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From the Centers for Disease Control and Prevention
March 26, 2003

Smallpox Vaccine Adverse Events Among Civilians—United States, January 24–February 18, 2003

JAMA. 2003;289(12):1497-1498. doi:10.1001/jama.289.12.1497
Smallpox Vaccine Adverse Events Among Civilians—United States, January 24–February 18, 2003

MMWR. 2003;52:136

1 table omitted

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 Nonserious events are reported via passive surveillance and are expected to be underreported. This report summarizes smallpox vaccine adverse events reported among civilians vaccinated as of February 14, 2003, and received by CDC from the Vaccine Adverse Event Reporting System (VAERS) as of February 18.

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 14, 2003, smallpox vaccine was administered to 4,213 civilian health-care workers in 27 jurisdictions. No potentially life threatening or moderate-to-severe adverse events have been reported. Among seven vaccinees with reported nonserious adverse events, the most common signs and symptoms were fever (n = two), rash (n = two), malaise (n = two), pruritus (n = two), hypertension (n = two), and pharyngitis (n = two). Surveillance for adverse events during the civilian smallpox vaccination program is ongoing. Regular surveillance reports will be published in MMWR.

CDC.  Smallpox Vaccine Adverse Events Monitoring and Response System for the first stage of the smallpox vaccination program.  MMWR Morb Mortal Wkly Rep.2003;52:88-9, 99.