Legend Tool 1 Morbidity and Mortality Risk Clinical Evaluation Tool for Vaccine Adverse Reactions based on clinical presentation. Dermatologic Reactions/ Localized to Site (3-12-2003 Version) Low www.bt.cdc.gov/agent/smallpox/vaccination/clineval

Moderate NO YES Go to Dermatologic Reactions/ Nontoxic Appearance, Distant from High Close Contact of Vaccine Recipient? Vaccine Recipient? Vaccination Site (or in a Contact) Clinical Evaluation Tool. YES

Erythematous Vaccination Normal Vaccination Reaction Severe Vaccination Reaction Reaction of Concern

Typical reaction timeline Common signs/symptoms Tape sensitivity Rapid progressive painless extension of Day Description after vaccination Try different tape. Erythema present along lines of central vaccination lesion or progression YES 0 Vaccination - Pruritus Change bandage adhesive tape and no or mild without apparent healing after 15 days. 3-4 Papule - Soreness at frequently, rotate systemic symptoms? Lesion often necrotic. Initially little or no 5-6 Vesicle with surrounding vaccination site bandage, or take a inflammation. May present with few or no erythema - vesicle with - Intense erythema judicious bandage systemic symptoms. depressed center ringing the “holiday” 8-9 Well-formed pustule vaccination site remembering to use NO 12+ Pustule crusts over and - Small papules or other means (e.g. becomes a scab vesicles around long sleeves) to Early Progressive (Vaccinia 17-21 Scab detaches revealing scar vaccination lesion prevent contact Erythema with induration, warmth, necrosum, Vaccinia gangrenosum) Timeline may be accelerated (satellite lesions) transmission. Use and pain. May also have regional Go to Clinical Evaluation Tool for in persons with history of prior - Headache antihistamines PRN; lymphadenopathy and fever. Dermatologic Reactions/Toxic smallpox vaccination. - Local avoid topical/ Appearance, Distant from Vaccination lymphadenopathy systemic steroids. Site (or in Contact). See Consultation - and Reporting Information. Major reaction. Area of definite - Myalgia induration or congestion surrounding a - Fever central lesion that may be a scab or ulcer Provide supportive care. Range of normal reactions, Consider Bacterial infection if: for localized 6-8 days after vaccination. Use antihistamines and including Robust take - Honey-crusted lesions (impetigo) smallpox vaccine adverse reactions Equivocal reaction. Any reaction or NSAIDs PRN; avoid (>3 inches or ~7.5 cm of or fluctuance is present at Consider conditions not related to smallpox response other than a “major reaction.” topical/ systemic steroids. redness with swelling, vaccination site. vaccine such as: Consultation and Reporting Information warmth and pain at - Symptom onset is within one - Acute contact dermatitis Civilian health care providers who need clinical consultation with or without vaccination site): week of vaccination or >15 days - Furuncle/ carbuncle release of vaccinia immune globulin (VIG) (first line agent) or - Symptoms expected to post vaccination. - Pyoderma/ ecthyma (second line agent) for potential smallpox vaccine adverse reactions should peak at 8-10 days post - Symptoms are not improving - (HSV) contact their state/ local health department or the CDC Clinician Information vaccination. within 72 hours after onset. - Anthrax Line at (877) 554-4625. Military health care providers (or civilian providers - Symptoms typically - Other concerning clinical features - Atypical mycobacteria treating a DoD healthcare beneficiary) requesting clinical consultation improve within 24-72 are present. - and should call (866) 210-6469, and if requesting VIG release should call (888) hours of peak Streptococcal or staphylococcal other pox USA-RIID or (301) 619-2257. inflammation. infection is the most likely etiology, - Pyoderma gangrenosum Provide supportive care. however other bacterial sources are - Brown recluse spider bite Health care providers should report smallpox vaccine adverse events to Use antihistamines and possible. Obtain cultures of skin/ their state/ local health department and to the Vaccine Adverse Event NSAIDs PRN; avoid topical/ blood, other lab tests (including Reporting System (VAERS) at http://www.vaers.org/ or (800) 822-7967. systemic steroids. Observe gram stain) and administer empiric Laboratory testing Please call (888) 246-2675 (Español (888) 246-2857, TTY (866) 874-2646) or & rest affected limb. as indicated. Use Consider use of licensed diagnostic tests visit http://www.bt.cdc.gov/agent/smallpox/index.asp for general public Observe vigilantly until infection control precautions; to rule out etiologies not related to vaccina information about smallpox vaccination. Persons experiencing urgent or improvement noted. lesions may contain vaccinia virus. virus contained in smallpox vaccine. life-threatening medical events should seek immediate medical assistance.

Disclaimer The CDC and its partners in the Clinical Immunization Safety Assessment (CISA) network have developed Clinical Evaluation Tools to help health care providers manage patients with potential adverse reactions from smallpox vaccination in the absence of circulating smallpox virus (pre-event setting). These Tools are based on studies conducted before routine US childhood smallpox vaccination was discontinued in 1972 and on expert opinion; they are not entirely evidence-based. The Tools may not apply to all patients with smallpox vaccine adverse reactions and are not intended to substitute for evaluation by a trained clinician. This Tool was last updated on 3-12-03. Please direct feedback on these Tools to [email protected]. Page 6.61