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Summary Tabulation 2021.07.27 Summary Tabulation 2021.07.27 Active Substance (High Level) COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV- 19) Reaction SOC Reaction PT Serious Non Total Serious Blood and lymphatic system disorders Anaemia 3 1 4 Autoimmune haemolytic anaemia 1 0 1 Coagulopathy 76 28 104 Coombs negative haemolytic anaemia 1 0 1 Disseminated intravascular coagulation 1 0 1 Eosinophilia 1 0 1 Immune thrombocytopenia 4 1 5 Increased tendency to bruise 1 0 1 Leukocytosis 1 0 1 Leukopenia 1 0 1 Lymph node pain 1 0 1 Lymphadenitis 1 0 1 Lymphadenopathy 12 3 15 Lymphocytosis 1 0 1 Lymphopenia 1 0 1 Necrotic lymphadenopathy 0 1 1 Neutropenia 3 1 4 Platelet disorder 1 1 2 Splenic embolism 1 0 1 Splenic infarction 1 0 1 Splenic vein thrombosis 1 0 1 Spontaneous haematoma 1 0 1 Thrombocytopenia 39 7 46 Cardiac disorders Acute cardiac event 1 0 1 Acute myocardial infarction 1 0 1 Angina pectoris 4 0 4 Angina unstable 1 0 1 Arrhythmia 12 2 14 Atrial fibrillation 1 0 1 Bradycardia 1 2 3 Cardiac arrest 3 0 3 Cardiac disorder 0 1 1 Cardiac failure 4 0 4 Cardio-respiratory arrest 1 0 1 Cardiovascular disorder 57 9 66 Cardiac disorders Coronary artery occlusion 1 0 1 Extrasystoles 1 1 2 Myocardial depression 1 0 1 Myocardial infarction 4 0 4 Myocarditis 3 0 3 Palpitations 46 13 59 Pericarditis 8 1 9 Pleuropericarditis 1 1 2 Postural orthostatic tachycardia syndrome 0 1 1 Sinus tachycardia 2 0 2 Tachyarrhythmia 1 0 1 Tachycardia 37 6 43 Congenital, familial and genetic disorders Von Willebrand's disease 1 0 1 Ear and labyrinth disorders Deafness 3 3 6 Deafness unilateral 8 1 9 Ear congestion 0 2 2 Ear discomfort 5 1 6 Ear pain 15 4 19 Hyperacusis 5 0 5 Hypoacusis 1 0 1 Meniere's disease 1 1 2 Sudden hearing loss 0 1 1 Tinnitus 16 7 23 Vertigo 43 8 51 Vertigo positional 1 0 1 Vestibular disorder 1 0 1 Endocrine disorders Adrenocortical insufficiency acute 1 0 1 Goitre 2 0 2 Eye disorders Accommodation disorder 1 0 1 Acute macular outer retinopathy 1 0 1 Amaurosis fugax 1 1 2 Asthenopia 5 0 5 Blindness 6 1 7 Blindness unilateral 5 0 5 Conjunctival haemorrhage 1 1 2 Dacryostenosis acquired 1 0 1 Diplopia 5 2 7 Eye disorder 1 1 2 Eye haemorrhage 2 6 8 Eye irritation 3 0 3 Eye oedema 1 0 1 Eye pain 9 5 14 Eye swelling 3 0 3 Eyelid oedema 1 0 1 Glaucoma 1 0 1 Hypermetropia 0 1 1 Macular oedema 1 0 1 Miosis 1 0 1 Mydriasis 1 0 1 Ocular discomfort 2 1 3 Eye disorders Ocular hyperaemia 1 1 2 Ophthalmic vein thrombosis 2 1 3 Papilloedema 1 0 1 Periorbital swelling 1 1 2 Photophobia 8 2 10 Photopsia 1 0 1 Pupils unequal 1 0 1 Retinal artery thrombosis 4 0 4 Retinal haemorrhage 1 1 2 Retinal ischaemia 1 0 1 Retinal oedema 1 0 1 Retinal vascular thrombosis 0 1 1 Retinal vein occlusion 3 0 3 Retinal vein thrombosis 7 1 8 Swelling of eyelid 1 1 2 Uveitis 1 0 1 Vision blurred 26 7 33 Visual acuity reduced 5 0 5 Visual field defect 4 1 5 Visual impairment 20 7 27 Visual snow syndrome 1 0 1 Vitreous floaters 0 1 1 Gastrointestinal disorders Abdominal discomfort 5 1 6 Abdominal distension 1 1 2 Abdominal pain 35 12 47 Abdominal pain upper 20 10 30 Abdominal wall haematoma 1 0 1 Abnormal faeces 1 0 1 Aphthous ulcer 0 1 1 Colitis ischaemic 2 0 2 Colitis