I was 10 weeks pregnant at the time of receiving the vaccine. Had a terrible headache. I took Tylenol for the headache. 3/17/21 9:45 chills followed by high fever 102.0 took 750mg of Tylenol and about 2:00 am fever subsided. 3/18/21 COVID19 VACCINE JANSSEN 0 days 1116538-1 severe muscle and body aches and severe headache. took Ibuprofen. Later in evening after vaccine administration: fever, chills, headache, nausea/vomting, body aches, exhaustion, facial COVID19 VACCINE JANSSEN 0 days 1116583-1 swelling, rash on face and head. Unaable to sleep all night 0845 Vasovagal with strong retching - no emesis Initial VS: HR 50's O2 sat 85% Subsequent VS: 110/63-HR 60-RR 20- O2 sat - 98% CBG 150 PMHx: HTN, HLD S: patient felt nauseated, dizzy, ""hot all over"", anxious O: Awake but unable to answer due to retching. Pale, diaphoretic, cool to touch. Cards: radial pulse thready - apical pulse in 50's RRR, no murmur. COVID19 VACCINE JANSSEN 0 days 1116585-1 Resp: clear to auscultation. No cough or evidence of aspiration. GI: strong retching but no emesis. A/P: 68 y/o female who just rec'd J&J Covid Vaccine was in monitoring lot and found to be diaphoretic and retching - semi conscious. · Vasovagal response - patient recovered VS within 5 min of start of event. Wanted to go to hospital for evaluation. She was alone in her car. Called her dtr to apprise of situation. Authority parked her car and returned her car keys to her prior to transport to hospital."" 5 hours after vaccine - Headache, muscle soreness, fever, chills, sweating due to fever. Fever lasted about 8-10 hours COVID19 VACCINE JANSSEN 0 days 1116597-1 during sleep. Tylenol was taken every 6 hours after vaccine. Minor Headache and muscle weakness lasted for 2 days post- vaccination. Described flushing on her face, took her own blood sugars = 62, then ate, came up to 300. Described eye swelling. Stayed COVID19 VACCINE JANSSEN 0 days 1116609-1 for full 30 min after vaccine. All symptoms went away and counseled to f/u with PCP or go to ED if urgent symptoms returned. 15-20 minutes after the injection, I started feeling a tightness in back of my throat; I broke out in cold sweat. I started getting dizzy and very whoozy. I felt my vision starting to close in. I thought I was going to pass out. I got the attention of the person across me to get an attendant and they brought me a chair with wheels. Two people got me up (and I'm not a big person) - they were worried I was going down and I was taken to exam room. They said I was white as a sheet. She checked my eyes and throat a few times and checked my blood pressure. It was lower than normal but she didn't seem really concerned about it - 104 over 60 something which is low for me. She gave me water to sip. She gave me very cold compresses to put on my forehead. They watched me pretty good. She had the epi-pen ready. She watched me and I sat in there and nurse came in a quite a few times to check me for about an hour. About an hour later the tightness COVID19 VACCINE JANSSEN 0 days 1116672-1 went away and I started feeling myself again. We went home. I went to sleep. I woke up at night to go to bathroom and I was still a little woozy but I didn't fall. Next day, I just didn't feel well. My left arm was starting to hurt - was no swelling; it was a little red at injection site. It hurt just a little. I was woozy. My eyes couldn't focus as well. I felt out of it. I drank a lot of water and took a nap. Yesterday, I felt pretty decent but still woozy somewhat. I tried to run errands with my husband - just wasn't quite right. Today, much better but I'm not quite myself yet. Just a little wooziness - weird feeling. Yesterday, I did feel a soreness in the back of my right calf muscle. It wasn't warm to the touch or swollen. I don't have it anymore, it went away. It could have been a muscle thing from the first day of the vaccine when I got home and I got up and almost fell down. I do still have some achiness in joints. Especially in my knees - which isn't normal because they are replaced. Pt remained in pharmacy 30 minutes after vaccination and then left. Returned within 5 minutes with left facial (upper/lower lip) swelling. Treated with ice pack and 25 mg of oral diphenhydramine (12.5 mg/5 mL oral solution). COVID19 VACCINE JANSSEN 0 days 1116725-1 Swelling began to go down. Provided patient with famotidine 10 mg tablet to take home and take prn. Stated never had any tingling or trouble breathing. Advised to call us with any changes. severe body and joint pain, 101.1 fever, chills, nausea started approx 5 1/2 hours after injection. Next morning, approx COVID19 VACCINE JANSSEN 0 days 1116726-1 20 hours after injection strong head ache in top of head and nausea. 30 hours after injection, all negative effects subsided. 48 hours after injection, normal function- no effects. Patient stated she felt like she had a lump in her throat. IM Benadryl given. Patient stated after dose of Benadryl that COVID19 VACCINE JANSSEN 0 days 1116735-1 she was feeling better. The pt doesn't like needles. Gave her the shot no problem. She waited 15 minutes then walked out with her boyfriend. She said she felt faint, then passed out. He caught her then put her in the car. Then she passed out again. He called COVID19 VACCINE JANSSEN 0 days 1116772-1 911. The ambulance came and brought them back in the store. She got checked out and refused to go to the hospital. She claimed she was fine and left. About 3 minutes after vaccine, pt began having having tickling in throat similar to prior allergic reactions. she reported usually she'll take benadryl x 1, then x2 after about 15 minutes, at that point she'll know if she's getting worse or not. COVID19 VACCINE JANSSEN 0 days 1116811-1 She took 25mg diphenhydramine po x 1--no worsening of symptoms. mild improvement, took 2nd benadryl and was driven home (about 10 minutes away) with strict precautions. dx mild allergic reaction.

COVID19 VACCINE JANSSEN 0 days 1116829-1 Pt had a syncopal episode following covid-19 vaccine. Pt states he has had similar episodes following needle injections. Pt was closely monitored for 30 min following syncopal event. Pt stated that he felt much better and was discharged home. Clinic nurse administered the Janssen vaccine to a 17 year old female in an offsite clinic. Administration error was not COVID19 VACCINE JANSSEN 0 days 1116840-1 caught until the client left the building after waiting 15 minutes post vaccination. No complications/reactions noted at the time. Facility held offsite vaccine pod on 03/18/2021 and offered Janssen Covid19 vaccine. Pt. had reported past hospitalization due severe allergic reaction to Sulfa drug. She received the Covid vaccine at approximately 11:25 AM and was directed to waiting area where she would be watched for 30 minutes. After 5 minutes, at approximately 11:30 AM, she alerted COVID19 VACCINE JANSSEN 0 days 1116867-1 the waiting area monitor (who was an ER nurse) that she felt her throat was closing up and she was struggling to breathe. 911 was notified. BP was 140/82, P 80. EpiPen 0.3 mg ( Lot # 0FM411 Exp: 01/31/2022) administered left lateral thigh. Transported to local hospital ER. Assessed, treated, and released home Strong chills set in around 2:30 PM. I ended up getting a fever that spiked at 103 and lasted on and off for 12 hours. The COVID19 VACCINE JANSSEN 0 days 1116878-1 following morning the fever and chills were gone. I felt extremely fatigued. Tingling, slight numbness in left arm, hand and face, quite vague, less noticeable in throat muscles. Symptoms remind me of shingles-caused neuralgia which I sometimes experience on left side. Facial tingling, feeling of tightness in muscles, COVID19 VACCINE JANSSEN 0 days 1116887-1 including inner ear are less familiar to me. Symptoms appear to change in degree--slight to more noticeable--as this first day wears on. (Now nearly five hours since vaccine.) I have gone about day as normal, eating and exercising, drinking plenty of water. Per patient she states she was having difficulty swallowing and was feeling dizzy after receiving the Covid vaccine, RN COVID19 VACCINE JANSSEN 0 days 1116902-1 states there was no swelling of the tongue and/or mouth, Vital signs within normal limits at this time. Janssen COVID-19 Vaccine EUA Received on 3/11/21. Symptoms began in the evening. Chills, low grade fever, sever body and head aches, some loosened bowel movements, fatigue. Could not attend work. Continued all through 3/12/21. All COVID19 VACCINE JANSSEN 0 days 1116912-1 had ceased except minor body and head aches along with fatigue by 3/13/21. Fatigue has continued. Significant body aches returned 3/18/21 and are still going today (3/19). Fatigue continues as well. Passed out within 2 minutes of getting the shot. I don't know how long I was out. The EMT's were called, my blood pressure was really low, but as I sat up for a while it got better and I was able to go home. The next day my arm was COVID19 VACCINE JANSSEN 0 days 1116937-1 really sore, I took too ibuprofen twice that day which helped. The next morning I woke up with hives all over my upper body that's itchy. Patient had a allergic reaction to Johnson and Johnson. EMS was called. Patient had numbness on left arm, limited mobility, and redness at site of injection. Vaccine given by nurse. She initially couldn't move her arm after the injection. We called 911 afterwards, and stayed with patient. We gave water/Benadryl and stayed with the patient until they COVID19 VACCINE JANSSEN 0 days 1116958-1 arrived. They checked on her vitals. BP 104/60, pulse 72. No SOB, or tightness in chest, no other areas of redness, and patient had more mobility after given Benadryl. EMS said she was fine to leave, and to follow up with PCP. No history of allergic reaction to vaccine. Patient reported to vaccinator before receiving vaccine that he normally passes out when he gets shots. After receiving shot, patient passed out for about 20 seconds and head fell back. Vaccinator called for assistance. Patient regained consciousness and stated, ""I didn't even know where I was."" Patient noted to be diaphoretic. He also had pulse rate of COVID19 VACCINE JANSSEN 0 days 1116975-1 42 and Bp of 98/48 which he reports as being normal for him as he is a runner. Patient stayed seated, vitals assessed, ice applied for sweating, and juice given. After 15 minutes, patient escorted in wheelchair to monitoring area where he remained in a cot for 20 minutes. Vitals reassessed with Bp 113/73 and pulse 49. Patient reported feeling well and able to ambulate steadily. Patient left at that time"" COVID19 VACCINE JANSSEN 0 days 1116976-1 DIZZINESS, NAUSEA, VOMITING COVID19 VACCINE JANSSEN 0 days 1117012-1 Metal ?tin? taste in mouth

Received vaccine at approximately 12:30 pm on 3/15/21 at 13 weeks pregnant (due date of 9/15/21). Weight and height 5'0"", approximates 136lbs. During injection there was a pain from the needle insert and immediate soreness. I would describe it as more painful than the flu shot that I received in November of 2021. I was then escorted to a chair for a 15 minute observation period. I did not have any allergic reactions to the shot. I continued to feel slight soreness in my left arm for the rest of the day. At approximately 8 pm I began to feel ""aches and pains"" similar to those during a cold and flu. I took (1) regular strength Tylenol Acetaminophen 325 mg tablet. I began to feel a little bit warm around 9-10 pm and checked my temperature with an infrared thermometer and it was slightly elevated by a degree (no exact measurement). I went to bed at approximately 11:30 pm. At approximately 12:45 am I woke up and took my temperature. I first used the infrared thermometer and it came back as 99.4 F. I felt very warm so I then switched to an Oral thermometer for accuracy and began to record the following: 101.1 F - 12:45am (was under blankets so got out of bed to cool off) / 100.0 F - 1:05 am / 100.9 F - 1:20 am At 1:10am I used a cold compress (small ice pack wrapped in a kitchen towel) to cool off and then took a luke-warm shower at 1:15 am (did not wet hair). I also drank a big water bottle of water (Tap Water) probably around 500ml. The room temperature was around 74 F. I re-measured my temp at 1:40 am and it decreased to 99.3 F. I took a 2nd Tylenol tablet (same as above) at 2 am. My temperature at 2:05 am was 100.0 F. I then went in and out of sleep and recorded my temps every time I woke up and went to the bathroom / drank COVID19 VACCINE JANSSEN 0 days 1117025-1 more water. 98.5 F at 3:55 am / 98.4 F at 5:55 am / 99.0 at 7:25 am. At 7:30am I took a 3rd & 4th Tylenol. Temp at 7:55am was 99.4F. I went back to sleep and then woke up at 9am to login remotely for work. Temp at 9:25 am was 98.7. I then took a nap from 9:30 am to 12:00 pm (my boss told me to go to sleep after our call) and slept very soundly. When I woke up I felt a lot better. Aches and pains were no longer present and fever appeared to be gone. The worst of the symptoms were over. I then spot checked my temp a few times throughout the day: 98.0F at 12:15pm / 98.3 F at 1:40pm / 98.7 at 2:05 pm. At 2:15 pm I took a 5th Tylenol just in case. I took my last official temp at 2:20pm at 98.3 F. At about 3pm 3/16 I had a telehealth visit with my OBGYN. She said that my symptoms were normal and everything looked ok. My test results from my 12 week sonogram I had 2 weeks prior were all OK as well. To my knowledge the baby is tracking healthy. Note that during the whole time I did not experience any symptoms related to the baby. No cramps or pains in my abdomen. I am happy to share any past or future data about my pregnancy if anyone reading this is interested in contacting me. I then randomly measured my temp until bed but it never came back as higher than normal (didn?t write it down). Slept through the next night normal and woke up normal temp as well. I would say I was more tired than usual on 3/17 but did not have any more flu like symptoms. The only thing that remained was a soreness at the injection site. It was at the spot of injection and also kind of the general area. The pain/feeling completely went away by the end of the week 3/19. This is a very long description of symptoms. I don?t know if it?s helpful or if anyone even read all of it. But I?m just writing it down for record."" Recently hospitalized for leg fracture. Current hospital policy is to administer Janssen COVID vaccine at time of discharge to those giving consent. Report received from interested party that individual had received and completed the Moderna COVID19 VACCINE JANSSEN 0 days 1117067-1 COVID vaccine series an indeterminate time earlier. No record of adverse event noted, though communication with interested family member is still pending.

Patient c/o ""numbness et tingling"" to lower extremeties. States she does not feel SOB at this time, states she has own EPI pen but has not given herself a dose. Nurse evaluated said person, noting HR is tachy, lungs clear et person states ""I COVID19 VACCINE JANSSEN 0 days 1117074-1 can breathe"" Person then states, ""My lips feel a little numb."" Person asked for a bottle of water. Nurse asked the person is she felt she needed Benadryl or possibly an ambulance. Person stated, ""If you tell me how to get to the ER, I will go there and get checked out."" Nurse led person to ER where she states she no longer needed nurse's services."" Patient died approx. 5 hours after shot was administered. Cause of death reported is Atherosclerotic Cardiovascular Disease. The death certificate was signed by the county coroner without autopsy, based on the report by the onsite COVID19 VACCINE JANSSEN 0 days 1117078-1 deputy coroner. No doctors or hospitals were involved. This report is FYI only; there has been no direct connection made between my mother's death and the vaccine other than one followed shorty after the other. COVID19 VACCINE JANSSEN 0 days 1117081-1 chills and sweats, tightness of breath for two days feels a knot above her collar bone - awoke her at 0100 in am while turning over no cough , - PND, - sore throat - runny nose felt weak tired and body aches and HA today much better no fever , no sinus pain, no NVD, -ear pain, mild sore COVID19 VACCINE JANSSEN 0 days 1117091-1 throat, -wheezing, -no SOB , + PND, no chest pain No chest heaviness, no strange sensation chest, no chest tightness , no diarrhea injection received in the RUE COVID19 VACCINE JANSSEN 0 days 1117105-1 Headache, 102 temperature, chills Head hurts Ball in throat (swollen lymph under jaw) Dizziness Tingling in arms Glucose 84 O2 99% Heart rate 63 COVID19 VACCINE JANSSEN 0 days 1117125-1 Breathing and a donut and relaxing Glucose to 83 Felt better after about 30 minutes Daughter picked her up and told daughter to have her relax hydrate eat well and to refer her to medical attention if symptoms get worse HCW was given pfizer first dose on 12/17/20. HCW thought she will have to re-start the series all over because she COVID19 VACCINE JANSSEN 0 days 1117215-1 waited too long to get 2nd dose of pfizer so she opted for the Janssen vaccine. She did not inform vaccinator that she had already received a covid-19 vaccine. HCW denies any side affects or adverse reactions at this time. COVID19 VACCINE JANSSEN 0 days 1117262-1 Patient reported numbness and tingling in hand shortly after administration. Patient came back to vaccine area at 9:30 am reporting light-headedness, tingling at lips, SOB. Vital signs taken: BP 180/100, P-80. Treated with 25mg. Benadryl by mouth with vital signs every 5 minutes until BP decreased to 140/90. COVID19 VACCINE JANSSEN 0 days 1117376-1 Patient placed in supine position with feet elevated. Patient remained under observation x 1 hour and left area without symptoms at 10:30. Itching on shoulder and neck during first 15 minutes after Janssen COVID vaccine administration. Observed for additional COVID19 VACCINE JANSSEN 0 days 1117468-1 20 minutes by EMS. No treatment provided. COVID19 VACCINE JANSSEN 0 days 1117550-1 Stroke We had a vaccine reaction today at pharmacy 1870. Patient signed up vaccine online. I saw on her form that she had a reaction to vaccine. , and discussed the vaccine reaction with her. She said she had hives to influenza vaccine five years ago, but had influenza vaccines every year since including 2020 without incident. I gave her the vaccine (Janssen) and almost immediately she said she felt tingling in her arm. I had her sit in site of my gatekeeper for the vaccines. In less COVID19 VACCINE JANSSEN 0 days 1117566-1 than 5 minutes, she was swelling and red in the arm and it crossed over to her chest neck and the other arm. She asked for a benadryl tablet and we complied, but the swelling continued to get worse. We immediately called 911 and the paramedics arrived in about 5 minutes. They gave her iv benadryl and transported her to hospital for observation. Employee followed up with patient this afternoon. She had been released from hospital and is doing well. She was very pleased that we called to ask about her well-being. Throat tightening and racing pulse almost within one minute. Oral meds: Benadryl, famotidine 40, Zyrtec, and prednisone Developed hives day 5 after injection. Full body itching remains unresolved. Treated with eucerin and COVID19 VACCINE JANSSEN 0 days 1117665-1 hydrocortisone topical cream. 2 visits to ER for iv steroids and normal saline fluids. Epi administered on second visit today 3/20/21 with good relief (best I?ve felt since getting it on Monday) 10/10 migraine today not relieved by oral triptans. Relieved by triple cocktail IV. COVID19 VACCINE JANSSEN 0 days 1117974-1 Experienced chills and slight fever 6 hours after the injection which continued for 4 hours. Patient was dizzy and then passed out. It was two minutes after vaccination that patient passed out. Patient was pale COVID19 VACCINE JANSSEN 0 days 1118006-1 and clammy. COVID19 VACCINE JANSSEN 0 days 1118314-1 She received the Johnson and Johnson vaccine on Wednesday and died on Sunday 3/14/2021. Her autopsy is pending. 3 minutes after vaccination, I started to feel warm, sweaty, and tingling sensation. On-site nurses noticed I started to COVID19 VACCINE JANSSEN 0 days 1118778-1 look pale and clammy and took me into evaluation room and checked my vitals. My vitals came back with low blood pressure and low oxygen levels. After resting and a cup of water, my vitals became all normal. Reported by EMS on site. client had syncope following vaccine and was transported to a local hospital. no phone COVID19 VACCINE JANSSEN 0 days 1123821-1 number given to this writer after the event. EMS called at 11 am and arrived at 11.01. blood pressure 101/68 pulse 71. second reading was 108/76 and pulse 69. COVID19 VACCINE JANSSEN 0 days 1124508-1 Anaphylaxis (tongue swelling, loss of airway, required oxygen) I exp headache, fever, body aches, chills, sweating and racing heart rate(tachycardia). I went to ER for heart rate shot up COVID19 VACCINE JANSSEN 0 days 1125918-1 to 155 beats per min while sitting in a chair was prescribed Migraine and Benadryl. I do exp heart rate regulation which is usually under control unless I'm hot. Acute - Got Johnson & Johnson COVID-19 vaccine this past Thursday - Thursday night starting cramping with abdominal pain radiating to the back; remained quite bothersome through Friday, Saturday, Sunday - Had nausea but no vomiting; mild HA - Some episodes of loose stools but no blood - No fever and chills but some diaphoresis - Has been drinking water COVID19 VACCINE JANSSEN 0 days 1126252-1 but not eating - Has been a little bit of SOB and dyspnea on exertion - No lightheadedness, syncope or near syncope; no palpitations or chest pain - No clear alleviating factors, worsens when he drinks too much water - no recent history of alcohol intake His clinic gave him Johnson and Johnson COVID vaccination and the next day, he developed abdominal pain, nausea, COVID19 VACCINE JANSSEN 0 days 1126694-1 vomiting and dehydration. It got progressively worse, so he came to the ED. He has been admitted, rehydrated, given antiemetics and feels somewhat improved. The decedent had significant medical conditions. The wife stated, the appointment for the vaccine shot was made on-line. Dept. of Health visited their home on 3/16. The shot was administered into the decedent's left arm at 0930hrs. The COVID19 VACCINE JANSSEN 0 days 1126732-1 decedent expressed no health complaints and had no visible indications of adverse affects. The decedent was found not breathing supine in bed at 2347hrs 3/16 (same day as vaccine shot). Patient was vaccinated in her home (COVID J&J) on 3/8. Vaccinator obtained consent and confirmed throughout the process that patient as at baseline since patient was nonverbal and bedbound. Later that same day she experienced an emergency and was take to the hospital and subsequently admitted to ICU. She died on 3/10, family present, on comfort care. Per HPI, ""Patient is a 85 y.o. female with advanced dementia (non verbal, wheelchair bound at baseline), chronic COVID19 VACCINE JANSSEN 0 days 1126863-1 aspiration, recurrent UTIs, voiding dysfunction currently self-straight cathing, has suspicious bladder and gallbladder masses (being worked up), has right sided hydronephrosis, BIBEMS for acute hypoxemia, difficult to bag en route, ED had difficulty intubating and so performed cricothroidotomy. Patient had brief PEA arrest due to hypoxia. ED provider noted ""excessive pulmonary edema in airway, unfavorable anatomy, and airway swelling."" Suspected insult stemming from J&J COVID vaccination reaction."" Elevated blood pressure 230/170 for over 24 hours. Dry mouth, Feeling of unease. Chilled, Insomnia. Loss of appetite. COVID19 VACCINE JANSSEN 0 days 1130201-1 Joint pain, Headache for 6 days. I had chills, fever, headache, extreme tiredness, almost passed out and tingling on right side arm/leg. When I almost COVID19 VACCINE JANSSEN 0 days 1130579-1 passed out felt like tunnel vision. COVID19 VACCINE JANSSEN 0 days 1131084-1 My sister died in her sleep six days after receiving the J&J vaccine in her sleep. Right Unilateral Cranial Nerve 7 Paralysis, 6 hours after administration of vaccine, associated symptoms included COVID19 VACCINE JANSSEN 0 days 1131797-1 diarrhea, emesis Treatment included prednisone and valacylovir Patient received Vaccine March 10 at 8am, Couple hours (10am) headache, muscle aches, Low Grade fever 38.4 chills. COVID19 VACCINE JANSSEN 0 days 1134120-1 Lasting for the remainder of the day and symptoms dissipated next morning I received the shot at the pharmacy location, they had us sit for about 10min after then we could go, my next appointment happened to be at a dr's office thank goodness because about 10 min after sitting in the waiting room I felt faint and spoke out to the receptionist that I needed to lie down, they laid me down on the couch where I was sitting my blood pressure had shot up to 165/126 or I was unable to stand on my own, I was beginning to convulse and my heart rate shot up, they got a wheel chair, put me in it and took me back to one of their rooms where they I think ran a few COVID19 VACCINE JANSSEN 0 days 1134439-1 test and then they made the decision to take me down to the er, the er which I told repeatedly that I had just received the covid shot, they hooked me up to machines, I think did a EKG, wheeled me to get a mri, and then did a chest xray, all while I was convulsing, they allowed this convulsing to continue for over 3+ hrs before they finally gave me something to calm down the convulsions, I was having sensory issues and could not handle, light, etc, for the next many days my heart rate would jump from the 60's too the top was I think 200BPM, I had to lie in a dark room, no sounds for a few days, I am just now felling a little bit better. COVID19 VACCINE JANSSEN 0 days 1135429-1 tongue and lip swelling concerning for anaphylaxis Hives, wheezing, itching,rash chest tightness and respiratory issue. I was treated at the hospital. Treatment medications COVID19 VACCINE JANSSEN 0 days 1135949-1 were Prednisone, metoprolol succinate, Benadryl. Approximately 12 hours after getting the vaccine, I began shivering uncontrollably for about an hour and felt hot (like a COVID19 VACCINE JANSSEN 1 day 1074405-1 fever) at the same time. I also ached all over. I took 2 Tylenol and was able to fall back asleep. I woke up sweaty, but the chills and fever were gone. I?m now just stiff, with some mild pain at the injection site. COVID19 VACCINE JANSSEN 1 day 1074434-1 woke up with fever, chills, joint aches, headache, general malaise COVID19 VACCINE JANSSEN 1 day 1074631-1 Little chills - fatigue nothing severe but there Janssen COVID-19 Vaccine EUA Beginning morning of 3/4/21. Nausea, extreme fatigue, body ache, severe headache, COVID19 VACCINE JANSSEN 1 day 1075814-1 chills, fever, coughing. Beginning morning of 3/5/21. Nausea, body ache, mild headache, coughing, chills, mild fatigue COVID19 VACCINE JANSSEN 1 day 1076958-1 Headache. Hives started around 4:00PM on Friday March52021 COVID19 VACCINE JANSSEN 1 day 1076967-1 Achy, fever of 100, chills fatigue COVID19 VACCINE JANSSEN 1 day 1077013-1 Fever, chills, stomach pain, muscle pain, headache, nausea, soft stool, fatigue. COVID19 VACCINE JANSSEN 1 day 1077341-1 Feet & calves extremely warm, no fever. Upset stomach, malaise, slight difficulty breathinh COVID19 VACCINE JANSSEN 1 day 1077359-1 Aches in both arms (mostly in arm that was vaccinated), backache, restlessness, insomnia, headache, overall body fatigue. All of these things caused me to wake up in the middle of the night around 3:30 AM the day after vaccination.

Patient had sudden onset of sensation of palpations and light headedness ""lasting one second"" in middle of night on the day after receipt of COVID-19 vaccine. Felt urgent need for medical treatment & came to our ER. Has had similar episodes COVID19 VACCINE JANSSEN 1 day 1077371-1 previously that have been partly diagnosed as anxiety though without light-headedness. Vitals in ER HR 141, BP 147/101. Believed to be sinus tachycardia. Has been prescribed venlafaxine, lorazepam, and metoprolol previously for this. Has seen cardiologist but per patient no specific diagnosis. As yet, patient has received a fluid bolus in ER."" COVID19 VACCINE JANSSEN 1 day 1077422-1 Headache/ achy bones, painful movement in most joints COVID19 VACCINE JANSSEN 1 day 1077453-1 Headaches, chills, fatigue Fever started 10 hours post injection. Fever was 99.1. Also body aches. Next day was fatigued and had small rash at the COVID19 VACCINE JANSSEN 1 day 1077499-1 base of my neck in front. COVID19 VACCINE JANSSEN 1 day 1077592-1 Severe headache, chills, body aches COVID19 VACCINE JANSSEN 1 day 1077755-1 Chills, muscle fatigue COVID19 VACCINE JANSSEN 1 day 1077782-1 Intense body aches, pain and chills COVID19 VACCINE JANSSEN 1 day 1077845-1 Eyes burning, fatigue, soreness at injection site, muscle aches (not manifest until following day).

Woke up at 4AM on 03/05/2021 with shaking chills, feeling very cold, couldn't get warm. Shaking so bad I couldn't get whole sentences out. Body aches and stiffness, affected my walking. Did not take temperature at that time. Got back into bed with 2 blankets and a comforter and still couldn't sleep. Got up a 7AM - temp 102.2, shaking less but still COVID19 VACCINE JANSSEN 1 day 1078114-1 feeling cold, body was hot to touch. I had a bad headache and body aches and stiffness were still there. I noticed at that time that I had a bright red flush on both cheeks and my nose that was hot to the touch. Took 600mg of Ibuprofen. Went back to bed feeling terrible. At 12 noon I got back up and temp was down to 99.7. Headache, body aches, stiffness, and ""red flush"" still on cheeks and nose. Went back to bed. Took more Ibuprofen at 7pm - temp was down to 98.7. Headache was better, body aches improved. Flushed hot face was still present. Went to sleep at 11:30PM and slept for 10 hours. Today, 03/06/21, all symptoms improved, no fever, redness of face is still present but less."" COVID19 VACCINE JANSSEN 1 day 1078153-1 Janssen COVID-19 Vaccine EUA Chills, fever, upset stomach, fatigue Fever so far reaching 100.2, headache, neck pain, weakness, skin sensitivity, hair sensitivity, nausea, muscle and joint COVID19 VACCINE JANSSEN 1 day 1078162-1 pain, muscle spasms/cramps with short term weakness. Moderate soreness at site of injection. Headache Mild fever (99-99.6) Body wide muscle ache Skin touch sensitivity COVID19 VACCINE JANSSEN 1 day 1078182-1 Tiredness Treated with 2 tablets of Extra strength Tylenol COVID19 VACCINE JANSSEN 1 day 1078376-1 Fever, body aches, headache, chills COVID19 VACCINE JANSSEN 1 day 1078413-1 Fever, Fatigue, Nausea, loss of appetite, muscle and joint aches and soreness, headache COVID19 VACCINE JANSSEN 1 day 1078485-1 Extreme headache, joint aches (especially hips), nausea, fatigue, fever 102.3, chills Mild fever around 100 degrees, severe chills, headache, fatigue, sore arm at injection site. Ongoing from around 7pm so COVID19 VACCINE JANSSEN 1 day 1078543-1 about 2 hours at this point. Arm felt a bit sore for the first time around 2pm today. COVID19 VACCINE JANSSEN 1 day 1078623-1 Nausea Headache Body ache Temperature 100.2 Fever, nausea, chills, headache, body pain more in the right side of my body. I had the vaccine in the left side. I was COVID19 VACCINE JANSSEN 1 day 1078631-1 feeling very tired.I started feeling better 24hrs after the vaccine. COVID19 VACCINE JANSSEN 1 day 1078664-1 Fever, chills, body aches, headache, fatigue COVID19 VACCINE JANSSEN 1 day 1078718-1 Fever of 104 Fatigue Headache Body aches Chills Nausea Neck pain I had all the side effect system, fever, chills, fatigue muscle and joint pain. The joint pain is what I would like to share my concern about. A little more than a year ago (Feb 2020) I have L4/L5 fusion surgery. The surgery was successful and for the last six month had little to no pain (no more than a 1 on the pain scale). Saturday a day after the vaccination my COVID19 VACCINE JANSSEN 1 day 1078789-1 lower back pain was significant (5 to 6 on the pain scale). I am not sure if this was just a coincidence but thought it was worth reporting. Today, Sunday March 7th the pain is much better (about a 2 on the pain scale and I think will completely go away as I move around more and loosen up. COVID19 VACCINE JANSSEN 1 day 1078828-1 Headache, fever, chills, muscle aches, fever, nausea Body aches and chills led to low-grade fever (100 degrees at peak) and headache over the course of midnight to 9:30 a.m. COVID19 VACCINE JANSSEN 1 day 1078855-1 the following day. Treated by hydrating. COVID19 VACCINE JANSSEN 1 day 1078890-1 Headache, fever, nausea, muscle aches, higher resting heart rate COVID19 VACCINE JANSSEN 1 day 1078900-1 Pregnant 17 weeks, Due August 14 2021 Adverse effects: Muscle aches, headache, low grade fever, sore injection site Severe chills, severe muscle aches, nausea, and headache. Began around 12:15 am. Severe chills got better with Tylenol COVID19 VACCINE JANSSEN 1 day 1078968-1 after 8 hours. Then fluctuated between hot and cold. Nausea/ vomiting comes and goes. The muscle aches got better, then came back. Itching and soreness at injection site 03/07/2021 Arthritis pain worse than usual 03/07/2021 Nausea 03/07/2021 Fatigue COVID19 VACCINE JANSSEN 1 day 1079031-1 03/07/2021 COVID19 VACCINE JANSSEN 1 day 1079052-1 Chills,fever,aches.fatigue Rest in bed, tylonol Still achy on second day, very tired Janssen-Covid19 vaccine eau Full body aches Extremely lethargic hard to grasp things with hands Dizzy when standing COVID19 VACCINE JANSSEN 1 day 1079093-1 Severe headache/migraine Fever Cold Runny nose Congestion Started with feeling tired around 6pm, woke up at 3:30 am (ish) to wanting to vomit, shivering, high fever over 103, COVID19 VACCINE JANSSEN 1 day 1079164-1 aweful headache, dizzy, breathing feels labored. Now at 12:30 pm, arm is extremely sore at site, chest still feels funny when taking deep breaths, head still aches but not as bad, not quite as tired. COVID19 VACCINE JANSSEN 1 day 1079169-1 Body aches and nausea started at 9 pm 9:30 am started vomiting Woke up at 1:30 am with shivers and vomited. Felt dehydrated. Woke up one hour later sweating and vomited. COVID19 VACCINE JANSSEN 1 day 1079176-1 Repeat back and forth cycle until 7am. Feeling much better now. Just achy. I fainted the following evening after my vaccination. I felt fine all day and after dinner started to feel flush, vision became COVID19 VACCINE JANSSEN 1 day 1079181-1 blurry and had trouble hearing. Within 3 minutes I fainted. Felt fine after coming to, and have felt fine so far the next day. Janssen COVID-19 - grade 3 fever-- 102.1 maintaining with tylenol and ibuprofen - chills - aches/sore joints - headache - COVID19 VACCINE JANSSEN 1 day 1079217-1 fatigue - nausea (dry heaving, can't eat)

