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Smallpox Vaccine Adverse Events Among Civilians --- United States, February 18--24, 2003

During the civilian smallpox vaccination program, CDC and state health departments are conducting surveillance for vaccine-associated adverse events. In the first stage of the program, active surveillance is being conducted for potentially life-threatening, moderate-to-severe, and other serious adverse events and for vaccinia transmission to contacts of vaccinees (1) (Table). Nonserious events are reported through passive surveillance and are expected to be underreported. This report summarizes smallpox vaccine adverse events reported among civilians vaccinated as of February 21, 2003, and received by CDC from the Vaccine Adverse Event Reporting System (VAERS) as of February 24.

Potentially life-threatening and moderate-to-serious events are classified on the basis of evidence in support of the reported diagnoses. For probable cases, other causes are excluded, and supportive information is available. Events are classified as suspected if they have clinical features compatible with the diagnosis but either further investigation is required or additional investigation of the case did not provide supporting evidence for the diagnosis and did not identify an alternative diagnosis. CDC and state health departments also receive reports of other events that are associated temporally with smallpox vaccination. Reported adverse events are not necessarily associated with vaccination, and some or all of these events might be coincidental.

During January 24--February 21, smallpox vaccine was administered to 7,354 civilian health-care and public health workers in 40 jurisdictions. No potentially life threatening adverse events were reported as of February 24.

One moderate-to-severe adverse event was reported, a suspected case of generalized vaccinia in a woman aged 39 years. Nine days after receiving smallpox vaccine, the patient reported increased pain at the vaccination site, malaise, and headache. The following day, she developed a pruritic, papular rash on her chest and back that progressed to scattered pustules by day 12 following vaccination. She was treated as an outpatient with antihistamines, and the rash was resolving by day 15. Specimens from the pustular lesions were collected and sent for virologic testing; results are pending.

One other serious adverse event was reported, angina in a man aged 60 years with a history of hypertension, hyperlipidemia, and exertional chest pain and a family history of coronary artery disease. Angina is not known to be associated causally with smallpox vaccination. The patient had onset of chest pain while playing tennis 4 days after smallpox vaccination and reported to an emergency department. The patient was diagnosed with right coronary artery occlusion, and an angioplasty was performed. He was discharged after being hospitalized for 2 days.

Among 23 vaccinees with reported other nonserious adverse events during January 24--February 24, the most common signs and symptoms were fever (n = six), pruritus (n = five), rash (n = four), vasodilation (n = four), asthenia (n = three), headache/migraine (n = three), malaise (n = three), paresthesia (n = three), and redness at injection site (n = three). Some vaccinees reported multiple signs and symptoms.

Surveillance for adverse events during the civilian smallpox vaccination program is ongoing; regular surveillance reports will be published in MMWR.


  1. CDC. Smallpox Vaccine Adverse Events Monitoring and Response System for the first stage of the smallpox vaccination program. MMWR 2002;52:88--9.


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