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Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality
tis B vaccine was administered. Of the 10 cases, 5 had been vaccinated with hepatitis B vaccine and 5 had not. Three of the vaccinees had experienced GBS prior to receiving hepatitis B vaccine, and two of the vaccinees had developed GBS long after vaccination (3 and 9 months, respectively). No relation between hepatitis B vaccination and GBS was demonstrated in that study.
Five case reports could be culled from the literature (Lin et al., 1989; Morris and Butler, 1992; Ribera and Dutka, 1983; Tuohy, 1989). Of these, a single case report related to the plasma-derived vaccine licensed for use in the United States (Ribera and Dutka, 1983), and the others were from Taiwan (plasma-derived), New Zealand (two cases, both plasma-derived), and Australia (recombinant). The cases of GBS in Taiwan, New Zealand, and Australia were in children ages 3-7 years, whereas the case of GBS in the United States was in an adult. These age differences probably reflect the predominant ages of the vaccinees in the respective countries. The case from the United States did not qualify clinically as GBS, because no weakness was demonstrated and the only symptoms were fatigue and paresthesias.
In the Monitoring System for Adverse Events Following Vaccination, three cases of GBS were reported as adverse events following hepatitis B vaccination from the time of the introduction of the vaccine until 1990. The Vaccine Adverse Event Reporting System (VAERS) contains 14 adverse reaction reports (submitted between November 1990 and July 1992) in which GBS is mentioned. Two of the reports are for the same patient; consequently, only 13 patients were reported. Of the 13 patients, 4 patients were described as having clinical syndromes that are incompatible with the diagnosis of GBS, and in 2 of these patients the latencies were 2 and 3 months, respectively. These four cases were considered to be other than GBS. An additional four reports contained virtually no information other than a listing of the diagnosis. For these cases, no conclusion regarding the diagnosis can be reached. Five cases appeared to be plausibly diagnosed as GBS, and the patients developed symptoms within 1 month of hepatitis B vaccination. All cases of GBS were in adults and all followed receipt of the recombinant vaccine.
Controlled Observational Studies
Controlled Clinical Trials
None of the clinical trials reviewed by the committee contained information regarding hepatitis B vaccine and GBS.