Page 355

Index

A

Adenylate cyclase, 334

Adults

anaphylactic reactions, 147

arthritis reactions, 21, 24, 187, 189, 194-195, 196, 197

pertussis incidence, 9

rubella incidence, 19, 21

rubella vaccination, 23, 24, 39

Adverse events, 1, 32-33, 46

causality, 3, 4-8, 33-36, 47-48, 59-62

data sources, 38-39, 48-52, 206, 293-294, 337

pertussis vaccination, v, vi, vii, 2, 4-8, 18-19, 32, 38, 46, 50n.3, 52, 323, 348

rubella vaccination, v, vi, vii, 2, 8, 23-24, 32, 38, 46, 52, 71, 328

Advisory Commission on Childhood

Vaccines (ACCV), vi, 325, 326, 329

Afebrile seizures, 2, 88, 90

DPT vaccination and, 72, 94, 106, 108, 111, 112, 113, 118, 118n.3, 338-339

meta-analysis of data, 52, 115

Agonal anoxia, 125

Airway obstruction, 145

Albumin, 116, 148

Allergic reactions, 40, 48, 144, 177

Aluminum salts, 70, 116, 153, 347-348

American Academy of Pediatrics (AAP), 17, 321, 324

American Medical Association (AMA), 17, 320

American Psychiatric Association (APA), 162

Anaphylaxis, 40, 47-48, 177, 283

animal studies, 148-149, 150

case reports, 146

controlled studies, 146-148

human studies, 146-148

pertussis vaccine and, 8, 71, 146, 149-150, 172, 175

Angioneurotic edema, 150, 172

Animal experiments, 4, 39-41, 59, 83, 118, 347

Continued on next page



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Page 355 Index A Adenylate cyclase, 334 Adults anaphylactic reactions, 147 arthritis reactions, 21, 24, 187, 189, 194-195, 196, 197 pertussis incidence, 9 rubella incidence, 19, 21 rubella vaccination, 23, 24, 39 Adverse events, 1, 32-33, 46 causality, 3, 4-8, 33-36, 47-48, 59-62 data sources, 38-39, 48-52, 206, 293-294, 337 pertussis vaccination, v, vi, vii, 2, 4-8, 18-19, 32, 38, 46, 50n.3, 52, 323, 348 rubella vaccination, v, vi, vii, 2, 8, 23-24, 32, 38, 46, 52, 71, 328 Advisory Commission on Childhood Vaccines (ACCV), vi, 325, 326, 329 Afebrile seizures, 2, 88, 90 DPT vaccination and, 72, 94, 106, 108, 111, 112, 113, 118, 118n.3, 338-339 meta-analysis of data, 52, 115 Agonal anoxia, 125 Airway obstruction, 145 Albumin, 116, 148 Allergic reactions, 40, 48, 144, 177 Aluminum salts, 70, 116, 153, 347-348 American Academy of Pediatrics (AAP), 17, 321, 324 American Medical Association (AMA), 17, 320 American Psychiatric Association (APA), 162 Anaphylaxis, 40, 47-48, 177, 283 animal studies, 148-149, 150 case reports, 146 controlled studies, 146-148 human studies, 146-148 pertussis vaccine and, 8, 71, 146, 149-150, 172, 175 Angioneurotic edema, 150, 172 Animal experiments, 4, 39-41, 59, 83, 118, 347 Continued on next page

