by IOM to conduct this study, recognized that its charge was to focus on questions of causation and not broader topics, such as cost-benefit or risk-benefit analyses of vaccination. These topics are therefore not addressed in the report.

After formation of the committee, additional adverse events were added both by the committee and at the request of the Advisory Commission on Childhood Vaccines. During the 20 months of the study, the committee reviewed altogether 17 adverse events for pertussis vaccine—infantile spasms; hypsarrhythmia; aseptic meningitis; encephalopathy (including acute encephalopathy and chronic neurologic damage); deaths classified as sudden infant death syndrome (SIDS); anaphylaxis; autism; erythema multiforme or other rashes; Guillain-Barré syndrome (polyneuropathy); peripheral mononeuropathy; hemolytic anemia; juvenile diabetes; learning disabilities and hyperactivity; protracted inconsolable crying or screaming; Reye syndrome; shock and ''unusual shock-like state'' with hypotonicity, hyporesponsiveness, and short-lived convulsions (usually febrile); and thrombocytopenia—and 3 adverse events for rubella vaccine—arthritis (acute and chronic); radiculoneuritis and other neuropathies; and thrombocytopenic purpura. Although the committee was not asked expressly to examine febrile seizures, afebrile seizures, or epilepsy in relation to diphtheria-pertussis-tetanus (DPT) vaccine, it did so because these conditions may also be serious and are considered by some to be components of encephalopathy. Conclusions regarding these conditions are given in Chapter 4. The committee's conclusions on acute encephalopathy, also presented in Chapter 4, refer only to conditions diagnosed as encephalopathy, encephalitis, or encephalomyelitis. (For additional information on the committee's charge and the events leading to the enactment of Public Law 99-660, see the Preface and Appendix B, Pertussis and Rubella Vaccines: A Brief Chronology.)

The following three sections of this summary briefly review the methods used by the committee to evaluate the evidence relating the 20 adverse events to pertussis or rubella vaccine, the evidence considered and the conclusions reached for each adverse event, and the research directions recommended by the committee.

METHODOLOGIC CONSIDERATIONS IN EVALUATING THE EVIDENCE

The committee undertook the task of judging whether each of a set of adverse events can occur as a result of exposure to pertussis or rubella vaccine. These judgments have both quantitative and qualitative aspects; they reflect the nature of the exposures, events, and populations at issue; the specific questions to be considered; the characteristics of the evidence examined; and the approach taken to evaluate that evidence. To facilitate the



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