I started to experience symptoms around noon time on the day of vaccination. It started with a low-grade fever. Slowly COVID19 VACCINE JANSSEN 1 day 1079247-1 over the course of the day, I started to experience body aches, chills and headaches. My left arm where I received the vaccine felt strange. My fever got up to 100.4. During the night I had chills. It felt like my fever broke early in the morning. I woke up okay and I feel like I could go about my day with no problem. I no longer have a fever. COVID19 VACCINE JANSSEN 1 day 1079279-1 Diarrhea started 10:30am 3/7/21 Chills began 12 noon 3/7/21 Took Extra-Strength Tylenol 2 x 500mg at 12:30pm 3/7/21 COVID19 VACCINE JANSSEN 1 day 1079340-1 High fever (>103 F), body aches, chills, nausea COVID19 VACCINE JANSSEN 1 day 1079349-1 headache, body aches, chills -- starting around 4 a.m. and gone by 11:00 a.m. same day. COVID19 VACCINE JANSSEN 1 day 1079374-1 Fever, nausea, extreme fatigue, body aches - non-stop since a little after midnight. COVID19 VACCINE JANSSEN 1 day 1079471-1 heart palpatation The patient experienced a metallic taste shortly after vaccination. The patient then experienced a severe headache and COVID19 VACCINE JANSSEN 1 day 1079476-1 nausea about 13 hours after vaccination . The patient experienced a metallic taste shortly after vaccination. The patient then experienced a severe headache and COVID19 VACCINE JANSSEN 1 day 1079495-1 nausea about 13 hours after vaccination . COVID19 VACCINE JANSSEN 1 day 1079627-1 DEVELOPED SWOLLEN THROAT GLANDS, SORE THROAT, SWOLLEN FACE, KNOT UNDER CHIN, PAIN AROUND NECK COVID19 VACCINE JANSSEN 1 day 1079638-1 chills, 101.5 fever 24 hr.s, soreness at injection site Chills woke me up at 5am, kept me up for at least an hour. Headache, pain in eyes, fever continued through the day. COVID19 VACCINE JANSSEN 1 day 1079669-1 Muscle pain in back significantly worse than previous days COVID19 VACCINE JANSSEN 1 day 1079689-1 Fever (99 degrees), headache, fatigue, muscle aches, chills Told to include this information in this box: Janssen COVID-19 Vaccine EUA Symptoms: Fatigue, nausea, body aches (entire body, but especially hips and injection site), and temperature between 98.5F-99.8F all day on the first day COVID19 VACCINE JANSSEN 1 day 1079717-1 following the day of injection. Tylenol taken once and Advil taken twice throughout the day, which mostly relieved symptoms. Second day following day of injection, moderate fatigue in the afternoon, even after full 8 hour sleep with CPAP on all night. After receiving the vaccine I had some common side effects such as nausea, vomiting, fever, chills, achiness, and COVID19 VACCINE JANSSEN 1 day 1079731-1 headache, but after several hours I tried to get out of bed and I lost consciousness. In addition I had two episodes of intense sweating and dizziness. COVID19 VACCINE JANSSEN 1 day 1079741-1 Fever, chills, nausea, body aches, chest pain COVID19 VACCINE JANSSEN 1 day 1079861-1 low grade fever 99.9 for 12 hours muscle/body aches for 12 hours tired for 12 hours+ headache for 12 hours Hives breakout all over face and arms - I've been taking Benadryl but still present, swelling on eyelids so I could barely COVID19 VACCINE JANSSEN 1 day 1079895-1 open eyes - Been taking benadryl, Fever of 105.3 degrees - Been taking tylenol for 2 days but still have fever, Sore arm and body aches, Overall weakness feeling I felt no affects after I received the shot at 2:30 PM. Woke up with chills, violent shivering, became sick to my stomach at 2 AM. I fell back to sleep an hour later after covering myself with another blanket and throwing up. My Apple Watch COVID19 VACCINE JANSSEN 1 day 1079920-1 shows at 4 AM my heart rate rose to 127 BPM when I was asleep. It is now 6 PM and I am feeling body aches, headache, stuffy nose, still a bit nauseous-- almost like cold symptoms. COVID19 VACCINE JANSSEN 1 day 1079972-1 Headache, body aches, fever, hot flashes, chills, high heart rate COVID19 VACCINE JANSSEN 1 day 1079997-1 Arms/hands and legs/feet feeling tingly, weightless or as they?re falling asleep. Severe headaches on the left side of head causing eye pain , temperature of 100.1, tingling throughout my whole body COVID19 VACCINE JANSSEN 1 day 1080011-1 including fingers and toes, extreme fatigue. All symptoms started at approximately 2:00am the day after vaccination when I woke up in the middle of the night. COVID19 VACCINE JANSSEN 1 day 1080034-1 Temperature - 102.2 Headache, extremely tired COVID19 VACCINE JANSSEN 1 day 1080039-1 Mild fever Headache Scratchy throat

Chills, shaking, headache, body aches, fever 101.5, fatigue. Chills and shaking started around 1:00 am without fever, COVID19 VACCINE JANSSEN 1 day 1080053-1 lasted about 1.5 hours. Woke up at 6:00 am with severe headache, body aches, and fever. Fever resolved with Tylenol and reoccurred later around 6:00 pm at 100.4 along with body aches and chills. Headache has persisted the entire day. Went to bed after getting my shot at 11:00 PM on 3/7/2021, feeling no symptoms. Woke up at 5:10 AM the next day on COVID19 VACCINE JANSSEN 1 day 1080371-1 3/8/2021 feeling tired, sore, and a little nauseous, with a headache. These symptoms are very similar to how my COVID symptoms were in early October 2020 Work up at 12:30 a.m. very hot and nauseous. When I tried to stand up I fainted. When I came to I crawled to the COVID19 VACCINE JANSSEN 1 day 1080378-1 bathroom and vomited several times. Continued to run fever for about an hour or so. Then headache began. As of 7:00 I still feel nauseous and have a slight headache. COVID19 VACCINE JANSSEN 1 day 1080405-1 100 degree fever, headaches and intermittent nausea COVID19 VACCINE JANSSEN 1 day 1080416-1 High fever, chills, sweating , thirst. Lasted 3 hours and subsided after taking tylenol Severe chills and shaking, fever ranging from 99-101.7 F, muscle aches, joint aches, headache lasting from 1 am - 11 pm COVID19 VACCINE JANSSEN 1 day 1080462-1 3/6 (day after injection). Acetaminophen every 8 hours, beginning at 3 am; ibuprofen every 8 hours beginning at 4 pm. Felt some general weakness on Sunday. COVID19 VACCINE JANSSEN 1 day 1080491-1 Vomiting, nausea, body aches, fatigue COVID19 VACCINE JANSSEN 1 day 1080528-1 Fever, muscle aches COVID19 VACCINE JANSSEN 1 day 1080559-1 Low grade fever (100), achiness, head ache, chills COVID19 VACCINE JANSSEN 1 day 1080560-1 Severe flu-like symptoms, including chills, ache, and headache Metallic taste in mouth Injection site swelling and pain COVID19 VACCINE JANSSEN 1 day 1080605-1 Fever 101F, extreme fatigue, weakness, aches, dizziness COVID19 VACCINE JANSSEN 1 day 1080622-1 Fever 102 Aches Nerve pain throughout body Weakness Nausea COVID19 VACCINE JANSSEN 1 day 1080623-1 Fever, headache, body ache, tiredness All started at 8:10 am the day after I received the vaccine COVID19 VACCINE JANSSEN 1 day 1080784-1 Headache, fever, fatigue, nausea, site pain, lasted about 12 hours. Slight dizziness and mild nausea occurring the day following the immunization (3/5) and continuing through present. No COVID19 VACCINE JANSSEN 1 day 1080821-1 treatment as of yet has been administered. I got the shot at 5:30 pm. Starting early the next morning (around 3 or 4am), I began to experience intense fever and headache. I got up to get Advil and had a seizure. I have epilepsy, and had not missed a dose of my medication. My last COVID19 VACCINE JANSSEN 1 day 1080868-1 seizure before this was 2 years ago. After recovering, taking Advil, taking a shower, and going back to sleep for about 4 more hours, I woke up feeling fine. Janssen COVID-19 Vaccine EUA - chills, extremely tired, low grade fever started about 12 hours after injection (only at COVID19 VACCINE JANSSEN 1 day 1080892-1 night)- reporting this 42hrs later - Advil helped with fever and sleep helped with tiredness COVID19 VACCINE JANSSEN 1 day 1081034-1 Extreme malaise, headache, chills Fatigue, fever, minor nausea for over 24 hours. Vaccine occured Saturday at 11:30AM and beginning of symptoms were COVID19 VACCINE JANSSEN 1 day 1081056-1 noticeable around 10 am the following day (Sunday). COVID19 VACCINE JANSSEN 1 day 1081072-1 None stated. COVID19 VACCINE JANSSEN 1 day 1081091-1 Fatigue, dizzy, nauseous COVID19 VACCINE JANSSEN 1 day 1081096-1 Headache, joints hurt, no appetite, fever. Injection site painful Starting 2:30 am, woke up nauseated, severe chills. Vomited 3am, severe chills, headache, body aches all night. Severe COVID19 VACCINE JANSSEN 1 day 1081119-1 Body aches and headache lasted all next day. Leg aches became extreme next night. Following night, I still had chills, body aches, headache. Second morning, I am still having headache, moderate body aches Headache, fever and fatigue. As for treatment Tylenol was used every 4 hours. Feeling better, headache is gone but still COVID19 VACCINE JANSSEN 1 day 1081156-1 feel fatigue and the temperature seems to be under control. Woke up around 5:30AM having to go to the bathroom. Went to Flush the toilet and passed out on the floor. My wife COVID19 VACCINE JANSSEN 1 day 1081167-1 found me unresponsive but breathing on the floor. My wife called 911 and was at the hospital around 6:15AM. COVID19 VACCINE JANSSEN 1 day 1081172-1 fever, tiredness, achy joints, nausea/lack of appetite

Within 12 hours of receiving the vaccine, around 2-3am, I began getting chills that lasted a couple of house. I had a COVID19 VACCINE JANSSEN 1 day 1081176-1 temperature of 99.5 but immediately came down. In the early morning (the next day since receiving the vaccine), I felt nauseous followed by a headache. I also felt dizzy, but that immediately subsided. All of the mentioned side effects have subsided. My arm has been sore since receiving the vaccine but the pain has relatively minimized over time. COVID19 VACCINE JANSSEN 1 day 1081204-1 Minor muscular pain throughout body most of the day. No treatment. Back to normal 2 days after receiving vaccine. After receiving the vaccine at 9:30pm, I was awoken at approximately 4:30am that night/the next morning with an extremely high heart rate. After about thirty minutes, I was able to calm down and my pulse/heart rate dropped down COVID19 VACCINE JANSSEN 1 day 1081206-1 to a level that still seemed elevated, but no longer caused a great deal of concern. This event was followed by nausea for the remainder of the day. About 9 hours after receiving the vaccine (around 2am) I had a fever, chills, headache, sore arm, and muscle soreness. I fell back asleep and when I woke up the fever had broken and the chills had improved but the soreness and headache remained. I took Tylenol in the afternoon and that helped the symptoms but by the time I had gone to bed the chills had COVID19 VACCINE JANSSEN 1 day 1081210-1 returned but not a fever. When I woke up in the middle of the night (night 2) the chills had stopped and I woke up with a moderate headache and sweating profusely. After falling asleep and awaking in the morning I felt much better with the exception of a minor headache. COVID19 VACCINE JANSSEN 1 day 1081243-1 Chills, fever (101.7) aches, sore arm, vomiting 11.5 hours after vaccine I began to vomit and continued for 48 hours with dry heaves. Only drank water then vomited . Ate 1/2 cut of chicken soup and vomited it up. Constant chills. Back ached so bad I couldn't sleep first 24 hours. Still feel COVID19 VACCINE JANSSEN 1 day 1081331-1 week 3 days later, however able to eat and drink with no nausea 1200 noon on 03/08/21. No health issues, no medications. COVID19 VACCINE JANSSEN 1 day 1081451-1 Fever, chills, nausea, severe headache (still on-going), severe lower back pain (still on-going) COVID19 VACCINE JANSSEN 1 day 1081489-1 102 fever with accompanying muscle ache. Took two tylenol. Fever and ache gone by morning COVID19 VACCINE JANSSEN 1 day 1081561-1 Headache, chills, nausea, fatigue Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Fainting / Unresponsive- COVID19 VACCINE JANSSEN 1 day 1081606-1 Medium COVID19 VACCINE JANSSEN 1 day 1081998-1 Fainting, nausea, weakness, dizziness, headache, and chills

Mild headache and nausea set in shortly after the injection on Friday, but went away after rest and eating/drinking. My arm was sore for the entire evening. I woke up around 2am Saturday morning and became dizzy. I fell to the floor and COVID19 VACCINE JANSSEN 1 day 1082014-1 passed out for a short period of time. When I woke, I was extremely nauseous to the point of nearly vomiting. I had chills and fever. I could hardly move due to weakness - I needed help getting back into bed. When I woke the next morning, I had 100.3 fever, I had a headache and my entire body was sore. My fever went away late Saturday afternoon, but I still felt mildly nauseous. It is Monday and I still have mild nausea and light-headedness. My arm is only slightly sore. COVID19 VACCINE JANSSEN 1 day 1082037-1 PATIENT'S WIFE STATED THAT HE HAD SYMPTOMS SIMILAR TO COVID AND WAS ADMITTED INTO THE HOSPITAL. COVID19 VACCINE JANSSEN 1 day 1082131-1 Severe pain in arm at site of shot. Fatigue. Whole body soreness. Feverish without fever. Loss of appetite Headache At approximately 9:00PM om March 7, 2021 I started to feel very tired and was starting to have trouble breathing. My COVID19 VACCINE JANSSEN 1 day 1082192-1 O2 level was between 89% and 91% and my heart was racing. The oximeter I have showed 98/99 BPM. I also had a temperature of 99.9 degrees. Most of these symptoms started to subside after about 2 hours **24 weeks pregnant. Due Date 6/24/21. 1st pregnancy** I got the vaccine at 5pm and was fine through the night. I was fine early in the morning and then stated feeling nausea and I vomited 3 times and was unable to retain fluids or food. Everything I tried to consume something I would throw it up. The vomiting and Dehydration was the worst, I had COVID19 VACCINE JANSSEN 1 day 1082197-1 nausea in my first trimester so not sure if it's linked to my pregnancy. I called my OB and spoke with them on the phone, they were concerned at on point but eventually was able to hold down an Gatorade and Tylenol . The other effect I had were mainly fatigue and headache but Tylenol helped with both of those. I still feel tired but other than that no other symptoms. By Friday evening I was feeling fine, the only thins that carried on was fatigue. I didn't experience site pain, no redness, swelling or hurting. I had the vaccine at 8:00am Saturday and symptoms started after midnight Sunday. Fever, extreme muscle aches, COVID19 VACCINE JANSSEN 1 day 1082249-1 headache, and fatigue. A bit of stomach upset as well. It is now Monday and I still feel achy and have a headache. Fine the day of the shot (5/6/2021), woke up the next day (5/7/2021) with headache, joint pain, muscle aches, fever, nausea, dizziness and what felt like severe heartburn, frequent urination and stomach pain. As of 5/8/2021 all symptoms COVID19 VACCINE JANSSEN 1 day 1082308-1 have subsided except for let arm still being a little tender, a little sore in left neck and that's it. Everything seems to be fine now vomitting, nausea, extreme muscle soreness-whole body, extreme joint pain, extreme head ache, skin hurt to touch, COVID19 VACCINE JANSSEN 1 day 1082352-1 fever, extreme fatigue I had immediate pain at injection site, which is still tender to the touch. I have experienced extreme fatigue over the past three days. I had diarrhea multiple times starting at 12AM on 03/07/2021. I became extremely weak, dizzy, COVID19 VACCINE JANSSEN 1 day 1082401-1 disoriented, and broke out into a cold, clammy sweat. My skin was very ashen/pale. Did not administer body temperature at time of incident but had cold chills. COVID19 VACCINE JANSSEN 1 day 1082481-1 Fever 101.5, Chills, Body Aches While waiting the 15 required minutes after the shot was administered..I experianced a headache and left jaw discomfort. Minor arm pain the first day, I expected that. Did my regular errands and was fine, a little tired. The next COVID19 VACCINE JANSSEN 1 day 1082522-1 day, (Sunday)...I went to church, had a headache, arms aching like mad, arthritic symptoms , legs cramping, joint pain in elbows especially, were off the chain! I returned home and took immediately to the couch, where I had a low grade fever and stayed all day. I had no appetite, no energy to get up except to go to the bathroom. I am feeling extremely dizzy, any time I move my head the room spins and my ears get hot. I feel achy all over my body COVID19 VACCINE JANSSEN 1 day 1082702-1 and very very cold. As the day has gone on the dizziness has gotten worse. At times it feels like I?m going to faint. (I haven?t yet fainted) I have not tried any treatment yet hoping it doesn?t last longer then today. COVID19 VACCINE JANSSEN 1 day 1082737-1 The next morning I woke up with a low-grade fever. It lasted on off that whole day but never went higher than 100.2 COVID19 VACCINE JANSSEN 1 day 1083038-1 Fever body aches sore back. COVID19 VACCINE JANSSEN 1 day 1083085-1 itchy, redness on leg COVID19 VACCINE JANSSEN 1 day 1083123-1 Headache, chills, nauseous COVID19 VACCINE JANSSEN 1 day 1083225-1 Headache body ache nauseous dizzy Fever of 102 all night, taken with forehead scanner. Highest fever 103. Headache and rapid heartbeat all night. Next COVID19 VACCINE JANSSEN 1 day 1083248-1 day headache. Arm soreness started Two days after the shot and continues, very painful in the muscle and skin is itchy over the injection site. 101.7 F fever, nausia, tiredness, runny nose, headache the night and day after the vaccine, that went away after 48 COVID19 VACCINE JANSSEN 1 day 1083279-1 hours. COVID19 VACCINE JANSSEN 1 day 1083289-1 Injection site is still sore, chills, severe head ache and severe body aches lasting for two full days post vaccine COVID19 VACCINE JANSSEN 1 day 1083301-1 Uncontrollable shaking for about half an hour About 12 hours after the vaccine, I experienced excruciating pain in my head and body. My fever rose to 102 and stayed COVID19 VACCINE JANSSEN 1 day 1083317-1 there for 36 hours after being vaccinated. I was also nauseous and was unable to keep food down until 48 hours after being vaccinated. I was taking both Tylenol and Advil, but getting sick almost instantly after taking them. Sore underarm and shoulder began on the morning of 03/07/2021 and has continued throughout the day on 03/08/2021. COVID19 VACCINE JANSSEN 1 day 1083355-1 The pain is sharp and persistent. I have been taking Tylenol to relieve the pain. COVID19 VACCINE JANSSEN 1 day 1083397-1 Extremely bad headache, exhausted, running a temperature of 99.5 (normal temp. 97.6). Advil did not help symptoms COVID19 VACCINE JANSSEN 1 day 1083418-1 Chills, body aches, fever. Around 24 hrs after getting vaccine I started to get dizzy when moving around. The dizziness and Nausea has continued COVID19 VACCINE JANSSEN 1 day 1083440-1 for now 9hrs since started. COVID19 VACCINE JANSSEN 1 day 1083452-1 Day 1- Fever of 102 F, body aches and pains, chills, Headache Day 2- sore throat and mild aches COVID19 VACCINE JANSSEN 1 day 1083494-1 Fatigue, but most interestingly - extreme depression with suicidal thoughts

COVID19 VACCINE JANSSEN 1 day 1083519-1 About ten hours after the vaccine I began to get the chills and severe body aches. I also had a low grade temperature. It is now 24 hours since I began feeling this way and I still feel the same. I?ve been taking Advil for the aches and fever. COVID19 VACCINE JANSSEN 1 day 1083522-1 Loss of appetite, headache, chills, feeling lethargic, running nose, sneezing, itchy throat COVID19 VACCINE JANSSEN 1 day 1083882-1 Fever, body aches,headache Severe joint pain in lower back, both hips, both knees, both ankles, left shoulder, left elbow starting from about 10-12 COVID19 VACCINE JANSSEN 1 day 1083898-1 hours after the injection. COVID19 VACCINE JANSSEN 1 day 1083902-1 Feeling somewhat sick with body aches and fatigue. Restless. Can?t sleep even though I?m tired. Fever (101 F), muscle ache, slight headache/sinus pressure in front nasal cavity. Woke from sleeping after feeling feverish COVID19 VACCINE JANSSEN 1 day 1083903-1 and achy at 2:30 AM. Ate a small bite and took 1 500mg Tylenol. COVID19 VACCINE JANSSEN 1 day 1083927-1 Headache, stomach pain and chills COVID19 VACCINE JANSSEN 1 day 1083957-1 Chills, aches, exhaustion and pain at shot site COVID19 VACCINE JANSSEN 1 day 1083985-1 Fever, Chills, runny nose, diarrhea, muscle and joint ache, extremely tired COVID19 VACCINE JANSSEN 1 day 1083988-1 Headache, fatigue, muscle aches, arm where injection occurred is sore

COVID19 VACCINE JANSSEN 1 day 1084011-1 I had a feverish episodes, low grade fever of 100.1 degrees Fahrenheit at the highest with some body aches, headache and mild soreness at the injection site. This took place about 5-10 hours after injection and last for about 24 hours. COVID19 VACCINE JANSSEN 1 day 1084059-1 headache, glassy eyes, fever, chills, full body muscle ache, nausea COVID19 VACCINE JANSSEN 1 day 1084080-1 8 hours of fever, nausea, aches, & headache. COVID19 VACCINE JANSSEN 1 day 1084106-1 Janssen COVID-19 Vaccine EUA Pain under my left armpit. Pain lasting for longer than 2 days. COVID19 VACCINE JANSSEN 1 day 1084136-1 Chest pain and elevated heart rate COVID19 VACCINE JANSSEN 1 day 1084141-1 body aches, Fever 102, runny nose. Woke up shaking with chills that lasted for about 1/2 hour. Was uncomfortable the rest of night. Got out of bed at 6 am COVID19 VACCINE JANSSEN 1 day 1084157-1 and had a head ache for most of the next day. COVID19 VACCINE JANSSEN 1 day 1084223-1 Janssen COVID-19 Vaccine EUA COVID19 VACCINE JANSSEN 1 day 1084238-1 Started running fever of 101 with chills. Body aches, nausea, headache. Blood pressure raised to 148/101 with dizziness COVID19 VACCINE JANSSEN 1 day 1084252-1 Starting 11 hours later, I got a bad headache, chills, my whole body aches, it hurts to move, I can?t sleep COVID19 VACCINE JANSSEN 1 day 1084267-1 Dizziness (pretty bad). Nausea satisfying 430am and persists

I have a mosquito bite looking mark on my arm from the injection. around 2 pm I had 102.5 fever and I had a headache COVID19 VACCINE JANSSEN 1 day 1084295-1 and felt really tired. I asked the nurse when I went in to get the vaccine if I could get the vaccine if I have already had covid, she said that I could still have the vaccine. The nurse proceeded to vaccine. My boss then told me that she was wrong and that I should not have been given the vaccine if I have already had covid. Is the nurse wrong? "Janseen COVID-19 Vaccine EUA"" - experienced following symptoms for 1 day: diarrhea, stomach pain, chills, brain COVID19 VACCINE JANSSEN 1 day 1084316-1 fog/headache, aches throughout my entire body, could barely walk"" Fever/chills and slight nausea overnight (24 hours post-shot). Temperature check is normal, but sweated through night COVID19 VACCINE JANSSEN 1 day 1084338-1 and general malaise 36 hours after shot still. Hot and cold flashes persist 36 hours after. COVID19 VACCINE JANSSEN 1 day 1084401-1 Low grade fever, muscle aches, chills lasted until about midnight. Felt fine next morning COVID19 VACCINE JANSSEN 1 day 1084431-1 Migraine, chills, diarrhea, vomiting, sore muscles, fatigue. Weak COVID19 VACCINE JANSSEN 1 day 1084443-1 Body aches, headache , fatigue, sore throat, Approximately 12 hours after the vaccine I developed a headache and became VERY tired. Approximately 14 hours after COVID19 VACCINE JANSSEN 1 day 1084453-1 the vaccine I developed a fever. As of 9:00 am everything is back to normal.

Around 11 AM on 3/6/21 I began to feel very tired and lethargic. As I had driven back that morning, I returned home COVID19 VACCINE JANSSEN 1 day 1084559-1 and laid down for a nap. Later in the evening, I was still very tired and lethargic. I had no pain, swelling, or redness around my vaccination site. By Sunday morning, 3/7/21 I was feeling fine and have not experienced any symptoms since. COVID19 VACCINE JANSSEN 1 day 1084566-1 Light rash on torso COVID19 VACCINE JANSSEN 1 day 1084575-1 redness, swelling, knot and pain in arm following injection, pt perceives it to be worsening After about 15H after the vaccine I strayed to feel very tired and started having severe body aches, chills, sweating and my teeth were hurting. By 2pm I had 102.5F /103F which lasted all day. At 1am I was in unbearable body ache and COVID19 VACCINE JANSSEN 1 day 1084589-1 103F that I took Tylenol and finally got some relief. The following morning I felt better still with 100F and body aches but better. COVID19 VACCINE JANSSEN 1 day 1084603-1 moderate nausea, chills, fever