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Page 356 Continued from previous page anaphylaxis, 148-149, 150 encephalopathy, 115-116, 117 juvenile diabetes,
160-161 pertussis, 14, 40, 115-116, 333-335 rubella, 40, 41, 194 thrombocytopenia, 178 Anoxemia, 89 Antibodies, 40 blood platelet, 199 DPT vaccine, 157, 158, 159 immunoglobulin, 144, 145, 146, 147, 150, 192 rubella, 192 Antigens, 40, 200 anaphylaxis, 144, 145 blood platelet, 199 in DPT vaccine, 54, 146, 148, 150, 157, 159 rubella, 195 tetanus, 156, 157 Apnea, 126, 140 Arachidonic acid metabolism, 144 Arthralgia, 187, 283 rubella vaccination and, 8, 21, 24, 55, 188, 191, 192, 195, 196, 328 Arthritis, vii, 187, 206, 283 case reports, 189, 191-193, 196 controlled studies, 39, 189-190, 194, 196 diagnosis, 195 epidemiology, 188 human studies, 189-194, 329 rubella vaccination and, 8, 21, 24, 55, 187, 188, 194-197, 328, 329 Arthropathy, 187, 283 rubella vaccination and, 189, 190, 191, 192, 195, 196 Arthus reaction, 145-146, 148, 150 Aseptic meningitis, 82, 283 case reports, 84 controlled studies, 84-85 diagnosis, 84 epidemiology, 83 human studies, 84-85 pertussis vaccination and, 4, 70, 83, 85-86 Aspirin, 169, 170, 171 Association of Parents of Vaccine Damaged Children, 19, 322 Attention deficit disorder (ADD), 4, 161, 162, 163, 164, 283-284 Attributable fraction, 284 Attributable risk, 35, 42, 284 encephalopathy, 104, 114-115, 117, 323 See also Relative risk Autism, 4, 284 diagnosis, 152 epidemiology, 151 human studies, 151-152 Autopsy, 129, 145, 146, 149 B Bacteremia, 145 Bacterial endotoxin, 40, 149 Bacterial meningitis, 70, 82 Bias, 3, 35, 50, 56, 138, 206, 284 ''information bias," 45 in NCES data, 44-45 "recall bias," 72, 103 Biologic plausibility, 3, 4, 54, 59 anaphylaxis, 47-48, 150 arthritis, 195, 196 erythema multiforme, 47-48, 154 hemolytic anemia, 48 radiculoneuritis, 199 sudden infant death syndrome, 140 thrombocytopenic purpura, 201 Birth trauma, 66 Birth weight, 126, 127, 136 Blacks arthritis incidence, 188 diabetes incidence, 159-160 sudden infant death syndrome and, 126, 127 Bordet, Jules, 320 Bordetella avium, 14 Bordetella bronchiseptica, 14, 334 Bordetella parapertussis, 14 Bordetella pertussis, 9, 10, 11, 12, 14-17, 320 animal studies, 14, 40, 115-116, 333-335 Continued on next page

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Page 357 Continued from previous page in vaccines, 17, 91 Bordet-Gengou technique,
11, 17, 320 Brachial neuritis, 156, 157 Brain damage, 162 neurologic illness and, 87 pertussis vaccination and, 91, 101, 149, 321, 323, 325-326 Bronchospasm, 145 Burnet, Macfarlane, 23, 327 C Campylobacter jejuni, 154 Cardiovascular collapse, 145 Carpal tunnel syndrome, 197, 198 Case-comparison (case-control) studies, 43-45, 59, 284-285 Case Report Review Form, 47, 302-311 Case reports and case series, 3, 4, 8, 46-48, 59, 300 anaphylaxis, 146 arthritis, 189, 191-193, 196 aseptic meningitis, 84 encephalopathy, 47, 91-95, 117 erythema multiforme, 152-153 Guillain-Barré syndrome, 155 hemolytic anemia, 158-159 hypsarrhythmia, 80 infantile spasms, 67-69, 76 juvenile diabetes, 160 learning disabilities, 163 peripheral mononeuropathy, 156-157 protracted crying and screaming, 165-166 radiculoneuritis, 55, 198-199 Reye syndrome, 170-171 shock, 172-173, 177 sudden infant death syndrome, 128-130, 138 thrombocytopenia, 178 thrombocytopenic purpura, 55, 200 "Catcher's crouch syndrome," 23-24, 191, 197, 198 Causality, 4-8 adverse events, inference of, 3, 33-36, 37-38, 48, 51, 52-55, 56, 59-62 anaphylaxis, 150 arthritis, 197 aseptic meningitis, 85, 86 autism, 152 encephalopathy, 118 erythema multiforme, 154 Guillain-Barré syndrome, 156 hemolytic anemia, 159 hypsarrhythmia, 82 infantile spasms, 77 juvenile diabetes, 161 learning disabilities, 164 neurologic damage, 168-169 peripheral mononeuropathy, 157 radiculoneuritis, 199 Reye syndrome, 171 seizures, 118n.3 shock, 177 sudden infant death syndrome, 130, 141 thrombocytopenia, 179 thrombocytopenic purpura, 201 Cellular hypersensitivity, 67 Centers for Disease Control (CDC), 12, 24, 48, 49, 169, 170, 322, 329 Central nervous system (CNS) complications of pertussis, 11-12 infections, 66, 70, 82, 84-85, 107 inflammation, 89 Cerebral anomalies, 66 Cerebral disorder. See Encephalopathy Cerebral edema, 169 Cerebral glucose utilization, 163 Cerebral injury, 98 Cerebral spinal fluid (CSF), 82, 86, 88, 98, 100, 154-155 Child Health and Education Study (CHES), 323-324 Children arthritis incidence, 188, 190, 191, 195 aseptic meningitis, 83 autism, 151 encephalopathy and seizures, 88, 106, 116 Guillain-Barré syndrome, 155 hypsarrhythmia, 67 Continued on next page

