Hepatitis B vaccination safety

• Published in: The Annals of pharmacotherapy 2002-03, Vol.36 (3), p.370-374
• Main Authors: Geier, MR, Geier, DA
• Format: Article
• Language: English
• Subjects: Adult; Adverse Drug Reaction Reporting Systems - statistics & numerical data; Biological and medical sciences; Databases, Factual; Female; Hepatitis B Vaccines - adverse effects; Humans; Immunopathology; Immunotherapy (general aspects); Incidence; Male; Medical sciences; Tetanus Toxoid - adverse effects
• ISSN: 1060-0280; 1542-6270
• DOI: 10.1345/aph.1A304

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. TRASFONDO: Estudios recientes sugieren que la vacunación para hepatitis B en adultos podría estar asociada con reacciones adversas.