COVID19 VACCINE JANSSEN 1 day 1084666-1 Had fever and headache but the event that occurred at the indicated time was uncontrollable movements - almost as if the chills except much more exaggerated movements and higher paced. This was very scary and lasted for an hour or two COVID19 VACCINE JANSSEN 1 day 1084698-1 Fever - treated with OTC (Motrin, Tylenol) Lethargy - treated with rest Symptoms cleared within 24 hours COVID19 VACCINE JANSSEN 1 day 1084704-1 Headache Full body muscle aches COVID19 VACCINE JANSSEN 1 day 1084707-1 Low grade fever and slight cough. Pain at injection site Woke next morning with rash and itching on front lower neck and upper chest. Buring sensation to touch. Rash still COVID19 VACCINE JANSSEN 1 day 1084730-1 present w/o change >72 hours. Recommended taking antihistamine and if no result trying topical steroid. Outcome pending COVID19 VACCINE JANSSEN 1 day 1084735-1 Extreme headach COVID19 VACCINE JANSSEN 1 day 1084740-1 Fever, joint pain, headache, chills. Treated with Tylenol. Lasted for approx. 19 hours. COVID19 VACCINE JANSSEN 1 day 1084757-1 Fever, muscle aches, joint aches, headache COVID19 VACCINE JANSSEN 1 day 1084774-1 Injection Site soreness, chills and fever about 12 hours after receiving Vaccine, slight headache the following morning . FEVER OVER 100, SEVERE HEADACHE, BODY ACHES, CHILLS, RIGORS, SHARP PAINS, CAUSED MY NERVE PAIN FROM THE COVID19 VACCINE JANSSEN 1 day 1084789-1 STROKE TO BE VERY BAD, TINGLING ON MY AFFECTED SIDE, NAUSEA, DIZZINESS, DEHYDRATION, FATIGUE. I WAS GIVEN TYLENOL, IBUPROFEN, ZOFRAN, ATIVAN, AND 2 BAGS OF FLUIDS. Janssen COVID-19 Vaccine EUA. Mid Saturday night I woke up to chills and was shaking so bad I couldn't fall back asleep even after adding another layer of clothes and blanket. Sunday morning I was still very cold and tired from not sleeping. I developed body aches but they were everywhere not just my arm. I was very fatigued and didn't have an appetite. The worst part was getting a migraine with extreme light sensitivity. I couldn't stand to be around any windows without COVID19 VACCINE JANSSEN 1 day 1084812-1 blinds. I spent the day in my bedroom sleeping with the curtains closed and an eye mask on. By that night, the migraine had subsided but I was adding hot flashes to the problem list. Had a pretty restless night again on Sunday. Woke up Monday to the light sensitivity back but not as severe. I took the day off work because I couldn't handle looking at a computer screen all day. By about 1pm I was feeling mostly back to normal. My arm is still sore near the injection site and I'm a bit fatigued at times but those are the only things remaining. COVID19 VACCINE JANSSEN 1 day 1084817-1 Fever, chills, fatigue, heart palpitations, headache The next morning after you got to church all of sudden had major flu-like symptoms. She went home immediately and noticed fever of 100.4, chills, body aches, nausea, headache. She took Tylenol for this, which eased up some of the COVID19 VACCINE JANSSEN 1 day 1084823-1 symptoms and reduced her fever. She still had the chills without the fever, but just slept. Yesterday around 5:00 PM, 3/8/21 the symptoms went away. COVID19 VACCINE JANSSEN 1 day 1084830-1 Chills, Fever (101.0), Achy, Sore muscles, Stiffness, injection site pain, mental fuzziness, Headache COVID19 VACCINE JANSSEN 1 day 1084838-1 Fatigue, chills Chills (inability to get warm) began at 9am for approx 3 hours. Increased room temp and more blankets. Finally warmed up enough to fall asleep for 2-3 hours. Awakened at 3pm flushed and hot. Began tracking temperature started at 100 COVID19 VACCINE JANSSEN 1 day 1084957-1 increased to 101.8. Forced water by mouth during the episode. Took a shower when temperature reached 101.8 and took OTC Tylenol extra strength. Slowly returned to normal. COVID19 VACCINE JANSSEN 1 day 1084968-1 Chills, headache, fatigue COVID19 VACCINE JANSSEN 1 day 1084979-1 Chills, sweating, back ache COVID19 VACCINE JANSSEN 1 day 1084981-1 Headache, muscle aches, stuffy nose, chills, fatigue. All very mild. All gone by the following morning. COVID19 VACCINE JANSSEN 1 day 1084985-1 Nausea body aches COVID19 VACCINE JANSSEN 1 day 1084991-1 Headache, muscle aches, fever over 100. Lasted one day. No treatment, only rest. Day two symptoms were gone. COVID19 VACCINE JANSSEN 1 day 1084996-1 36 hours of body aches, fever, headache. 48 hours of fatigue. COVID19 VACCINE JANSSEN 1 day 1085001-1 Fatigue, headache, muscle aches, fever of 100.7 body aches starting 15 hours post-injection, fatigue starting 17 hours post-injection, fever starting 18 hours post- COVID19 VACCINE JANSSEN 1 day 1085014-1 injection. Fever lasted 6 hours, fatigue and body aches continued into next day lasting 24 hours COVID19 VACCINE JANSSEN 1 day 1085025-1 Muscle cramps, nausea , headache, chills, fever 100.4 Fever, fatigue, congestion, sore arm, sore muscles. The fever started the morning after the shot, and lasted all day. On the second day I woke up with the fever continuing, though the symptoms weren't as strong, and by 3pm they were COVID19 VACCINE JANSSEN 1 day 1085046-1 gone. But that evening when getting ready for bed I experienced extreme shaking and chills, and sweated all throughout the night. On day three I continue to be fatigued, but no fever. COVID19 VACCINE JANSSEN 1 day 1085062-1 Fever, aches I experienced body aches, headache, anxiety in my chest (once), tiredness. One other thing that happened that may not be related is that my secondary implant eye socket became very sore and swelled up. It could of been for another reason but the timing was uncanny. I am feeling fine now and none of my reactions were that troubling. I have COVID19 VACCINE JANSSEN 1 day 1085063-1 experienced about 3 times a sudden feeling in my body that made me think I wonder if that was the vaccine but I am feeling great now and all is good. Thank you so very much for all the research and production of these life saving vaccines. Woke up at 1:00am with chills and uncontrollable shaking. Took Tylenol PM and fell back to sleep. Woke up at 5:30am COVID19 VACCINE JANSSEN 1 day 1085081-1 with headache and full body muscle aches. 1:00 pm took Advil and felt much better an hour afterwards. COVID19 VACCINE JANSSEN 1 day 1085114-1 I woke up with swollen lymphnodes the next day and the area is still swollen and tender to the touch. COVID19 VACCINE JANSSEN 1 day 1085133-1 Nausea, headaches, tired. Chills COVID19 VACCINE JANSSEN 1 day 1085183-1 I had body aches, slight headache and felt drained of energy. Flu like symptoms Adverse events: Severe chills, fever, fatigue, muscle aches, joint pain, dizziness, injection site pain Treatment: COVID19 VACCINE JANSSEN 1 day 1085278-1 Acetaminophen, ice applied to injection site, rest/sleep Duration: chills lasted about 2 hours, fever lasted about 24 hours, muscle/joint pain lasted about 24 hours, injection site pain lasted about 48 hours Woke up the next morning with a neck ache. It got worse as the day went on. Around 11:00 a.m. I developed a COVID19 VACCINE JANSSEN 1 day 1085288-1 headache. Later in the day I had chills for about 3 hours. When I woke up the next morning my neck ache and chills were gone but I had a mild headache. I had Covid in June - and felt the same - fever (not real high - 101), chills, nausea, no energy, headache - lasted from 7pm ish until sometime around 5am woke up sweating and only had slight headache that went away after some fluids - it was COVID19 VACCINE JANSSEN 1 day 1085367-1 not fun at all, but didn't last too long - I didnt take any Advil until about 2 am, then could sleep. Stayed home Monday because I could, but by noon felt nearly 100%, by 6pm felt 100%. 11 am March 8 onset of fatigue, body aches, ""brain fog"" which increase over course of afternoon and persist rest of day/evening Body temperature climbs to 99.5 in late afternoon Focused pain in hip joints, left side neck and jaw Unable COVID19 VACCINE JANSSEN 1 day 1085392-1 to work/pursue normal daily activities entire day of March 8 Symptoms resolve as of March 9, when temp returns to normal, fatigue and aches abate"" COVID19 VACCINE JANSSEN 1 day 1085411-1 Chills - Fever (100 degrees) - Weak/Tired Symptoms lasted 8-10 hours COVID19 VACCINE JANSSEN 1 day 1085425-1 Headache and chills approx 12-14 hrs after dose. Treated with ibuprofen Covid 19 Johnson and Johnson, first and only dose ( not found above) Fever, chills, muscle aches, headache and loose stool COVID19 VACCINE JANSSEN 1 day 1085451-1 Symptoms onset approximately 12hrs after shot lasting 36 hours Treatment Acetaminophen No medical professional consulted Upon waking the morning after my vaccine, I experienced arthralgia, mainly in the knees, myalgia, injection site pain, COVID19 VACCINE JANSSEN 1 day 1085461-1 head heaviness, palpitations/premature ventricular contractions, and general tiredness/malaise. All AEs lasted the entire day until I went to sleep at 10:30 PM, and all were resolved upon waking the following morning at 7:00 AM. COVID19 VACCINE JANSSEN 1 day 1085468-1 Low grade fever Nausea Headache Exhaustion COVID19 VACCINE JANSSEN 1 day 1085493-1 Chills, headache, fatigue I had a headache all day during the day after the vaccination. Nothing too horrible, maybe a 5 out of 10 at the most. I COVID19 VACCINE JANSSEN 1 day 1085528-1 took 3 extra strength Tylenol about every 4 hours to help. COVID19 VACCINE JANSSEN 1 day 1085545-1 Sore arm at injection site COVID19 VACCINE JANSSEN 1 day 1085570-1 Severe muscle and joint pain, fever (+1.7 degrees above typical 97.3 = 99.1), upset stomach, lethargic. COVID19 VACCINE JANSSEN 1 day 1085573-1 Fever 102 degrees F, severe diarreah. Miserable COVID19 VACCINE JANSSEN 1 day 1085603-1 Body aches, head ache, extreme tired. Treated with rest and Tylenol/Tylenol PM I started to feel fatigued around 10:30/11;00 am the morning after my J&J Covid vaccine. By lunchtime, I had chills, fever, COVID19 VACCINE JANSSEN 1 day 1085609-1 nausea, aches and slept the better part of the next 19+ hours. Day 2 after my injection, I woke up with a horrible headache. I am still weak but improving each hour. COVID19 VACCINE JANSSEN 1 day 1085629-1 Vertigo. Nausea. COVID19 VACCINE JANSSEN 1 day 1085633-1 Flu like symptoms and metallic taste in mouth Rv day vaccine at 9:25pm and starting having symptoms around 10am next day. Body aches, headache, chills, lethargy, COVID19 VACCINE JANSSEN 1 day 1085640-1 fatigue. Finished AM work (substitute teaching) and then came home. Minimal appetite: stuck to diet, slept 2.5 hours. Have taken 3 Advil at 4pm. Difficulty swallowing, severe chills, high fever, and severe joint pain appeared 6 hours after the injection. Was treated COVID19 VACCINE JANSSEN 1 day 1085666-1 with Benadryl, Tylenol, and ibuprofen. COVID19 VACCINE JANSSEN 1 day 1085686-1 Janssen COVID-19 Vaccine EUA Muscle and joint aches, headache, Fever 100 degrees, lethargic, trouble sleeping COVID19 VACCINE JANSSEN 1 day 1085737-1 fever 100 degrees, lethargy, aches, cold symptoms, tiredness , dizziness Janssen COVID-19 Vaccine EUA COVID19 VACCINE JANSSEN 1 day 1085751-1 Janssen COVID-19 Vaccine EUA. Side effect has been getting tired with little exertion. Pt presented with AMS. History provided by father at bedside. For 2 days after vaccine pt reported not knowing what he was doing and where he was. Father brought him to ED after having breakfast together and son didn't know how to COVID19 VACCINE JANSSEN 1 day 1085779-1 pay or what foods he liked. Was unable to recall his father's name. Treatment: DAPT with ASA and plavix x21 days and then transition to plavix 75mg daily, atorvastatin 80mg (stroke treatment) Outcome: TBD COVID19 VACCINE JANSSEN 1 day 1085828-1 Fever (102.8), body aches, headache, chills/hot COVID19 VACCINE JANSSEN 1 day 1085845-1 No symptoms after receiving the shot. Next day had a 102.8 fever, chills, body aches & head pressure. COVID19 VACCINE JANSSEN 1 day 1085900-1 Lethargic, chills, loss of appitite I started to feel extreme fatigue around noon the day after but what I found very concerning is I lost probably 80-90% of the strength in my arms. I couldn't palm a ball i had for the kids which i normally can easily. I had chills and nausea as COVID19 VACCINE JANSSEN 1 day 1085902-1 well. I can't really remember much from that day and it feels like a big blur. I woke up the next day feeling very irritable with brain fog. Today its gotten better and I am hoping tomorrow I will be back to normal. Horrendous headache starting 13 1/2 hrs later. Then nausea, and I passed out. Came to and had extreme chills. After the COVID19 VACCINE JANSSEN 1 day 1085917-1 24 hr mark, just tired and had to stay in bed. Today 3/9, all good. COVID19 VACCINE JANSSEN 1 day 1085954-1 Severe chills, headache, mild nausea and diarrhea, and fatigue. COVID19 VACCINE JANSSEN 1 day 1085957-1 extend amounts of pain in the head, mouth, legs inability to walk COVID19 VACCINE JANSSEN 1 day 1086077-1 Chills and body aches sensation of cold, circulation issues in extremities, Severe shakes, Chills, fever: 100.4 at highest, fatigue, muscle aches, COVID19 VACCINE JANSSEN 1 day 1086084-1 abdominal pain. as of now, 15 hours later after incident started at 3:15 am, still low fever of 99.4 ad feel like crud, like have a flu. Woke up with body aches and migraine. Migraine took me out all day. Serve lightheadedness, pass out (full on collapse, COVID19 VACCINE JANSSEN 1 day 1086112-1 woke up laying on ground with hand twitching). Serve lightheadedness continued for next 5 days, where would become dizzy just sitting and if moved would need to stop and let body catch up. Around 1:30 am 3/6/21 I woke up nauseous. Did not vomit. When I got up around 8:30 am the nausea had eased up a lot. Later in the morning I started experiencing muscle aches in my neck, shoulders, back and arms along with a COVID19 VACCINE JANSSEN 1 day 1086127-1 headache. Late afternoon I took my temperature and it was 100.6. I felt like crap! Went to bed around 9:00 pm still feeling bad Saturday night. I was much better when I woke up 9 hrs later. COVID19 VACCINE JANSSEN 1 day 1086176-1 Fever, chills, lower back pains and achiness COVID19 VACCINE JANSSEN 1 day 1086209-1 lt foot is vibrating under skin, like a surge COVID19 VACCINE JANSSEN 1 day 1086277-1 Headache, severe body aches, tiredness Chills (severe for an hour) Fever (100.0), all day relieved briefly with tylenol Body aches, over 16 hours Dizziness, on and COVID19 VACCINE JANSSEN 1 day 1086306-1 off Weakness, all day Headache, all day Arm pain around injection site I had dizziness for the majority of the day Saturday and Sunday. I was fatigued, but made myself stay awake up the whole day Saturday. I had a very weird dream Saturday night and woke up very tired Sunday morning around 8 am. I COVID19 VACCINE JANSSEN 1 day 1086336-1 went back to bed 11:15 am and slept until 1:30. The dizziness lasted the rest of Sunday. I have only slept for 5 hours between Sunday night and today (Tuesday March 9th). Cluster headache behind right eye that turned into eye pain around/behind eye (not the eye itself) Headache subsided COVID19 VACCINE JANSSEN 1 day 1086346-1 with ibuprofen and Tylenol but pain around/behind eye persisted (currently on day 4, discomfort has subsided some but still noticeable) COVID19 VACCINE JANSSEN 1 day 1086357-1 Arm/shoulder pain, chills, low-grade fever (100.2) from approximately 3:30 a.m. - 3:30 p.m. about 15 hours after shot developed fever (99.5) and chills and headache. This laster about a day. Then I felt like I had a cold and had ntermittent slight sore throat. On the third day after shot experienced mild nausea. Headache disappeared COVID19 VACCINE JANSSEN 1 day 1086359-1 as did sore throat. At no time was there soreness at injection site, and I had no arm pain at all. So in toto, I was out of commission for 3 days. COVID19 VACCINE JANSSEN 1 day 1086373-1 Chills, aches and pains - lasted approximately 12 hours COVID19 VACCINE JANSSEN 1 day 1086417-1 Fatigue, muscle aches, headache, nausea and continuing pain in right jaw joint COVID19 VACCINE JANSSEN 1 day 1086433-1 Fever, chills, headache, body aches COVID19 VACCINE JANSSEN 1 day 1086474-1 swollen / puffiness on left collarbone neck area. still swollen / puffy March 8th Body ache, tired, congestion, chills. I Left work at 5pm, went to bed at 6pm, Took ibuprofen PM. Slept until COVID19 VACCINE JANSSEN 1 day 1086506-1 10:30pm, had some water, went back to bed. Woke up at 4:30am (March 9th), wet from sweat/fever, difficulty breathing through nose. Took two more ibuprofen PM. Slept until 11:30 am. Felt better, but stayed home. I had Covid in January. I felt fine after 12::30vaccine then awoke at 4:30an .. chills, earache, hot neck, extreme COVID19 VACCINE JANSSEN 1 day 1086519-1 tiredness... body aches.. lasted until 6:00pm that day COVID19 VACCINE JANSSEN 1 day 1087221-1 Flu-like symptoms, stabbing chest pain, dizziness, fatigue, rash, and wheezing that developed around 0930 on 3/9. COVID19 VACCINE JANSSEN 1 day 1087236-1 Fever (101f), body aches all over, headache COVID19 VACCINE JANSSEN 1 day 1087247-1 Fever (101.8), body aches, chills onset about 8 hours after injection. Treated successfully with nsaid Headache, dizziness, temporary tingling and numbness of lips and loss of smell; foggy brain , inability to complete COVID19 VACCINE JANSSEN 1 day 1087249-1 sentence and thoughts lasting 3-5 hours with slightly slurred speech COVID19 VACCINE JANSSEN 1 day 1087256-1 Pain in injection site, mild fever, nausea COVID19 VACCINE JANSSEN 1 day 1087262-1 Strong headache; cold feet COVID19 VACCINE JANSSEN 1 day 1087279-1 Fever: 100.4 Chills Headache Fatigue Body aches Treatment: OTC/naproxen 1:20am: woke up with full body chills and felt feverish. Temperature was 99.1 4:30am: woke up with full body chills. Temperature 101.7. full body aches. headache. 6:30am: took ibuprofen. 8:00am-4pm: fever went away. aches and COVID19 VACCINE JANSSEN 1 day 1087324-1 headache remained. 12:00pm: took ibuprofen 4pm: diarrhea 7pm: achy and lethargic. took ibuprofen 8pm: went to bed. 6:00am: woke up sweaty. Felt 99% back to normal. Left arm still sore. COVID19 VACCINE JANSSEN 1 day 1087345-1 Chills Fatigue Headache Muscle aches Loss of appetite COVID19 VACCINE JANSSEN 1 day 1087371-1 100 fever Severe aches pain Headaches Happened 12 am COVID19 VACCINE JANSSEN 1 day 1087376-1 Janssen COVID-19 Vaccine EUA headache, fever, chills, nausea COVID19 VACCINE JANSSEN 1 day 1087396-1 Severe headache pain in the eyes a lot of pain in the body breast pain the arm swollen and red nausea Woke up with a severe headache, threw up, had chil. A rash on my neck developed that was red, itchy, and scaly and has COVID19 VACCINE JANSSEN 1 day 1087398-1 persisted for 4 days. COVID19 VACCINE JANSSEN 1 day 1087422-1 Chills, tiredness, muscle aches, fever Severe headache (to the point where it was affecting my vision), dehydration, sweats and chills as though I had a fever, COVID19 VACCINE JANSSEN 1 day 1087434-1 muscle aches, and difficulty sleeping. All of these symptoms lasted for approximately 9 hours. They started 10 hours after the vaccine itself. 5:30AM (time I got up) Injection site soreness and stiffness, headache and body aches (skin sensitivity). Took Ibprophen COVID19 VACCINE JANSSEN 1 day 1087445-1 and hot shower; symptoms subsided in about 30 to 60 minutes. Headache. Low grade fever. Body aches. Exhaustion. Started 24 hours after shot. And lasted less than 24 hours. COVID19 VACCINE JANSSEN 1 day 1087448-1 Symptoms are totally gone now. Received my Covid shot yesterday at a Mall Testing Site.About 8pm I began having severe chills. I went to bed at 9:30pm, woke up at 1:00am and took some Motrin. This morning at 6:40 am I still had chills so I took my temperature COVID19 VACCINE JANSSEN 1 day 1087449-1 and it was 100.0 degrees. It has remained 100 degrees this morning. I took some more Motrin. My right arm is also sore at injection site. COVID19 VACCINE JANSSEN 1 day 1087459-1 Chills, headache, body ache, start 1am-9pm, took ibuprofen COVID19 VACCINE JANSSEN 1 day 1087482-1 Headache, fatigue, loss appetite, light head, COVID19 VACCINE JANSSEN 1 day 1087500-1 High fever 102.3 following morning with significant body aches COVID19 VACCINE JANSSEN 1 day 1087513-1 Brutal headache day following About 9 hours after the injection, I experienced chills, increased heart rate, and headache. I began taking alternate doses COVID19 VACCINE JANSSEN 1 day 1087552-1 of aspirin and acetaminophen. By 5 a.m., chills were gone. COVID19 VACCINE JANSSEN 1 day 1087570-1 chills (woke up cold in middle of the night and couldn't stop shivering) :Took vaccine at 1:15pm March 9 then 12 hours later at 1:15 am March she started shivering and threw up once. Felt COVID19 VACCINE JANSSEN 1 day 1087586-1 lousy. Headache No rashes, injection site clear. No fever Took Tylenol 9:30 am for headache Janssen COVID-19 Vaccine EUA Sore arm, woke up at 1:00am with chills but no fever. I went back to sleep. When I got up COVID19 VACCINE JANSSEN 1 day 1087587-1 at 5:40am, I had a headache and my body was aching. I took ibuprofen. After a few hours, those symptoms are much milder. I felt pain in my left arm where the vaccine was injected, but not limited to the site, but also under the arm and in the COVID19 VACCINE JANSSEN 1 day 1087596-1 full arm till the arm wrest. Also, it included pain in the arm pit. I didn't go to a doctor. The pain was reduced after taking two 500 mg Tylenol, but there I still feel my left arm heavy and not normal. Chills, headache, body aches and very tired for about 24 hours. Took Tylenol every 6 hours. Redness and raised area COVID19 VACCINE JANSSEN 1 day 1087599-1 where shot was administered and is still that way. COVID19 VACCINE JANSSEN 1 day 1087606-1 Nausea, Ice Pick headaches behind eyes, fever , joint soreness I woke up with an excruciating headache (with light sensitivity) that did not initially respond to Tylenol. Although I did COVID19 VACCINE JANSSEN 1 day 1087609-1 not have a fever, I had temperature regulation issues all night - alternating between hot and cold - and woke up sweaty. Headache responded to Advil in the morning but I still have a minor lingering headache a few hours later. COVID19 VACCINE JANSSEN 1 day 1087613-1 Fever Severe muscle pain whole body Headache Pain at injection site COVID19 VACCINE JANSSEN 1 day 1087639-1 Muscle aches, nausea, fatigue COVID19 VACCINE JANSSEN 1 day 1087654-1 Chills, fever, fatigue, increased heart rate started at 6 hours after vaccine COVID19 VACCINE JANSSEN 1 day 1087664-1 Started feeling dizzy the next morning. COVID19 VACCINE JANSSEN 1 day 1087720-1 Fever Chills Headache Nauseated Dizzy Light Headed Tired COVID19 VACCINE JANSSEN 1 day 1087721-1 Fever, Aches, Fatigue for a 48 hour period beginning 12 hours after the injection. Highest fever was 102 deg COVID19 VACCINE JANSSEN 1 day 1087728-1 Headache, chills, body aches and low fever for 2 days Janssen COVID-19 Vaccine EUA Injection site bruising, swelling, redness, burning General - headache, very very tired, bloating/puffiness, muscle aches, nausea, low grade fever, light dizziness Took ibuprofen and drank lots of water... cold COVID19 VACCINE JANSSEN 1 day 1087768-1 compress on arm...rest when needed As of Wednesday morning, the reactions are lowering and slowing down. The site is still swollen some and bruised and red. COVID19 VACCINE JANSSEN 1 day 1087792-1 Night sweats, headache, fatigue. Fast and elevated heart rate beginning on 3/9/2021 and continuing on 3/10/2021. COVID19 VACCINE JANSSEN 1 day 1087802-1 HEADACHE, CHILLS,BODY ACHES, NAUSEA, FATIGUE

I woke up the day after my vaccine feeling slightly nauseous and with chills, which I expected. However, by 8:00 am I had a headache equal to the worst migraine I've ever had. I laid in bed all day trying not to move as any movement caused COVID19 VACCINE JANSSEN 1 day 1087811-1 intense nausea. At times, I felt that my heart was fluttering or irregular. I vomited 3 times, but despite having eaten dinner the night before, I seemed to have nothing to throw up. I vomited clear liquid, if anything at all, which had a strong metallic taste. The vomiting was very intense, leaving me sweating and exhausted. I fell asleep around 8:00 pm, and when my husband woke me at 9:15 to check on me, I could tell that the sharpness and intensity of the headache was gone. I still had a headache, but it was a normal headache. Today, the 10th, I woke up feeling mostly normal, just weak. COVID19 VACCINE JANSSEN 1 day 1087818-1 Fever, nausea, pain under left arm in armpit, diarrhea, headaches, aches. COVID19 VACCINE JANSSEN 1 day 1087832-1 Severe headache for 24 hours, lethargy, body soreness COVID19 VACCINE JANSSEN 1 day 1087866-1 Chills, fever, body aches, headache, sore arm at injection site. Lasted two days. COVID19 VACCINE JANSSEN 1 day 1087875-1 Headache, nausea, dizziness, chills, fever, runny nose, watery eyes COVID19 VACCINE JANSSEN 1 day 1087876-1 Very tired for three days. Difficulty thinking for three days. Fever and chills the next day. At 3:00 pm the day after I received the Johnson&Johnson COVID-19 vaccine I developed a red, raised, swollen, hot, COVID19 VACCINE JANSSEN 1 day 1087895-1 painful circle 5'' in diameter on my left arm under the injection site. My arm is hot to touch, swollen, and still painful the next day and the circle has spread more and has started to turn purple. Caller is pt's mother; not sure if fever and diarrhea are r/t vaccine or hx of Crohn's disease as he had a low grade temp of COVID19 VACCINE JANSSEN 1 day 1087917-1 99 at home yesterday prior to receiving vaccine. COVID19 VACCINE JANSSEN 1 day 1087920-1 Muscle aches, feverish, stomach upset, sinus/cough COVID19 VACCINE JANSSEN 1 day 1087922-1 chills, low grade fever, nausea, headache, body aches COVID19 VACCINE JANSSEN 1 day 1087935-1 Nausea, fatigue, muscle aches, chills, headache - started about 8 hours after injection and lasted about 12 hours Patient developed hives the day after receiving the vaccination 3/6/2021. Hives come and go, very itchy. Continues to have sporadic hives on 3/10/2021. She is using Benadryl PRN. Recently prescribed prednisone for Hives. She also had a COVID19 VACCINE JANSSEN 1 day 1087956-1 swollen throat day after receiving the vaccination without difficulty swallowing. Took Benadryl PRN, this has since subsided. 24 hours of receipt my eyes hurt. My bones and joints hurt. I was extremely cold. Lasted approximately 4 hours 50 hours after receipt my eyes hurt again. I was freezing and shaking. My bones hurt again.I would start sweating and become COVID19 VACCINE JANSSEN 1 day 1087959-1 extremely hot then cold again. My mouth was dry and I was extremely thirsty. I could not sleep. This lasted approximately 6 hours and I was fine. All reactions were very similar to those experienced when I had COVID in December 2020. Allergic skin reaction/break out at the site of the injection on outside of the arm and continuing under the arm down the COVID19 VACCINE JANSSEN 1 day 1087967-1 arm. Bumpy itchy and redness. Started with fatigue and aching in the morning following the vaccination. Approximately 24 hours after the vaccination I COVID19 VACCINE JANSSEN 1 day 1087969-1 had developed a fever that reached as high as 103F. By the next morning (a little over 36 hours later) I still had a fever of 100F but am feeling progressively better. COVID19 VACCINE JANSSEN 1 day 1087977-1 Fever, chills, body aches, headache, lightheaded Morning day 2: Onset of overwhelming tiredness, slight headache and some ""arthritis-like"" discomfort in my joints . I COVID19 VACCINE JANSSEN 1 day 1088034-1 had Lyme disease about 5 years ago and it felt very similar to those initial symptoms. The elbow that was most affected by the Lyme disease was much more uncomfortable than other joints."" Body Aches, Chills, headache, tired. Started at 11am then got worse as day progressed. Took Tylenol at 7. Heavy sweat COVID19 VACCINE JANSSEN 1 day 1088051-1 (fever broke) at about 8pm. Felt a little better 10. Took Advil and went to sleep. Felt fine by 7am. Shoulder and arm slightly sore; one day; vaccine area still slightly tender legs muscles extremely tight; warm soak in COVID19 VACCINE JANSSEN 1 day 1088100-1 epsom salt and overnight rest seem to dissolve the situation COVID19 VACCINE JANSSEN 1 day 1088117-1 Headache that lasted 10-12hours. Excedrin did not ameliorate which is very atypical for me.

COVID19 VACCINE JANSSEN 1 day 1088129-1 Within 24 hours I experienced profuse sweating followed by aching in my neck, shoulders, arms and lower back. This was then followed with severe fatigue, cold chills and diarrhea. Symptoms subsided after approximately 24 hrs of onset. COVID19 VACCINE JANSSEN 1 day 1088148-1 Flu-like symptoms, bad headache (no fever). Chills, dizziness, general achiness Chills and body aches in the middle of the night. Still achey feeling a little rough today. Nothing serious. I have had COVID19 VACCINE JANSSEN 1 day 1088174-1 similar responses from annual flu shots. COVID19 VACCINE JANSSEN 1 day 1088181-1 Woke up in middle of the night freezing while being super hot to the touch. Realized I probably had a fever. Immediate muscular pain and soreness at injection site Delayed muscle soreness in back, legs, and arms. Chills COVID19 VACCINE JANSSEN 1 day 1088185-1 Headache/Sinus Pressure Nausea/dizziness COVID19 VACCINE JANSSEN 1 day 1088186-1 headache, chills, fever, body aches, lower back pain. brief dizziness followed by onset of chills and muscle aches that lasted for approximately 2 hours. Now, approximately 22 COVID19 VACCINE JANSSEN 1 day 1088237-1 hours later, I am experiencing fatigue, light nausea, headache, and hot flashes. COVID19 VACCINE JANSSEN 1 day 1088245-1 eye twitching; all day and sporadic the next day COVID19 VACCINE JANSSEN 1 day 1088251-1 Fever (102.8), severe headache, moderate body aches, mild nausea. Mild pain right after the injection lasted for about 30 seconds. About 8 hours later, I started getting some nausea and an COVID19 VACCINE JANSSEN 1 day 1088254-1 upset stomach, along with some mild aches and pains. After taking a short nap, I woke up feeling a little feverish (though no fever). COVID19 VACCINE JANSSEN 1 day 1088256-1 body aches starting the next day and lasting a full day Stinging, burning pain in upper right thigh, at the site of where I developed shingles about 3-4 yrs ago. I will be COVID19 VACCINE JANSSEN 1 day 1088286-1 watching that area and if it looks like a shingles outbreak, I will go see my PCP, Dr. COVID19 VACCINE JANSSEN 1 day 1088327-1 fever, cramps, and fatigue Severe fatigue, migraine, dizziness starting day after vaccine and continuing for at least 24 hours. Treated at home with COVID19 VACCINE JANSSEN 1 day 1088335-1 rest, lots of sleep, hydration. COVID19 VACCINE JANSSEN 1 day 1088366-1 102 degree fever, body aches, chills, muscle soreness throughout body, headache COVID19 VACCINE JANSSEN 1 day 1088394-1 fever up to 102.3, headache, chills, nausea, dizziness, body aches, weakness swollen ankles and toes, toe swelling resolved after 3 days, patient still had some ankle swelling on day 4 but was COVID19 VACCINE JANSSEN 1 day 1088432-1 muchimproved 3-09-2021-4:30 am,Immobility, felt like I took a muscle relaxer, sever muscle and joint pain, blinding headache, chills, I felt COVID19 VACCINE JANSSEN 1 day 1088437-1 frozen all day. Some diarrhea and felt severely fatigued. Was unable to work I took a sick day. 3-10-2021 Another sick day still had symptoms. COVID19 VACCINE JANSSEN 1 day 1088481-1 Chills, achy, fatigue. No fever. Treating with tylenol COVID19 VACCINE JANSSEN 1 day 1088522-1 vertigo, lethargy, tinnitus, malaise, mild diaphoresis, confusion, nausea & vomiting I spiked a fever of 101, had joint pain in all joints except fingers and toes, my muscles ached and spasmed a bit and a had COVID19 VACCINE JANSSEN 1 day 1088549-1 an incredibly bad headache. COVID19 VACCINE JANSSEN 1 day 1088593-1 Body aches and chills, little headache COVID19 VACCINE JANSSEN 1 day 1088608-1 Bad Headache Chills Body and Muscle Aches Extreme fatigue Pain at Injection site Moderate flu-like symptoms for 24 hours -- sore muscles, joint pain, headache, fatigue, nausea, constipation, loss of COVID19 VACCINE JANSSEN 1 day 1088622-1 appetite. Severe enough that I took afternoon off from work. COVID19 VACCINE JANSSEN 1 day 1088629-1 Slight muscle soreness , fever of 102.5, weak, tired , slight nausea Janssen COVID-19 Vaccine EUA - Developed fatigue 24 hours later, and a fever. Went as high as 101.1. Went down to COVID19 VACCINE JANSSEN 1 day 1088683-1 normal by Weds. morning, but was back up to 100.8 by 9 am. Now at 12:00 its 100.1. Otherwise feel fine. Janssen covid-19 vaccine EUA Aside from injection site pain, about 12 hours after receiving the shot, at 12pm Tuesday, I COVID19 VACCINE JANSSEN 1 day 1088708-1 had a headache, muscle aches, and chills with a temperature of 99 degrees. It subsided with Tylenol but returned as it wore off. On Wednesday morning my temperature was 100 degrees. 5:00PM or so the following evening 3/9/21 I started to not feel well. Headache, nausea and general ill feeling. 6:30PM COVID19 VACCINE JANSSEN 1 day 1088762-1 started running fever of close to 108. Fever went up to 102 at its highest. 3/10/21 felt ""ok"" but stayed home from work. No fever until around 3:00 when it was 100.4."" 2 hours after vaccination I noticed left arm started hurting . Went to bed at my usual time and woke up at 2:00 am with the chills I could not get warm late that night around 5:00 am I started having joint pain and fatigue with a headache and hot skin. I had taken my temperature and it was 100.7. I tried to wait out symptoms but I seem to bee get worse COVID19 VACCINE JANSSEN 1 day 1088775-1 throughout the morning. Around 10:00 am I was in terrible pain and my body hurt all over. I once again took my temperature and it had gone up to 101.9. I had to call of work because I was so ?out of it?. I started taking Tylenol ever 4 hrs for my fever and I was trying to hydrate. My temperature slowly went down but still had body pain. I then started thank ibuprofen to help. Later that night around 9:00 pm my temperature was 99. The next day I called off work for fatigue and body pain. Today my temperature is normal and I?m starting to feel like my self again COVID19 VACCINE JANSSEN 1 day 1088829-1 rash on my back that is very sensitive, also, top of my scalp is very sensitive (no rash) Patient complained of a shingles flare the day after receiving vaccine and also described intensification of chronic pain, COVID19 VACCINE JANSSEN 1 day 1088851-1 above and beyond normal, for the two days since her vaccine. Approx 8 hours after the shot, 12:30am, I started to have chills. The chills prevented me from sleeping well. Also when I laid down for the night, I was accutely aware of my heartbeat, which according to my smartwatch was beating at a rate of 71. The next morning, I still was experiencing chills, and felt achy/stiff/sore muscles - possibly from tensing up and COVID19 VACCINE JANSSEN 1 day 1088870-1 shivering all night. Pain at the injection shot also started the morning after the shot. By bedtime the day after the shot, the symptoms had eased up. The next morning the symptoms were gone, except for a little residual injection site discomfort. Patient described a shingles flare the day after her injection and also described intensification of chronic pain, above and COVID19 VACCINE JANSSEN 1 day 1088892-1 beyond normal pain, for the two days after her vaccination. COVID19 VACCINE JANSSEN 1 day 1088904-1 Fever up to 100.9, fatigue Within 24 hours a fever of 101.3 and extreme fatigue set in. 1"" raised red lump at injection site with redness, pain, and COVID19 VACCINE JANSSEN 1 day 1088907-1 itching. Benedryl and Tylenol taken as indicated on package and symptoms were mostly alleviated in 36 hours. Redness and itching remain at swollen injection site 72 hours post injection.""

Around 3:15 in the afternoon, I began experiencing severe aches and muscle pains, combined with a growing migraine. Not realizing what it may be related to, I took two ibuprofen and I've acetaminophen. By the time I around home around 6:30, I could barely hold myself up. I ate dinner, which only helped minimally, and by 8 pm felt like death. My COVID19 VACCINE JANSSEN 1 day 1088910-1 husband notice I looked red and felt my forehead, immediately going for the thermometer. I had a fever of 100.5. We eventually got me into bed after downing a lot of water, but the pain would not ease up. The pain was too excruciating. At 10:30 my husband came to bed and we took my temp again which was 101.6. To help me sleep I took another Tylenol. At 5:45 my work alarm went off and I checked my temp again; still 101.6. I got a cold pack for my migraine and went back to sleep. Slowly throughout the day my fever dwindled, until it finally broke in the early afternoon. By 4:15, as I am writing this, all that's left is done tiredness, thirst, and a small bit of achiness. COVID19 VACCINE JANSSEN 1 day 1088976-1 3/10/21 am - developed low grade fever, dizzy, neck, shoulder, arm area soreness, fatigue COVID19 VACCINE JANSSEN 1 day 1088979-1 Fever 102.4 Starting the morning after receiving the vaccine, the injection site was painful, red, sore, and very swollen. Every single day since (It is now 03/10 - 5 days after), the injection site welt has grown in size and redness, as well as painful to touch, COVID19 VACCINE JANSSEN 1 day 1089049-1 warm to touch, and soreness extending down left arm. It is very similar to the ""COVID Arm"" hypersensitivity effects seen with the Moderna vaccine."" patient developed a rash and hives on head neck and face. Patient went to work and was identified to have an adverse reaction to the Janssen immunization. Patient was sent to the clinic for treatment and was told to use Benadryl for the COVID19 VACCINE JANSSEN 1 day 1089077-1 rash. patient did take two capsules for a 50 mg dose. Patient worked about two to three hours and was then sent home for high blood pressure which patient claims lasted three hours. Patient is feeling fine on 03/10/2021 and says they do not have a rash today. COVID19 VACCINE JANSSEN 1 day 1089115-1 Fever (104.4) localized pain, accelerated heart rate, nausea, headache, dizziness COVID19 VACCINE JANSSEN 1 day 1089141-1 Nausea, body aches, fever all started 24 hours after vaccine. Slept 12 hours. Ok next morning. Developed Fever of 105 at 12:30 am - fever finally to 99.7 at 4:00am; chills, body aches, severe lethargy. Sunday 3/7/2021 devleoped knot on arm that has sever burning sensation, hot to touch. Monday 3/8/2021 a fever blister COVID19 VACCINE JANSSEN 1 day 1089171-1 developed on mouth; Tuesday 3/9/2021 - knot still there- Urgent Care visit diagnosed cellulitis - dr stated a puss pocket could be seen under skin and knot on arm size of two quarters. COVID19 VACCINE JANSSEN 1 day 1089208-1 Headache, nauseous- vomited multiple times COVID19 VACCINE JANSSEN 1 day 1089229-1 tiredness, breathing heavy, low raspatory rate COVID19 VACCINE JANSSEN 1 day 1089237-1 Welt, Redness, & Pain at injection site After my Johnson & Johnson vaccine, the following day I developed a red, diffuse in radius size (like a spider bite) rash COVID19 VACCINE JANSSEN 1 day 1089259-1 that is warm to touch and very painful. I am still in pain, the site has some color to it and will be having an appointment with my PCP on 03-11-2021. COVID19 VACCINE JANSSEN 1 day 1089260-1 extreme fatigue COVID19 VACCINE JANSSEN 1 day 1089292-1 Fever and restlessness for about two hours, followed by low-grade headache, and body ache, generally feeling tired. COVID19 VACCINE JANSSEN 1 day 1089295-1 head ache, nausea, vomiting, extreme fatigue Received COVID-19 Vaccine on 03/08/2021. About 7:00 am the next morning began having N/V x4 past 12 hrs, diarrhea x 6, headache and blood in urine. Chronic illness of stage 4 kidney disease with bilateral nephrostomy and acute bloody discharge, ulcerative colitis with colostomy and acute high output, CAD with 7 cardiac stents and 2 CABG. A&Ox4, COVID19 VACCINE JANSSEN 1 day 1089419-1 Malaise, tachycardia and hypotension, afebrile. Patient reports chronic abdominal pain unchanged today. Denies back pain, chest pain, cough, or SHOB. Afebrile. Patient has new diagnosis of UTI. IV fluids administered, IV Zofran, Meropenem, and po Hydrocodone/APAP. Transferred due to creatinine of 4.3, bloody urine, and UTI. T: 98.1 HR 91, R-14 BP 106/71, O2 sat 97% Dizziness, nausea, hyperglycemia (see below) despite reduced PO solid food intake and increased PO water intake. A1c 4 months prior 6.8%, home self monitored blood sugar readings of 322 in the AM after 12 hours of fasting, with reduction COVID19 VACCINE JANSSEN 1 day 1089431-1 in PO solid food intake and increased PO water intake patient's blood sugar in the late afternoon reduces to 150's however her dizziness and nausea continue. COVID19 VACCINE JANSSEN 1 day 1089447-1 Temperature of 101.3 resolving after approximatley 36 hours COVID19 VACCINE JANSSEN 1 day 1089455-1 Pt stated that he had experience side effect of Janssen Vaccine like Headache, Muscle aches, Fever , Pain When I woke up the next, I had severe muscle pain for the whole body, chills, nausea, headache, sharp pain to the back COVID19 VACCINE JANSSEN 1 day 1089648-1 of the head. Today (3/10/2021) I don't feel muscle pain for the whole body, chills, nausea but I have sharp pain inside left ears, headache and dizzy. COVID19 VACCINE JANSSEN 1 day 1090340-1 Fever, nausea, vomiting At 1:30am I woke up with the chills and body aches, I had to bundle up with my jacket, over my pajamas and add a COVID19 VACCINE JANSSEN 1 day 1090376-1 second blanket. I also felt wide awake and I'm not a morning person. My entire body aches every for my head. My joints and muscles hurt from my toes up to my shoulders COVID19 VACCINE JANSSEN 1 day 1090385-1 headache, feeling tired, muscle aches, fever, nausea COVID19 VACCINE JANSSEN 1 day 1090398-1 Fever of 102 for 4 days Arm sore and red hot to the touch Headaches for 4 days Tired COVID19 VACCINE JANSSEN 1 day 1090426-1 Systemic: Fever-Medium, Systemic: Headache-Medium Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Medium, Additional Details: 1:19PM: Pt expressed anxiety, received vaccination, c/o of panic attack and sad down by the chair. 3 secs later, looked flaccid, unresponsive, discolorized, jerked breafly, bladder COVID19 VACCINE JANSSEN 1 day 1090432-1 incontinent, loud sound, no difficulty breathing, no allergic reaction. RPH open airway, layed on side, head raised and called 911. Pt immediated had a deep breath and became responsive, alert/oriented x3. Ambulance, SaO2 97%.Pt later didn't see the need to urgent care, husband insisted, transported out by ambulance. COVID19 VACCINE JANSSEN 1 day 1090481-1 Achy, sluggish, runny nose, sore throat Jansen Covid-19 Vaccine EUA Within hours of the vaccine I experienced body aches and sore arm about 16 hours later I had extreme body aches with chills so bad I could hardly walk from shivering accompanied by a mild headache. Even the COVID19 VACCINE JANSSEN 1 day 1090508-1 inside of my mouth was freezing. I then experienced nausea and extreme tiredness. Then about 8 hours later I was drenched in sweat thru the night and woke today with only a sore arm and slight body aches. COVID19 VACCINE JANSSEN 1 day 1090535-1 Fatigue, chills, slight nausea. COVID19 VACCINE JANSSEN 1 day 1090540-1 Pounding headache, nausea, chills, muscle and body aching and pain at the injection site. COVID19 VACCINE JANSSEN 1 day 1090581-1 a brief moment of vertigo COVID19 VACCINE JANSSEN 1 day 1090583-1 Fever, chills, fatigue COVID19 VACCINE JANSSEN 1 day 1090610-1 Fever, muscles aches, headache, slight nausea COVID19 VACCINE JANSSEN 1 day 1090614-1 Body aches Chills Headache Fever The first day at night woke up with night sweats and fatigue. Second-day headache and have a rash on the upper front COVID19 VACCINE JANSSEN 1 day 1090615-1 part of my body and the upper part of my body on my back. COVID19 VACCINE JANSSEN 1 day 1090676-1 awoke at 5am with severe chills and body aches, severe fatigue chills, fatigue, ache around both elbows, nausea. Chills and nausea starts early morning at last until late morning early COVID19 VACCINE JANSSEN 1 day 1090684-1 afternoon. Fatigue and elbow ache is stronger during morning hours. Patient had normal side effects of low grade fever, chills, headache, but then developed a swollen lymph node under her right arm. (Right Axillary Node) Patient is retired healthcare worker. She said upon palpitation the node feels ""golf- COVID19 VACCINE JANSSEN 1 day 1090707-1 ball"" sized. She stated it does seem to be shrinking in size by this morning. We felt it may be an important symptom to document due to her Lupus diagnosis and lack of studies in patients with this disease."" COVID19 VACCINE JANSSEN 1 day 1090729-1 Low grade fever the day after and migraine headache since. Ibuprofen eases headache