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Page 358 Continued from previous page juvenile diabetes,
159 neurologic illness, 44, 87 neuropathies, 198 pertussis incidence, 9, 13, 14, 19 pertussis vaccination, 17, 33, 39, 89-90, 127, 321, 322, 324 rubella incidence, 19, 21, 327 rubella vaccination, 22-23, 24, 326-327 sudden infant death syndrome, 125, 127 See also Human studies Children's Hospital (Boston), 92 Children's Hospital Medical Center (Cincinnati), 170 Children's Memorial Hospital (Chicago), 81 Chomel, A. F., 154 Chromosomal disorders, 66 Circulating immune complexes (CIC), 194-195 Clinical trials, 34 acellular pertussis vaccines, 18 rubella vaccine, 24 Cohort studies, 42-43, 130, 285 Coma, 88, 100, 169 "Compensation for Vaccine-Related Injuries" (OTA), 200 Computed tomography, 66 Confidence intervals, 58, 136, 139, 341-342 Confounding factors, 3, 33, 35, 50, 101, 103-104, 206 Controlled epidemiologic studies, 3, 4, 38-39, 41-46, 59, 285, 300 anaphylaxis, 146-148 arthritis, 39, 189-190, 194, 196 aseptic meningitis, 84-85 encephalopathy, 41, 42, 43, 52, 107-115, 117, 118 hypsarrhythmia, 80-82 infantile spasms, 69-76, 78-79 juvenile diabetes, 160 learning disabilities, 163-164 protracted crying and screaming, 166-168 Reye syndrome, 170 shock, 173-177 sudden infant death syndrome, 130-140 Controlled Study Review Form, 312-319 Convulsions, 71, 87, 88, 98, 101, 106. See also Afebrile seizures; Febrile seizures; Seizures Convulsive disorder, 107 Cortical atrophy, 66 Cost-benefit analysis, 1-2, 38 Coulter, Harris L., vii, 324 Cross-sectional surveys, 45 Cyanosis, 172, 176 Cytomegalovirus, 154 D Data sources, 293-294 de Baillou, Guillaume, 9-10 Denmark, 66, 69-70, 76-77 Developmental abnormalities, 104, 105 Diagnosis arthritis, 195 aseptic meningitis, 84 autism, 152 encephalopathy, 113, 117 Guillain-Barrè syndrome, 154-155, 156 infantile spasms, 66, 74 learning disabilities, 164 pertussis, 11 rubella, 20 Diagnostic and Statistical Manual of Mental Disorders (APA), 162 Dialysis, 347 Diphtheria antibodies, 158 Diphtheria-pertussis-tetanus (DPT) vaccine, 2, 4, 8, 39, 42, 338-339 aluminum salts in, 116, 153, 347, 348 development of, 17, 321 endotoxin in, 149, 150 immunization schedules, 54-55 and sudden infant death syndrome, 33, 51, 127, 128-129 and ventilatory patterns, 140 See also Pertussis vaccine Diphtheria vaccine, 54, 150

