Hepatitis B vaccination safety.

BACKGROUND

Recent studies have suggested that adult hepatitis B vaccination may be associated with adverse reactions.

OBJECTIVE

To further examine the relative risk, percentage association, and statistical significance of arthritic, immunologic, and gastrointestinal adverse reactions reported after adult hepatitis B vaccination compared with control vaccines.

DESIGN

The Vaccine Adverse Events Reporting System (VAERS) database was analyzed for the incidence of adverse reactions after adult hepatitis B immunization compared with the incidence of adverse reactions reported to VAERS about vaccine control groups.

SETTING

The medical and scientific communities have generally accepted that hepatitis B vaccine, a highly purified, genetically engineered single-antigen vaccine, is a safe vaccine.

METHODS

The VAERS database was analyzed from 1997 to 2000 for adverse reactions associated with adult hepatitis B vaccination and from 1991 to 2000 for adverse reactions reported about vaccine control groups.

RESULTS

The results showed a statistically significant increase in the incidence of adverse reactions reported after adult hepatitis B vaccination when compared with the incidence of adverse reactions reported to VAERS about control vaccines.

CONCLUSIONS

Patients and physicians need to be fully informed of the potential adverse reactions associated with hepatitis B vaccination so that together they can make an informed consent decision about the risk versus the benefit. Patients who may have had an associated adverse reaction to hepatitis B vaccine should be made aware that they may be eligible for compensation from the no-fault Vaccine Compensation Act, administered by the US Court of Claims.