First Moderate Reaction to Pox Jab Reported
Nurse breaks out in pustules, but no patients affected

By Amanda Gardner
HealthScoutNews Reporter

THURSDAY, Feb. 27 (HealthScoutNews) -- Health officials today reported the first two instances of what they call moderate-to-severe "adverse events" associated with the government's civilian smallpox vaccination program.

"We have known from outset that vaccine reactions will occur and that some of these reactions may be moderate to severe or potentially life threatening," said Dr. Eric Mast, an immunization expert with the Centers for Disease Control and Prevention in Atlanta.

Between Jan. 24 and Feb. 21, the CDC says, 7,354 health-care workers were vaccinated.

The first of the two moderate-to-severe events, detailed in the Feb. 28 issue of the CDC's Morbidity and Mortality Weekly Report (MMWR), involved a 39-year-old nurse in Florida. Nine days after receiving the vaccine, the woman experienced increased pain at the vaccination site, malaise, and headache. The next day a rash broke out on her chest and back, which progressed to scattered pustules.

"We're classifying it as a suspected case of generalized vaccinia, because she has signs and symptoms that are characteristics of generalized vaccinia," Mast said at a telebriefing. The CDC is awaiting the results of lab tests to confirm the diagnosis. Generalized vaccinia is the spread of the smallpox virus beyond the site of the vaccination.

The woman was treated with antihistamines as an outpatient and is recovering. She did miss some days of work because of the reaction, but "there's no concern or evidence that there are any patients at risk of transmission," Mast said.

The other adverse event involved a 60-year-old man, also in Florida, who experienced angina, or chest pain, while playing tennis four days after receiving the vaccine. Angina is not a known reaction to the vaccine, and the man does have a history of hypertension and a family history of coronary artery disease. He was hospitalized for two days and released. Mast said the case was "unlikely to be connected" to the smallpox vaccine.

A third case, not reported in the MMWR but announced by state health officials, involves yet another Floridian, this one with acute gallbladder inflammation. The patient was hospitalized but, again, gallbladder inflammation has not been associated with the smallpox vaccine, Mast said.

The fact that the only cases reported so far have all occurred in Florida has raised questions about the CDC's surveillance system.

The system is a two-tiered one, according to Mast. The active component monitors moderate-to-severe and life-threatening events and has clinicians report directly to the CDC.

In addition, the CDC is about to launch a survey of 10,000 vaccinees to collect information on non-severe adverse events. So far, 23 of these events, ranging from fever to redness at the injection site, have been reported.

"We expect them to be underreported because they are reported through a passive system," Mast said. Here, people who have been vaccinated are surveyed at 10 and at 21 days after vaccination.

Forced to defend the CDC's efforts before testy reporters, Mast said, "Our surveillance system is very good. It's working."

More information

For more on the smallpox vaccination and possible adverse events, visit the CDC. Get a history of the disease from the National Library of Medicine.

SOURCES: Centers for Disease Control and Prevention telebriefing with Eric Mast, M.D., immunization expert; Feb. 28, 2003 Morbidity and Mortality Weekly Report

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