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Page 359 Disease surveillance systems,
49 Dissatisfied Parents Together, 19, 93, 300, 323, 324 Dose-response relation, 52, 53 DPT: A Shot in the Dark (Coulter and Fisher), vii, 324 Drop seizures, 69 Dyslexia, 161 E Early and Periodic Screening, Diagnosis, and Treatment, 327 Electroencephalogram (EEG) pattern, 100, 162 hypsarrhythmia, 65, 73, 77, 80-82 infantile spasms, 77, 82 Encephalitis, 2, 21, 84, 86, 90, 100, 101, 112, 118. See also Encephalopathy Encephalomyelitis, 2, 86, 100, 118. See also Encephalopathy Encephalopathy, 2, 12n.3, 86-88, 149, 285, 347 animal studies, 115-116, 117 case reports, 47, 91-95, 117 controlled studies, 41, 42, 43, 52, 107-115, 117, 118 diagnosis, 113, 117 epidemiology, 90 following pertussis, 11-12, 88-89 human studies, 91-115, 117 National Childhood Encephalopathy Study (NCES), 52, 99-107 pathology, 89-90, 206 pertussis vaccination and, vii, 8, 47, 87, 88, 89-90, 91, 117-118, 344-345, 348 in Reye syndrome, 169 Endotoxemia, 145 Endotoxin, 40, 145, 153, 335 in DPT vaccine, 148, 149, 150, 166 Enteroviruses, 83 Enzyme-linked immunosorbent assay (ELISA), 192 Epidemiologic studies, 8, 33, 34, 35, 206, 337 resolution, 56-58 See also Controlled epidemiologic studies Epidemiology arthritis, 188 aseptic meningitis, 83 autism, 151 encephalopathy, 90 erythema multiforme, 152 Guillain-Barrè syndrome, 155 hemolytic anemia, 158 hypsarrhythmia, 77 infantile spasms, 65-66 juvenile diabetes, 159-160 learning disabilities, 162-163 peripheral mononeuropathy, 156 pertussis, 9-14, 40 radiculoneuritis, 197-199 Reye syndrome, 170 rubella, 19-22 sudden infant death syndrome, 125, 126-127 thrombocytopenia, 178 thrombocytopenic purpura, 199 Epilepsy, 65, 88, 90, 95 pertussis vaccination and, 2, 70, 93-94, 98, 106, 107, 108, 118, 118n.3, 173 Epstein-Barr virus, 154 Error types, 57 Erythema multiforme, 46, 285 case reports, 152-153 epidemiology, 152 human studies, 152-153 pertussis vaccination and, 4, 47-48, 153-154 Experimental studies, 3, 8, 39, 206-207, 285 F Family income, 126 Faroe Islands, 18, 320-321 Febrile convulsions, 72 Febrile seizures, 2, 87-88, 90 meta-analysis of data, 52, 115 pertussis vaccination and, 70, 94, 98- Continued on next page