I woke up at 2 AM in the morning and had unbearable pain in my legs, as if I had run a marathon, but laying down was COVID19 VACCINE JANSSEN 1 day 1090757-1 not helping, nor was stretching etc. I almost went to the emergency room because it was so painful. I took Aleve and it eventually helped, but this morning my legs are still feeling weak down to my bones. I am afraid I have nerve damage. At 2am, I woke up with severe chills and uncontrollable shaking. No fever. Around 6am woke up with severe aches, and COVID19 VACCINE JANSSEN 1 day 1090791-1 flu like fatigue. Severe nausea. I am 12 weeks pregnant, due September 19, 2021. This is my first pregnancy and I had my doctor?s approval to get the vaccine. I have had no complications so far in my pregnancy. On the day after receiving the vaccine, I developed a severe COVID19 VACCINE JANSSEN 1 day 1090803-1 headache, congestion, dehydration, and fatigue. I felt feverish and had chills, but I did not have a fever. I was unable to go about my daily activities (I was not working on this day). These symptoms went away about 36 hours after being vaccinated. I also had pain at the injection site. Just Sore arm and a bad Headache for 2 days. Sending just for information value on the vaccine. Just took tylenol on COVID19 VACCINE JANSSEN 1 day 1090875-1 next day. COVID19 VACCINE JANSSEN 1 day 1090882-1 1:30 am 102.4 fever, body ache, chills, and headache throughout the night 6:30 am severe headache COVID19 VACCINE JANSSEN 1 day 1090886-1 Fever, achy body, headache COVID19 VACCINE JANSSEN 1 day 1090891-1 Reduction in taste/unusual flavors COVID19 VACCINE JANSSEN 1 day 1090911-1 HIgh fever, fatigue, headache and nauseous Arm sore after injection. Loss of appetite for dinner. Woke up around 2:00 AM with chills. Added more clothes and tried to go back to sleep. Felt hot and took temperature and had a temperature of 100. Body aches. Took Tylonel around COVID19 VACCINE JANSSEN 1 day 1090941-1 3:30 AM. Couldn't sleep. Tylonel helped and I was able to fall back asleep. Woke up at 6:00 AM for my day. Fever gone, aches still a little there, tired from lack of sleep and a little bit of chills. It was a rough night but overall feeling good today. Subject woke up to use the bathroom and passed out while on the toilet. She called my name immediately prior to the COVID19 VACCINE JANSSEN 1 day 1090947-1 event. She fell prostrate on the floor resulting in facial bruising/cuts. Subject regained conciousness one minute later. She was able to work the next day and had chills for the next 2 days. I had fever, extreme chills, a terrible headache, super fatigue, upset stomach-loose bowels Sunday into Monday. Fever, COVID19 VACCINE JANSSEN 1 day 1090960-1 extreme chills, a terrible headache, super fatigue lasted until Tuesday. July 30, 2021 is my estimated date of delivery. I am 19 weeks gestation.

Janssen COVID-19 Vaccine EUA. I had the vaccine at around 4:00 pm and felt fine until I woke up around 12:30 am. I had COVID19 VACCINE JANSSEN 1 day 1090961-1 severe chills and shakes, body aches, and a headache. It eventually turned into sweating. Around 8:30am, it's not as severe. I took tylenol around 8:30 am and do not feel like I have the chills anymore, just body aches and some fatigue. COVID19 VACCINE JANSSEN 1 day 1090973-1 Headache, lasted 27 hours. starting 15 hours after injection Fatigue starting 10 hours after injection lasting 40 hours COVID19 VACCINE JANSSEN 1 day 1090993-1 Headache, fatigue, dizziness, weakness, brain fog, nausea COVID19 VACCINE JANSSEN 1 day 1091024-1 Fatigue, slight to moderate headache COVID19 VACCINE JANSSEN 1 day 1091131-1 Fatigue, slight to moderate headache Bad headache, fatigue. Started about 15 hours after vaccination. Fever 100.1. Normal ?shot hurt? pain in arm. Took COVID19 VACCINE JANSSEN 1 day 1091150-1 Advil. Slight improvement. Submitting this form 17 hours after injection. Ten hours after vaccination into my left arm, my right arm, right leg, and right hip bones felt as if they were being crushed. I finally fell asleep for an hour or two, then awaken just in time to make it to the bathroom where I sat on the toilet ALL night having severe diarrhea and vomiting into a container on my lap. I would fall asleep, then wake up, on COVID19 VACCINE JANSSEN 1 day 1091197-1 the toilet, very sick. The vomiting ended after that first night, but the diarrhea has persisted. It is getting better, though. (It has been 72 hours since the shot.) I had a headache, my left arm ached, I was nauseous, and feverish until about 8 a.m., today, when my fever broke. I still feel like I have a low-grade flu, which I have not had in over 40 years. And, I still have some diarrhea. I am sipping Coke and can eat some Cheerios, with milk and banana, but that is all that I want to attempt. Fever, cold sweats for about an hour in the middle of the night (2AM). I took an Aleve and was better in the morning COVID19 VACCINE JANSSEN 1 day 1091201-1 (7AM). COVID19 VACCINE JANSSEN 1 day 1091224-1 Headache and low grade fever Took Advil COVID19 VACCINE JANSSEN 1 day 1091244-1 Pain in arm at injection site, hives up side of neck and face Symptoms started around noon the next day and consisted of beginning with chills and then led to a fever of 101.6 for COVID19 VACCINE JANSSEN 1 day 1091289-1 the rest of the afternoon. Ached all over felt like been hit by a truck. Around 9pm the fever broke and then just had slight headache. I was fine the next day. COVID19 VACCINE JANSSEN 1 day 1091351-1 broke out in large red hives felt very poorly Fatigue lasted from 1:00 PM until the morning of the following day around 5:00 AM. Slight headache from 1:00 PM until COVID19 VACCINE JANSSEN 1 day 1091372-1 8:00 AM. COVID19 VACCINE JANSSEN 1 day 1091384-1 Insomnia at 3am on Headache moderate, Fatigue , mild malaise Mild ache at injection site fever up to 101.2, chills, achy all over, tired - all day the following day on 7th, nauseas for about 3-4 hours that morning. COVID19 VACCINE JANSSEN 1 day 1091429-1 achy and tired continued for several days Janssen COVID-19 Vaccine EUA was administered on Monday March 8th at 4:30pm. On Tuesday evening of March 9th, I COVID19 VACCINE JANSSEN 1 day 1091441-1 experienced stomach cramping, abdominal paid, and explosive diarrhea. I took an Imodium following this episode. Then on the morning of Tuesday March 10th around 9:30am, I had another round of explosive diarrhea. COVID19 VACCINE JANSSEN 1 day 1091550-1 Fatigue and moderate headache which continue into 3/10/2021 but abated. COVID19 VACCINE JANSSEN 1 day 1091558-1 Wicked headache,nauseous COVID19 VACCINE JANSSEN 1 day 1091570-1 Fever of 102+, chills, headache, body aches, fatigue Pain at injection site, headache, fever, fatigue, extreme pain all over body , skin is painful to the touch, nauseous, dizzy COVID19 VACCINE JANSSEN 1 day 1091619-1 and difficulty walking, extreme perspiration while sleeping first night high fever 103, bad chills, muscle pain. Next night tinnitus. I have existing tinnitus that is not that noticable. COVID19 VACCINE JANSSEN 1 day 1091639-1 This increased the volume 3 times. lost weight, 3 pounds not since injection. stomach pain 3rd night. COVID19 VACCINE JANSSEN 1 day 1091694-1 FEVER, CHILLS, HEADACHE, SHIVERING, BODY ACHES, GENERAL WEAKNESS, PAIN AT INJECTION SITE COVID19 VACCINE JANSSEN 1 day 1091702-1 Migraine. Nausea. Chills. Body aches Patient complained of swelling to the pectoral area that spread towards the arm pit. No pain or redness. Patient is COVID19 VACCINE JANSSEN 1 day 1091738-1 using ice packs and Ibuprofen to treat. Janssen COVID-19 Vaccine EUA. Approximately 15 hours after the vaccine the left eyelid began swelling. the swelling COVID19 VACCINE JANSSEN 1 day 1091811-1 has lasted for 36 hours Patient became hypoxic with chest pain. Wheezing noted throughout lung fields. SPO2 80% on room air. Tachycardic 115 COVID19 VACCINE JANSSEN 1 day 1091877-1 with decreased level of consciousness. Admitted to hospital with diagnosis of COPD exacerbation with Hyperkalemia (6.2). Currently stabilized on O2 at 3l/m Felt a little cold about 4 hours after. Didn?t realize it was the start of chills. Woke up at 1am shivering, chills, felt warm COVID19 VACCINE JANSSEN 1 day 1091937-1 but could not get up to take temp, sweat through my clothes, headache, nausea. 6am headache was worse like a migraine. Severe nausea, felt cold. started vomiting at 1:30 and I felt really dizzy and confused. My roommate found me on the floor passed out. I am not sure how long I was passed out. I woke up and I was talking gibberish. I was aware that nothing I said was making sense. COVID19 VACCINE JANSSEN 1 day 1091980-1 I went to bed and slept almost 24 hours. I woke up feeling wiped out but I wasn't confused and I was talking normal again. Right arm hurt and is numb. ( right side of my body typically is kind of numb but the right arm seemed more so numb after the vaccine) COVID19 VACCINE JANSSEN 1 day 1092073-1 couldn't walk, chills, no fever, dehydrated, slight headache, fatigue COVID19 VACCINE JANSSEN 1 day 1092124-1 Fever, body aches, nausea, headache, fatigue, restlessness, muscle and joint aches mild facial swelling, peripheral edema, hypotension - started about 12 hours after vaccination. pt does have history of COVID19 VACCINE JANSSEN 1 day 1092156-1 dermo-filler where facial swelling is present Summary: dose exacerbated two of my allergic symptoms. Approx 33 hrs after receiving dose, noticed my eyes were ""stinging"", (symptom I have, spring and fall for a day or two each, controlled by Patanol 1 drop ea eye BID. (Did not use the med at this time), although I followed my usual routine of un educated ""tears"" in the eyes at bedtime and 2x in COVID19 VACCINE JANSSEN 1 day 1092181-1 morning. Awaking next morning found eye surrounds (lids, ...) were quite puffy, perhaps 1/4 ""swollen shut"", eyes still stinging though still not terribly so. Also noted morning breath measurements (Peak flow, FEV1, on a hand-held device) were 5-10% lower than normal. No ""sore arm"" or other musculature symptoms. At ~ 50 hours post-vaccine, am ""better"", will now go use some Patanol."" swollen painful glands under arm at vaccination site, painful groin gland, runny nose, cough mucous, headache, light COVID19 VACCINE JANSSEN 1 day 1092229-1 headed , weakness, abdominal pain chest pain , rt arm pain. Arm pain and swelling at the injection site; swelling in armpit. Tenderness in the armpit where swollen and there COVID19 VACCINE JANSSEN 1 day 1092272-1 appears to be a knot; chills, and body aches. Janssen COVID-19 Vaccine EUA At 7:00am on 3/11/2021 felt light headed as waking up along obvious soreness on the arm where I received the vaccine- left arm. Then later around 10:00am a feeling of tiredness came over my whole body. Around 12:00pm I felt even more tired, lightheaded and my eyeballs felt as if with high pressure in them and are feel COVID19 VACCINE JANSSEN 1 day 1092276-1 sensitive to the sunlight. Also, at 12pm, I had lunch, which was my first meal of this day and felt the necessity to lay in bed and take a nap for 20 minutes before returning to work. While taking the nap I felt tingling on my feet, arms, hands and neck along with certain sudden muscle contractions on the same parts. COVID19 VACCINE JANSSEN 1 day 1092313-1 Headache, sore throat, fatigue, muscle aches Janssen COVID-19 Vaccine EUA I got up and was light headed and dizzy the day after. I went to the Urgent Care and they said they couldn't find COVID19 VACCINE JANSSEN 1 day 1092329-1 anything wrong, and gave me medication to help with the dizziness. Dizziness lasted one day and just some fatigue. COVID19 VACCINE JANSSEN 1 day 1092375-1 Exhaustion, headache, chills, fever, unsettled stomach lasted 1 & 1/2 days COVID19 VACCINE JANSSEN 1 day 1092383-1 Fever (101f), chills, extreme headache, body aches, joint pain Janssen COVID-19 Vaccine EUA The morning after the vaccine was administered, I awoke with a scratchy throat, itchy eyes and feeling very tired. Throughout the morning, the fatigue increased and I felt flushed in my face, but chilled in COVID19 VACCINE JANSSEN 1 day 1092389-1 my arms and body. I went home at noon and found I had developed a fever of 100.9, which eventually increased to 101.3 later that afternoon. I felt joint pain and general malaise. Two days after the vaccine, the fever had broken and the joint pain was better. I still have fatigue, but it is improving throughout the day. I had no noticed issues for about 18 hours after the injection Tuesday evening. Sometime early Wednesday afternoon I began to experience body aches, a low-grade fever, and extreme tiredness. I slept most of the rest of the day and night and felt better when I woke up Thursday morning, well enough to go about a normal day. It is now late Thursday COVID19 VACCINE JANSSEN 1 day 1092431-1 afternoon and I am still a little tired and mildly achy with no fever but otherwise much improved. One other thing to report, initially there was no pain or tenderness to the injection site but that started changing about 24 hours after the injection. Now about 46 hours after injection the site has a constant noticeable soreness even if I am not moving my arm. COVID19 VACCINE JANSSEN 1 day 1092439-1 Fever 102.8, Chills, Severe back pain and hip pain, muscle aches, breast pain (still happening), Chest pain, Brain fog Immediately experienced pain and soreness in arm upon administration of vaccine. Started experiencing additional side effects 9-10 hours after vaccine administration: at night I developed a severe migraine, nausea and chills. When I woke COVID19 VACCINE JANSSEN 1 day 1092480-1 up the next morning, I still had a migraine, my nausea was less apparent, but I did begin to experience fatigue/exhaustion and muscle aches. I've experienced chills and hot flashes in waves throughout March 11th. I took my temperature for the first time at 4PM on March 11th and I have a low grade fever of 99.6. degrees Fahrenheit. Janssen COVID-19 Vaccine EUA Within the first 24 hours I had headache, fever, nausea, muscle aches, tiredness, COVID19 VACCINE JANSSEN 1 day 1092494-1 weakness, dizziness, and difficulty breathing. That all went away after 24 hours though. Now, five days later, my tongue is swelling. COVID19 VACCINE JANSSEN 1 day 1092495-1 Lower right side of back muscle pain with tightness. Mostly mild. COVID19 VACCINE JANSSEN 1 day 1092541-1 fever, chills, cough, severe headache, nausea, body aches, mental confusion severe shivering for an hour as I mounted a fever of 103.3 I ameliorated it by taking Tylenol and Ibuprohen every COVID19 VACCINE JANSSEN 1 day 1092576-1 alternate 2 hours. COVID19 VACCINE JANSSEN 1 day 1092600-1 Mild chills, loss of appetite SORE VACCINATION SITE FOR 1 ST DAY, THEN KNOT UNDER SKIN, SWELLING, REDNESS, HEAT, ITCHING, SORENESS FOR COVID19 VACCINE JANSSEN 1 day 1092604-1 DAYS 2,3,4 AND CONTINUING

At 2:50 am on 3/9/21 (about 7.5 hours after receiving the vaccine), I awoke to my body shaking intensely. It felt like a muscle spasm or like electricity was being pulsed through my body. First it would happen in one leg, and then the leg would curl up under my body. Then it would spasm in my chest and my arms would be drawn inward. Then the other leg, COVID19 VACCINE JANSSEN 1 day 1092648-1 or sometime multiple locations at once. I didn't feel cold at the time. This lasted for 40 minutes total. I took 1000 mg Acetaminophen at 3:00 am. Then, as the shaking lessened, I became very cold. I put on lots of clothes and laid on a heating pad under my comforter. Sometime later, I became very hot. Throughout the night into the morning, I felt feverish and chilled back and forth. At 6:00 am I took 200 mg Ibuprofen. I then spent the rest of the day with fever, chills, and body aches. Everything was achy and I was very tired. I slept well that night. The next day I was fatigued. Fever reaching 102.5, chills, muscle aches 9 hours following vaccination Acute appendicitis - approximately 20 hours COVID19 VACCINE JANSSEN 1 day 1092684-1 following vaccination Janssen COVID-19 Vaccine EUA Chills- morning of 3/10 Aches- all day Fever- afternoon of 3/10 High Heart Rate- 130-150 COVID19 VACCINE JANSSEN 1 day 1092704-1 resting Headache- all day Fatigue- all day COVID19 VACCINE JANSSEN 1 day 1092759-1 Dry cough , headaches, light headedness, loss of appetite, Janssen Covid-19 vaccine EUA caused me to feel extreme muscle pain, lower back pain specifically, I felt nauseous, had a COVID19 VACCINE JANSSEN 1 day 1092793-1 severe headache, was light sensitive COVID19 VACCINE JANSSEN 1 day 1092801-1 Pain in armpit of arm where shot was given, body aches (shoulders,back), fever 101.0, fatigue COVID19 VACCINE JANSSEN 1 day 1092803-1 Patient experienced Vomiting.. Pain and swollen arm to the touch. Also severe fatigue. COVID19 VACCINE JANSSEN 1 day 1092807-1 Low grade fever- 100.0; general aches, malaise, fatigue COVID19 VACCINE JANSSEN 1 day 1092837-1 Janssen COVID-19 Vaccine EUA Fever, body aches, headache, exhaustion Whole body pain; sweaty, feverish feeling but never registered a fever when checked. Extreme fatigue and brain fog, COVID19 VACCINE JANSSEN 1 day 1092859-1 headache COVID19 VACCINE JANSSEN 1 day 1093013-1 Headache and child severe body, muscle and joint pain/ache, fever, fatigue, weak, dizzy, fuzzy, nausea, headache, loss of appetite, unable to COVID19 VACCINE JANSSEN 1 day 1093025-1 go to school Tylenol every 4-6 hours COVID19 VACCINE JANSSEN 1 day 1093027-1 Very sore arm still. Tempature of 103 for about 4 hours then normal again. Very tired for about 3 days after Woke up next morning with headache. Around 1 PM got very tired. Woke from a nap at 4 with indigestion and reflux. COVID19 VACCINE JANSSEN 1 day 1093028-1 Low grade fever (99-100) and chills started at 6 PM. Two mornings later most symptoms were gone except fatigue (Sun). Lingering symptom: aerobic capacity seems diminished during vigorous exercise. I woke up noticing a slight headache, but I figured it was from poor sleep the night prior. I noticed after breakfast that I felt really cold and felt an internal shiver, especially in my chest. My fingers and toes were ice cold even with a sweater, blanket, and a warm tea. I noticed my skin starting to feel tender and I felt very fatigued. I wanted knew I needed to eat so that I could take ibuprofen, but I experienced a loss of appetite. I had a mild cough, but I felt too tired to even cough. I rocked in a chair in the sunlight outside for about 15 minutes and still felt cold. When I took my oral temperature after COVID19 VACCINE JANSSEN 1 day 1093454-1 coming inside, I was reading 99.9. I took 400mg of Ibuprofen by 1130 and layed down to rest. Bundled in 3 layers, I felt the shivering couldn't stop. My headache got worse and my skin was tender to the touch. I was able to sleep for approximately 3 hours and I woke up drenched in sweat. I took my oral temperature again and was at 101.1. I drank some more water and tried to sleep some more. When I woke up around 4:30 pm, I felt a lot better. My temperature went down to 97.8 and I had a boost in energy and appetite. I no longer had a headache and I had only mild muscle aches. By the next morning, I felt completely normal again. COVID19 VACCINE JANSSEN 1 day 1093472-1 Severe headsche, nausea, vomiting COVID19 VACCINE JANSSEN 1 day 1093476-1 Fever 101.7 COVID19 VACCINE JANSSEN 1 day 1093477-1 fever of 101.6, chills, aches, and headache, began the morning after the shot and lasted until about midnight. Woke up at midnight and had severe chills. A few hours later took my temperature and it was 101.3. Took 2 Tylenol. COVID19 VACCINE JANSSEN 1 day 1093494-1 Few hours later temp was 99.1. For the remainder of the day had body aches, fatigue and large headaches. Finally subsided 24 hours later and now I feel relatively fine. After the injection I felt fine. After falling asleep that evening, I awoke around 12:30am with body aches and slight COVID19 VACCINE JANSSEN 1 day 1093520-1 amount of nausea. It lasted for a few hours through the night in which I did not sleep. COVID19 VACCINE JANSSEN 1 day 1093550-1 Fever and flu symptoms 1. Chills and body aches after 7 hours 2. Sweating and fever after 8 hours 3. Numbness in left toes after 8 hours 4. Low COVID19 VACCINE JANSSEN 1 day 1093595-1 grade fever (99.1) after 18 hours 5. Vomiting and nausea after 18.5 hours COVID19 VACCINE JANSSEN 1 day 1093599-1 Aching head, neck, both shoulders. Acetaminophen with limited improvement. COVID19 VACCINE JANSSEN 1 day 1093609-1 Fever - started at 100.1 and reached 102.4 by 7am. Severe chills Joint and body ache Severe headache 3/7/21 - The day of the vaccination, minimal adverse side effects encountered. Minor soreness at the injection site, as well as general tiredness. 3/8/21 - Day after vaccination - mild soreness in arm, shoulder. Tiredness. 3/9/21 - Day - moderate soreness and pain experienced in the injection arm, shoulder, and back. Body aches, chest aches. Occasional COVID19 VACCINE JANSSEN 1 day 1093639-1 waves of discomfort, similar to nausea but without stomach discomfort. Overall tiredness. Occasional mild headaches. No noticeable fever. Total 1000mg paracetamol taken throughout the day. 3/9/21 - Night - unable to sleep soundly due to moderate pain and aches in upper body, lots of discomfort. 1 dose of Nyquil liquid taken to reduce pain and aid sleep. 3/10/21 - Most pain has gone away, just some mild soreness remains. Still some overall tiredness. 3/11/21 - Side effects appear to have subsided by this day. 3/6 vaccination. 6PM HA, neck pain, body aches, chills, fatigue; 12:AM woke up with increased HR. HR was too fast; up to 178-200. 911 called by husband. A fib with rapid pulse, convert with IV medicines. Low potassium and magnesium COVID19 VACCINE JANSSEN 1 day 1093663-1 levels. Nitro administer by husband before EMS arrived; had gone down by time ambulance arrived by was irregular. Kept me in observation floor. *still not feeling 100%; fatigue, high HR COVID19 VACCINE JANSSEN 1 day 1093680-1 Janssen COVID-19 Vaccine EUA - had headache, tired, nausea. The night I received the shot, I felt ""achy"" and took two Tylenol and went to bed. I woke up the next morning with a headache, chills, runny nose, fatigue, and nausea. I took an allergy medication and stayed in bed. This lasted all day. I COVID19 VACCINE JANSSEN 1 day 1093702-1 woke up the next day feeling fine, except for the constant runny nose. Also, on that day, I started having ""floaters"" in my left eye that I never had before (probably unrelated but I want to let you know)."" At approximately 1 AM I woke up to chills and sweats. Had a fever of approximately 102¶F, body achiness from head to COVID19 VACCINE JANSSEN 1 day 1093715-1 toe a severe headache, slight cough and general muscle fatigue. Slight pain at injection site.

8:00 am on 3/11 - Fever of 100 degrees and extreme fatigue, body aches, chills 10:00 am - Started to become nauseous COVID19 VACCINE JANSSEN 1 day 1093728-1 and threw up Until midnight - could not keep any food or liquids down, fever fluctuated between 100 degrees and 104 degrees, extreme body aches and chills 12:30 am - no fever, body temp returned to normal, still could not keep food or water down 4 am on 3/12 - able to drink some water and felt almost normal other than some lingering body aches COVID19 VACCINE JANSSEN 1 day 1093742-1 Janssen COVID-19 Vaccine EUA Rash all over the body. Burning sensation we skin is pinched or moved. Hives and burning /itching from the inside . Light bruising on areas NOT around the injection site. Calf, wrist, opposie COVID19 VACCINE JANSSEN 1 day 1093766-1 arm At 1 am, I woke up with chills. I was freezing, but my body was not cold to the touch according to my fiance. When I woke up around 7 am, I was exhausted for the rest of the day. I had a bad headache all day. I had a 100-degree fever COVID19 VACCINE JANSSEN 1 day 1093793-1 that broke during the early afternoon. On the following two days, I had a mild headache that lasted through the afternoon. It felt like someone was pulling the muscle behind my right eyebrow. Extreme Joint Pain beginning approximately 12 hours after the injection. Joint pain did not subside until 03/11/2021. Treated by alternating ibuprofen, and Tylenol, heating pads, and rest. Was unable to work for 3 days (Days 3-5). Would COVID19 VACCINE JANSSEN 1 day 1093808-1 not have worked Day 2, but it was a Sunday. Called medical provider on Day 4. Was advised to continue with ibuprofen and Tylenol, and continue to rest.

13 hours after the vaccine, I experienced intense headache, body aches, and nausea. I vomited violently 3 hours after the onset of symptoms. I took 400 mg of ibuprofen and was able to sleep. The following day I had intense body aches and extreme exhaustion all day long. I managed it through doses of ibuprofen. I was able to sleep all night the following COVID19 VACCINE JANSSEN 1 day 1093810-1 night with some NyQuil. The second day, I woke up feeling still a little weak and tired, but the body aches have subsided significantly. It's nothing crazy, but it felt like I should report so there is more information for the researchers and public. I did have COVID March/April 2020. I had body aches, fatigue, chest tightness, loss of taste and smell, but NO FEVER. It was undiagnosed at the time (no fever), but in October 2020, I gave blood and I did have COVID antibodies. I gave again in January 2021 and I still had the COVID antibodies. I received the vaccine March 10. Thank you! COVID19 VACCINE JANSSEN 1 day 1093839-1 Temperature 99.7F, chills, slight head ache COVID19 VACCINE JANSSEN 1 day 1093842-1 22 hours s/p vaccine, low grade fever, chills, exhaustion, pain in joints (hip, shoulder, back, knees) COVID19 VACCINE JANSSEN 1 day 1093943-1 whelps, round rings around shot site. some redness. slight soreness in arm shot was given. COVID19 VACCINE JANSSEN 1 day 1093955-1 Shaking chill for 10 min x 1 time, headache for 1 day, lethargy for 1 day, neck pain for 1 day The following day, around 11:30 AM after receiving the J & J inoculation, I experienced ringing in my left ear. It has not COVID19 VACCINE JANSSEN 1 day 1093957-1 subsided. Today is March 12, Friday and I am writing this at 9:52 AM COVID19 VACCINE JANSSEN 1 day 1093978-1 Chills, Body Aches, Headache & Fever COVID19 VACCINE JANSSEN 1 day 1094000-1 Felt sick in my stomach. Developed a fever of 104F at 14 hours after injection. After taking acetaminophen, the fever dropped to around 101 and stayed there for 12 hours before subsiding. Body aches and extreme fatigue were also present. 48 hours after injection COVID19 VACCINE JANSSEN 1 day 1094003-1 (03/08/2021) I woke up with major skin irritation. There were no visible signs like a rash or any redness, but my skin felt sunburned and wearing clothes was extremely uncomfortable. This lasted until 03/10/2021. I used lotions and took cool showers to help with the symptoms. Vomiting, fever, dizziness started at 2am following vaccination at approximately 10:45am. In the morning of 3/12/21 COVID19 VACCINE JANSSEN 1 day 1094066-1 reported vomiting black. Sent to ER. Fatigue, Moderate body aches Intermittent Fever first 24hours Headache Red & soreness around injection site. Persisted COVID19 VACCINE JANSSEN 1 day 1094076-1 for 48hours. Took Motrin, hot showers & herbal teas. Bed rest COVID19 VACCINE JANSSEN 1 day 1094128-1 Fever, bruising, itching, tenderness at injection site, flu-like symptoms. COVID19 VACCINE JANSSEN 1 day 1094139-1 Chills, body aches, low fever (100.7), head cold symptoms (congestion, sneezing, runny nose), mental ?fog? Immediately after receiving the vaccine, I felt pretty good. Just some soreness in arm and a minor headache an hour later. I took Tylenol and symptoms were bearable the rest of the day. By around 6 or 7p that night, I experienced full body pain and chills, similar to the flu. I also had some chest pain and tightness but attributed that to the overall body pain. I was also very winded and short of breath. I called my Primary Care Doctor to report this, and she said this was a normal reaction and it meant my immune system was working. It continued into the next day, and I took my temperature and had a 102 fever. I slept most of the day and was unable to work. I also had a severe headache. The next day, on Day 3, my flu symptoms were getting better; however, I felt dizzy and short of breath. I also fainted . This is the first time this has ever happened to me. I have never fainted in my life. My symptoms seemed to resolve after eating COVID19 VACCINE JANSSEN 1 day 1094194-1 and drinking, so I figured it may have been dehydration. On Day 4, I was concerned because I was having shortness of breath and chest pain, along with dizziness. I could not take a deep breath without having pain. I called my Primary Care Doctor, and she told me she was concerned I might have covid and to go to the ER. I do not believe I have covid. No one in my household has these symptoms except for me. I believe it is from this vaccine. My chest pain/shortness of breath seemed to go away. for a bit so I did not go to ER. I'm on Day 5 now, and the chest pain/shortness of breath has come back, so I decided to report this because I do not listed on the list of common side effects for the Johnson and Johnson vaccine. I joined a J&J social media group where others are also reporting these symptoms, so I decided to report to Vaers. I also have had night sweats every day since taking the vaccine and my blood pressure is lower since taking the vaccine. As expected soreness in left arm, not unexpected stiffness in left shoulder and left side of neck + back extending down to left shoulderblade. The unexpected effect is tingling and coldness in both hands/fingertips. I could logically assume it is COVID19 VACCINE JANSSEN 1 day 1094219-1 from the swelling in the neck pressing on the nerves, as I have experienced a similar feeling occasionally in the past due to compressed discs in my spine and neck. At this point I am not particularly alarmed but I wanted to make you aware of this side effect. Chills started 7 hours after shot, subsided around 12 hours after shot. Fever of 103 started 10 hours after shot, subsided COVID19 VACCINE JANSSEN 1 day 1094222-1 30 hours after shot. Fatigue and muscle aches for 36 hours after shot. No particular pain or aches at site of injection, aches were more general. Begun feeling fatigued and weak when waking up in the morning, progressed into chills and feeling of faintness. Difficulty COVID19 VACCINE JANSSEN 1 day 1094278-1 swallowing and some pain and shortness of breath when swallowing. COVID19 VACCINE JANSSEN 1 day 1094295-1 Patient reports rash on trunk and arm the was vaccinated, diarrhea, swelling at injection site COVID19 VACCINE JANSSEN 1 day 1094307-1 24 hour sickness, but adverse reaction has been a growing red circle on my arm. It is raised, itchy, painful, and hot. 1 day after shot: Extreme headache, fatigue and body aches. 3 days after shot: Headaches off and on 3 days after shot: COVID19 VACCINE JANSSEN 1 day 1094324-1 Sweating profusely, fatigue, and headaches off and on 4 days after shot: Headaches off and on 5 days after shot: Broke out in hives and very itchy, felt tingly and off and on headaches, fatigue Immediate pain after injection in arm at injection site with some pain moving up in the neck muscle and lower arm. COVID19 VACCINE JANSSEN 1 day 1094369-1 After 24 hours the pain increased and moved into shoulder and neck pain increased. No redness in injection site but muscle pain increased and continued into day three. COVID19 VACCINE JANSSEN 1 day 1094370-1 for about 24 to 36hr after the shot I had joint pain, fatigue, and Myalgia. She got her vaccine, and woke up with fever of 99.4, headache and soreness on her left arm. She has not taken anything COVID19 VACCINE JANSSEN 1 day 1094372-1 for these symptoms other than her regular medications. Husband did call her doctor and waiting to hear back from them. COVID19 VACCINE JANSSEN 1 day 1094399-1 Fever, aches, pains, fatigue, migraine COVID19 VACCINE JANSSEN 1 day 1094422-1 Fever, Chills, muscle ache tired in AM then extreme chills and muscle ache for 12 hours then fever for 24 hours COVID19 VACCINE JANSSEN 1 day 1094430-1 Tinnitus. Woke up this morning with annoying ringing in my ears. COVID19 VACCINE JANSSEN 1 day 1094433-1 Joint pain - relieved with over the counter pain medication COVID19 VACCINE JANSSEN 1 day 1094450-1 Insomnia, chills , knee pain, fast heart rate, headache , cough On the morning of 3/11/2021 Patient experienced periods of confusion. slight loss of memory (couldn't remember where COVID19 VACCINE JANSSEN 1 day 1094518-1 to turn to get to destination). The episode lasted approximately 6-8 hours. The remainder of the evening did not experience any symptoms previously described. Upon wakening this morning pt reports L arm numbness, tingling and flaccidity. pt walked to kitchen and he began feeling sweaty and hot, the next thing he awoke laying in the floor after passing out . Pt was incontinent of urine during COVID19 VACCINE JANSSEN 1 day 1094532-1 event. He now reports some mild shortness of breath but no acute distress or known injuries from syncope episode. pt advised to go to the ER. Pt's states his wife is on her way home and will drive him to the ER. Woke up overnight with a black eye, a pretty good shiner. No trauma to the eye area. I feel great. Face was slightly COVID19 VACCINE JANSSEN 1 day 1094654-1 puffy in the AM. Nose bleed started day after vaccination along with nausea which makes it hard to eat. Had flu like symptoms day of COVID19 VACCINE JANSSEN 1 day 1094691-1 vaccination with head ache and body aches persisting. COVID19 VACCINE JANSSEN 1 day 1094717-1 Headache, muscle ache, back ache, nausea, vomiting, fatigue, fever, chills COVID19 VACCINE JANSSEN 1 day 1094718-1 bad headache , fever , chills and feels like got hit by a bus. COVID19 VACCINE JANSSEN 1 day 1094743-1 fever (99.9) chills fatigue asthmatic attack - resolved with inhaler ** 35 weeks pregnant, due date 4/14/2021, 1st pregnancy * I had a fever about 8 hours after the vaccine. The highest I COVID19 VACCINE JANSSEN 1 day 1094756-1 got to was 105, I also had really bad chills. The next day I had a low grade fever and just had a headache and fatigue. After 24 hours my symptoms went away. Patient reported to the pharmacy the following morning complaining of the following symptoms: knee pain, insomnia, chills, and increased heart rate. Counseled the patient on potential reactions and how the chills may be due to a low COVID19 VACCINE JANSSEN 1 day 1094766-1 grade fever, insomnia/HR due to anxiety about potential side effects. Patient asked about the ability to get paid time off while recuperating from the vaccination, he was referred to the HR department. Patient reports that he called Vsafe and VAERS. He was going to talk to personnel at the end of the conversation at the pharmacy. March 8: 6pm: chills, body muscle aches, headache 7pm: fatigue had to lie down 11pm: fewer chills, a little spine pain COVID19 VACCINE JANSSEN 1 day 1094777-1 (maybe caused by inflammation?) March 9: Noon: Only sore throat, which went away after drinking and eating 24 hours after receiving the vaccine I began experiencing adverse side effects that have continued to last (Tuesday- COVID19 VACCINE JANSSEN 1 day 1094793-1 Friday). I've experienced constant migraines, nausea, fatigue, diarrhea since Monday, all of which have caused difficulty with eating and sleeping. 3/10/21 - right arm (injection site) pain 3/11/21 - right arm(injection site) pain/soreness 3/11/21 - under right armpit COVID19 VACCINE JANSSEN 1 day 1094819-1 swelling; injection site mild soreness 3/12/21 - under right armpit swelling Headache then nausea then went to the hospital due to shortness of breathe and doctor told her it was due to the COVID19 VACCINE JANSSEN 1 day 1094835-1 vaccine The morning after he received his vaccine he started feeling sick and then started to run a temperature. By evening his temperature was 102.9. Then the seizures started, first his ""left"" hand up his arm and down his left side. His right hand COVID19 VACCINE JANSSEN 1 day 1094851-1 and arm was shaking rapidly. His left leg stiffened and his toes pointed down and then the seizure traveled to his right side. He remained conscious but somewhat dazed. This went on all night. By 10:00 the next day, Thursday the seizures stopped. His temperature went back to normal Friday morning."" One day after shot i started uncontrollable nose bleeds. Wen to the ER twice locally. Sent to specific location via COVID19 VACCINE JANSSEN 1 day 1094912-1 ambulance for a surgery to stop bleeds.

