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Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality
Case Reports, Case Series, and Uncontrolled Observational Studies
Two cases of multiple sclerosis were reported by Herroelen et al. (1991) in Belgium in two women (ages 26 and 28 years) 6 weeks after receiving recombinant hepatitis B vaccine. One patient had a prior diagnosis of multiple sclerosis and would have been considered to have had a relapse of multiple sclerosis; the onset of the relapse was 6 weeks after receipt of the third dose. The other patient had no history of neurologic disease; the onset of disease occurred 6 weeks after receipt of the first dose of recombinant vaccine. The vaccines administered to both women were licensed in the United States. In both cases, the diagnosis of multiple sclerosis was convincing.
Two more cases of multiple sclerosis were reported to the Institute of Medicine (Waisbren, 1992). One occurred in a 37-year-old pediatric nurse 3 weeks following receipt of her third dose of plasma-derived vaccine. A second case was described in a 32-year-old nurse 2 weeks after receipt of her second dose of recombinant vaccine. Both cases were atypical of multiple sclerosis but were thought to be a form of demyelinating disease. The second patient appeared to have a clear-cut episode of optic neuritis in one eye.
Three cases of transverse myelitis were reported by Shaw et al. (1988) in their postmarketing surveillance study of plasma-derived vaccine. The three cases were in adults, and transverse myelitis occurred 2 to 7 weeks after receipt of doses one to three. (A fourth case reported by Shaw et al. (1988) was not considered because it occurred 16 weeks after vaccination.) Five more cases of transverse myelitis that occurred after administration of recombinant vaccine were reported in VAERS (submitted between November 1990 and July 1992).
Five cases of optic neuritis were reported by Shaw et al. (1988). They were in adults and occurred 1-6 weeks after receipt of doses one to three of plasma-derived vaccine. Fourteen more cases were reported in VAERS (submitted between November 1990 and July 1992). As is usual in VAERS reports, there was variable documentation of the cases.
Controlled Observational Studies
Controlled Clinical Trials
None of the clinical trials reviewed by the committee contained information regarding hepatitis B vaccine and transverse myelitis, optic neuritis, multiple sclerosis, or other central demyelinating diseases.