Adverse Effects of Pertussis and Rubella Vaccines -- Copyright -- Preface -- Acknowledgments -- Contents -- Adverse Effects of PERTUSSIS and RUBELLA Vaccines -- 1 Executive Summary -- METHODOLOGIC CONSIDERATIONS IN EVALUATING THE EVIDENCE -- SUMMARY AND CONCLUSIONS -- RESEARCH NEEDS -- 2 Histories of Pertussis and Rubella Vaccines -- PERTUSSIS VACCINES -- Epidemiology of Whooping Cough -- Clinical Description -- Diagnosis -- Complications -- Descriptive Epidemiology -- Nature of the Causative Organism, B. pertussis -- Major Milestones in the Development of Pertussis Vaccines -- Whole-Cell Vaccines -- Acellular Vaccines -- Brief History of the Controversy Pertaining to Adverse Events Following Pertussis Vaccination -- RUBELLA VACCINES -- Epidemiology of the Disease Rubella -- Clinical Description -- Diagnosis -- Complications -- Descriptive Epidemiology -- Nature of the Rubella Virus -- Major Milestones in the Development of Rubella Vaccines -- Brief History of the Controversy Pertaining to Adverse Events Following Rubella Vaccination -- REFERENCES -- 3 Methodologic Considerations in Evaluating the Evidence -- THE NATURE OF THE EVIDENCE -- QUESTIONS TO BE ADDRESSED -- (1) Can vaccine cause the adverse event? -- (2) How frequently does vaccine cause the event? -- (3) Did vaccination cause a particular case of the adverse event? -- THE BURDEN OF PROOF -- CATEGORIES OF EVIDENCE -- Experiments in Humans -- Randomized Controlled Trials -- Other Experimental Studies -- Experiments in Animals: Animal Models -- Controlled Epidemiologic Studies (Observational) -- Cohort Studies -- Case-Comparison Studies -- Other Controlled Studies -- Case Reports and Case Series -- Searching for Patterns -- Historical Comparisons -- Causation of the Individual Case -- Monitoring System for Adverse Events Following Immunization -- ASSESSMENT OF THE EVIDENCE.

Evaluation of Single Studies -- Integration of the Collective Results -- Meta-Analysis -- Considerations in Inferring Causality -- THE NATURE OF THE CONCLUSIONS -- Quantitation -- Resolution -- Uncertainty and Confidence -- Quality -- Comprehensiveness -- Neutrality -- Judgment -- SUMMARY OF THE EVIDENCE -- REFERENCES -- 4 Evidence Concerning Pertussis Vaccines and Central Nervous System Disorders, Including Infantile... -- INFANTILE SPASMS -- Clinical Description -- Descriptive Epidemiology -- History of Suspected Association with Pertussis Vaccines -- Evidence from Studies in Humans -- Case Reports and Case Series -- Controlled Epidemiologic Studies -- Summary -- Conclusion -- HYPSARRHYTHMIA -- Clinical Description -- Descriptive Epidemiology -- History of Suspected Association with Pertussis Vaccines -- Evidence from Studies in Humans -- Case Reports and Case Series -- Controlled Epidemiologic Studies -- Summary -- Conclusion -- ASEPTIC MENINGITIS -- Clinical Description -- Descriptive Epidemiology -- History of Suspected Association with Pertussis Vaccines -- Evidence from Studies in Humans -- Case Reports and Case Series -- Controlled Epidemiologic Studies -- Summary -- Conclusion -- ENCEPHALOPATHY -- Clinical Description -- Encephalopathy Following Whooping Cough -- Pathology -- Descriptive Epidemiology -- History of Suspected Association with Pertussis Vaccines -- Evidence from Studies in Humans -- Case Reports and Case Series -- Studies in Defined Populations -- The National Childhood Encephalopathy Study -- Other Controlled Studies in Humans -- Evidence from Studies in Animals -- Aluminum Salts -- Summary -- Conclusion -- REFERENCES -- 5 Evidence Concerning Pertussis Vaccines and Deaths Classified as Sudden Infant Death Syndrome -- CLINICAL DESCRIPTION, DIAGNOSIS, AND PATHOLOGY -- DESCRIPTIVE EPIDEMIOLOGY.