COVID19 VACCINE JANSSEN 1 day 1094917-1 Patient states they received Vaccine on Monday, became confused at work on Tuesday and then presented to ED after multiple seizures overnight Wednesday and then was having trouble ambulating. also complains of left elbow pain For the first 24 hours I had no symptoms and no in in the injection site. But a little over 24 hours after dose, I have now COVID19 VACCINE JANSSEN 1 day 1094931-1 developed chills and a fever. Fatigue, 12+ hours after vaccination Tachycardia, heart rate 130-140 resting,, onset 12+ hours after vaccination Nausea, COVID19 VACCINE JANSSEN 1 day 1094976-1 onset 1 hour after vaccination Headache, onset 1 hour after vaccination COVID19 VACCINE JANSSEN 1 day 1095006-1 Fever between 98-100 for 3 days so far With mild headache Approximately 4 minutes after the injection, while sitting down, I felt light headed, sweating, weak, face turned white. I was close to passing out but didn't. I requested attention after about 10 minutes. While being treated by medics they mentioned color had returned to my face. I felt better enough so I refused to go to hospital and was driven home. Later that morning, 03/08/2021 about 10 AM, I developed a fever and body aches with sharp pains thru out my body and COVID19 VACCINE JANSSEN 1 day 1095046-1 joints. First temperature check was 100.5. My fever, pains/weakness increased thru out that day and overnight with chills. Highest temp check was 102.8 that evening prior to bedtime. I don't know if it could have been higher at some point overnight. It felt like I had a moderate to bad case of the FLU. The next morning, 03/09/2021 the fever broke down to about 101. By 03/11/2021, aside from a little residual weakness I felt more like myself. However, as of the writing of this report my temp seems to fluctuate between normal and 99.8. Will report this to my Doctor on next visit. Worth noting that I haven't had any Flu like symptoms to that degree in many years. On the morning of admission, patient had another episode. She was sitting at the kitchen table and then slumped forward unconscious. She has no memory of the episode. Daughter is unsure how long she was unconscious for. She was COVID19 VACCINE JANSSEN 1 day 1095066-1 taken to the ER via ambulance. Head CT in the ER showed only age-related changes. Chest x-ray showed an increase in infiltrate. Influenza test negative. Rapid COVID-19 test negative. Urinalysis only had 2+ leukocyte esterase. White count of 3.3. Cardiac enzymes negative. BNP normal. remains hospitalized at Hospital - inpatient High fever (99-103F) for about 12 -16 hrs, numbness in arm for 1.5 days, injection site soreness lasting 4-5 days Rested COVID19 VACCINE JANSSEN 1 day 1095085-1 and hydrated for 2 days Returned to work after 2 days COVID19 VACCINE JANSSEN 1 day 1095136-1 fever, chills, headache, fatigue, sore muscles, stomach irritation. Lasted 2 days. Took Tylenol and rested. Vaccine received at 4:40 p.m. on 03/11/21. Chills started at 2:00 a.m. the following day lasting about an hour. Then fever and hot sweats started around 3:00 a.m. Fever was 100.3 f in the early morning and then 102.2 around 9:30 a.m. on COVID19 VACCINE JANSSEN 1 day 1095259-1 03/12/21. Headache and some nausea in the a.m. of 03/12/21 and continued until this writing (03:45 p.m.). Current temperature is 99.4. COVID19 VACCINE JANSSEN 1 day 1095268-1 Headache, body aches, exhaustion, nausea COVID19 VACCINE JANSSEN 1 day 1095394-1 103.9 fever, aches, chills, sweating, back ache, headache Discovered that patient was 17 years and 9 months of age later in the day after vaccine was administered. No adverse reaction reported from patient, however when I reached out to mother on 3/12/21 (the next day) to discuss age COVID19 VACCINE JANSSEN 1 day 1095402-1 guidelines the mother reported that patient did have a fever of 104F and a headache. The mother states she is/will give OTC fever reducers and monitor her for further adverse reaction. COVID19 VACCINE JANSSEN 1 day 1095498-1 temp 99.4, achy, tired, headache

COVID19 VACCINE JANSSEN 1 day 1095599-1 Extended Spike in blood pressure and heart rate. Went from home by ambulance to the ER. Sent home after six hours. No crisis event but went to my dr. Saw cardiologist 3/12 and wearing a two-week Zio patch to rule out other issues. Patient has recurring fever sometimes as high as 103 degrees. Fever reducer has alleviated the symptoms but it is COVID19 VACCINE JANSSEN 1 day 1095706-1 recurring. Most concerning reaction was: on Wed., 3/10/21, at approx. 9:30am, I fainted. I had just had a couple bites of food then felt really warm and nauseous. I fainted at table, then my spouse didn't know when he came downstairs, he thought my head was just resting at the table. He asked if I wanted to walk to the couch to rest, and as he helped me do so, I fainted COVID19 VACCINE JANSSEN 1 day 1095709-1 and he caught me and carried me to the couch. Recovered within 1 minute but my hearing was fuzzy for a couple more minutes, sounded like static in my ears. Other reactions were: Standard ones I read could happen- Fever of 100.1 that lasted less than a day, chills, aches, warm feeling and fatigue. Exhaustion Headache Dizziness Watery eyes Feels like bronchitis Muscle aches Arm discomfort Radiating pain all Over COVID19 VACCINE JANSSEN 1 day 1095823-1 body Double vision Hazy vision Easily get out of breath Bright yellow urine output Insomnia COVID19 VACCINE JANSSEN 1 day 1095828-1 After vaccination patient developed fever and chills lasting though today as well as severe GI issues. COVID19 VACCINE JANSSEN 1 day 1095831-1 Weak/fatigue Nausea Headache COVID19 VACCINE JANSSEN 1 day 1095923-1 Flu type symptoms. Chills, sever muscle aches and weakness Started 8hrs after injection and lasted for 18 hrs COVID19 VACCINE JANSSEN 1 day 1095949-1 Headache, jaw ache, other minor body aches, chills, 99.4 F fever, mild fatigue, initial soreness of arm on day of injection Has not had a SZR since april of last year. He was not feeling well after vaccine, (body aches, subjective fever, tiredness) COVID19 VACCINE JANSSEN 1 day 1095965-1 and wife found him having a seizure while lying in bed. Pain in injection site and hand, with little difficulty to breathe. that night start feel chili, wake up with fatigue, body COVID19 VACCINE JANSSEN 1 day 1095967-1 ache, headache and fever at 102 degree. COVID19 VACCINE JANSSEN 1 day 1096013-1 Chills, fever, headache, aches, fatigue, nausea I was achy and became weak and dizzy about 1pm. By 2pm , I developed Ortho static hypotension which caused my blood COVID19 VACCINE JANSSEN 1 day 1096025-1 pressure to drop and travel to ER via ambulance . COVID19 VACCINE JANSSEN 1 day 1096123-1 Headache, pain at injection site, and excessive swelling of lymph nodes under left arm pit only. I developed a rash at the shot site that spread down my back and across my neck. My blood sugars have been high since COVID19 VACCINE JANSSEN 1 day 1096125-1 Wednesday. I have been struggling to get them within range since then. I have an antihistamine cream that I?m applying and have had to adjust my insulin to improve my blood sugar levels. COVID19 VACCINE JANSSEN 1 day 1096136-1 102.7 fever and projectile vomiting COVID19 VACCINE JANSSEN 1 day 1096185-1 I had cold chills, fever all night, body aches, that lasted throughout the night. I felt better the next day. COVID19 VACCINE JANSSEN 1 day 1096186-1 High fever 102, chills, aches, lethery, headache, burning eyes, trouble concentrating, nausea COVID19 VACCINE JANSSEN 1 day 1096193-1 headache, tiredness/fatigue, herpes outbreak COVID19 VACCINE JANSSEN 1 day 1096226-1 Nausea, chills, headache, fever of 99.5, body aches, spotting in middle of menstrual cycle Headache in forehead area with light sensitivity, one Motrin pill taken 12:30 pm then sleep, awoke with mild headache, COVID19 VACCINE JANSSEN 1 day 1096238-1 one Motrin pill taken 01:30 am. COVID19 VACCINE JANSSEN 1 day 1096247-1 Muscles aches and chills at 12:30am, then gradual fever that peaked at 101.4, taking acetaminophen at 4am At 6:00 PM 3/12 I began to feel slightly dizzy. It did not effect my ability to stand or move around very much, but my head did feel strange and if I turned to quickly I would need a second to gather myself. However, it was not severe enough to force me to sit or lay down. By 7:00-7:30 I began to feel hot and uncomfortable and I took my temperature at COVID19 VACCINE JANSSEN 1 day 1096342-1 7:30 and I was running a low grade fever at 99.8 degrees F. I began to feel very fatigued and was in bed by 9:00 PM. I woke up feeling fine and my temperature at 7:00 AM 3/13 is 97.8 degrees F. My only possible side effect this morning (3/12 as I write this) is that I am mildly stiff, mostly in my left arm, neck, and back (the side of the injection site). Despite the mild fever I did not feel any nausea, nor did I have difficulty breathing. Overall the side effects were mild but uncomfortable. About 10 hours after receiving the J and J vaccine, I woke in the middle of the night shivering uncontrollably, teeth COVID19 VACCINE JANSSEN 1 day 1096361-1 chattering. Following that I had a headache, nausea, flu like symptoms, body aches, and a fever. Missed 2 days of work. My symptoms from the vaccine were worse than when I had the COVID virus. felt fine until about 6 hours after (approx 12 am 03/13/2021) and then i got severe chills, felt feverish, had severe muscle and joint aches, a moderate headache. woke up at 4 am with nausea but no vomiting, still had muscle and joint aches. COVID19 VACCINE JANSSEN 1 day 1096377-1 felt like i had the flu. it's about 13 hours since i got the shot, now having headache, muscle and joint pain, and increased heart rate COVID19 VACCINE JANSSEN 1 day 1096394-1 Severe headache everyday since injection, lightheaded, extreme fatigue, no appetite, vomiting, brain fog elevated temperature of 99.3, some shivering soreness through upper back, shoulders, and neck with a bit of stiffness COVID19 VACCINE JANSSEN 1 day 1096401-1 all mild COVID19 VACCINE JANSSEN 1 day 1096405-1 very tired, chills and fever of 103.8. Took an Alieve this AM to try and get fever down. 3/8/21 - woke up at 2:30am with elevated temp (normally at 97.6 and showed 98.9) sleep was restless, couldn?t go back COVID19 VACCINE JANSSEN 1 day 1096416-1 to sleep and had chills. Felt punky on 3/8/21 - still worked all day and all week. 3/13/21 - woke up at 4:30am and had exact same symptoms as above but with a 99.7 temp. Feeling punky. COVID19 VACCINE JANSSEN 1 day 1096441-1 Chills, headache, nausea, fever, sore arm COVID19 VACCINE JANSSEN 1 day 1096442-1 Experiencing severe body/muscle pain. Cannot raise left arm (site of injection) above chest level. Dull headache. Felt very cold with shivering and very cold feet starting about 28 hours after vaccination. Woke up with COVID19 VACCINE JANSSEN 1 day 1096456-1 cold sweats during the night 36 hours later (very wet tee shirt - changed into dry t-shirts twice during the night). No symptoms upon waking the next morning 42 hours later. Woke up at 4:00 am restless. Could not sleep. Body aches. Flu like symptoms by 10:00 am that lasted all day. Bad COVID19 VACCINE JANSSEN 1 day 1096484-1 headache in the afternoon. Went to sleep around 9:00 pm. Felt normal by the next morning. Extreme vertigo Vomiting Extreme migraine Stomach pain Extreme tiredness... could not hold my head up Lasted almost COVID19 VACCINE JANSSEN 1 day 1096499-1 48 hours Patient woke up on 3/12 with headache, body aches, and nauseous. She went to the bathroom thinking she was going to COVID19 VACCINE JANSSEN 1 day 1096541-1 vomit and ending up passing out and then waking up covered in sweat. COVID19 VACCINE JANSSEN 1 day 1096611-1 Fever of 99.4 Sore at injection site with some swelling Pain at time of injection - probably insignificant with soreness till presently Within 24 hrs., All over body weakness, COVID19 VACCINE JANSSEN 1 day 1096614-1 inflammation of the mouth & right nasal passage, diarrhea, difficulty walking - low energy, body chills all day Today I am better

COVID19 VACCINE JANSSEN 1 day 1096646-1 strong chills overnight (approx5-6 hours after injection), could not sleep through it, whole body aches, headache, took Motrin and felt a little better (by 2pm the following day) but not 100%. Notably better by second day but still a tad sore. COVID19 VACCINE JANSSEN 1 day 1096685-1 Shoulder soreness upon movement. He has limited movement in his arm COVID19 VACCINE JANSSEN 1 day 1096733-1 LEFT ARM WAS EXTREMELY SORE. BODY ACHES ALL OVER, LOW GRADE FEVER, NO APPETITE, FATIGUE FOR 24 HOURS, Around 1:00 am I started having chills and body aches. At 5:00 am I woke up with a headache and cold like symptoms, COVID19 VACCINE JANSSEN 1 day 1096746-1 sore throat, headache, waves of nausea, soreness. COVID19 VACCINE JANSSEN 1 day 1096747-1 LEFT ARM WAS EXTREMELY SORE. BODY ACHES ALL OVER, LOW GRADE FEVER, NO APPETITE, FATIGUE FOR 24 HOURS, Rapid Heart rate and elevated BP 3/13 Rapid heart rate was 127 at Patient first 3/13 Highest BP was 160/92 3/13 fever COVID19 VACCINE JANSSEN 1 day 1096786-1 100.4 3/13 Full body ache, chills, low grade fever, very sore arm on which injection occurred, extreme exhaustion, which lasted COVID19 VACCINE JANSSEN 1 day 1096791-1 about 36 hours. Also seems to have delayed menstrual period by two days (which has started in the meantime with no other notable change). When I first took the Covid vaccination I had no symptoms then later that day into the next morning about 1-2 am COVID19 VACCINE JANSSEN 1 day 1096825-1 3/12/21 started feeling fever, chills, headache, body aches, restlessness weak. Later the same day no appetite. Made myself eat so I could take some tylenol for fever and pain. COVID19 VACCINE JANSSEN 1 day 1096914-1 Headache, body aches, low grade fever, chills, nausea, vomiting for 7 hours. Dull headache for 24 hours. COVID19 VACCINE JANSSEN 1 day 1096922-1 3/13/21 03:00 am, chills, shakes 3/13/21 04:00 am, fever 102, threw up 3/13/21 07:00 am, dizziness, cold sweats, nausea 3/7: No adverse reactions observed 3/8: 12:30 a.m. Awoke vomiting and with fever of 99.8 F 2:30 a.m. Fever of 102 F Multiple measurements prior to 10 a.m. fever of 101.6-102 F 10:00 a.m. Full adult dose Vick COVID19 VACCINE JANSSEN 1 day 1096955-1 NyQuil Severe Cold & Flu. Additional doses as directed. Scheduled rapid Covid-19 test at pharmacy 2:00 p.m. fever of 99.5 F 4:50 p.m. COVID-19 test, no fever 6:00 p.m. Negative test result Remaining evening of 3/8 and until early morning, 3/12, heavy night sweats, clamminess, extreme fatigue

Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, COVID19 VACCINE JANSSEN 1 day 1096961-1 Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: Patient about 12-24 hours after shot started to develop a rash on arms/neck and hands. Her arms/hands started to swell and she developed blisters in the mouth and had blisters on her hands and neck as well. She had itching all over her arms and hands and swelling of the arms and hands too. She also felt a warming/hot and burning sensation in her arms and hands too. She has been putting clobetasol and hydrocortisone cream/ointment and Levicyn (compound by Dr.) on the blisters and rash. COVID19 VACCINE JANSSEN 1 day 1097068-1 Side effects: headache, tired, muscle ache, fever COVID19 VACCINE JANSSEN 1 day 1097079-1 Red swelling around injection which grew in size I suffered a fever from 3/10/21 at 2am until 3/12/21 at 11pm. 9n 3/13 at 7am I woke up with red blotches all over the COVID19 VACCINE JANSSEN 1 day 1097101-1 tops of my feet and toes and my hair is falling out in clumps. I've also had migraines off and on and brain fog. COVID19 VACCINE JANSSEN 1 day 1097107-1 Severe Chills, headache. COVID19 VACCINE JANSSEN 1 day 1097118-1 Body rash After about 12 hours from injection, started to feel headache, body aches, and nausea, by the morning 7 am, the headache was so intense that I could barely move. (I have migraines, but this pain was on the left side of my head, not COVID19 VACCINE JANSSEN 1 day 1097157-1 my right like usual, and was even more intense than usual.) I had chills and sweats, and body aches. I checked several times and had no fever. By the next morning (Saturday, March 13 at 7 am) I was feeling fine. developed fever 100 F at midnight and fever of 102.5 F at 4 am. Assoc with body aches, HA and decrease sense of taste COVID19 VACCINE JANSSEN 1 day 1097189-1 and smell COVID19 VACCINE JANSSEN 1 day 1097194-1 the day following vaccine patient had episode of afib. they had never previously had a diagnosis of afib. PATIENT WAS CALLED BY OUR PHARMACY TO CHECK IF PATIENT WAS OK AFTER ADMINSTERING THE VACCINE. PATIENT REPORTED HE WENT TO THE EMERGENCY ROOM THE EVENING AFTER HE GOT THE SHOT. HE REPORTED A HEART RATE COVID19 VACCINE JANSSEN 1 day 1097223-1 OF OVER 120. HE STATED THAT HE FELT HIS HEART RACING AND DECIDED TO GO TO THE EMERGENCYROOM AND WAS OK AFTER THAT. THE PATIENT DID NOT TELL HIM WHAT HE WAS TREATED WITH. COVID19 VACCINE JANSSEN 1 day 1097260-1 Headache, nausea, vertigo COVID19 VACCINE JANSSEN 1 day 1097378-1 Fever of 104.4¶F, severe headache, severe bodyaches, severe chills. Moderate fatigue and nausea COVID19 VACCINE JANSSEN 1 day 1097401-1 12 hrs after vaccination I developed flulike symptoms- chills, aches, fatigue, headache. It was over 24 hrs later. Difficulty breathing -3/12-2:00 am - 9:00am Dizziness and weakness 3/12-6:30am - 8:00am muscle ache - 3/11 - 8:30pm - COVID19 VACCINE JANSSEN 1 day 1097415-1 3/13-1:00pm chills- 3/11 - 9:30pm-1:00am headache Chills began approx 1:30am on 3/12 (13 hrs after dose), mostly resolved 46 hours after dose inflamed lungs / coughing - began approx. 9pm on 3/11 ( 8 hours after dose), mostly resolves by 1am 3/13 (36 hours after dose) Body aches - began COVID19 VACCINE JANSSEN 1 day 1097424-1 approx 9am on 3/12 (20 hours after dose), greatly improved 4:30pm 3/13 (52 hours after dose), took naproxene 3/12-3/13 Headache - began approx. 9am on 3/12 (20 hours after dose), greatly improved by 9am 3/13 ( 52 hours after dose), took naproxene 3/12-3/13 Nausea - began approx 9am on 3/12 (20 hours after dose), continues, not resolved

Received JANSSEN COVID-19 vaccine EUA at 11:10am, March 12th, 2021. In the evening, began to experience extreme COVID19 VACCINE JANSSEN 1 day 1097429-1 fatigue, and in morning of Saturday, March 13th, 2021 began to experience fever, 100.3F, very bad headache, fatigue, and bad muscle aches--aching legs, back. Fever has is gone as of afternoon March 13th, however, still experiencing headache, fatigue, and aching muscles, similar with what I experience when I had influenza B a couple of years back. COVID19 VACCINE JANSSEN 1 day 1097441-1 Body aches, fever COVID19 VACCINE JANSSEN 1 day 1097461-1 Chills, fatigue, aches, fever, headache COVID19 VACCINE JANSSEN 1 day 1097498-1 DAY AFTER SHOT DEVELOPED 104 DEGREE FEVER, BODY ACHES AND HEADACHE COVID19 VACCINE JANSSEN 1 day 1097505-1 Headache, arm soreness, fatigue, muscle pain COVID19 VACCINE JANSSEN 1 day 1097600-1 Fever of 101¶, sore muscles, exhaustion. Started symptoms around 3 pm and grew worse over time. COVID19 VACCINE JANSSEN 1 day 1097603-1 injection site becoming sore and tender. little headache, really tired. low energy, nausea. This is all very unusual for me. COVID19 VACCINE JANSSEN 1 day 1097613-1 Fever, chills, body aches and severe headache staring around 2am lasting through Friday evening COVID19 VACCINE JANSSEN 1 day 1097627-1 102 fever, bad stomach pain COVID19 VACCINE JANSSEN 1 day 1097665-1 Extreme lethargy for 36 hours and a huge fever blister. COVID19 VACCINE JANSSEN 1 day 1097679-1 Pain and tenderness in associated arm and 101*F fever 30 hours after vaccine was administered. COVID19 VACCINE JANSSEN 1 day 1097691-1 Flu like. Cold, chills, low fever, cold sweats, headaches and body aches. COVID19 VACCINE JANSSEN 1 day 1097707-1 shaking, shooting pain, sick, throwing up, fever lasting 1 day

Starting at 0100 on 03/11/2021. Awoke with symptoms of fever with chills, headache, neck and back pain (moderate to severe), pain in what seemed the bones of the skull and mandible (moderate to severe), nausea and vomiting, unable to COVID19 VACCINE JANSSEN 1 day 1097730-1 take fluids, unable to sleep besides 60 mins. 24 hrs post vaccine. Vomiting lasting 12 hours and nausea continued without ability to take fluids. Dr. prescribed Zolfan and after the first dosage, fluids were tolerated. Fever lasting less than 48 hours, muscle soreness was mild by 48 hrs and continues as mild at this point, 78 hrs hrs post vaccine.

COVID19 VACCINE JANSSEN 1 day 1097813-1 Fever of 102 degrees for 16 hours ongoing. Chills. Headache. Lower back pain. Fatigue. Injection site pain. Using 440mg of naproxen sodium po every 6 to 8 hours to relieve symptoms. Fever does not break with naproxen administration. Rash development 4x4 inch on back of neck and shoulder base, small 2 inch section of left side, abdominal region, upper COVID19 VACCINE JANSSEN 1 day 1097828-1 left chest base of neck 2x2 inch section and small bumps 3 inches below bellybutton( no growth there). Taking Benadryl 4hr. And using topical hydrocortisone cream. Received vaccine Thursday at 1:23 pm. Friday at 10:30 am started getting chills and body aches. Throughout the day body aches continued to get worse and nausea began around 2:30 pm and continued all night. No appetite, and only COVID19 VACCINE JANSSEN 1 day 1097874-1 slept 3.5 hours then awoke and began to throw up for several hours. (mostly dry heaving due to not being able to eat) Saturday all day was heavy and sore eyes, headache, nausea, sore throat but the body aches were getting better. Saturday at 8:23 pm still feeling nausea with a sore throat and very tired... To Be Continued COVID19 VACCINE JANSSEN 1 day 1097893-1 Chills, headache, felt week and tired. This is what the employee let me know about signs and symptoms -""At about 1am, I started feeling nauseous. Then I woke up at 4am I have had very bad HA, body aches, Dizziness and tachycardic. My heart rate is staying 129-140 and COVID19 VACCINE JANSSEN 1 day 1097947-1 I?ve been vomiting. I talked with my Doctor and he ordered some medication for me to take."" Names and types of medication was not disclosed.""

Headache presented soon after dose. Tiredness presented soon after dose. Headache worsened through night. 99.9¶ COVID19 VACCINE JANSSEN 1 day 1097967-1 fever presented ~8 hours after vaccine. Intermittent coughing presented ~10 hours after vaccine. 103.5¶ fever presented ~10 hours after vaccine. Intense chills presented ~10 hours after vaccine. Nausea presented ~12 hours after vaccine. COVID19 VACCINE JANSSEN 1 day 1097992-1 Vomiting, nausea, chills, low grade fever COVID19 VACCINE JANSSEN 1 day 1098003-1 headache, fatigue, chills, joint pain, muscle soreness COVID19 VACCINE JANSSEN 1 day 1098028-1 Cardiac arrest, death approx 12 hours later Fever (101), aches, chills, nausea. Felt like I was as sick as I have ever been. Resolved mostly in 24 hours. Dizziness and COVID19 VACCINE JANSSEN 1 day 1098061-1 nausua remained for several days. Sore arm with continued sharp pains for a week. COVID19 VACCINE JANSSEN 1 day 1098087-1 chills, body aches, low-grade fever, headache, muscle aches, pain at injection site

COVID19 VACCINE JANSSEN 1 day 1098094-1 Received vaccine at 9:25AM. Felt achy around 4PM and two Advil. Felt better. 12:15AM awoke to fever 101.4, chills, body aches and headache. Persisted through night into morning. Switched to 2 Tylenol at 8AM and felt a bit better. COVID19 VACCINE JANSSEN 1 day 1098096-1 Extreme fatigue COVID19 VACCINE JANSSEN 1 day 1098100-1 Head Headache and vomiting the next day. Felt fine later that day Took the vaccine at 6:00 P.M. the night before, no side effects besides occasional dull throbbing pain Woke up at 7:30 COVID19 VACCINE JANSSEN 1 day 1098101-1 A.M., right arm is sore and hurts to lift, experiencing chills, fever of 101.3 At 9pm I started to feel tired and went to bed. At 3am I woke up with nausea, headache, and arm very sore at site of COVID19 VACCINE JANSSEN 1 day 1098131-1 injection. I was also a bit dizzy when I got up. By 10am, I just had a bit of a heachache and fatigue. 7hrs post- Fever, 100 & chills begin 9hrs post- Fever, 100 11hrs post- Fever 101 13hrs post- Fever 103, mild sore throat 15hrs post- Fever 103-104 16hrs post- Fever 102, headache begins (Ibuprofin Taken) 22hrs post- Fever 100, (Ibuprofin COVID19 VACCINE JANSSEN 1 day 1098142-1 Taken) 28hrs post- Fever 100, (Acetometaphin Taken) 30hrs post- Fever 102, severe convulsing 36hrs post- Fever 100, headache 42hrs post- Fever normal, headache ends (Acetometaphin taken) COVID19 VACCINE JANSSEN 1 day 1098158-1 48 hours of fever, severe headache and aches. Swollen and painful limphknots in armpit. COVID19 VACCINE JANSSEN 1 day 1098166-1 fever, chills, headache, muscle aches, fatigue Chills at about 8pm on 3/6/2021. The woke with a rapid pounding heart rate just after midnight 3/7/2021. I went to the Hospital emergency room. They ran tests; ekg, blood tests, chest X-ray. They gave me fluids and Tylenol. My heart rate COVID19 VACCINE JANSSEN 1 day 1098172-1 and blood pressure were fluctuating when I first went to the ER but then they went back to normal and I was released around 6:00pm 3/7/2021. COVID19 VACCINE JANSSEN 1 day 1098173-1 Chills, fever, nausea, weakness, over 101 temp. after 12 hours; weak for several days after Janssen COVID-19 Vaccine EUA - had numbness and tingling in pinky and ring finger on left hand. Woke up at 1:40AM COVID19 VACCINE JANSSEN 1 day 1098184-1 with skin hurting, fever was 100.9. Really bad headache, lightheaded 100.2 fever, chills, soreness in left arm at site, body aches all over. These symptoms started around 2 am and continued COVID19 VACCINE JANSSEN 1 day 1098195-1 throughout the morning About 14 hours after receiving the injection, I started to have some minor chills. After 24 hours of receiving the injection COVID19 VACCINE JANSSEN 1 day 1098197-1 I also developed a fever of 100.4, felt slightly achy, and had a headache. My symptoms lasted for about 36 hours total. I drank a lot of water, had a normal appetite, and took some Tylenol. COVID19 VACCINE JANSSEN 1 day 1098198-1 Severe bodyaches, and severe chills. COVID19 VACCINE JANSSEN 1 day 1098208-1 Fever chills headache body aches Severe hives all over body that come and go and get worse with heat, hives started about 7am on March 12 and until COVID19 VACCINE JANSSEN 1 day 1098214-1 now Sunday 14 they come and go out COVID19 VACCINE JANSSEN 1 day 1098216-1 Swelling of the face and hives all other the body. Woke up feeling like I had the flu. Very achy and tired. Very sore head and horrible back ache. Next day added hives all COVID19 VACCINE JANSSEN 1 day 1098219-1 over my legs. COVID19 VACCINE JANSSEN 1 day 1098227-1 Symptoms started at 1am: fever of 101¶, chills, body aches and headache. Still experiencing all symptoms 10 hours later Woke up next morning with headache. Neck began to ache through the day. By 4pm had 102 fever and muscle aches and COVID19 VACCINE JANSSEN 1 day 1098278-1 cramps in neck, arms, legs, feet, and back. For the next 8 hours had fever and chills. And sweated profusely soaking the bed. Fever broke around 2 am and now just feel sore and weak. 12:00 AM: Sore Muscles, Nausea 04:30 AM: Vomiting, Fever (107.4 ¶F). No treatment provided. Symptoms resolved COVID19 VACCINE JANSSEN 1 day 1098377-1 naturally by 13:00 (1PM) 03/12/21. Day 1: 11 hours after injection - severe fatigue, dizziness, diminished ability to mentally focus, severe weakness in legs and diminished ability to control legs. Legs intermittently felt numb and at time with ""pins and needles"" tingling. Knee joints felt as if in danger of flexing backwards. Arms were similarly affected but not as drastically as legs. Arms had COVID19 VACCINE JANSSEN 1 day 1098424-1 better function and control than legs but with marked weakness. Day 2: Some improvement. Able to go to work but still have fatigue and leg weakness persist. It takes additional mental and physical effort to walk. Walking does not feel automatic or safe like it was before. Still have high level of fatigue. Symptoms improve some later in the afternoon. Days 3"" I got a knot and soreness in my arm directly below the injection site that began immediately after the shot and lasted COVID19 VACCINE JANSSEN 1 day 1098519-1 for one day. 24 hours after the vaccine, I began a low grade fever and general fatigue that lasted for several hours. The next morning, I felt fine. COVID19 VACCINE JANSSEN 1 day 1098539-1 Headache, muscle aches, chills for 1 day Neck swelling, general pain, flu like symptoms, fever, exhaustion, muscle and body aches, swollen glands, headache, COVID19 VACCINE JANSSEN 1 day 1098634-1 injection arm feels like it?s going to fall off COVID19 VACCINE JANSSEN 1 day 1098639-1 Janssen COVID-19 Vaccine EUA Fever of 101.7 at 10 am on 3/14/2021. Started with chills at 3:00 am on 3/14/2021