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Page 360 Continued from previous page 99,
106, 107-110, 112, 113, 117-118, 118n.3 Females arthritis incidence, 21, 24, 188, 189-190, 191, 192-193, 194-195, 196, 197 autism rates, 151 pertussis incidence in, 13, 88 rubella epidemic and, 327 rubella vaccination, 23, 329 Fever, 172 Finland, 66 Fisher, Barbara Loe, vii, 324 Food and Drug Administration (FDA), 322-323 Fountain Hospital (London), 92 France, 23 G Gengou, Octave, 320 German measles. See Rubella Gregg, Norman McAlister, 327 Group Health Cooperative hospitals, 72, 108, 137 Guillain-Barrè syndrome (polyneuropathy), 46, 285 case reports, 155 diagnosis, 154-155, 156 epidemiology, 155 human studies, 155 MMR vaccination and, 198 pertussis vaccination and, 4, 155-156 H Haemophilus influenzae meningitis, 72 Haemophilus influenzae vaccine, 153 Hamsters, 335 Handicapped children, 75 Hatch, Orrin G., 324 Hawkins, Paula, 323, 324 Hemagglutination inhibition (HAI), 192 Hemagglutinin, 334 Hemiparesis, 98 Hemolytic anemia, 38, 46, 157, 178, 285-286 case reports, 158-159 epidemiology, 158 human studies, 158-159 pertussis vaccination and, 4, 48, 159 Hepatitis vaccine, 155 Hess, A. F., 326 Hill, A. B., 52 Hiro, Y., 22-23, 326-327 Histamine, 16, 144, 147-148, 153 Hives, 150 Human immunodeficiency virus, 154 Human studies, 4, 38-39, 59, 206-207, 300 anaphylaxis, 146-148 arthritis, 189-194, 329 aseptic meningitis, 84-85 autism, 151-152 encephalopathy, 91-115, 117 erythema multiforme, 152-153 Guillain-Barrè syndrome, 155 hemolytic anemia, 158-159 hypsarrhythmia, 80-82 infantile spasms, 67-76 juvenile diabetes, 160 learning disabilities, 163-164 peripheral mononeuropathy, 156-157 protracted crying and screaming, 165-168 radiculoneuritis, 198 Reye syndrome, 170-171 shock, 172-176 sudden infant death syndrome, 128-140 thrombocytopenia, 178 thrombocytopenic purpura, 200 Hyperactivity, 161, 162, 163, 173, 286 Hyperimmunization, 148 Hyperinsulinemia, 16 Hyperkinesis, 162 Hypoglycemia, 16, 93, 160 Hypotonia, 91 Hypotonic diplegia, 67 Hypotonic, hyporesponsive episodes (HHE), 52, 93, 147, 160, 161, 171-177. See also Shock Hypotonicity, 286 Hypovolemia, 116

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Page 361 Hypsarrhythmia (mountainous arrhythmia), 65, 69,
73, 286 case reports, 80 controlled studies, 80-82 epidemiology, 77 human studies, 80-82 pertussis vaccination and, 8, 67, 77, 82, 98 I Immune system, 40, 41, 67, 145, 157, 178, 195 Immunization, 286. See also Vaccination Immunization Practices Advisory Committee, 127, 128 Immunoglobulin (Ig) antibodies, 144, 145, 146, 147, 150, 192 India, rubella epidemic in, 20 Infantile spasms, 286 case reports, 67-69, 76 controlled studies, 69-76, 78-79 diagnosis, 66, 74 epidemiology, 65-66 human studies, 67-76 pertussis vaccination and, 8, 57, 67, 76-77, 100, 101, 103, 112 Influenza vaccination, 154 "Information bias," 45 Institute of Medicine (IOM), v, vii, 1-2, 325, 326, 328, 329 Insulin-dependent diabetes mellitus (IDDM), 159 Interleukin-1, 145 International Classification of Disease (ICD) codes anaphylaxis, 147 arthritis, 193 aseptic meningitis, 84 autism, 151 encephalopathy, 94 epilepsy, 95 erythema multiforme, 153 Guillain-Barrè syndrome, 155 hemolytic anemia, 158-159 hypotonic, hyporesponsive episodes, 173 infantile spasms, 69 juvenile diabetes, 160 learning disabilities, 163 . peripheral mononeuropathy, 157 radiculitis, 198 Reye syndrome, 171 screaming, 166 seizures, 94 sudden infant death syndrome, 129 thrombocytopenia, 178 thrombocytopenic purpura, 200 International Symposium on Pertussis, 105, 326 Intracerebral mouse protection test, 334-335 Intracranial hemorrhage, 66 Intranasal mouse protection test, 116, 335 IQ scores, 97, 162, 175 Islet-activating protein (pertussis toxin), 160 Italy, 23 J Japan, 17-18, 322 Japanese encephalitis vaccine, 68 Jarisch-Herxheimer reaction, 145, 150 "Joint manifestations," 187 Juvenile diabetes, 4, 286 animal studies, 160-161 case reports, 160 controlled studies, 160 epidemiology, 159-160 human studies, 160 pertussis vaccination and, 4, 161 K Kanner, L., 151 Kendrick, Pearl, 17, 321 L Laryngeal edema, 145, 146 "Late dysfunction," 105 Lawsuits, 324, 325