HISTORY OF SUSPECTED ASSOCIATION WITH PERTUSSIS VACCINES -- EVIDENCE FROM STUDIES IN HUMANS -- Case Reports and Case Series -- Controlled Epidemiologic Studies -- SUMMARY -- CONCLUSION -- REFERENCES -- 6 Evidence Concerning Pertussis Vaccines and Other Illnesses and Conditions -- ANAPHYLAXIS -- Clinical Description and Pathologic Aspects -- History of Suspected Association with Pertussis Vaccines -- Evidence from Studies in Humans -- Case Reports and Controlled Epidemiologic Studies -- Evidence from Studies in Animals -- Endotoxin -- Summary -- Conclusion -- AUTISM -- Clinical Description -- Descriptive Epidemiology -- Evidence from Studies in Humans -- Summary -- Conclusion -- ERYTHEMA MULTIFORME OR OTHER RASH -- Clinical Description -- Descriptive Epidemiology -- Evidence from Studies in Humans -- Case Reports -- Aluminum Salts -- Summary -- Conclusion -- GUILLAIN-BARRÉ SYNDROME (POLYNEUROPATHY) -- Clinical Description -- Descriptive Epidemiology -- Evidence from Studies in Humans -- Case Reports -- Summary -- Conclusion -- PERIPHERAL MONONEUROPATHY -- Clinical Description -- Descriptive Epidemiology -- Evidence from Studies in Humans -- Case Reports -- Summary -- Conclusion -- HEMOLYTIC ANEMIA -- Clinical Description -- Descriptive Epidemiology -- Evidence from Studies in Humans -- Case Reports -- Summary -- Conclusion -- JUVENILE DIABETES -- Clinical Description -- Descriptive Epidemiology -- Evidence from Studies in Humans -- Controlled Epidemiologic Study -- Case Report -- Evidence from Studies in Animals -- Summary -- Conclusion -- LEARNING DISABILITIES AND HYPERACTIVITY -- Clinical Description -- Learning Disability, Reading Disability, and Dyslexia -- Hyperactivity, Hyperkinesis, and Attention Deficit Disorder -- Descriptive Epidemiology -- Evidence from Studies in Humans -- Case Reports -- Controlled Epidemiologic Studies -- Summary.

Conclusion -- PROTRACTED INCONSOLABLE CRYING AND SCREAMING -- Clinical Description -- Descriptive Epidemiology -- Evidence from Studies in Humans -- Case Reports and Case Series -- Controlled Epidemiologic Studies -- Summary -- Conclusions -- REYE SYNDROME -- Clinical Description -- Descriptive Epidemiology -- Evidence from Studies in Humans -- Controlled Epidemiologic Study -- Case Reports and Case Series -- Summary -- Conclusion -- SHOCK AND ''UNUSUAL SHOCK-LIKE STATE" WITH HYPOTONICITY, HYPORESPONSIVENESS, AND SHORT-LIVED CONVULS ... -- Clinical Description -- Descriptive Epidemiology -- Evidence from Studies in Humans -- Case Reports and Case Series -- Controlled Epidemiologic Studies -- Summary -- Conclusion -- THROMBOCYTOPENIA -- Clinical Description -- Descriptive Epidemiology -- Evidence from Studies in Humans -- Case Reports and Case Series -- Summary -- Conclusion -- REFERENCES -- 7 Evidence Concerning Rubella Vaccines and Arthritis, Radiculoneuritis, and Thrombocytopenic Purpura -- ARTHRITIS -- Clinical Description and Pathologic Aspects -- Descriptive Epidemiology -- History of an Association with Rubella Vaccines -- Evidence from Studies in Humans -- Acute Arthropathy and Arthritis -- Chronic Arthritis -- Evidence from Studies in Animals -- Possible Mechanisms -- Summary -- Acute Arthropathy and Arthritis -- Chronic Arthritis -- Conclusions -- RADICULONEURITIS AND OTHER NEUROPATHIES -- Clinical Description -- Descriptive Epidemiology -- Evidence from Studies in Humans -- Case Reports and Case Series -- Summary -- Conclusion -- THROMBOCYTOPENIC PURPURA -- Clinical Description -- Descriptive Epidemiology -- Evidence from Studies in Humans -- Case Reports -- Summary -- Conclusion -- REFERENCES -- Afterword on Research Needs -- Bibliography -- Glossary of Terms B -- Appendixes.

A Strategies For Gathering Information: Adverse Effects of Pertussis and Rubella Vaccines -- LITERATURE SEARCHES -- Electronic Data Bases -- OTHER SOURCES -- Reference Lists -- Presentations -- Public Meeting (January 10, 1990) -- Workshop (May 14, 1990) -- Committee Meeting (May 15, 1990) -- Additional Individuals and Organizations Who Provided Information -- Review of Interim Bibliography -- ABSTRACTION OF DATA FROM CASE REPORTS, CASE SERIES, AND CONTROLLED STUDIES -- Rationale -- Procedures for Abstraction and Adjudication of Study Data -- B Pertussis and Rubella Vaccines: A Brief Chronology -- PERTUSSIS VACCINES -- RUBELLA VACCINES -- REFERENCES -- C Animal Models for the Study of Whooping Cough and the Testing of Vaccine Materials -- ANIMAL MODELS FOR THE STUDY OF WHOOPING COUGH -- STANDARDIZED ANIMAL TESTS OF VACCINE MATERIALS -- REFERENCES -- D Technical Details of Power Calculations and Meta-Analyses -- POWER CALCULATIONS -- META-ANALYSES -- Formal Analysis -- Informal Analysis -- REFERENCES -- E Possible Involvement of Aluminum Salts in Erythema Multiforme, Encephalopathy, or Other Adverse E ... -- REFERENCES -- F Committee and Staff Biographies -- COMMITTEE -- STAFF -- Index.