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Adverse Effects of Pertussis and Rubella Vaccines (1991) / Chapter Skim
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1 Executive Summary
Pages 1-8

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From page 1...
... to conduct a thorough review of the evidence pertaining to a set of serious adverse events and immunization with pertussis or rubella vaccine. The request to IOM originated in the 1986 National Childhood Vaccine Injury Act (Public Law 99-660)
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From page 2...
... ; 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)
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From page 3...
... These and other features raise a number of difficulties both in the investigation and in the evaluation of the resulting evidence. The committee considered causal questions of three kinds in connection with adverse events that have been reported to occur after administration of pertussis or rubella vaccine.
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From page 4...
... . As shown in Table 1-2, the committee found: · no evidence bearing on a causal relation between DPT vaccine and autism; · insufficient evidence to indicate a causal relation between DPT vaccine and aseptic meningitis, chronic necrologic damage, erythema multiforme or other rash, Guillain-Barre syndrome, hemolytic anemia, juvenile diabetes, learning disabilities and attention deficit disorder, peripheral mononeurop
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From page 5...
... is c` o ~ 'e Hi cd v o · Hi o c)
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From page 7...
... . Aseptlc menlngltls Chronic necrologic damage Erythema multiforme or other rash Guillain-Barre syndrome Hemolytic anemia Juvenile diabetes Learning disabilities and attention-deficit disorder Peripheral mononeuropathy Thrombocytopenia Infantile spasms Hypsarrythmia Reye syndrome Sudden infant death syndrome Acute encephalopathyg Shock and "unusual shocklike state" Radiculoneuritis and other neuropathies Thrombocytopenic purpura Chronic arthritis 5.
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From page 8...
... ~ RESEARCH NEEDS In the course of its review, the committee encountered many gaps and limitations in knowledge bearing directly and indirectly on the safety of vaccines. These include inadequate understanding of the biologic mechanisms underlying adverse events following natural infection or immunization, insufficient or inconsistent information from case reports and case series, inadequate size or length of follow-up of many population-based epidemiologic studies, and limited capacity of existing surveillance systems of vaccine injury to provide persuasive evidence of causation.
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Key Terms

  • rubella vaccine
  • adverse events
  • dpt vaccine
  • supporting causation
  • adverse event

  • evidence checked
  • hemolytic anemia
  • inconsolable crying
  • pertussis component
  • reye syndrome

  • learning disabilities
  • aseptic meningitis
  • biologic plausibility
  • erythema multiforme
  • available evidence

  • acute encephalopathy
  • juvenile diabetes
  • sudden infant
  • infant death
  • peripheral mononeuropathy

  • thrombocytopenic purpura
  • chronic arthritis
  • death syndrome
  • evidence indicates
  • acute arthritis

  • evidence pertaining
  • infantile spasms
  • vaccine injury
  • vaccine cause
  • rubella vaccines


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