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Page 362 Learning disabilities,
4, 161-162, 173, 286 case reports, 163 controlled studies, 163-164 diagnosis, 164 epidemiology, 162-163 human studies, 163-164 pertussis vaccination and, 4, 164 Leukocytes, 82, 196 Leukocytosis, 167, 176 Longitudinal studies, 106 Lyme disease, 154 Lymphocytes, 40, 88, 195 Lymphocytosis, 16 Lymphocytosis-promoting factor (LPF), 18, 94 M Madsen, Thorvald, 17, 18, 46, 320-321 Males arthritis incidence, 192-193 autism rates, 151 meningitis rates, 83 sudden infant death syndrome, 126 Masked studies, 286-287 Maternal characteristics, SIDS risk, 126, 127, 136 Measles, 323 Measles immunization, 103 Measles-mumps-rubella (MMR) vaccine, 55, 93, 153, 155, 163, 171, 178, 200, 289 and arthritis, 193, 196 and radiculoneuritis, 198-199 See also Rubella vaccine Medicaid, 42, 110-111, 137, 327 Megakaryocytes, 200 Meningitis, 84. See also Aseptic meningitis Menstrual cycle, 194 Mental retardation, 87, 165-166, 168, 177, 206 Merck Sharp & Dohme Company, 23, 200 Meruvax II, 200 Meta-analysis, 3, 51-52, 56, 58, 115, 138-140, 141, 176, 340-345 Metabolic disorders, 66 Methodology, 2-3, 32-33 meta-analysis, 340-345 power calculations, 37, 56-58, 337-340 Mice, 16, 115-116, 148, 153, 333-335 Microcephaly, 66 Monitoring System for Adverse Events Following Immunization (MSAEFI), 48-49, 287, 300 anaphylaxis, 147, 150 arthritis, 193 aseptic meningitis, 84 autism, 151 encephalopathy and seizures, 93, 94 erythema multiforme, 153-154 Guillain-Barrè syndrome, 155-156 hemolytic anemia, 158-159 hyperactivity and learning disability, 163, 164 infantile spasms, 69 juvenile diabetes, 160 peripheral mononeuropathy, 157 protracted crying and screaming, 166 radiculitis, 198 Reye syndrome, 171 shock, 173 sudden infant death syndrome, 129 thrombocytopenia, 178-179 thrombocytopenic purpura, 200-201 Monitoring System for Illness Following Immunization (MSIFI), 322 Mortality, 1 anaphylaxis, 145 encephalopathy, 88 pertussis, 13, 14 pertussis vaccination, 18-19, 71, 89-90, 91, 93, 116, 148, 320-321, 322 pneumonia, 92 rubella, 21 shock, 172 sudden infant death syndrome, 125, 126-127, 128, 140, 141 Motor retardation, 87, 165-166, 168, 177 Mouse weight gain test, 116, 166-167, 335