I received the vaccine at 4:20 PM on Friday (3/12). I had no adverse effects until after I fell asleep. I woke up at 2:00 AM COVID19 VACCINE JANSSEN 1 day 1098676-1 with a fever, body aches, headache, and severe nausea. I proceeded to vomit until 6:00 AM. The following day (3/13) included mild headache, mild body aches, and slight nausea. By Sunday (3/14), all negative symptoms had gone away. COVID19 VACCINE JANSSEN 1 day 1098730-1 chills,tired,weak,and sore all over Patient is breastfed by mother, who was vaccinated on 3/10. Patient developed jaundice 3/11, and was admitted for COVID19 VACCINE JANSSEN 1 day 1099241-1 evaluation of hemolytic anemia. Evaluation ongoing. Likely not related to vaccine, but occurred within 2 days of possible to vaccine components via breastmilk COVID19 VACCINE JANSSEN 1 day 1099262-1 Swelling in neck, left side, abive adams apple; jawbone tenderness, difficulty opening mouth Upon injection into the right arm, blood started to pour out of the injection site. Bleeding stopped once the nurse administered pressure. There were no immediate side effects present, other than soreness at the injection site. COVID19 VACCINE JANSSEN 1 day 1099266-1 Approximately 17 hours after the vaccination, the following symptoms started: nausea, malaise, fever (102.3), chills, headache, and lower back pain. The onset of side effects was intense and required that I immediately stop what I was doing and rest. Clusters of mouth ulcers formed on lip, tongue and cheek. Some very deep and painful, in the 3 days since I?ve COVID19 VACCINE JANSSEN 1 day 1099288-1 experienced these, new ones have sprung up and none have healed COVID19 VACCINE JANSSEN 1 day 1100607-1 Seizure Severe anxiety, nervousness, panic feeling, pacing, shaking, aches, chills, irritability, headache. Unable to function COVID19 VACCINE JANSSEN 1 day 1100701-1 mentally due to severe irritability. Experiencing similar symptoms to when actually tested positive for COVID 19 in March of 2020. Janssen Covid 19 Vaccine EAU - 3/14/21 -Headache, Fever (99.2) , joint aches, Took Ibuprofen X 400mg at 9AM. Had COVID19 VACCINE JANSSEN 1 day 1100864-1 headache and felt tired and achy all day. At about 6:30PM took Ibuprofen 400mg, Awoke morning 3/15 with slight headache but nothing requiring medication. Feel that reaction is 99% resolved COVID19 VACCINE JANSSEN 1 day 1100865-1 Patient died within 24 hours of vaccine. Unknown at this time if related. Janssen COVID vaccine was administered on 3/13/21- patient was screened twice and denied receiving any vaccines in the past 2 weeks. after administration it was noted today (3/15/21) that the patient received the Moderna COVID vaccine (one dose) on 3/4/21. I attempted to reach out to patient to discuss and noted that she is admitted to Hospital COVID19 VACCINE JANSSEN 1 day 1102547-1 for a NSTEMI. Per chart notes patient reported symptoms of fever, nausea, malaise on 3/13/21 after vaccination. The next day 3/14/21 developed syncope and chest pain. Patient reported to emergency room and was admitted with NSTEMI COVID19 VACCINE JANSSEN 1 day 1103106-1 Patient died on 01/24/2021. Began exhibiting symptoms similar to Covid 1 day after vaccination. Started with nausea. Then omitting (without GI disturbances). Around noon, symptoms included severe body pain, feet swelling, headache, light and noise sensitivity, foggy thought process, and facial rash with noticeable hair loss comparable to a Lupus flare prior to treatment several years ago. Low grade temperature of 99 for a few days. The COVID19 VACCINE JANSSEN 1 day 1103681-1 symptoms have improved, however, thinking is very foggy. Physician ordered Phenergan for nausea and vomiting; as well as: hydration and rest. Ibuprofen for headache and joint and body pain. Ambien to sleep. This has been going on for four days. Bad headache, sudden onset 18 hours after shot. Took two Aleve, which reduced intensity but I still have it as I complete COVID19 VACCINE JANSSEN 1 day 1103689-1 this form at 9:30 PM. I also had tremors in my extremities (left leg, both hands) about 4 hours after the shot, which lasted a couple of hours and haven't returned. I woke up less than 24 hours later feeling very achey and fatigued. My body ached all day the day after and I had a bad COVID19 VACCINE JANSSEN 1 day 1103714-1 head ache. My arm that the shot was in, hurt to move but was bearable. The injection spot is inflamed and raised and the arm muscle still had a deep ache almost a week later. COVID19 VACCINE JANSSEN 1 day 1103726-1 2 nights of sleeplessness on top of the most common side effects. Fatigue also marked by inability to sleep. 8am: woke up with a moderate headache and it subsided after taking 2 advil 6pm: blurry vision, hard to focus on computer screen, lasted for about an hour 7pm: fatigue, lightheaded 8pm: very sensitive to light, wanted to lie down COVID19 VACCINE JANSSEN 1 day 1103729-1 8:30pm: chills, mild fever, slight cough 11pm: some sweating while sleeping, felt very dehydrated *didn't take any other medicine throughout the day, slept it off and felt much better the next morning besides tolerable headache Pt c/o hypoglycemia. Healthcare provider indicated pt has been trending down ( in the 50's) with blood glucose over the COVID19 VACCINE JANSSEN 1 day 1103981-1 past few days prior to receiving the vaccine. Mother of patient insists the hypoglycemia is from the vaccine. Death Narrative: Patient has been admitted to a home hospice program since approximately 11/12/20 with an initial COVID19 VACCINE JANSSEN 1 day 1104430-1 terminal diagnosis of dysphagia which was later changed in February 2021 to vascular dementia. Patient with significant past medical history of several CVA's which led to aphasia and vascular dementia. Patient has a long history of seizures. He has seizures on a daily basis. He lives with his family, who are his primary caregivers, they family provides all of his activities of daily living. Patient received vaccine on Friday morning, feeling COVID19 VACCINE JANSSEN 1 day 1104671-1 well throughout the day according to the father. Went to bed, during the night in bed he had seizures which is typical for him, and during the episode the father noticed that he had stopped breathing. called 911 who came to the house and the patient died in the house. I do not believe he went to the hospital. Initially had chills, fatigue for two days, then on 3/15 awoke with severe weakness in the right lower extremity. COVID19 VACCINE JANSSEN 1 day 1105572-1 Presented to ER, MRI showed acute stroke ( Small acute infarction within the posterior left corona radiata). Admitted for stroke stabilization and rehab evaluation. Will be discharged to home with outpatient PT and OT headache and feeling ?high? about an hour afterwards. fatigue persisting. seven hours later (12 am) fever 100.5, severe COVID19 VACCINE JANSSEN 1 day 1107381-1 chills and shakiness and a migraine type headache. nausea came sometime after 12 am. COVID19 VACCINE JANSSEN 1 day 1107387-1 Severe Headache, Stomache Pain, Vommiting Headache, dizziness and brain fog initially. Significant arm, shoulder and neck pain on left side. (Injection site). Neck pain COVID19 VACCINE JANSSEN 1 day 1107402-1 continues after two days/seems worse. COVID19 VACCINE JANSSEN 1 day 1107425-1 Severe chills, mild fever (100.0). Lasted for a few hours. Took Tylenol and helped. Fever broke next night. COVID19 VACCINE JANSSEN 1 day 1107487-1 Migraine, low grade fever, tachycardia, sweating, chills Received shot on 3/11/2021 felt okay, a little tired. 3/12 extremely tired - no energy, 3/13 felt a lot better but had a COVID19 VACCINE JANSSEN 1 day 1107532-1 little sore throat, 3/14 extremely tired sore throat mucus drainage down throat, 3/15 tired no energy, sneezing, dry cough, 3/16 tired no energy sneezing dry cough. Today 3/17 finally feeling better but still a little tired. COVID19 VACCINE JANSSEN 1 day 1107567-1 Fever, chills, achy. Duration 12 hours. COVID19 VACCINE JANSSEN 1 day 1107593-1 Woke up with severe headache, muscle aches, fever, chills. Fever lasted for 24 hours. 101.3 COVID19 VACCINE JANSSEN 1 day 1107605-1 Discomfort under right arm pit Constant Has not resolved at present time COVID19 VACCINE JANSSEN 1 day 1107624-1 48 hours of exhaustion, severe body aches 8 hours of 102¶F Fever Left Arm Pain-6 days COVID19 VACCINE JANSSEN 1 day 1107641-1 Head ache, chills, low grade fever COVID19 VACCINE JANSSEN 1 day 1108447-1 Death - deemed of natural causes, was on hospice COVID19 VACCINE JANSSEN 1 day 1108465-1 Heart was in A-fib, blood clot formed and had a Left Posterior Parietal Stroke Chills, shivers, uncontrollable shaking, freezing, Fever (102.5), chest pains, high blood pressure, nauseous, aches and pain. COVID19 VACCINE JANSSEN 1 day 1109976-1 Tylenol, motrin, liquids (tea and water). Fatigue 2-3 hours after vaccination. Sweating/elevated heart rate about 11 hours after vaccine. Severe Headache 11 COVID19 VACCINE JANSSEN 1 day 1110037-1 hours after vaccination. Janssen COVID-19 Vaccine EUA Side effects felt upon waking up @ 4:00am. Lymph node felt on the left armpit (left arm is the injection site). Slightly elevated temperature Muscle soreness on the injection site. 6:00 am Felt slight body and COVID19 VACCINE JANSSEN 1 day 1110081-1 joint pain (feeling fatigued) 7:15 am - took 1000mg paracetamol 9:00 am Felt slight nausea and continuous headache 1:30 pm - took 500mg paracetamol (slight headache still present) 3/12 4:30 pm started with frequent liquid diarrhea for the next 3 days but on 3/13 at about 9pm broke out in full body COVID19 VACCINE JANSSEN 1 day 1110155-1 hives, very red and became flushed and hot Fever of 101.2F at highest, headache, chills, feeling very tired all appeared at 5am on 3/14 the following morning after receiving vaccine. Took Tylenol and slept until about 1:30pm. At that time all symptoms except tiredness and slight COVID19 VACCINE JANSSEN 1 day 1110219-1 headache were gone. Took a few more hours for headache to go away and by next morning everything was back to normal. COVID19 VACCINE JANSSEN 1 day 1110222-1 Chills, fever, body aches - night of vaccine Muscle twitching in arm of vaccine starting 3/17 Night sweats 3/17 COVID19 VACCINE JANSSEN 1 day 1110236-1 Exhausted, no energy, no motivation, not wanting to get out of bed or go to work. Maybe depression from shot Janssen COVID-19 Vaccine EUA Strong fatigue, brain fog, pain throughout body, strong flare up of fibromyalgia COVID19 VACCINE JANSSEN 1 day 1110295-1 symptoms. Janssen COVID-19 Vaccine EUA Body aches - pain level 10/10 from 3am - 7am, pain level 7/10 from 7am-12pm, pain level COVID19 VACCINE JANSSEN 1 day 1110308-1 4/10 from 12pm-7pm Chills/sweating/fever off and on from 3am-7pm Nausea, loss of appetite Took Tylenol and ibuprofen every 4-6 hours Severe chills starting at 1:30 am 17Mar21 followed by fever/sweats at approximately 3:00 am 17Mar21, Headache and COVID19 VACCINE JANSSEN 1 day 1110395-1 body aches 8 am 17Mar21, vomiting 10 am 17Mar21. Headache and body aches present until 10:30 pm 17Mar21. My blood sugar went to 364 and stayed there all day and then that night it was 267 and then it was the next morning 202 and then it went to normal in the low 100s. Hives in the crook of my right arm. Burning, itchy little red bumps. I COVID19 VACCINE JANSSEN 1 day 1110416-1 couldn't swallow but I think that was from the high blood sugar as my mouth was very dry. I felt like I had a really bad cold, my head felt foggy. COVID19 VACCINE JANSSEN 1 day 1110420-1 Flu-Like Symptoms, Muscle Aches, Earaches in both ears, not ringing, but earaches for two days. COVID19 VACCINE JANSSEN 1 day 1110422-1 fever to 100.4, headache, neck pain for 10 hrs then 3 days later developed fever 100.6 and abd pain, diarrhea, COVID19 VACCINE JANSSEN 1 day 1110488-1 Flu like - low fever, chills, muscle aches, headache (left rear), fatigue,. Lasted about 24 hours from onset. COVID19 VACCINE JANSSEN 1 day 1110637-1 Experienced COVID-like symptoms. Headache, sweating, body aches for roughly 12-16 hours woke up about 12:30 am Friday 3/12 with signs of fever (too sick to look for thermometer) , sweats, chills, vomiting, until about 5am. I was very sicks. Then continued with fatigue, nausea, terrible headache and neckpain until about 5pm COVID19 VACCINE JANSSEN 1 day 1110708-1 on Saturday 3/13. At that point everything seemed to have passed. I could not go to work on Friday 3/12. Been fine since 5pm on 3/13. COVID19 VACCINE JANSSEN 1 day 1110735-1 Headache, muscle aches, pain at injection site, cough & fever of 100.1 F Was fever free by 10am 3/17/21 COVID19 VACCINE JANSSEN 1 day 1110881-1 Shock, Body aches and pains, Fever, Shortness of breath, Chills, Loss of appetite, Had nausea, body aches, chills and slight aches at injection site. Some diarrhea as well. Symptoms lasted for a few hours COVID19 VACCINE JANSSEN 1 day 1110990-1 (except diarrhea which lasted a couple of days). All fine currently. 3-12-21 redness and progressively gotten worse. Took tylenol and was icing compresses Recommended antihistamine, to COVID19 VACCINE JANSSEN 1 day 1111015-1 ice 10mins on/10mins off, and to draw a line around the affected area to monitor changes; caller verbalized understanding. My blood pressure went up very high, pain in my chest, shortness of breath, rash on my face, swollen arm and redness at COVID19 VACCINE JANSSEN 1 day 1111849-1 injection site. Went to the hospital. Monday, March 15th at hospital from 2:00 p.m. until 7:00 p.m. I had general fatigue and headaches. The after I woke up my left arm was red and puffy. Overnight the area had doubled in size, itchy and painful. The area was circular and 2-3 inches in diameter. I went to Urgent care and they gave me COVID19 VACCINE JANSSEN 1 day 1112621-1 Benadryl and a Steroid to take. The area is still painful and swollen and is starting to improve. It has been seven days and the area is still red swollen, warm and itchy. I have three more days of Steroid medication left. I just had a headache and fatigue for the first couple of days. COVID19 VACCINE JANSSEN 1 day 1114083-1 Fever, upset stomach, headache, nausea, body aches COVID19 VACCINE JANSSEN 1 day 1114451-1 besides sore arm, I also had dry heaves, headache x3 days, fever, chills, fatigue COVID19 VACCINE JANSSEN 1 day 1114456-1 insomnia COVID19 VACCINE JANSSEN 1 day 1114479-1 Fever 100.9F, tiredness, chills, muscle aches, headache COVID19 VACCINE JANSSEN 1 day 1114482-1 Severe chills and sweating. Fever of 102 Early the next morning after the vaccine I woke up with chills, body aches and felt feverish so I took 2 tylenols and went back to sleep. Around 7am I woke up still with the same symptoms so I took another 2 tylenols. I remained up but COVID19 VACCINE JANSSEN 1 day 1114487-1 started feeling bad so I laid down and took a nap. Around 4pm I took 2 more tylenols because I just didnt feel well. I didnt feel well the remaineder of the day and laid down for bed around 7pm and woke up the next morning and all symptoms had subsided. I was 16 weeks gestation at the time of the vaccine. EDD-8/25/2021. Around 1am (~13 hr after vaccination) I began experiencing severe joint pain in my ankles, knees, hips and spine. Enough COVID19 VACCINE JANSSEN 1 day 1114488-1 to wake me up from my sleep. The pain was also accompanied by chills. I took Tylenol for the symptoms but the pain did not subside. This morning, at 8:30am the joint pain is still very strong. I was up all night with chills, fever (101+) and severe headache. The headache is what kept me from being able to sleep. I wasn't sure if it was ok to take otc pain meds so I waited until morning (9:30 am) to call my doc. Fever had subsided, COVID19 VACCINE JANSSEN 1 day 1114707-1 but still had intense headache. Doc told me to take 2 extra strength Tylenol which I did. Headache was relieved within 45 minutes. I was able to sleep. Felt much better afterwards although still struggled with fatigue and mild headache for approx 80 hours following vaccine. COVID19 VACCINE JANSSEN 1 day 1114727-1 Fever, fatigue From about 1am to about 7am I felt like I had the flu or a bad cold. Headache. Feverish (but no fever when measured at COVID19 VACCINE JANSSEN 1 day 1114739-1 8am). Body aches. I took three ibuprofen at about 4am. Now I feel fine. Maybe just a little tired. But that could be from sleeping poorly last night. Severe headache, severe abdominal pain just below the sternum - occurred at approximately 02:00-03:00 am, on March COVID19 VACCINE JANSSEN 1 day 1114753-1 19, 2021. The abdominal pain lasted for several hours, and the headache, while lessened, continues. After injection the initial side effect was only a sore arm. By 9:15 the next morning (Friday) body aches began to set in, with sore joints. At 10:30 when I took my temperature, it was 101 and chills set in. For the remainder of the day I COVID19 VACCINE JANSSEN 1 day 1114774-1 alternated with tylenol and advil. Aches and fever remained the rest of the day. By Saturday morning, fever was down and it was only 99.8. The only side effect on Saturday was a sore arm and headache. All symptoms were gone by Sunday morning. fever, chills, body aches, swelling of lymph nodes in left side of neck and shoulder (injection site was left arm), COVID19 VACCINE JANSSEN 1 day 1114841-1 fatigue/sleepiness COVID19 VACCINE JANSSEN 1 day 1115060-1 none at this time Dizziness, Throwing up, nausea, headache, weak, muscle aches, diarrhea , no energy, sleeping more, flu like feeling; All COVID19 VACCINE JANSSEN 1 day 1115088-1 symptoms kept for the week and still have them 5 days later. Loss of appetite as well. Monday and Thursday of the week was only time of throwing up. COVID19 VACCINE JANSSEN 1 day 1115203-1 Tiredness COVID19 VACCINE JANSSEN 1 day 1115378-1 Joint Pain, Muscle cramping, Headache, and increase in resting heart rate COVID19 VACCINE JANSSEN 1 day 1115401-1 Body aches and lethargy x 10 days COVID19 VACCINE JANSSEN 1 day 1115417-1 Chills, hot flashes, full-body sweats, nausea, vertigo, dizziness, tunnel vision, disorientation No immediate reaction. Symptoms began about 10-12 hours after receiving vaccine shot. Experienced intense chills, COVID19 VACCINE JANSSEN 1 day 1115427-1 possible fever, muscle aches, headache, nausea, and fatigue for the following 18-24 hours I woke up nauseated and dizzy in the middle of the night. At 5 AM when I tried to get up for work, I couldn?t walk due COVID19 VACCINE JANSSEN 1 day 1115455-1 to the dizziness and headache. I attempted to shower, but was so dizzy I had to go back to bed. I felt terrible all day - nausea, headache, dizziness, muscle aches, pain at the injection site, and severe fatigue.

Woke up with severe chills around 3:45 AM the morning after my vaccine. Temp was low grade at first but then climbed, max was 102.2¶F. All over body aches, no appetite, weakness, fatigue, headache, nasal congestion, burning eyes, ataxia, COVID19 VACCINE JANSSEN 1 day 1115459-1 lightheadedness. Took my AM meds including hydrocodone-APAP which caused the fever to break but stayed low grade until the following afternoon around 2 PM. Helped with the body aches somewhat as well. Appetite started to return this morning, 3 days after the vaccine but the fatigue, weakness, muscular pain and a general unwell feeling continues.

COVID19 VACCINE JANSSEN 1 day 1115472-1 10 hours after vaccination - fever, chills, body aches, severe headache, exhaustion, metallic taste in mouth 36 hours after vaccination - fever, chills, and body aches are gone; mild headache and metallic taste remain; very easily worn out COVID19 VACCINE JANSSEN 1 day 1115477-1 Rash over body progressive worse over 5 days COVID19 VACCINE JANSSEN 1 day 1115562-1 Chills 102 fever Achy Headache 12 hours Took 800 mg ibuprofen and zinc and vitamin d Headache lasting at least 12 days (time of appointment scheduled) w/ sensation of ""foggy"" vision day after vaccine COVID19 VACCINE JANSSEN 1 day 1115754-1 (that resolved after that). Headache is improving, but not resolved at day 12, and was ""excruciating"" day after he received."" COVID19 VACCINE JANSSEN 1 day 1115924-1 Sore arm where vaccination went. High fever of 102 and body aches resident began to experience stroke like symptoms at approximately 0300, resident noted with slurred speech, left arm COVID19 VACCINE JANSSEN 1 day 1115946-1 and leg flacid, facial drooping to left side of face. B/P 193/116. transferred to ER for evaluation COVID19 VACCINE JANSSEN 1 day 1115950-1 Injection site reaction with redness, itching, swelling, 2 inches around. Resolved3/19/2021 COVID19 VACCINE JANSSEN 1 day 1115999-1 Muscle aches, headache, sore neck/throat, joint pain, very sore arms (both), chills Hives on most of body; feet, legs, arms, hands. Hives are widespread and itchy. They continue to spread. No welling in COVID19 VACCINE JANSSEN 1 day 1116074-1 or around mouth and no difficulty breathing. Only treatment so far has been with benadryl tablets. Reported nausea with bloody emesis x 1 on 3-18-21 at 2247 . sent to Emergency Room for rule out of GI bleed. Diagnosis COVID19 VACCINE JANSSEN 1 day 1116214-1 of nausea and vomiting from ED physician. Pt received vaccination around 9am on 3/18. Started having lip swelling next day and presented back to the pharmacy on 3/19 around 1:15pm. Pt states he was having no tongue swelling or any other symptoms, just swelling of the lower COVID19 VACCINE JANSSEN 1 day 1116222-1 lip. We administered 25mg of benadryl and kept an eye on him in pharmacy for 15 minutes and he said he was feeling fine and would check back with us. Pt is an associate so pharmacy is keeping an eye on him. COVID19 VACCINE JANSSEN 1 day 1116288-1 Pain at injection site, large red area surrounding injection site COVID19 VACCINE JANSSEN 1 day 1116336-1 Fever, tiredness, weak, dizziness , frequent urinating 24 hours after vaccine, hard lump, swollen and pink, moderate chills. The next day, bigger lump, swollen, all just below injection and red, moderate chills, a bit itchy, nausea., and painful. Same on 3rd day but much bigger redness spreading down arm, 2 1/2 by 2 1/2' hard mass and red, itchy, painful, chills and nausea. Next morning called Dr. I am taking COVID19 VACCINE JANSSEN 1 day 1116411-1 amoxicillin-clav 875-125ng tab. Three days later mass is turning from red to pink and retreating. Still hurts and now bruses show around the injection site, which I thought was strange. The vaccine actually hurt when given (I get injections every three months, so I know what they will feel like, but this hurt and went very deeply and then burned). I felt warm afterwards for about 10 minutes. Night of vaccine, I woke up at about 4am experiencing chills and a headache. Headache and minor chills still remain as COVID19 VACCINE JANSSEN 1 day 1116586-1 well as fever, aches, fatigue, and weakness. COVID19 VACCINE JANSSEN 1 day 1116658-1 Shortness of breath, fever, chest pain. She was readmitted after emergency department visit. Upon waking up the following morning, I experienced leg cramps and nausea. As the day progressed I had an overall achiness and fatigue, often had chills, and had periodic leg cramps and head aches. This continued into the early morning COVID19 VACCINE JANSSEN 1 day 1116740-1 the next day, when I broke out into sweats in my sleep, and then the symptoms passed. Total time from onset to resolution was approximately 18 hours. Severe chills and stabbing pain in joints for 3 hours beginning around 4:15 am on 3/14/2021. Insomnia from 3/14- COVID19 VACCINE JANSSEN 1 day 1116806-1 3/17/2021. 24 hours post-injection started with redness and pain to Left deltoid injection site and has gradually worsened with COVID19 VACCINE JANSSEN 1 day 1116836-1 1.5inch circular area of induration and redness and warm to touch Soon after vaccination, pt developed generalized muscle aches and SOB along with low grade fevers. Pt was admitted to hospital on 3/13/2021 for fever, diffuse myalgia, arthritis, rash, tachycardia, and dsyphagia and got diagnosed with COVID19 VACCINE JANSSEN 1 day 1116850-1 likely serum sickness like reaction after COVID-19 vaccination after all the work up for autoimmune etiology such as vasculitis or SLE came back negative. she's currently getting IV solumedrol 50mg BID since 3/17 (switched from prednisone 40mg daily) with a good response. I experienced pain in my right side of my back. It was not back pain, it felt like my kidney. The intense pain began March 10, on a scale from 1-10, the pain was a 6. I was uncomfortable when I tried to sleep, lasting throughout the day COVID19 VACCINE JANSSEN 1 day 1117001-1 time hours. and lasted until March 15, 2021. I was prescribed Metocabamol and Meloxican. Also, I applied heat which was not affective, ice, worked at 50%.and I used a portable muscle stem for 1-2 hours at a time. This treatment worked the best. doctor diagnosis was a sprain ligaments of lumbar spine. Patient called Thursday around 2 pm and asked if it was normal to hurt all over. I told her muscle pain could be an COVID19 VACCINE JANSSEN 1 day 1117023-1 adverse effect. The patient then said she felt that her blood pressure was up and felt as though a mack truck was on her chest. I instructed her to go to the ER. about 15 hours post-shot, felt achey. For the next 8 hours I had muscle and joint aches. I felt relief when I slept, therefore COVID19 VACCINE JANSSEN 1 day 1117068-1 I was in bed all day resting. My head was a bit foggy, I couldn?t do too much. I took an advil in the afternoon, and I was fine by the evening. COVID19 VACCINE JANSSEN 1 day 1117092-1 Headache, fever, chills, body aches I was fine when I went to bed. I woke up with violent chills, a fever, a headache and a sore arm. It lasted between 24 COVID19 VACCINE JANSSEN 1 day 1117142-1 and 36 hours. Gradually dissolved. I am due any day now and my pregnancy has progressed well. Pregnancy history: progressed well EDD: any day now Birth Weight: N/A 20 y/o national guard male, presented to ER with weakness and fatigue, on exam was tachycardic, febrile and had chills. COVID19 VACCINE JANSSEN 1 day 1117721-1 EKG showed sinus tachycardia, EKG with sinus tachycardia with RBBB, Echo normal. Troponin mildly elevated at 0.11, admitted for serial troponins and telemetry, released later in the morning.

