A case-series of adverse events, positive re-challenge of symptoms, and events in identical twins following hepatitis B vaccination: analysis of the Vaccine Adverse Event Reporting System (VAERS) database and literature review.

OBJECTIVES Adverse events and positive re-challenge of symptoms reported in the scientific literature and to the Vaccine Adverse Event Reporting System (VAERS) following hepatitis B vaccination (HBV) were examined. METHODS The VAERS and PubMed (1966-2003) were searched for autoimmune conditions including arthritis, rheumatoid arthritis, myelitis, optic neuritis, multiple sclerosis (MS), Guillain Barré Syndrome (GBS), glomerulonephritis, pancytopenia/thrombocytopenia, fatigue, and chronic fatigue, and Systemic Lupus Erythematous (SLE) following HBV. RESULTS HBV was associated with a number of serious conditions and positive re-challenge or significant exacerbation of symptoms following immunization. There were 415 arthritis, 166 rheumatoid arthritis, 130 myelitis, 4 SLE, 100 optic neuritis, 101 GBS, 29 glomerulonephritis, 283 pancytopenia/thrombocytopenia, and 183 MS events reportedfollowing HBV A total of 465 positive re-challenge adverse events were observed following adult HBV that occurred sooner and with more severity than initial adverse event reports. A case-report of arthritis occurring in identical twins was also identified. CONCLUSIONS Evidence from biological plausibility, case-reports, case-series, epidemiological, and now for positive re-challenge and exacerbation of symptoms, and events in identical twins was presented. One would have to consider that there is causal relationship between HBV and serious autoimmune disorders among certain susceptible vaccine recipients in a defined temporal period following immunization. In immunizing adults, the patient, with the help of their physician, should make an informed consent decision as to whether to be immunized or not, weighing the small risks of the adverse effects of HBV with the risk of exposure to deadly hepatitis B virus.