ulcerative 1 0 1 Constipation 1 1 2 Crohn's disease 1 0 1 Diarrhoea 76 16 92 Diarrhoea haemorrhagic 1 1 2 Dry mouth 8 0 8 Dysbiosis 1 0 1 Dyspepsia 6 1 7 Dysphagia 2 2 4 Eructation 1 0 1 Faeces discoloured 1 0 1 Faeces soft 2 0 2 Flatulence 1 0 1 Functional gastrointestinal disorder 1 0 1 Gastrointestinal disorder 5 0 5 Gastrointestinal haemorrhage 1 0 1 Gastrointestinal inflammation 1 0 1 Gastrointestinal pain 2 0 2 Gastrointestinal sounds abnormal 1 1 2 Gastrointestinal vascular malformation haemorrhagic 1 0 1 Gastrointestinal disorders Gastrooesophageal reflux disease 1 0 1 Gingival bleeding 3 0 3 Glossodynia 1 1 2 Haemoperitoneum 1 0 1 Haemorrhoidal haemorrhage 1 0 1 Haemorrhoids thrombosed 1 1 2 Hypoaesthesia oral 0 1 1 Intestinal congestion 1 0 1 Intestinal infarction 1 0 1 Intestinal ischaemia 3 0 3 Lip pain 1 1 2 Lip swelling 0 4 4 Melaena 1 1 2 Mesenteric arterial occlusion 1 0 1 Mesenteric vein thrombosis 4 0 4 Mouth haemorrhage 0 2 2 Mouth swelling 1 0 1 Mucous stools 1 0 1 Nausea 942 101 1.043 Oesophageal spasm 1 0 1 Oral discomfort 2 0 2 Oral mucosal blistering 1 0 1 Pancreatic enlargement 1 0 1 Paraesthesia oral 4 4 8 Plicated tongue 0 1 1 Rectal haemorrhage 1 2 3 Regurgitation 1 0 1 Retching 3 0 3 Splanchnic hypoperfusion 1 0 1 Stomatitis 0 1 1 Swollen tongue 2 1 3 Thrombosis mesenteric vessel 1 0 1 Tongue discomfort 0 1 1 Tongue disorder 0 1 1 Tooth discolouration 0 1 1 Tooth disorder 1 0 1 Toothache 0 1 1 Vomiting 108 17 125 General disorders and administration site Administration site pain 0 1 1 conditions Adverse drug reaction 3 0 3 Adverse event 2 2 4 Application site joint warmth 1 0 1 Asthenia 55 8 63 Axillary pain 4 2 6 Brain death 1 0 1 Chest discomfort 19 3 22 Chest pain 38 9 47 Chills 1608 153 1.761 Condition aggravated 3 1 4 Death 24 0 24 General disorders and administration site conditions Decreased activity 1 0 1 Discomfort 1 2 3 Disease recurrence 1 0 1 Drug ineffective 0 9 9 Exercise tolerance decreased 3 0 3 Extensive swelling of vaccinated limb 107 19 126 Face oedema 4 0 4 Facial pain 0 1 1 Fatigue 1663 196 1.859 Feeling abnormal 25 4 29 Feeling cold 32 9 41 Feeling drunk 2 1 3 Feeling hot 21 6 27 Feeling of body temperature change 16 2 18 Feeling of relaxation 0 1 1 Gait disturbance 12 4 16 Gait inability 2 0 2 General physical health deterioration 8 0 8 Hyperpyrexia 0 1 1 Hyperthermia 2 1 3 Hypothermia 2 0 2 Illness 1 6 7 Induration 2 2 4 Inflammation 2 1 3 Influenza like illness 189 33 222 Injected limb mobility decreased 1 0 1 Injection site bruising 1 1 2 Injection site discomfort 3 0 3 Injection site erythema 16 8 24 Injection site haematoma 2 0 2 Injection site haemorrhage 3 0 3 Injection site hypersensitivity 0 1 1 Injection site hypoaesthesia 2 0 2 Injection site induration 7 2 9 Injection site inflammation 3 0 3 Injection site movement impairment 2 2 4 Injection site necrosis 1 0 1 Injection site oedema 1 0 1 Injection site pain 113 20 133 Injection site paraesthesia 1 0 1 Injection site phlebitis 0 1 1 Injection site plaque 0 1 1 Injection site pruritus 0 3 3 Injection site rash 1 0 1 Injection site reaction 807 69 876 Injection site swelling 20 5 25 Injection site warmth 10 1 11 Lithiasis 1 0 1 Local reaction 1 0 1 Localised oedema 2 0 2 General disorders