Pulmonary embolism with acute Cor Pulmonale/hypoxia I had shortness of breath, dizziness, coughing. I had Covid test COVID19 VACCINE JANSSEN 1 day 1120494-1 on 3/12/21 that was negative. Went to Urgent Care on 3/12/21. Gave me an albuterol inhaler which was not effective in relieving symptoms. I wasn't improving, so went to emergency room at the hospital on 03/18/2021. I was admitted to hospital and placed on oxygen and kept overnight. I was also given Xarelto. I am at home and on Xarelto. COVID19 VACCINE JANSSEN 1 day 1120711-1 Hospitalized with the following. Fever, chills, nausea, shaking, vomiting Pain in upper thigh when walking. Each step causes pain. Tylenol/Advil is effective treatment for it. It?s not severe, but COVID19 VACCINE JANSSEN 1 day 1120984-1 it?s enough to make me limp around. Patient received vaccine in the AM of 3/16/21. Patient was in his usual state of health when he went to bed the evening of 3/16/21. He ate dinner normally and his PD was started as usual. There were no overnight complications with his PD and he got up shortly before 8 AM. Mom reports the dialysate from his bag was clear and normal and none of his dwell was retained. She heard a loud thud from the bathroom around 8 AM and the patient was found by his mother having generalized convulsions (bilateral upper and lower extremities) and he appeared to be foaming at the mouth. He did not COVID19 VACCINE JANSSEN 1 day 1122987-1 respond to her and she called 911. The seizure stopped by the time EMS arrived and his initial GCS was 12, and 15 by the time they started transport. He had another seizure en route around 9:30 AM and was given 2.5 mg versed and required bagging. Patient was loaded with Keppra and now has been on maintenance Keppra. Patient has not suffered any additional seizures and is currently undergoing an extensive workup by inpatient neurology team. Vaccine adverse effect currently remains on the differential for inciting event leading to seizure however additional labs are pending to rule out other causes (eg. viruses causing PML). Patient was also diagnosed with multifocal pneumonia and started on antibiotics at time of admission. The NP gave him my vaccine and him mine. No symptoms at time. Headache and seizures, black eye from falling, slow COVID19 VACCINE JANSSEN 1 day 1124795-1 brain. Function I woke up on 3/7 right ear hurting, head throbbing felt warm with no temp.On 3/10 I went to the school nurse at my employer stated my right ear was red call doctor for antibiotic. I did contact my doctor the symptoms I was exp by then COVID19 VACCINE JANSSEN 1 day 1126432-1 my tooth (bottom right side) was hurting diagnosed trigeminal neuralgia. On last 3/17 my tooth/ear was still exp pain I followed up with my dentist stated he dint see anything. Then on 3/20 I exp a lot of pain went to ER had a CT and concluded I do have trigeminal neuralgia was told to follow up with neuro surgeon. Caller is pt's son, reporting side-effects/reaction of the father, to Janssen COVID-19 Vaccine. All information collected was by the caller (pt's son) and not by the pt. The pt received the Janssen COVID-19 Vaccine Lot# 1805029 at facility 03/13/2021, time unknown. The following day, 03/14/2021 the pt was speaking incoherently, easily agitated, wasn't speaking to gf. The pt's history of ministrokes lead to the family calling 9-1-1. Pt was admitted to Medical Center on COVID19 VACCINE JANSSEN 1 day 1126461-1 03/14/2021. Pt vomitted, aspirated, was put on a ventilator, admitted to the ICU for 2-3 days and discharged 03/19/2021. Pt takes Atorvastatin (Eliquis) 2.5mg bid, Furosemide 20mg qd, Lisinopril 40mg qd, Metropolol tartrate 12.5mg bid, and Folic Acid 1mg qd. Pt has a pacemaker and hypertension. Caller denies pt has any allergies. Currently the pt is only experiencing a loss of hearing. Caller was advised to take pt to primary doctor to have ears and hearing examined. Agent was consulted and Dr. was notified. COVID19 VACCINE JANSSEN 1 day 1126876-1 Patient passed away in the early morning of 3/13/21. Pt developed sudden-onset of severe left-sided chest pain with heavy pressure, shortness of breath and diaphoresis; pt collapsed and had a period of unresponsiveness lasting approximately 10 minutes. EMS was called and noted significant COVID19 VACCINE JANSSEN 1 day 1127237-1 ectopy as well as frequent NSVT on ECG. Pt was transported to the Emergency Department and subsequently admitted for observation. Pt states she got her COVID vaccine on Wednesday 3/17 and has been having nausea, vomiting, hoarseness, and fever COVID19 VACCINE JANSSEN 1 day 1129128-1 since. Family noted route post vaccination symptoms including fatigue, fever shortly after vaccination and within first 24 hours. COVID19 VACCINE JANSSEN 1 day 1129482-1 >24 hours patient began having increase in activity level, emotional lability, hyperactivity, flight of ideas, auditory and visual hallucinations, etc. COVID19 VACCINE JANSSEN 1 day 1131295-1 pulmonary embolism Constant and loud Tinnitus started in the middle of the night in both ears on the 2nd day of VAX and has remained COVID19 VACCINE JANSSEN 1 day 1133312-1 constant and consistent currently, almost 2 weeks later. Also, slight nausea began within 5 minutes of injection and has not totally diminished, but the MAJOR issue is the tinnitus!! Patient reportedly passed away on 3-24-21 on the day after the vaccine was given. We have no further information at COVID19 VACCINE JANSSEN 1 day 1134697-1 our facility regarding the event. Patient reported fevers as high as 105 at rehab and myalgias along with weakness, She was subsequently admitted to COVID19 VACCINE JANSSEN 1 day 1136535-1 the hospital for these symptoms. Patient had cardiac arrest secondary to MI less than 24 hours from receiving the vaccine. Now on 3 pressors. Although COVID19 VACCINE JANSSEN 1 day 1136622-1 due to the patient's health condition, this may not have been attributed to the vaccine. COVID19 VACCINE JANSSEN 1 day 1136908-1 Severe chills, shaking Fever of 101F Knee partially paralyzed for 3 days in a row (difficulty walking) Severe headache COVID19 VACCINE JANSSEN 2 days 1067448-1 None stated. About 4:30, 6 hours after receiving vaccination I felt nauseated, muscle aches, horrific headache, and weak. By 6:30 I felt like my body was burning up on the inside but had no fever. My muscles in my neck became extremely tight and my ears COVID19 VACCINE JANSSEN 2 days 1071859-1 aches. The injection site is extremely tender and hurts to lift my arm. As of 11 am the next day I have also added diarrhea to the list of symptoms. sudden flushing of upper body starting around 4PM 3/6/21 - about 50 hrs post-dose - took Benadryl 50mg seemed to COVID19 VACCINE JANSSEN 2 days 1078184-1 diminish some 30-40 minutes later - itch gone, still minor redness on upper chest, shoulders and face Vertigo or dizziness. Symptoms are mild. They became evident 30 hours after inoculation. I will remain home for the day COVID19 VACCINE JANSSEN 2 days 1079076-1 and see how I feel tomorrow. Around 10:30pm day of injection it started with severe body aches, including arms, hips, calf muscles. Then chills and dizziness. This occurred all night, waking at 7:45am with a 101.2 fever. This continued during the day after injection. COVID19 VACCINE JANSSEN 2 days 1079114-1 Waking on 3/6 with sores in throat and on the roof of my mouth. This is the one thing that I have not see as a symptom of the COVID vaccine. COVID19 VACCINE JANSSEN 2 days 1079165-1 Severe pain in wrist, minor swelling in wrist join shot given 3-5-21 3-7-21 at 2:00 am was woken up by bad muscle and joint pains. But I was freezing. I had the chills very badly I sleep with an electric blanket, but I had not had chills in years. I was very sore and cold, but did not do anything COVID19 VACCINE JANSSEN 2 days 1079662-1 until 4:00am. I went and got an expired prescription of oxycontin. I took 2 and went back to bed. I woke up at 6 and was fine. So it lasted maybe 4 hours. COVID19 VACCINE JANSSEN 2 days 1080368-1 Vertigo COVID19 VACCINE JANSSEN 2 days 1080753-1 Patient reports redness of left injection site and left breast crease. About 36 hours after injection I developed a painful golf ball size hard cellulitis. We drew a circle around it to track its spread. I am now 72 hours from time of vaccination and red site is larger and more painful. I also had a low fever last COVID19 VACCINE JANSSEN 2 days 1080854-1 night (100) which is high for me, since cancer treatment I struggle to get a fever, just the side effects ( chills aches). I was also very fatigued yesterday morning and the day before. COVID19 VACCINE JANSSEN 2 days 1080893-1 I had chills and muscle aches COVID19 VACCINE JANSSEN 2 days 1082243-1 Extreme tiredness- slept almost all day Monday Vaccine on fri 1pm. Sat had 102 fever, headache. Sun 7pm had possible heart attack symptoms? pain in jaw and from throat to sternum. It went away after giving aspirin so I did not call 911. Monday night 10:30 pm SEVERE headache and COVID19 VACCINE JANSSEN 2 days 1083968-1 severe nausea . Pain on top of head. She said it was unlike any headache in her life. After asprin and tylenol it subsided but she was up for hours with the pain. NOT NORMAL! COVID19 VACCINE JANSSEN 2 days 1085027-1 Started developing a sore throat two days after the vaccination. Initially Fever, Fatigue, Joint Pain. 2 days later pain in right abdomen, diagnosed with Appendicitis and had emergency COVID19 VACCINE JANSSEN 2 days 1085536-1 appendectomy performed. COVID19 VACCINE JANSSEN 2 days 1085596-1 lost grp in left arm, COVID19 VACCINE JANSSEN 2 days 1085875-1 Aches in upper torso muscles COVID19 VACCINE JANSSEN 2 days 1085964-1 Rash starting under the breast area around to the side and up to the armpit on both sides of body COVID19 VACCINE JANSSEN 2 days 1086111-1 Body ache, chills and headache and feeling hot COVID19 VACCINE JANSSEN 2 days 1086265-1 A hard painful knot developed at the injection site; surface of skin became pink. General malaise, Vaginal spotting began two days after with increased volume each day (no reason for spotting and have never spotted). COVID19 VACCINE JANSSEN 2 days 1086350-1 Neck pain started on day three. Took ibuprofen to reduce pain. Pain returned after medication wore off. Itchy rash, red bumps in and around injection site. Injection site soreness four days later. Hard callously feeling around COVID19 VACCINE JANSSEN 2 days 1086366-1 injection site on left arm where vaccine was given. I'm not sure if the Janssen is the same as Johnson and Johnson? But I'm type 1 diabetic and my blood sugars have been at dangerously high levels for 3-4 days now. They still haven't gone down. I've been taking two times as much long acting insulin as I usually take, tripling the amount of fast acting insulin I usually take, and am only eating protein and COVID19 VACCINE JANSSEN 2 days 1086443-1 vegetables (no carbs) to try to keep my sugars in normal range, and even then they are stubbornly sticking around 250 to 400. I want doctors and patients to be aware of this side effect because it was really scary for me and it still hasn't resolved itself. About 36 hours after the injection (Sunday 3/9 8:00am), I started getting a headache mostly at the base of my skull. It got progressively worse and spread to the front of my head too. By that evening (Sunday 3/9) it was throbbing like one of the worst headaches I have had. Monday was so bad that I called in and didn't work. Tuesday 3/9 was still bad. COVID19 VACCINE JANSSEN 2 days 1087429-1 Finally, Tuesday night is started letting up and was able to sleep. I still have a little headache at the back of my head, 9:00am 3/10. Also, I couldn't sleep Sunday 3/8 and Monday 3/9 night . I had a Tylenol 3 prescription and used it. I was taking 2 at a time and it was not helping much. Also mixed in some ibuprofen. COVID19 VACCINE JANSSEN 2 days 1087754-1 Headache. Cough. Lump in throat COVID19 VACCINE JANSSEN 2 days 1087845-1 nausea, aches, headache, very tired and weak COVID19 VACCINE JANSSEN 2 days 1088153-1 I woke up at 2:00 in the morning and had the chills. Approximately 39 hours after I was vaccinated, I got a flat, red, lacy rash on my forearms, abdomen, and back. It was not COVID19 VACCINE JANSSEN 2 days 1089039-1 itchy and mostly resolved within 24 hours. Typically, if I have a virus (common cold), I get a red, lacy rash but only on my arms. I have photos I can share if that would be helpful. COVID19 VACCINE JANSSEN 2 days 1089179-1 Swollen lymphnode above collarbone on same side of body as vaccination site. The patient had swelling of the face and hives on her arms and chest. Also itching of the head, eyebrows, and ears. This COVID19 VACCINE JANSSEN 2 days 1089210-1 started 2 days after the vaccine. She had fever and chills the night after the vaccine During a conversation, I was told I began smacking my lips then proceeded to completely ?zoneout? for 5-7 minutes. My arm was touched and I was asked a couple of questions to which I did not respond. After a few minutes, I became alert COVID19 VACCINE JANSSEN 2 days 1089226-1 and continued conversation where I left off. I was unaware any of this was happening. I was pretty much wiped out for about 5 days. I have never had a seizure before. Rash - raised red and itchy all over face - mostly on left side of face (same side as shot given). On cheeks, forehead, nose, COVID19 VACCINE JANSSEN 2 days 1089383-1 and neck

My injection was on a Monday at 1pm. I had no issues for about a day and a half. On Wednesday afternoon I started having itching and redness on my forearms and top of both hands. Both arms on Wednesday evening were swollen, quite COVID19 VACCINE JANSSEN 2 days 1090650-1 red and sore (a bit of a burning sensation). It almost feels like a bad sunburn at times. I took an antihistamine to help with the itching and swelling and this morning actually put calamine lotion on my arms to help soothe the burning feeling. It is more irritating that painful and nothing needing medical attention but I thought it should be reported. COVID19 VACCINE JANSSEN 2 days 1090716-1 Chills sweats vomiting diarrhea body aches no energy slept for most of day COVID19 VACCINE JANSSEN 2 days 1091185-1 ITP flare - Platelets declined, prednisone for 2 days, came back up Received injection on the R arm. However, injection was administered very close to the shoulder instead of the deltoid muscle. Area is very swollen and it has not decreased in swelling in several days despite applying ice, taking ibuprorfen, COVID19 VACCINE JANSSEN 2 days 1091284-1 and also applying heat. There is also a knot. I massaged the area to try to loosen the knot. However, I noticed it gets more swollen instead of getting better. The pain subsides momentarily. However, it returns. It is affecting my range of motion, I cannot lift my arm above my head as it causes extreme pain. COVID19 VACCINE JANSSEN 2 days 1091361-1 Repeated bouts of vertigo The patient received Janssen COVID vaccine on 3/6 to RIGHT deltoid. She has a past medical history significant for LEFT sided breast cancer, treated with lumpectomy and radiation ~5 yrs prior. Remains on Letrozole. 1 day post-vaccine, she developed fevers (tmax 104), chills, malaise. 2 days post-vaccine, the fevers, chills, malaise dissipated but she developed a ""rash"" to her LEFT breast (same site as prior malignancy). This rash became a widespread erythematous area COVID19 VACCINE JANSSEN 2 days 1091397-1 encompassing her entire breast. Axilla excluded. No palpable lymphadenopathy. She reports area to be tender and itching. Rash is blanchable. It is somewhat response to OTC antihistamines (Claritin/Benadryl) and OTC hydrocortisone. She has no respiratory distress, lingering fever, or other allergic reactions. She was given a prescription topical steroid (triamcinolone) and will follow up with her in a few days, if she remains stable. If not back to baseline within the week, will obtain breast MRI for further evaluation."" 9 hours after injection, woke up with chills, body aches, head ache, and extremely dizzy. Lasted 8 hours then all COVID19 VACCINE JANSSEN 2 days 1091478-1 symptoms were gone except the continued dizziness I still have whenever sitting up or rolling over when I'm laying down. Been 7 days now and hasn't subsided. COVID19 VACCINE JANSSEN 2 days 1091635-1 headache, muscle aches and pains, night sweats, fever, arm very sore at site of injection 3 days later COVID19 VACCINE JANSSEN 2 days 1091789-1 patient had chest pain, went to ER, and was found to have heart attack COVID19 VACCINE JANSSEN 2 days 1092078-1 Body aches, migraines. These symptoms started about 8 hours after the vaccine was recieved and lasted about 16 hours. Received shot on Tuesday at 11:30am. On Thursday morning at 5:00am, left arm injection site red, warm, painful and COVID19 VACCINE JANSSEN 2 days 1092255-1 swollen. Redness at injection site measures 5 x 3cm. Swelling is close to 8 x 5cm. COVID19 VACCINE JANSSEN 2 days 1092687-1 My right arm has a large hard knot that is warm to the touch at the injection site. 3/10/2021 at approximately 7 p.m. I noticed my gums, roof of mouth and inside bottom lip hurting when I was eating. I COVID19 VACCINE JANSSEN 2 days 1092730-1 discovered I had approximately 10 sores, similar feeling to a small blister or canker sore. COVID19 VACCINE JANSSEN 2 days 1093053-1 Swollen/redness of the Uvula in throat. Started 6am 3/10/21 and still going as of now 3/11/21 at 10pm. COVID19 VACCINE JANSSEN 2 days 1094154-1 dizziness day 2 minor arm soreness, body aches & chills

COVID19 VACCINE JANSSEN 2 days 1094885-1 Histimine reaction: re-emergence of poison-ivy type rash on left wrist area (had poison-ivy in this area in 2019) Treating with Benadryl spray / topical, and with Benadryl oral. 48 hours itch and rash still present / no significant change COVID19 VACCINE JANSSEN 2 days 1095014-1 Injection site red and swollen, also experienced achy body COVID19 VACCINE JANSSEN 2 days 1095260-1 Severe trigTminal neuralgia flare that began about 36 hours after receiving the vaccination COVID19 VACCINE JANSSEN 2 days 1096063-1 Jansen Covid 19 vaccine eua Fever 100 chills body ache sweats Very bad gastrointestinal gurgling. Strong need to use the bathroom. Very lose stools. Going to the bathroom several COVID19 VACCINE JANSSEN 2 days 1096475-1 times per day since March 10, 2021. This is not usual. I currently have numerous cold sores (herpes labialis) on my upper lip - started as tingling. I typically get a single cold COVID19 VACCINE JANSSEN 2 days 1096903-1 sore when I am on the verge of having a cold or flu, but not three at once. I also experienced pain in my left armpit (assuming lymph nodes) for two days post-vaccine. COVID19 VACCINE JANSSEN 2 days 1097451-1 Janssen COVID-19 Vaccine EUA Mild case of hives begun around 54 hours after receiving vaccine shot; will take Benadryl. Hard painful lump on arm Hurts to raise arm to heart level 5 days Noticeable loss of hair 2 + days later Nasal drainage2 COVID19 VACCINE JANSSEN 2 days 1097698-1 days Throat clearing 2 days Tiredness 2 days COVID19 VACCINE JANSSEN 2 days 1098046-1 Severe dizziness Slightly sore arm with red spot. Very sore underarm (lymph node area) - hard ball and tender area. Discomfort is COVID19 VACCINE JANSSEN 2 days 1098154-1 slowing subsiding. Not treating with anything. COVID19 VACCINE JANSSEN 2 days 1098913-1 a hard lump that is warm and somewhat red has happened, hurts a little too. Fever, muscle aches, tender skin, started the night of and passed by the next evening. Nausea lasted about an hour. COVID19 VACCINE JANSSEN 2 days 1100698-1 Facial rash, bumpy and itchy started the 2nd day and is ongoing. COVID19 VACCINE JANSSEN 2 days 1103930-1 Acute gallstone pancreatitis 3/14/2021 1AM. Underwent cholecystectomy (laparoscopic) 3/15/2021

Patient with known history of ITP status post splenectomy in 2018, with stable platelet counts off treatment, developed COVID19 VACCINE JANSSEN 2 days 1104764-1 petecchial rash in lower extremities 2 days after receiving COVID vaccine during a mass vaccination campaign. Platelet counts check 2 days after the vaccination was 1,000. Patient was admitted to the hospital for ITP, received 2 doses of IVIG and was initiated on prednisone with improvement in platelet count to 72,000 by 03/14/2021. Give COVID19 VACCINE JANSSEN 2 days 1107528-1 congestion fever stuffy nose wheezing body aches productive cough Three days after A raised red painful rash that is spreading and much bigger than the actual injection site. Pain COVID19 VACCINE JANSSEN 2 days 1107631-1 increasing so far each day as is the size of rash/reddened area COVID19 VACCINE JANSSEN 2 days 1107654-1 Hives on stomach and arms Severe exacerbation of idiopathic capillary leak syndrome 48 hours following administeration of Janssen vaccine leading COVID19 VACCINE JANSSEN 2 days 1108312-1 to profound vasodilatory shock, renal failure and DIC and death 3/12/21 Sudden cardiac arrest at home; unable to be resuscitated at scene (Brother) Caller is a family friend who was COVID19 VACCINE JANSSEN 2 days 1110099-1 asked by family to call and report incident. If f/u is needed, please contact him first. Current Medical History: unknown by caller Current Medications: unknown by caller COVID19 VACCINE JANSSEN 2 days 1110442-1 NUMBNESS IN FINGERS IN SAME ARM AS INJECTION COVID19 VACCINE JANSSEN 2 days 1110596-1 large redness and swelling and pain - over 3 inches in size. COVID19 VACCINE JANSSEN 2 days 1110611-1 pain in left back and neck that has expanded over a week to include left shoulder and left arm. Severe pain in hips and lower back like passing a kidney stone, severe bone pain in chest area, could not sleep for 2 COVID19 VACCINE JANSSEN 2 days 1110642-1 nights and then slept 12 straight hours, headache and blood pressure spike on 3/14 resulting in ER trip with bp at 204/100. Anxious and nervous with low appetite. 3/18/21 ER Triage Nurse Note: ""To er via EMS for eval of weakness and dizziness. States he started with sore throat and head congestion last week. Seen PCP Monday 03-15-21. Started amoxil. Took it for 2 days and became dizzy so he COVID19 VACCINE JANSSEN 2 days 1112120-1 quit taking it. Dizziness got worse and came to ER."" 3/18/21 ER HPI: 76 y.o. male who presents with c/o weakness cough and fever for the past seven days. Pt report sx are mod better with rest and worse with movement. · Transferred to Hospital, dx: pneumonia dt covid-19 virus"" Patient was admitted for Multi drug resistant UTI (for which he has been admitted many times before). Was hospitalized for 3 days while awaiting cultures, hemodynamically stable, with no lab abnormalities. On the day of discharge (sensitivities to UTI came back, pt to be discharged on cefepime, had PICC line) pt got up from bed, sat on the edge of the COVID19 VACCINE JANSSEN 2 days 1112122-1 bed and was being given belongings by the nurse, alert and oriented and in a pleasant mood, when suddenly pt grabbed at his chest and stated ""I can't breathe"" and became combative and altered when O2 was attempted to be placed on pt's face; then pt had PEA arrest x3 and unable to achieve ROSC."" A few days after the shot, the injection site became very red, itchy, warm, and swollen. It has lasted 4 days now and is COVID19 VACCINE JANSSEN 2 days 1115166-1 starting to get better. COVID19 VACCINE JANSSEN 2 days 1115673-1 pain at injection site, fatigue, chills Janssen COVID-19 Vaccine EUA: Adverse effects were nausea, vertigo, headache, body aches, chills, cold sweats for 6 COVID19 VACCINE JANSSEN 2 days 1115951-1 days total. Took Bonine for Vertigo and Nauzene for Nausea. Patient called pharmacy complaining of tight throat, hives, and itching. All occurred about 36 hours after vaccination. Advised patient to take 50mg of Benadryl 4 hours apart then 25mg every 4 to 6 hours. Patient described a close form of COVID19 VACCINE JANSSEN 2 days 1116847-1 anaphylaxis. Advised patient to proceed to ER if difficulty breathing or symptoms progress. Also advised patient to follow up with PCP if symptoms continue for another 24-48 hours. Neck and back pain night of vaccine... then 30 hours later Heart Attack (Myocardial infarction); Treatment: blood COVID19 VACCINE JANSSEN 2 days 1124611-1 thinners (TNK and Heparin), Stent in coronary artery. outcome: hospitalization 3 days and then recovery and fatigue ongoing... Patient was febrile at 104F. Found passed out on floor at home. SIRS from vaccine administration is the likely cause of COVID19 VACCINE JANSSEN 2 days 1125856-1 this event Patient developed rash on 3/8/21 two days following covid 19 vaccination. Red, patches, pruritic encompassing chest, back, legs, arms, and abdomen (sparing face, palms, and soles). Dermatology stated on prednisone 20mg daily to help. Due to progression, patient presented to medical center on 3/19/21. Rash appeared to have some pustules and COVID19 VACCINE JANSSEN 2 days 1127523-1 desquamation. Also, had some swelling and pain to the areas. Dermatology biopsies on 3/20/21 which showed findings consistent with drug eruption. Rash began to improve on 3/23/21 and patient was discharged home with continued Triamcinolone cream for presumed acute generalized exanthematous pustulosis. Patient started to complain of not feeling well on 03/18/2021 and went to the ER and was found to be in Complete Heart COVID19 VACCINE JANSSEN 2 days 1130187-1 Block and was transferred to ICU with EP and Cardiology consults pending> He was found to be covid and Flu negative but strep positive. I smelled a dirty, smelly gym shoe odor on my skin earlier this evening. My partner did not smell it, and I stopped COVID19 VACCINE JANSSEN 3 days 1080238-1 smelling the odor after about 4 hours. My sense of smell is not otherwise affected. I am still feeling occassional muscle pain in both arms 3 days after the vaccine. Loss of consciousness Client was said to have ·passed out while sitting at the waiting area about 5 minutes after vaccination. He was brought to the First Aid area ·on a wheelchair. Client was noted to having urinary incontinence immediately he arrived at the First Aid area. His head was repositioned and ice pack applied to his forehead and client ·recuperated and started talking. Duration of witnessed episode lasted for 15 seconds . Patient claimed having similar COVID19 VACCINE JANSSEN 3 days 1080756-1 episodes with last episode occurring 6 years ago while at work. Vital signs was taken, monitored for ·additional 30 minutes and was driven home by his significant other. Vital signs recorded Temp: 96.9deg. F; BP: 102/62 MAP: 76; H.Rate: 78; Oxygen sat: 97%. ·(Vasovagal syncope). Neurologic: Loss of consciousness (Comment: Patient had Vasovagal reaction with patient having urinary incontinence, lasting for 15 seconds 5 minutes after vaccination. Patient claimed having similar episodes 6 years ago. ) COVID19 VACCINE JANSSEN 3 days 1082699-1 Photosensitivity, pain behind eyes, stiffness in neck, chills and overall body aches lasting over 48 hours post-vaccination. On 3/9/21 woke up with slight injection site swelling, erythema, localized red rash circular about 2x2 inches, very tender COVID19 VACCINE JANSSEN 3 days 1084041-1 with injection site puritus. Took 400mg PO Iburpofen at 0700. 0830am applied caladryl cream and ice compress to the arm. Resembles a smaller "" moderna arm"" type appearance.""

COVID19 VACCINE JANSSEN 3 days 1087756-1 Woke up March 9th and had trouble breathing. Fell well short of getting full breaths, chest hurt. Took aspirin and slept for 6 hours. Felt about the same through the evening. Next day, still having trouble getting full breaths but less pain. COVID19 VACCINE JANSSEN 3 days 1088023-1 Fatigue overall feeling blah nasal congestion cold sore on lower lip I experienced severe vertigo. I visually saw the room spinning. I had to close my eyes but I still felt the spinning in my COVID19 VACCINE JANSSEN 3 days 1089084-1 head. I used the wall to lean on to get down on the floor. Lasted about 1 1/2 - 2 minutes with nausea. I never had vertigo. When I went to bed I had an ache under my left breast. It eventually subsided. Woke up in the early morning and was real dizzy, a little later in the morning in went away. Itchy around the eyes for a COVID19 VACCINE JANSSEN 3 days 1090768-1 day and a half. Seems to of gone away this morning. 64 y.o. female who is consulted for possible stroke. Patient reports that she awoke this morning (3/10/2021) at about 4:30 PM with severe spinning dizziness. She reports associated nausea, diaphoresis, blurred vision and bilateral hand COVID19 VACCINE JANSSEN 3 days 1091497-1 numbness and tingling. She denies speech or language problems or weakness. She reports she got a COVID vaccine (Johnson & Johnson) Sunday 93/7/2021) and felt a little ""woozy"" Monday (3/8/2021)."" COVID19 VACCINE JANSSEN 3 days 1092252-1 Vertigo, dizziness, nausea, sweats, headache COVID19 VACCINE JANSSEN 3 days 1092776-1 Vomiting began at 10am, continued all day. No food was consumed, and small sips of water not tolerated until 7:00pm COVID19 VACCINE JANSSEN 3 days 1093530-1 flu like symptoms--low grade fever, muscle and joint aches, diarrhea COVID19 VACCINE JANSSEN 3 days 1095582-1 Severe abdominal pain Urticaria and angioedema with nausea/vomiting 48 hours after vaccination. Symptoms persisted responded to treatment COVID19 VACCINE JANSSEN 3 days 1097383-1 but came back 6 days later and required further treatment with steroids. COVID19 VACCINE JANSSEN 3 days 1101924-1 Tiredness first two days after injection Tongue swelling on 3/15/2021 COVID19 VACCINE JANSSEN 3 days 1102572-1 Was notified by a third party that patient died on morning of 3/15/2021. No other information available. COVID19 VACCINE JANSSEN 3 days 1103748-1 Cardiac Arrest/Death COVID19 VACCINE JANSSEN 3 days 1106737-1 weakness/malaise per daughter, death on 3/14 (did have underlying medical conditions) Was in his USOH until this morning whilst he was at work. He noticed that he was having difficulty finding his words and that he felt spaced out. Decided to schedule appointment see his PCP early afternoon. He was brought to the emergency room for further evaluation due to concern of an underlying stroke. · On further questioning, he has a history of atrial fibrillation for which he has been on Cardizem. Not placed on any anti-platelet or anticoagulants. Does mention that he has a family history of this. · Recently had the COVID-19 vaccine. Notes that he did have some body aches and COVID19 VACCINE JANSSEN 3 days 1106846-1 fatigue. The symptoms cleared up by yesterday was went to work. He was feeling normal today until he began to develop the above symptoms. He denies any weakness today however he does recollect that last week, as he was walking the dog, he fell. He was able to get up unassisted. About a year ago in August, he had a similar episode of falling, came to the emergency room the following day and was found to be in atrial fibrillation with a rapid ventricular rate. States he has been diagnosed with atrial fibrillation since his early 20s. He is unaware of any history of hypertension. He states that he is on Cardizem for treatment of atrial fibrillation COVID19 VACCINE JANSSEN 3 days 1110006-1 Janssen COVID-19 Vaccine EUA 3/15 12:30pm -Rash developed on injection arm and down right side of upper body. Patient received single dose vaccine of Janssen / Johnson and Johnson Covid-19 vaccine to R deltoid on 15 MAR 2021 and COVID19 VACCINE JANSSEN 3 days 1110018-1 presented to clinic here on 18 MAR 2021 with excess left shoulder pain (2/10 rest but increased with active range of motion) and slight limitation in range of motion to R shoulder due to pain COVID19 VACCINE JANSSEN 3 days 1110129-1 Left collarbone, swollen neck lymph node Pt received COVID19 shot on 3/12/2021. Pt passed away on 3/15/2021. Dr called us to inform us that our patient had COVID19 VACCINE JANSSEN 3 days 1112701-1 passed away but he did not believe it was caused by the vaccination at this time. Woke with bilateral conjunctivitis and scleral erythema. Burning of both eyes. No vision impairment but a lot of tearing. COVID19 VACCINE JANSSEN 3 days 1114814-1 No treatment needed and resolved in 48 hrs. 3 days after the vaccine i passed out. I threw up several times. My husband called 911 and ambulance took me to ER. COVID19 VACCINE JANSSEN 3 days 1115879-1 Took blood work, urine sample, chest xray and ekg. Everything came back normal. Occipital stroke involving vision on 3/14/21, was seen at ophthalmologist and sent to Hospital and stroke confirmed on COVID19 VACCINE JANSSEN 3 days 1116598-1 MRI. COVID19 VACCINE JANSSEN 3 days 1116616-1 fatigue and occasional tingling on L side on mid. back, no rash COVID19 VACCINE JANSSEN 3 days 1116736-1 vomiting 10 minutes, cold Had vaginal ulcers and pain/burning upon urination. Went to a medical facility to be evaluated. The physician was COVID19 VACCINE JANSSEN 3 days 1117435-1 convinced I had genital herpes. Symptoms lasted about 7 days I experienced acute vertigo and nausea three days after vaccine. I was treated at the ER at Hospital on Wed. 3/17/21, and discharged on 3/19/21. The diagnosis was Unilateral Vestibular Hypofunction; it was the same side I got the shot on COVID19 VACCINE JANSSEN 3 days 1118788-1 (left). I was treated with meclizine and given outpatient eye-hand exercises to do. The symptoms have faded, but not disappeared as of today, 3/20/21. COVID19 VACCINE JANSSEN 3 days 1124517-1 Weakness in right shoulder, right deltoid not activating at all, potential axillary nerve damage COVID19 VACCINE JANSSEN 3 days 1124688-1 Sudden death March 20, 2021 Patient stayed in health center under routine observation for 15-20 minutes after vaccine injection and showed no symptoms and was subsequently released to go home. A friend drove her home after her injection. On 3/19/21 at 09:09 COVID19 VACCINE JANSSEN 3 days 1125903-1 a.m. a medical assistant from our facility called pt. to inform her of normal lab results. On 3/21/21 at approximately 05:43 p.m. the on call provider took a call from Deputy from the Sherriffs office informing us that pt. was found deceased in her bed on the afternoon of 3/21/21. I have had tingling feelings all over body for 21/2 weeks now ..... I am very scared and have been to the ER twice and COVID19 VACCINE JANSSEN 3 days 1128193-1 they won?t do a lumbar puncture to check for Gillian Barre because my symptoms aren?t bad enough - I don?t want to wait ! This is Very scary Experiencing muscle weakness in my proximal muscles severe enough to be in a wheelchair. The symptoms began three days after my vaccination. I had COVID-19 (diagnosed Feb. 1st, 2021) and 3 days after my COVID symptoms went away, I had severe weakness in my proximal muscles which put me in a wheel chair for 4 weeks. I was diagnosed as a ""long COVID19 VACCINE JANSSEN 3 days 1128348-1 hauler"" with Post-Covid syndrome. I had just started walking again on Monday, March 15, 2021 and my vaccine was Friday, March 19, 2021. I asked my neurologist prior to the vaccine if he thought it was safe for me. He assured me that it was. I started experiencing muscle weakness again 3 days after vaccination, which coincidentally, was the same time frame that I experienced these same symptoms post COVID. It appears the vaccine caused a relapse of post-COVID syndrome."" COVID19 VACCINE JANSSEN 3 days 1132777-1 They found her unconscious and rushed to ER and MRI showed mild stroke 3-13 developed dizzyness with room spinning, cleared after 1 hour of additional sleep. 3-14 repeat of dizzyness with room COVID19 VACCINE JANSSEN 3 days 1132846-1 spinning, did not clear. Diastolic B/P elevated from 87 to 107 mmHg; Systolic from 143 to 166 mmHg; Tilt Test Positive. Symptoms onset around 0715 hrs and lasted until 1600 hrs when EMS called and taken to Hospital About 4 days after receiving his vaccine he began to have difficulty with chewing, swallowing and speaking. He describes waking up in the morning with paresthesias of numbness from the nose down to his jaw. He is scared to eat due to fear of choking. He notes as he continues to chew or speak he gets fatigued. He denies any difficulty with COVID19 VACCINE JANSSEN 3 days 1133280-1 breathing or generalized weakness. He does report coughing with secretions. He reports his symptoms have been ongoing for 2 weeks with no improvement. Patient ended up getting admitted to the hospital for IVIG treatment for the myasthenia gravis flare. COVID19 VACCINE JANSSEN 3 days 1134651-1 The patient had a hemorrhagic stroke approximately 3 days after receiving the vaccine and died. COVID19 VACCINE JANSSEN 4 days 1074566-1 Itchiness all over the body COVID19 VACCINE JANSSEN 4 days 1085812-1 redness below injection site, warm, mild soreness and tender COVID19 VACCINE JANSSEN 4 days 1087337-1 leg cramp Patient was admitted for pancreatitis with history of cholecystectomy, no alcohol consumption, and unclear etiology. COVID19 VACCINE JANSSEN 4 days 1087914-1 There is a concern of unknown effects of COVID vaccines. Patient received COVID Johnson and Johnson vaccine on 3/5 before developing nausea, vomiting, and diarrhea before being admitted for pancreatitis. I noticed it felt like a sinus cold coming on along with face, head and minor toothaches to the my left side of my face on the the 8th or 9th. I took Tylenol everyday for my sore arm and the headaches but it did help suppress them so I didn?t think much of it. My throat also started to feel kind of raw or itchy but I didn?t have a cough and I noticed a slight post COVID19 VACCINE JANSSEN 4 days 1092939-1 nasal drip. Ok the 10th in the evening I felt exhausted and my face and sinuses were much worse. I took cold medicine and fell asleep early but had a hard time sleeping. I?m a side sleeper and if I turned on my left side, my ear felt like it was burning and my face would go numb. It also made me very dizzy. I woke up with body aches and light headed. My throat doesn?t hurt but it feels different. Almost numb like nothing and I can?t smell or taste. COVID19 VACCINE JANSSEN 4 days 1094451-1 woke up not feeling well, little dizzy & chills, diarrhea. Got worse the next day with nausea & headache. COVID19 VACCINE JANSSEN 4 days 1095863-1 dizziness, sleepyness First three days 102 fever, legs were in so much pain I could not walk or get up. The fourth and fifth day my lips and face would become tingly/numb and my left arm would get weak and I would feel a little disoriented, my sleep has been COVID19 VACCINE JANSSEN 4 days 1096548-1 pretty disturbed. It felt like I was having a stroke. I did not have a stroke, I continue to occasionally feel the above symptoms, a little less potent than they were, they might be going away, I can't tell. I will be calling my doctor if it continues. I noticed a red rash on my legs, arms, and torso at about 8 pm yesterday, March 12; it is red blotches (no hives) and feels more like a sunburn . There is a burning sensation with mild itching and red blotches/spots. I contacted my physician COVID19 VACCINE JANSSEN 4 days 1096800-1 who recommended OTC treatment at home and advised me to report it to VAERS. It is mild in terms of impact but not expected four days after the vaccination date. Headache that began shortly after vaccination and has continued into day four. Bruising at the site of injection. On the COVID19 VACCINE JANSSEN 4 days 1097224-1 morning of day four, redness and itchiness appeared. COVID19 VACCINE JANSSEN 4 days 1098656-1 Developed hives and upset stomach Patient presented to hospital on 3/11 with shortness of breath. History of chronic oxygen dependency at night. Became more sob over last several days and was not able to make it to md appointment. Had a recent abnormal stress test. Family states she was febrile at home. Was low on oxygen level on 2LNC, placed on non-rebreather and then BIPAP. COVID19 VACCINE JANSSEN 4 days 1102815-1 Positive for Rhinovirus. Chest xray showed bilateral lower infiltrates. Patient detiorated through the night and was intubated and placed on vasopressors for septic shock. Patient was made DNR and family refused hemodialysis. Family then made decision to withdraw care. COVID19 VACCINE JANSSEN 4 days 1105817-1 Bells Palsey symptoms have returned. Right side of my face twitching and drooping About 5 days after receiving the injection, I suddenly developed mild shortness of breath, aches, and fatigue. Less than 24 COVID19 VACCINE JANSSEN 4 days 1114507-1 hours later, the symptoms seem to be resolving. COVID19 VACCINE JANSSEN 4 days 1114540-1 Transient ischemic attack confusion, mouth droop, delay in responses SUDDEN ONSET CHEST PAIN PT WAS TRANSFERRED FROM LOCAL ED TO ANOTHER FACILITY WITH AN ICU BED COVID19 VACCINE JANSSEN 4 days 1114740-1 AVAILABLE COVID19 VACCINE JANSSEN 4 days 1115435-1 Tinnitus Feeling sluggish and fatigued, starting on March 16th. More tired than usual, especially in the evening. Intermittent COVID19 VACCINE JANSSEN 4 days 1121222-1 headache throughout the day but not constantly hurting.

