viduals reported transient systemic reactions consisting of fever, chills, nausea, and body aches (Friedlander et al., 1999).

VAERS reports. As described earlier in this chapter, the Vaccine Adverse Event Reporting System is a passive surveillance system consisting of reports filed by health care providers, individuals receiving vaccinations, family members, or others. As noted earlier, VAERS data are useful as a sentinel for adverse events but are limited in their usefulness for assessing the rate of adverse events since underreporting is likely and the information may be incomplete or duplicative, or may not always have been confirmed by medical personnel (IOM, 1994).

The committee reviewed summaries of VAERS data but did not review the individual VAERS forms. From its inception in 1990 through July 1, 1999, there have been 215 VAERS reports regarding anthrax vaccination (Ellenberg, 1999). The majority of the reports describe local or systemic symptoms including injection site edema, injection site hypersensitivity, rash, headache, and fever. Twenty-two of the VAERS reports are considered serious events8 and were described as occurring (or being diagnosed) from 45 minutes to 4½ months after receiving the vaccination. Reports of serious events include five patients hospitalized with severe injection site reactions, one individual with a widespread allergic reaction, one individual with a case of aseptic meningitis 9 days after vaccination, two individuals who experienced Guillain-Barré syndrome, one individual diagnosed with bipolar disorder 3 weeks after receiving the vaccine, one individual with an onset of multi-focal inflammatory demyelinating disease, and one individual who experienced the onset of lupus (Ellenberg, 1999). In recent congressional testimony FDA stated, “None of these events, except for the injection site reactions, can be attributed to the vaccine with a high level of confidence, nor can contribution of the vaccine to the event reported be entirely ruled out…. [T]he reports on anthrax vaccine received thus far do not raise any specific concerns about the safety of the vaccine” (Ellenberg, 1999). An external review panel, the Anthrax Vaccine Expert Committee, has recently been established by the Department of Health and Human Services at the request of the Department of Defense (DoD) to review each VAERS report received regarding anthrax vaccination.

Special Immunization Program Safety Study. Since 1973, 1,590 workers at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) have received 10,451 doses of the anthrax vaccine (Claypool, 1999; Friedlander et al., 1999). Visits to the occupational health clinic were used as a method of collecting and passively monitoring information on adverse reactions. Four percent of doses resulted in a local reaction (redness, induration, itching, or edema) at the site of injection. Systemic reactions (headache, fever, chills, malaise, muscle and joint aches) occurred with 0.5 percent of doses. Individuals received annual physical

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Adverse events resulting in life-threatening illness, hospitalization, permanent disability, extended hospital stay, or death (Ellenberg, 1999).



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