Urticaria, Exanthems, and Other Benign Dermatologic Reactions to Smallpox Vaccination in Adults

Abstract

A phase 1 smallpox vaccine trial involving 350 adult volunteers was conducted. Of these subjects, 250 were naive to vaccinia virus vaccine (i.e., "vaccinia naive"). Volunteers received a new cell-cultured smallpox vaccine or a live vaccinia virus vaccine. Nine self-limiting rashes (3.6%) were observed in the vaccinia-naive group. None of the vaccinia-experienced patients had a rash. Rashes appeared 6-19 days after vaccination and had 5 different clinical presentations. Five volunteers had urticarial rashes that resolved within 4-15 days, 1 had an exanthem that lasted 20 days, and 1 each presented with folliculitis, contact dermatitis, and erythematous papules found only on the hands and fingers. Volunteers reported pruritus, tingling, and occasional headaches. Relief was obtained with antihistamine and acetaminophen therapy. No volunteer experienced fever or significant discomfort.

Benign hypersensitivity reactions to smallpox vaccine

“…Five subjects had urticarial eruptions that resolved within 4–15 days, one had an exanthem that lasted 20 days, and one each presented with folliculitis, contact dermatitis, and erythematous papules found on the hands and fingers. None of the vaccinia‐experienced patients had a cutaneous reaction 9 …”

“…None of the vaccinia-experienced patients had a cutaneous reaction. 9 We report a group of patients in a military vaccination program with adverse reactions to the smallpox vaccination who had benign outcomes. These patients' clinical, laboratory, and histopathologic findings were not sufficiently defined by any of the existing patterns of adverse reactions to vaccinia.…”

Adverse Events Following Smallpox Vaccination With ACAM2000 in a Military Population

“…9,10 However, more recent reports describe eruptions occurring as late as 12 to 19 days following vaccination. 8,11,12 The clearance time for these benign eruptions varies widely in the literature. Early data suggested resolution within 2 to 4 days 11,13 ; however, subsequent studies report a delay of 10 to 20 days.…”

Adverse Events Associated With Smallpox Vaccination in the United States, January-October 2003

“…14,[21][22][23][24][25] Following 7 cardiacrelated adverse events, including 2 sudden deaths in civilian vaccinees, and 10 cases of myocarditis and/or pericarditis (myo/pericarditis) in DoD vaccinees, 26 the CDC issued a Health Alert Notice on March 26, 2003, 27 that described these events and provided provisional recommended deferral criteria for persons at risk for ischemic cardiac events; finalized criteria were published on April 4, 2003. 28 We describe the vaccine safety profile among civilians who received small-pox vaccine between January 24 and October 31,2003. Smallpox vaccine adverse events among DoD personnel or research participants in clinical trials are described elsewhere.…”

“…Smallpox vaccine adverse events among DoD personnel or research participants in clinical trials are described elsewhere. 7,[29][30][31][32]…”