and administration site conditions Malaise 1002 106 1.108 Mucosal inflammation 1 0 1 Multiple organ dysfunction syndrome 1 0 1 No adverse event 1 1 2 Oedema 3 1 4 Oedema peripheral 5 4 9 Pain 28 24 52 Peripheral swelling 69 8 77 Puncture site pain 0 1 1 Pyrexia 1633 224 1.857 Secretion discharge 1 0 1 Sensation of foreign body 1 0 1 Sense of oppression 2 0 2 Sick building syndrome 0 2 2 Sudden death 9 0 9 Suprapubic pain 0 1 1 Swelling 7 6 13 Swelling face 5 1 6 Tenderness 3 1 4 Therapeutic response unexpected 0 1 1 Thirst 10 0 10 Tissue infiltration 0 1 1 Unevaluable event 1 1 2 Vaccination site bruising 0 1 1 Vaccination site discharge 0 1 1 Vaccination site erythema 1 0 1 Vaccination site haematoma 1 0 1 Vaccination site movement impairment 1 0 1 Vaccination site pain 2 7 9 Vaccination site plaque 0 1 1 Vascular stent occlusion 1 0 1 Vascular stent thrombosis 1 0 1 Hepatobiliary disorders Gallbladder necrosis 1 0 1 Hepatic failure 1 0 1 Hepatic pain 1 0 1 Hepatic steatosis 1 0 1 Hepatitis 1 0 1 Hyperbilirubinaemia 1 0 1 Jaundice 0 1 1 Liver disorder 2 0 2 Portal vein occlusion 1 0 1 Portal vein thrombosis 4 0 4 Venoocclusive liver disease 1 0 1 Immune system disorders Anaphylactic reaction 10 4 14 Anaphylactic shock 2 0 2 Autoimmune disorder 11 1 12 Eosinophilic granulomatosis with polyangiitis 1 0 1 Hypersensitivity 30 12 42 Multiple allergies 1 0 1 Seasonal allergy 1 0 1 Infections and infestations Abdominal infection 0 1 1 Abscess 0 1 1 Asymptomatic COVID-19 1 0 1 Bacterial infection 1 0 1 Brain abscess 1 0 1 Brain empyema 1 0 1 Bronchiolitis 1 0 1 Bronchitis 1 0 1 COVID-19 65 7 72 COVID-19 pneumonia 1 0 1 Cavernous sinus thrombosis 1 0 1 Chronic sinusitis 1 0 1 Conjunctivitis 1 1 2 Conjunctivitis viral 0 1 1 Cystitis 3 0 3 Diverticulitis 2 0 2 Ear infection 0 1 1 Encephalitis 4 0 4 Endocarditis 1 0 1 Erysipelas 1 2 3 Eye infection 1 0 1 Gastrointestinal infection 0 1 1 Herpes zoster 2 15 17 Infection 1 1 2 Infectious mononucleosis 0 1 1 Influenza 15 13 28 Injection site cellulitis 0 1 1 Laryngitis 1 0 1 Lymphangitis 0 1 1 Mastitis 1 0 1 Meningitis bacterial 1 0 1 Mycoplasma infection 1 0 1 Nasopharyngitis 17 6 23 Ophthalmic herpes zoster 0 1 1 Oral herpes 3 0 3 Ovarian abscess 1 0 1 Pharyngitis 0 2 2 Pneumonia 4 0 4 Pneumonia bacterial 1 0 1 Pyelonephritis 1 0 1 Pyelonephritis acute 1 0 1 Respiratory tract infection 1 0 1 Sepsis 2 0 2 Septic shock 2 0 2 Sinusitis 2 0 2 Streptococcal infection 1 0 1 Subcutaneous abscess 0 1 1 Suspected COVID-19 0 1 1 Sweating fever 0 1 1 Tooth abscess 1 0 1 Urinary tract infection 2 1 3 Vestibular neuronitis 2 0 2 Viral myocarditis 1 0 1 Injury, poisoning and procedural complications Contusion 10 14 24 Epicondylitis 1 0 1 Exposure during pregnancy 1 2 3 Exposure via breast milk 0 1 1 Fall 12 3 15 Head injury 1 0 1 Heat stroke 1 0 1 Inappropriate schedule of product administration 1 2 3 Incorrect route of product administration 1 6 7 Intentional dose omission 1 0 1 Intentional product misuse 2 0 2 Kidney rupture 1 0 1 Maternal exposure during breast feeding 2 6 8 Medication error 1 6 7 Muscle rupture 0 1 1 Nasal injury 1 0 1 Off label use 2 2 4 Product administered at inappropriate site 0 1 1 Product
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