Adverse Effects of Pertussis and Rubella Vaccines (1991) / Chapter Skim
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Appendix A: Strategies for Gathering Information: Adverse Effects of Pertussis and Rubella Vaccines
Appendix A: Strategies for Gathering Information: Adverse Effects of Pertussis and Rubella Vaccines
Pages 293-319
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pertussis vaccine or rubella vaccine and the subheading adverse effects produced 589 articles on pertussis vaccine and 363 articles on rubella vaccine. Comparable searches were then done in the other 17 data bases, using 293
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These included reference lists; presentations to the committee at its public meeting, ~ A more detailed document entitled "Searches of Electronic Data Bases: Adverse Events Following Pertussis and Rubella Vacination" is available from the National Technical Information Service, 5285 Port Royal Road, Springfield, Virginia 22161 (703-487-4650)
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" Dr. Wilkins followed up her presentation by sending the committee an extensive bibliography of citations on Pertussis vaccine and its possible adverse effects.
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Mortimer, Jr., Case Western Reserve University School of Medicine, Cleveland. The Epidemiologic Evidence Relating DTP to Acute Encephalopathy, Infantile Spasms and the Sudden Infant Death Syndrome.
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Zahalsky, Southern Illinois University, Edwardsville. Scientific Basis for Including Tests of Acute Phase Reaction Products in Clinical Protocols Designed to Investigate the Cause of Adverse Reactions Following Inoculationfs)
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Evidence Linking Pertussis Vaccines to Sudden Infant Death Syndrome (SIDS)
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Dirk Teuwin, SmithKline Biologicals, Rixensart, Belgium Aubrey Tingle, University of British Columbia, Vancouver Jeanette Wilkins, University of Southern California, Los Angeles. Bibliographic material on pertussis vaccine.
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Procedures for Abstraction and Adjudication of Study Data Case series and case reports were identified from a variety of sources: the published literature; parents or affected individuals; organizations such as Dissatisfied Parents Together and its National Vaccine Information Center; reports from the Centers for Disease Control's Monitoring System for Adverse Events Following Immunization (MSAEFI) ; and reports from the Study of Neurologic Illness in Children (SONIC)
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(The Controlled Study Review Form appears later in this appendix.)
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DT 3. Rubella APPENDIX A CASE REPORT REVIEW FORM Date: 1.
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Duration of follow-up after adverse event: (days/mos/yrs)
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Fever 2. Protracted inconsolable crying or screaming 3.
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Protracted inconsolable crying or screaming 3. Alterations in level of consciousness a.
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306 1 l.Anaphylaxis 1 2.Thrombocytopenia 1 3.Arthralgia 14.Joint swelling, redness, or tenderness 1 5.0ther Specify: APPENDIX A
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APPENDIX A 307 Ce Laboratory measures: Indicate by a check mark whether tests were done coincident or after the onset of symptoms of the adverse event and whether the results were normal or abnormal. Coincident/After 1.
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308 APPENDIX A IV. Permanent Sequelae For each condition in the report considered to be a chronic, late outcome of immunization, indicate whether the condition was coincident with or had its onset after the acute adverse event, the interval from immunization to onset of the chronic outcome, and the duration of the condition.
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Chronic arthritis 8. Chronic arthralgia ication use 9.
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Infantile spasms 7. Shock and unusual shock-like state with hypotonicity, hyporesponsiveness 8.
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Thrombocytopenia or thrombocytopenic purpura 19. Other Specify: 20.
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APPENDIX A READER: CITATION: ~DATE: Section A General Information P/C/PG/L l.What specific questioners) was this study designed to address?
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Hypsarrhythmia Infantile spasms Juvenile diabetes (IDDM) Learning disabilities Mental retardation Motor handicap Reye syndrome SIDS Other Specify: 11.
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APPENDIX A 315 14. How were the study subjects selected (i.e., consecutive sample, all survivors, geographic catchment area, etc.~?
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316 23. Was there adjustment for covariates?
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APPENDIX A P/C/PG/L 317 Section H Conclusions 31. What were the investigators' conclusions?
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STUDY TYPE: Codes: Randomized clinical trial Controlled prospective study Case-control study Case report/case series Other noncontrolled observation Non-random experiment/humans Animal study Other controlled study Other laboratory observation Other Specify: 2 3 4 6 8 9 10 APPENDIX A FIRST PAGE OTHERS STUDIED:
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: Codes: Arthritis Aseptic meningitis Autism "Brain damage" Encephalitis Encephalopathy Epilepsy Febrile seizures Hemolytic anemia Hyperactivity (hyperkinesis) 10 Hypotonic/hyporesponsive 1 1 1 Hypsarrhythmia 2 Infantile spasms 3 Juvenile diabetes (IDDM)
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