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Rare Serious Events Reported by Smallpox Vaccination Programs

Cheryl Thompson

As many as seven moderate-to-severe events and two potentially life-threatening illnesses have occurred in the more than 250,000 civilians and military personnel who have recently received smallpox vaccine, officials announced this week. Two other people had serious problems not previously known to be related to smallpox vaccine.

Today's Morbidity and Mortality Weekly Report (MMWR) from the Centers for Disease Control and Prevention (CDC) described one suspected case of generalized vaccinia in a 39-year-old woman and one incident of angina in a 60-year-old man with hypertension, hyperlipidemia, chest pain on exertion, and a family history of coronary artery disease.

Generalized vaccinia, which CDC classifies as a moderate-to-severe event regardless of whether the patient requires aggressive treatment, appears as pustular lesions on the body, usually the trunk and abdomen. The pustules contain vaccinia virus, the active agent in smallpox vaccine. Angina has not been considered by CDC to be associated with smallpox vaccination.

CDC immunization expert Eric Mast acknowledged during a teleconference Thursday that the woman suspected of having generalized vaccinia is a nurse and that she and the angina patient had received smallpox vaccine in the past. Mast also confirmed that a case of acute gallbladder inflammation, a condition not previously considered to be associated with smallpox vaccination, was under investigation. This patient, he said, was not described in the Feb. 28 MMWR because the article covered only adverse events reported to CDC as of Feb. 24.

Earlier in the week during a CDC-hosted teleconference for clinicians, Col. John Grabenstein said two Army soldiers were treated for encephalitis after smallpox vaccination and three, possibly four, military personnel were diagnosed with myocarditis. Grabenstein, a pharmacist and epidemiologist in the Army Surgeon General's office, also noted two possible cases of ocular vaccinia, which results from the transfer of vaccinia virus to the eye.

No one, Grabenstein said, has died from the Department of Defense smallpox vaccination program, which so far has inoculated over 250,000 combat personnel and health care workers against smallpox. "We've exempted probably 10 to 20 percent of the [military] force for personal medical reasons—skin conditions, allergies, pregnancies, immunosuppressant conditions—and then another 10 percent because of their household contacts."

Several people vaccinated in the military program have had a vesicular or pustular rash "that can be generalized vaccinia," Grabenstein said. "The nine that we've seen so far have all been extremely mild, and all treated as outpatients. All treated symptomatically."

As for adverse events in general, Grabenstein said the military is seeing "all the things we expect—swollen lymph nodes under the arms, itching, fever, malaise." About 3 percent of vaccinees have taken one or more days of sick leave, he said. "They just don't feel like coming to work—nothing much more complicated than that."

Among civilians, 19 nonserious adverse events, such as rashes and episodes of hypertension, not clearly related to the vaccine have been reported, said Raymond Strikas, with CDC's National Immunization Program.

Strikas said CDC has not been notified of any needlestick injury from the bifurcated needle used to administer smallpox vaccine. But, he expects "that it's only a matter of time before it would occur."

CDC reported that 7,354 civilians have been recently vaccinated against smallpox and that, as of Feb. 19, 274,000 vaccine doses had been received by 52 states and counties across the country.