3/11/21- pt was feeling fine. She stood up got dizzy and seamed to have a seizure. when she came to she did not know that it had happened. about 5 hours later she stood up again got dizzy and seamed to have had another seizure. her husband called 911. EMTs took her vitals but did not detect anything to be wrong at the time and was advised to see COVID19 VACCINE JANSSEN 4 days 1125625-1 PCP. Next day 3/12/21 she went to her PCP. She had blood work which showed high enzymes for heart failure so was sent to hospital to be admitted. Pt had blood work, chest xray which showed blood clots in both lungs. She was administered blood thinner. MRI of head was clear. Echocardiogram was clear. Pt stayed about 4 days. Enzymes for heart failure was clearing up. Pt was released and had a FU appt w/ PCP on 3/22/21. Pt found out that she also had bilateral deep vein thrombosis in both legs while she was in the hospital. Pt is improving and is almost back to normal. on 3/22/2021 pt developed altered mental status, right sided weakness, right sided gaze, aphasic. Patient was COVID19 VACCINE JANSSEN 4 days 1126402-1 administered 65 mg IVPB alteplase 3/22 1245 with last known well 3/22 1000. Received Covid vaccine 3/18/21. Pt was usual state of health prior to stroke with no illnesses. initial NIH score was 18. post tpa NIH of 12 am of 3/23. Death on 3/23/2021 at 9 AM. Home Health Nurse who gave immunization on 3/19/21 verbalized pt was fine after injection, stayed in home for 1 hour after injection was given. Wife verbalized pt was very tired the following day and COVID19 VACCINE JANSSEN 4 days 1127361-1 through out the weekend. Pt stopped eating one day prior to death. Respirations changed on the morning of 3/23/2021 and wife called EMS, pt died at home. COVID19 VACCINE JANSSEN 4 days 1132787-1 Within a week of getting the vaccine I developed a blood clot in the lining of my stomach Broke out in hives in the middle of the night. All over my legs and arms. Very itchy but otherwise doesn?t seem like a COVID19 VACCINE JANSSEN 5 days 1088924-1 problem. Patient presents to ED with left hand swelling, fever, and left arm pain on 3/10/21 after receiving his COVID 19 vaccine at Clinic on 3/4/21. I'm unable to determine the route of administration from the immunization documentation. Patient reports that the swelling significantly increased over the past day with increased swelling in his left hand and pain from COVID19 VACCINE JANSSEN 5 days 1088962-1 his left clavicle to his left hand. Patient is febrile upon presentation with a documented temperature of 38.7 and sinus tachycardia. EKG is otherwise unremarkable. Patient has been diagnosed with left arm cellulitis and is being admitted to our hospital. He has been started on vancomycin 800 mg and Zosyn 3.375 g IV. COVID19 VACCINE JANSSEN 5 days 1090974-1 Fever and chills 3/6 and 3/7 Rash/hives entire body 3/10 treated with benedryl I started having very itchy feet and it gradually got hot and made it's way up my legs and on to my back and buttocks. I had extremely itchy, angry, red, hot raised skin rash. I have never had a rash like that. Luckily, I did not have any COVID19 VACCINE JANSSEN 5 days 1096720-1 problem with breathing. I took a cool shower and took 2 Claritin. I also put Caladryl on my skin. This was 5 days and a couple of hours after taking the vaccine. It seem ""Janssen COVID-19 Vaccine EUA"""" COVID19 VACCINE JANSSEN 5 days 1097845-1 Painful blister on under-side of tongue COVID19 VACCINE JANSSEN 5 days 1098000-1 Developed fever, vomiting, diarrhea, body aches COVID19 VACCINE JANSSEN 5 days 1103705-1 101 Fever, Body Aches, Headache Severe total body Hives, lasting days, requiring multiple medications, treated with medrol, benadryl, pepcid, COVID19 VACCINE JANSSEN 5 days 1114463-1 hydroxyzine Sore arm, fatigue about 12 hours, then 4 days after the injection I woke up in the middle of the night itching intensely all over, especially my lower legs. I developed a very red rash, mostly on my lower legs up to the knees, some slight rash on COVID19 VACCINE JANSSEN 5 days 1115063-1 forearms. I used topical benadryl and it went away, but came back later that day. That lasted 36 - 48 hours and was completely gone. About 20 hours after injection, I had mild flu-like symptoms, including headache and muscle ache, lasting about 12 hours. But about 5 days after my injection (5 days + 5 hours, actually), I experienced a bewildering all-over rash that freaked me out. It started as itching around my elbows and ankles -- it felt like mosquito bites and sunburn together -- and spread to wrist and knee areas. The rash climbed by legs and arms. I applied coat after coat of Benadryl, which seemed to help. The COVID19 VACCINE JANSSEN 5 days 1115096-1 rash would disappear and move somewhere else. I had it on my left foot, but then that resolved, only to find it on my right foot. After about 3 hours, it had spread to my stomach, the bridge of my nose, and my cheeks. It started to calm down around midnight. I woke up at 6:00 am (12 hours after onset) with extremely itchy hands. At 8:00 am (14 hours after onset), it had mostly disappeared except for patches on my back, and my wrists still itch. I'm hoping it goes away later today! It was crazy! COVID19 VACCINE JANSSEN 5 days 1116053-1 Exceptionally healthy Patient suffered a stroke within 5-6 days after receiving the J & J vaccine. COVID19 VACCINE JANSSEN 5 days 1116977-1 Sore arm for two days. Diarrhea. Developed Bell's Palsy after six days. COVID19 VACCINE JANSSEN 5 days 1128150-1 STROKE 4 days after COVID19 VACCINE JANSSEN 6 days 1078729-1 Woke up a chills Nd a fever of 102. This is higher than I had when I had Covid. COVID19 VACCINE JANSSEN 6 days 1079817-1 30-40 min severe dizziness- ambulance called on way home from driving Severe chills, for an hour and a half starting at 10:30pm. Headache and severe tiredness. Injection site very minimal COVID19 VACCINE JANSSEN 6 days 1080706-1 pain/soreness. Stiff neck. No report of negative event after 15 min wait past receipt of vaccine. Notified by Coronor, on 3/11/2021 that this COVID19 VACCINE JANSSEN 6 days 1093939-1 patient expired on 3/11/2021 at home. Not sent to hospital. Pronounced at home. Sent to Funeral Home 6 days after vaccine, patient experienced lower back ache which spread over next 24 hours down to back of thighs. It COVID19 VACCINE JANSSEN 6 days 1094306-1 worsens with rest and when lying down. It is waking her up at night and is an achy, cramping feeling. Day 6 after Injection: Hives/rash on arms, legs, hands, feet, torso. Itchy and raised. Treated with 1 Benedryl around 1.5 hrs after rash first appeared. Also used some cortisone cream on the worst areas. Symptoms mostly relieved although some rash still present. Took 2nd Benedryl before bed (10 pm). Day 7 after injection: Hives returned at 4am slightly COVID19 VACCINE JANSSEN 6 days 1096704-1 worse than when it first appeared. Took 1 Benedryl and after 2 hrs the rash started to go down and itchiness greatly reduced. 1 Benedryl around 11am. By evening only a few bumps remained. Residual itchiness lingers. No more Benedryl taken. I have never had a rash or hives like this. There have been no changes to detergents, soaps, diet. COVID19 VACCINE JANSSEN 6 days 1096935-1 Loss of taste and smell. COVID19 VACCINE JANSSEN 6 days 1097824-1 Welts redness rashes on back buttocks legs arms and injection site Saturday night around 9:45 my hands and arms began itching. Then i noticed they had broken out in a red rash with whelps beginning on my arms. It then began breaking out on my face and legs. I took 25 mg of benadryl. The rash continued to spread so I went to the ER. They administered prednisone, pepcid, and benadryl. After about 1 hour the COVID19 VACCINE JANSSEN 6 days 1098202-1 itching was better and the rash began to fade but it didn't go away. The ER sent my home with a predisone dose pack for 6 days and to take 50 mg benadryl every 6 hours. When i awakened this morning I had the rash on other sites on my arms, legs and stomach and in my right eye, it was red and a little swollen. I took the first day's dose of prednisone and 50 mg benadryl and 20 mg of famotidine. After about 30 mins to 1 hour the itching and redness improved but has not completely gone. 3-11-21 C/O RASH TO BOTH LEGS & ABD SINCE 9:30AM. NO SOB OR DYSPNEA. 1:42PM BENADRYL 50MG GIVEN PO. STATES SHE WILL SPEND THE REST OF THE WORK DAY SITTING DOWN AND HUSBAND WILL DRIVE HER HOME. 3-15-21 10:46AM: STATES SHE DID GO TO ER X2, FACILITY ADMITTED HER FOR VASCULITIS X1DAY. 'THOUGHT IT MAY BE A COVID19 VACCINE JANSSEN 6 days 1102080-1 DELAYED VACCINE REACTION.' RASH ON LEGS, ABD & NOW FOREARMS IS NOW 'PURPLE'. HAD LOTS OF JOINT PAIN ALSO. SHE WAS GIVEN SOLUMEDRAL AND PREDNISONE AND IS FEELING BETTER NOW, WILL RETURN TO WORK TOMORROW. On 3/14/21 patient started with left flank pain that radiated to left shoulder and increased pain while taking a deep breath. Mother called on 3/16/21 and patient was seen in primary clinic for issue. She had labs and xray done. Xray COVID19 VACCINE JANSSEN 6 days 1107565-1 showed possible mild opacity in left lower lobe and to do ct scan. Ct pe study done same day showing bilateral lower lung pulmonary emboli and lower lung patchy infiltrates. Patients pain progressively got worsened and was seen in the er to be transferred to outgoing facility for care. COVID19 VACCINE JANSSEN 6 days 1110608-1 rashed welts, red itchy patches, bilateral extremity itching, hives over much of body COVID19 VACCINE JANSSEN 6 days 1114074-1 Allergy or Rash all over the body (arms, legs). Diagnosis: Cortical vein thrombosis, massive intracerebral hemorrhage with tentorial herniation, thrombocytopenia. Clinical Presentation and Course: 1 week after receiving Janssen COVID19 vaccination, patient developed gradually worsening headache. On March 17th, patient presented to Hospital with dry heaving, sudden worsening of headache and COVID19 VACCINE JANSSEN 6 days 1114806-1 L sided weakness. Evaluation with head CT revealed a large R temporoparietal intraparenchymal hemorrhage with 1.3cm midline shift. She ended up getting intubated for worsening mental status. On evaluation at arrival in Medical Center, she was noted to have extensor posturing. Repeat imaging revealed worsening midline shift to 1.6cm. CTA showed cortical vein thrombosis involving the right transverse and sigmoid sigmoid sinus with tentorial herniation. Patient developed brain herniation and brain death was pronounced on March 18th, 2021. On Friday, March 19 around 9:10am I had seizures - loss of awareness, very pale, shaking (but not quite convulsions). This happened before 25 years ago and is likely unrelated to the vaccine. Expected cold/flu-like symptoms did occur on March COVID19 VACCINE JANSSEN 6 days 1116430-1 14 and part of March 15 but things have been fine since then. I've followed up with my GCP and am scheduling a Neuro appointment for followup. COVID19 VACCINE JANSSEN 6 days 1116993-1 Pain in shoulder started about 5 days after, and persists at 2 weeks later Beginning on 3/19 he developed a progressive ascending numbness first in his toes, then progressing to include bilateral legs up to knees and bilateral arms up to mid forearm. He also had mild leg weakness bilaterally. He has absent reflexes. COVID19 VACCINE JANSSEN 6 days 1133722-1 His lumbar puncture showed albuminocytologic dissociation. He was diagnosed with Guillan-Barre syndrome and is being treated with IVIG. COVID19 VACCINE JANSSEN 7 days 1084086-1 High fever and chills for several hours. Headache. Achy. COVID19 VACCINE JANSSEN 7 days 1084588-1 Fever moderate muscle pain moderate weakness confusion COVID19 VACCINE JANSSEN 7 days 1091989-1 Headaches ,nausea , fatigue, body aches on March 8,2021 - March 9 2021 About 10 minutes after pt received the vaccine, she started to feel dizzy. After that, she developed a racing heart and COVID19 VACCINE JANSSEN 7 days 1093395-1 dry mouth. She has a history of palpitations. EMS was called to evaluate her Hives throughout the body, will treat with Benadryl at home but if I don?t see improvement I?ll go in to doctors office COVID19 VACCINE JANSSEN 7 days 1093481-1 for evaluation. Janssen COVID-19 Vaccine EUA One week after vaccination, patient awoke with intense generalized itching (she described as a ""internal burning itchiness"" that was ""all over""). She saw no rash or hives. Continued for remainder of night, difficult to sleep. Next day her husband found what he described as a few ""faint, non raised patches of very light hives"" on the patient's back. She looked more carefully and found a few small similar patches on both arms and legs. Treated with OTC lotion, CeraVe Itch COVID19 VACCINE JANSSEN 7 days 1094875-1 Relief Lotion from store. Patient says 12 hours after onset that the ""insane burning/ itching has subsided for now."" Patient reports no new foods, clothing, washing machine detergent, illnesses, or other exposures. I am a physician, and the patient called me (her brother) to ask me whether this was a known side effect of the Janssen COVID vaccine. I did not see this described in the FDA advisory committee data package, but just a general reference that urticaria would be an expected side effect to a vaccine."" COVID19 VACCINE JANSSEN 7 days 1096558-1 Round Pink Rash on Opposite Arm and upper Legs. Looks a bit like chicken pox or measles COVID19 VACCINE JANSSEN 7 days 1112822-1 Pulmonary embolism one week after injection I woke up on 3/16/21 feeling my heart beating rapidly. I was slight dizzy upon standing from bed. I took my blood COVID19 VACCINE JANSSEN 7 days 1115070-1 pressure at 6:06 -- readings were 112/84 and 120BPM. My usual BPM is between 60 and 75. I meditated and took my readings again at 7:44 a.m.. They were 105/78 and 95 BPM. I verified this on an oximeter. The first night I had a severe headache, but it was gone the next day, had no symptoms until yesterday, March 18th, after waking up with a huge rash all over my upper thighs and stomach, and the next day, March 19th, it had spread to my arms, and further down my legs, and is starting to spread to my face. No rash has appeared at the injection site, COVID19 VACCINE JANSSEN 7 days 1115106-1 which led me to believe this wasn't a result of the vaccine, but I have made any behavior or diet changes, and have no known allergies, so the only thing I could think to cause the rash was due to the vaccine. I am not saying at all that this means I regret getting the vaccine, I just thought it would be responsible of me to report these symptoms, in case others were experiencing a delayed rash and was concerned. The rash hasn't caused any distress other than existing, there's no itching or pain from it, it just keeps spreading fairly rapidly. COVID19 VACCINE JANSSEN 7 days 1115934-1 Severe Fever, Chest pain, Body pains, Spinal cord pain I was unable to walk properly for 2 days 1st day of symptoms. Hands started itching. Felt like I had placed my hands in scalding hot water. Slightly red blotchy look to palms of hands. 2nd day I have additional Symptoms, I woke up with strange feeling in my mouth. Feels like i COVID19 VACCINE JANSSEN 7 days 1117079-1 drank scolding hot drink. Mouth is also Tingly feeling, I am definitely having some kind of allergic reaction i-week after the Covid vaccination. Pt describes rash as bruising, and burst blood vessel on the top of the feet Rash is located on the; top of the feet without COVID19 VACCINE JANSSEN 7 days 1117159-1 trauma Patient developed Severe INflammatory response syndrome . Was hospitalized as her cbc was abnormal and no infection COVID19 VACCINE JANSSEN 7 days 1123222-1 could be found, could not walk or take care of herself Shingles- on head, scalp, face - treatment valacyclovir, lost of 10 teaching days, Atrial fibrillation - irregular heart beat, COVID19 VACCINE JANSSEN 7 days 1129449-1 4 EKG ?s, 1 physicians care facility, 1 emergency room visit, 1 urgent care facility, 1 phone call to family doctor, 1 visit to Dr. cardiologist , suppose schedule of a cardiac stimulus procedure ; treatment apixaban and metoprolol She developed a large pulmonary embolus, and she died on 3/17 at Hospital. She developed symptoms of SOB on 3/11, and was admitted to the hospital. She was initially stable and not requiring oxygen and was sent home on anticoagulation. However she returned the same day with worsening symptoms, troponin now elevated, and ECHO COVID19 VACCINE JANSSEN 7 days 1134819-1 showing signs of right heart strain. Embolus on imaging had increased in just over days from previous CT scan. She became pulseless and died despite resuscitative efforts. It is my opinion (Dr.) that she died of a pulmonary embolus, and an autopsy is pending. COVID19 VACCINE JANSSEN 8 days 1088299-1 Right arm very painful from injection site to elbow COVID19 VACCINE JANSSEN 8 days 1092198-1 Fever, blurry vision Left arm was sore after injection, but on day 8 after receiving the vaccine my arm throbs all the time. I have had pain in my left arm from the shoulder to the elbow for the past 5 days and it seems to get worse. Ibuprofen and Tylenol did not COVID19 VACCINE JANSSEN 8 days 1113666-1 seem to help much. It is difficult to use the arm because of the pain . I can?t sleep right now so I figured I would fill this out. COVID19 VACCINE JANSSEN 8 days 1116623-1 Hives on both arms and hands with pain COVID19 VACCINE JANSSEN 9 days 1087600-1 I had a head-splitting headache and body aches. I would not take this vaccine again. Pain at sight immediately that continued for 30min At 7:30pm fever chills constant shaking that subsided at 9:00pm COVID19 VACCINE JANSSEN 9 days 1090360-1 woke up at 10:45pm and can?t stop shaking legs and rapid breathing....still going in at 12;30am as I wrote this Fever and spotting (very early in pregnancy. About 4 weeks) spotting happened with fever. No damage to the pregnancy COVID19 VACCINE JANSSEN 9 days 1092726-1 know so far. Spotting stopped Severe muscle aches and spasms, chills nausea, headache, neck pain, congestion . Started around midnight, muscle COVID19 VACCINE JANSSEN 9 days 1094009-1 spasms became severe at 2:00 am. Last until March 11, 2021. Patient reported a ""tingling sensation"" to his face 10 minutes post vaccine. Swelling under eyes were also noted. At COVID19 VACCINE JANSSEN 9 days 1095612-1 1410 patient reported symptoms subsided. By 1440 patient requested that he leave and another individual to drive was confirmed. Importance of following with PCP was enforced."" Chills started at 10pm on 3/10/21 Woke up very achy, weak & a bit short of breath No energy at all ALL day! Slept off & COVID19 VACCINE JANSSEN 9 days 1096362-1 on all day. No appetite. Most symptoms went away by 9pm on 3/11/21 weakness, nausea, dry heaving, abdominal cramping and headache for a 2 day duration. Abdominal CT showed 5 cm left adrenal mass consistent with acute adrenal hemorrhage. Platelets were 32,000 on admission. On the evening, the COVID19 VACCINE JANSSEN 9 days 1107887-1 patient had a change in mental status; head CT revealed acute subarachnoid hemorrhage and small intraparenchymal hemorrhage. Patient developed an extensive acute, occlusive thrombus in the external iliac, common femoral, popliteal, and COVID19 VACCINE JANSSEN 9 days 1112768-1 gastrocnemius veins COVID19 VACCINE JANSSEN 9 days 1114718-1 Difficulty breathing 3/16/21. Taken by ambulance to hospital 3/17/21. Hositalized and treated for double pneumonia. Approximately 48 hours after receiving the vaccine, i developed what may be described as ""Covid Arm"": A warm, red large circle surrounding the injection site that was tender to the touch and itchy at times. Additionally, I developed a hard mass under the skin at the injection site. The redness and itchiness lasted about a week. The redness increased with COVID19 VACCINE JANSSEN 9 days 1116212-1 touch and after showers. The itchiness slighlt subsided with topical cortisone. The pain/tenderness surrounding the hard mass lasted about 12 days. I'm currently 13 days out from receipt of vaccination and continue to have the hard mass under the injection site."" Roughly a week following vaccination he cut his hand and was unable to stop the bleeding. 2 days later he developed mucosal lesions inside his mouth which began to bleed without resolution. He also cut himself shaving with prolonged bleeding. Following this event his rehabilitation center performed a CBC and he was found to be profoundly thrombocytopenic with platelets of 7. He presented to hospital where he was transfused with platelets which did not COVID19 VACCINE JANSSEN 9 days 1123168-1 resolve his thrombocytopenia. He was transfused 2 more units with immediate CBC followup which did not improve his platelets; this was very suggestive of a consumptive process. Hematology was consulted and per their recommendations steroids were started. After initiation of systemic IV medrol platelet count began to rise. Per our hematology team, most likely culprit is the COVID vaccine. Patient had no medication changes, had been stable in his chronic conditions, and had never had any autoimmune or thrombocytopenic event before this time. This happened twice fever went up to 102 for few hours. After going to sleep went away. I went to urgent care nothing COVID19 VACCINE JANSSEN 9 days 1126990-1 seem out of place(lab results). Received injection on Sunday. Monday was nauseated and had chest pressure. Nausea and CP came in waves and occurred about 10 times. Then stopped. Felt ""off"" for 4 days. Felt fine on Friday and through Wed 3/23/21 until 9:10 PM. Developed visual changes in left peripheral bilat. Appeared like waves in an arc. Then began to not be able to breathe. I had to tell myself to breathe. Called squad, arrived 9:45pm. BP 170/110, HR 118. By 10pm, the visual changes COVID19 VACCINE JANSSEN 9 days 1130492-1 disappeared BUT developed chest pressure in same area as the MOnday after the vaccine. Then became extremely nauseated, almost vomiting. Nause came in waves for next 6 hours until it calmed down. Then returned Wed am for several hours, again in waves along with hollow chest feeling and pain. Continued with headache off and on with brain fog the remainder of Wednseday 3/23/21. Discussed with hospitalist at Hospital and was told to report it to the CDC as likely an adverse effect to the vaccine. Was still in the 14 day window. Thank you, RN, PhD, MSN, MS, BSN"" The patient was experiencing headaches 1 week ago. She also had aphasia later in the week. She went to an outside COVID19 VACCINE JANSSEN 9 days 1133212-1 hospital on 3/24/2021 and was found to have intraparenchymal hemorrhage in addition to venous sinus thrombosis. She is being treated for the venous sinus thrombosis with heparin. The symptoms are dizzy, headaches, and chills and it started around 4:00 a.m. 3/12/2021. I still feel dizziness occasionally COVID19 VACCINE JANSSEN 10-14 days 1094749-1 every hour. COVID19 VACCINE JANSSEN 10-14 days 1095065-1 Within 5-6 hours of injections. She developed high fever. Chills and hallucinations Patient was sitting in chair when she alerted Medic she was feeing dizzy and lightheaded. Patient had syncope episode COVID19 VACCINE JANSSEN 10-14 days 1096355-1 lasting approximately 45 seconds. Patient did not strike her head and was placed in recovery position on the floor by two medics. EMS was called to facility. EMS cleared patient to return home with spouse. Symptoms started abruptly and all at the same time 12 hours after receiving vaccine: Continuous ?head zaps? Severe COVID19 VACCINE JANSSEN 10-14 days 1097966-1 headache top of head Chilled (shivering and teeth chattering) (No fever) Muscle aches all over body Nerve pain in legs Neck pain COVID19 VACCINE JANSSEN 10-14 days 1098114-1 Extreme fatigue, headache, muscle aches. Currently 24 hours of fatigue and aches. COVID19 VACCINE JANSSEN 10-14 days 1098612-1 Light headed, headache, muscle aches did not have treatment yet been laying down to see if it helps Patient developed symptomatic COVID infection with symptoms starting 3/13, was admitted to the hospital for COVID19 VACCINE JANSSEN 10-14 days 1111699-1 respiratory failure on 3/16 and expired on 3/18/21 COVID19 VACCINE JANSSEN 10-14 days 1114827-1 Ovarian cysts - severe pain in RLQ mimicking appendicitis Started on day 5. Began day feeling extreme fatigue, dizziness, chest pain. Went to emergency room for chest pain. No COVID19 VACCINE JANSSEN 10-14 days 1116589-1 indication of heart attack per ER. Extreme fatigue lasted for 3 days. COVID19 VACCINE JANSSEN 10-14 days 1116936-1 Itchy all over. Patient notified pharmacy today (03/22/2021) that Janssen Covid-19 Vaccine that she received on 03/03/2021 caused COVID19 VACCINE JANSSEN 10-14 days 1123216-1 Pneumonia. Patient says that on 03/11/2021 went to hospital for treatment and MD told her that Pneumonia was caused by Janssen Vaccine she had received. Patient says was treated at hospital with 2 kind of IV antibiotics. Just walked in the house from work. Sudden total numbness of left arm. Had hard time speaking, words were slow COVID19 VACCINE JANSSEN 10-14 days 1123399-1 coming out and were slurred. After about 10 minutes the numbness gave way to weakness. The speech was improving but slurred slightly for another 20 minutes. Checked out by emt's and paramedics, then husband drove me to hospital. COVID19 VACCINE JANSSEN 10-14 days 1128206-1 DIC, intracerebral hemorrhage, intubation, requiring plts transfusion, seizure COVID19 VACCINE JANSSEN 10-14 days 1134203-1 Guillan-Barre syndrome COVID19 VACCINE JANSSEN 15-30 days 1093611-1 None stated. COVID19 VACCINE JANSSEN 15-30 days 1107712-1 Fever, bad chills, aches, headache, painful lymph nodes, racing heart Itching all over body and red splotches on chest. This began about 30 minutes after the shot. The red splotches are gone COVID19 VACCINE JANSSEN 15-30 days 1116348-1 after an hour and the itching is still occurring but minor now. COVID19 VACCINE JANSSEN 15-30 days 1134437-1 Left sided Bell's palsy Four hour after injection I started to shiver almost uncontrollably. My temperature around midnight spiked to 103 and COVID19 VACCINE JANSSEN 31-60 days 1079388-1 my heart rate was constant at 150. I was dizzy. Very little sleep. Temperature broke at 4:00AM Woke up at midnight (approximately 8 hrs after injection) with uncontrollable chills/shaking/shivers that lasted at least COVID19 VACCINE JANSSEN Over 120 days 1088614-1 10 minutes, before subsiding on their own. patient given vaccine and during the 15 minutes wait afterward, patient fainted and hit head on floor. Provider on sit COVID19 VACCINE JANSSEN Over 120 days 1092287-1 attended to patient and advised patient to go to emergency room. Patient is a 33 y/o male c/o having dizziness and nausea while he is sitting after 5 minutes of getting vaccine. vitals BP COVID19 VACCINE JANSSEN Over 120 days 1094730-1 100/60 HR 66 Oxygen sat 95 pain 0/10 resp. 18 Clamy to touch. Negative for shortness of breath, throat swelling, facial swelling, negative for rash. Negative for numbness or tingling of lips or throat. Vasovagal synciope Reasurrance given. Monitor. Patient standing walking around after 30 mintues. Refuses to call parents reports he feels much better. Patient complained of tongue tingling 45 mins post vaccine administration 11:02am . Benadryl 25mg oral liquid COVID19 VACCINE JANSSEN Over 120 days 1098005-1 administered. Patient VS stable and no other sx reported. Patient left walking without any symptoms of illness. Fifteen mins after receiving vaccine, I had a numb feeling in left jaw and lower teeth which spread to the arm and then hand. It was not severe, rather it felt like the after effects of having a dental numbing shot. About 20 minutes later I could feel it in my hip and left leg. The numbness subsided after about an hour. After that I felt a little tired with sore muscles everywhere. This is the same feeling as when the flu is coming on. That evening at approximately 9:00PM I became sick with high fever of 102 with uncontrollable shaking related to the fever . After a hot shower which calmed the shaking and 2 Motrin I was able to sleep and by morning the fever was broken. I felt hungover upon awakening COVID19 VACCINE JANSSEN Unknown 1079511-1 with a headache. Two more Motrin and feeling much better, just tired after a long night. I had not expected these side effects and when I searched the expected side effects and didn't see these symptoms I thought I should report it. Prior to taking the vaccine, my husband and I were in deep quarantine for the birth of our granddaughter for 3 weeks. The first time out among other people was at the vaccine facility. It is highly unlikely that I could have been exposed to an illness before the vaccine. And, it was immediately upon receiving the vaccine that I began to feel symptoms. I am 100% positive my illness overnight was due to the vaccine. Appx 8 hours after injection site became so painful bi could not use my arm and my finger tips are tinglin, BOTH EVENTS ARE STILL OCCURRING. I have this issue but normally only in the morning. . Today my stomach began having hard COVID19 VACCINE JANSSEN Unknown 1079621-1 cramps when I woke. In general I feel like I have the old fashioned file weak, tired and s headache residing in the front of my head. Pain and burning when given the vaccine, pain and swelling from the shoulder to my elbow, diarrhea, chills, headache, COVID19 VACCINE JANSSEN Unknown 1079634-1 very tired, nausea, muscle aches, fever. 8 hours after vaccination with Johnson and Johnson brand , the fever started, its now 32 hours passed and the fever does COVID19 VACCINE JANSSEN Unknown 1080001-1 not go away and it somewhat under control with ibuprofen and acetaminophen COVID19 VACCINE JANSSEN Unknown 1082046-1 Chills, Body Aches, Fever COVID19 VACCINE JANSSEN Unknown 1086198-1 Fever up to 101.5, chills, fatigue, body aches and joint pain Caller is a M of unknown age reporting he has just called PC. He took the first dose of the Johnson and Johnson COVID-19 COVID19 VACCINE JANSSEN Unknown 1087585-1 vaccine at 1000 on 3/5 and wants to know if he can take ibuprofen or acetaminophen for a headache. Advised caller would need to contact MD or pharmacist for advice. H/A, body ache & feel warm; suggested to take Tylenol or ibuprofen as recommended. Hydrate well and call poison COVID19 VACCINE JANSSEN Unknown 1088518-1 center if any questions or concerns. COVID19 VACCINE JANSSEN Unknown 1090503-1 Headache, body pain, fever, feeling tired About 2 minutes I blacked out and blood pressure went down. I got very cold and chilled. Once I came back around my COVID19 VACCINE JANSSEN Unknown 1091786-1 hands started tingling and started sweating. A full sixth dose of 0.5 mL was in a 5 dose vial. Full dose of 0.5 mL withdrawn and administered to patient. - No COVID19 VACCINE JANSSEN Unknown 1094309-1 Adverse events with patient. COVID19 VACCINE JANSSEN Unknown 1095604-1 Vanishpoint needle safety feature activated and vaccine imploded on arm symptoms: felt light headed, dizzy, low bp, flushed tx: water, controlled breathing and after 5- 10min gave 50mg COVID19 VACCINE JANSSEN Unknown 1096071-1 Benadryl outcome: patient was ok after 30 min, felt fine and stood up with ease, husband was with her COVID19 VACCINE JANSSEN Unknown 1096712-1 Have no adverse but was asked to submit for following progress by cdc COVID19 VACCINE JANSSEN Unknown 1114515-1 Rapid heartbeat. Consistently 100-120 bpm for 6 hours COVID19 VACCINE JANSSEN Unknown 1115168-1 I have developed a metallic/salty taste in my mouth effecting the taste pf food and causing nausea at times. COVID19 VACCINE JANSSEN Unknown 1115479-1 Fever 102, headache, chills, dizziness and diarrhea Pt came to office 3/17/21 with reaction -she had received at another facility on 3/13/21. Pt reports received through school district/employer. Received COVID vaccine LA and felt ""tingling"" all over and told staff who told her it was COVID19 VACCINE JANSSEN Unknown 1116810-1 normal. Later that day her left arm developed hives, with significant edema and erythema and puritis. She was evaluated in our office on 3/17/21- no respiratory distress, or perioral edema. Advised to use antihistamine and hydrocortisone and reviewed red flags. Returned on 3/19/21 with improving symptoms."" --- Dataset: The Vaccine Adverse Event Reporting System (VAERS) Query Parameters: State / Territory: The United States/Territories/Unknown Vaccine Manufacturer: JANSSEN Vaccine Products: COVID19 VACCINE (COVID19) VAERS ID: All Group By: Vaccine Type; Vaccine Manufacturer; Onset Interval; VAERS ID Show Totals: False Show Zero Values: Disabled --- Help: See http://wonder.cdc.gov/wonder/help/vaers.html for more information. --- Query Date: Apr 3, 2021 6:50:18 PM --- Suggested Citation: Accessed at http://wonder.cdc.gov/vaers.html on Apr 3, 2021 6:50:18 PM --- Messages: 1. The full results are too long to be displayed, only non-zero rows are available. 2. VAERS data in CDC WONDER are updated every Friday. Hence, results for the same query can change from week to week. 3. These results are for 2,790 total events. 4. When grouped by VAERS ID, results initially don't show Events Reported, Percent, or totals. Use Quick or More Options to restore them, if you wish. 5. Click on a VAERS ID to see a report containing detailed information for the event. --- Footnotes: 1. Submitting a report to VAERS does not mean that healthcare personnel or the vaccine caused or contributed to the adverse event (possible side effect). --- Caveats: 1.

VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to VAERS. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. Most reports to VAERS are voluntary, which means they are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.

The strengths of VAERS are that it is national in scope and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA's multi-system approach to post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also known as "safety signals." If a safety signal is found in VAERS, further studies can be done in safety systems such as the CDC's Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have the same limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine.

Key considerations and limitations of VAERS data:

• Vaccine providers are encouraged to report any clinically significant health problem following vaccination to VAERS, whether or not they believe the vaccine was the cause.
• Reports may include incomplete, inaccurate, coincidental and unverified information.
• The number of reports alone cannot be interpreted or used to reach conclusions about the existence, severity, frequency, or rates of problems associated with vaccines.
• VAERS data are limited to vaccine adverse event reports received between 1990 and the most recent date for which data are available.
• VAERS data do not represent all known safety information for a vaccine and should be interpreted in the context of other scientific information.

2 3. Some items may have more than 1 occurrence in any single event report, such as Symptoms, Vaccine Products, Manufacturers, and Event Categories. If data are grouped by any of these items, then the number in the Events Reported column may exceed the total number of unique events. If percentages are shown, then the associated percentage of total unique event reports will exceed 100% in such cases. For example, the number of Symptoms mentioned is likely to exceed the number of events reported, because many reports include more than 1 Symptom. When more then 1 Symptom occurs in a single report, then the percentage of Symptoms to unique events is more than 100%. More information: http://wonder.cdc.gov/wonder/help/vaers.html#Suppress. 4. Data contains VAERS reports processed as of 3/26/2021. The VAERS data in WONDER are updated weekly, yet the VAERS system receives continuous updates including revisions and new reports for preceding time periods. More information: http://wonder.cdc.gov/wonder/help/vaers.html#Reporting. 5. For more information on how many persons have been vaccinated in the US for COVID19 to date, see https://covid.cdc.gov/covid-data-tracker/#vaccinations/