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Page 363 Mumps virus, 83 Mycoplasma, 154 Myoclonic seizures, 67 N National Childhood Development Study,
164 National Childhood Encephalopathy Study (NCES), 322, 323 encephalopathy and seizures, 12, 52, 86, 99-107, 117-118, 344 infantile spasms, 73-74, 76-77, 100, 101, 103 methodology, 44-45, 100-101, 112-113 Reye syndrome, 170, 171 National Childhood Vaccine Injury Act (1986), v-vi, 1, 324, 325, 328 National Collaborative Perinatal Project (NCPP), 88, 99, 106, 107 National Health Examination Survey (NHES), 188 National Health Interview Surveys (NHIS), 188 National Health and Nutrition Examination Survey (NHANES), 188 National Institute of Allergy and Infectious Diseases (NIAID), v, 326 National Institute for Biological Standards and Control (NIBSC), 55 National Institute of Child Health and Human Development (NICHD), 126 National Institutes of Health (NIH), 148 National Reye Syndrome Surveillance System, 170 National Vaccine Advisory Committee (NVAC), 325, 329 National Vaccine Information Center (NVIC), 326 National Vaccine Injury Compensation Program (VICP), 325, 326, 329 National Vaccine Program (NVP), 325, 328 Netherlands, 55 Neurocutaneous syndromes, 66 Neuroimaging techniques, 66 Neurologic damage, 4, 19, 105, 107, 117, 118, 168-169, 177 Neurologic disability, 88-89, 91 Neurologic disorders, 19, 71, 100 Neurologic illness, 44, 72, 87, 101, 102-103, 104, 113, 323. See also Encephalopathy Neuropathies, 8, 23, 46, 328. See also Peripheral mononeuropathy Neurotoxic effect, 67 Neurotransmitter systems, 163 Neurotropic virus infection, 67 Neva, F. A., 22 New and Nonofficial Remedies (AMA), 17, 320 Nicolle, Charles, 17, 320 Noncontrolled clinical studies, 46, 287 North West Thames Study, 71, 76, 97, 146-147, 167, 175, 324 Null hypothesis, 35, 57 Nutritional deficiencies, 12 O Odds ratio, 34, 43-44, 51-52, 53, 287, 337-338 infantile spasms, 76-77 neurologic illness, 113 sudden infant death syndrome, 136, 138, 341, 342-344 Optic neuritis, 198 Otitis media, 193n.1 P Paralysis, 100 Paralytic syndromes, 112 Parapertussis, 14, 287 Paresis, 156-157 Paresthesias, 197, 198 Parke-Davis & Company, 321 Parkman, Paul D., 22, 23, 327 Pathologic mechanisms, 206 Perinatal hypoxia, 66 Peripheral mononeuropathy, 4, 46, 287 Continued on next page

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Page 364 Continued from previous page case reports, 156-157 epidemiology, 156 human studies, 156-157 pertussis vaccination and,
4, 157 Peripheral neuropathy, vii, 197, 198, 199 Pertussis (whooping cough), 9n.1, 287 complications, 11-12 encephalopathy following, 11-12, 88-89 epidemiology, 9-14, 40 Pertussis antibody, 158 "Pertussis reaction syndrome," 87 Pertussis toxin (PT), 16, 94, 147, 149, 160, 334, 335 Pertussis vaccine, 1, 13, 39, 44, 45-46, 57, 207, 289 acellular vaccines, 17-18, 39 adsorbed vaccines, 54, 55, 98, 167, 289, 347-348 animal models, 40, 41, 333-335 development of, 17-18, 320-326, 334-335 exposure, 3 toxicity, 166-167 whole-cell vaccines, 17, 18, 39, 54, 55 Pertussis vaccine, adverse events, v, vi, vii, 2, 4-8, 18-19, 32, 38, 46, 50n.3, 52, 323, 348 anaphylaxis, 8, 71, 146-150, 172, 175 aseptic meningitis, 4, 70, 83-86 autism, 4, 152 encephalopathy, 8, 47, 87, 88, 89-90, 91-118, 344-345, 348 erythema multiforme, 4, 47-48, 153-154 Guillain-Barrè syndrome, 4, 155-156 hemolytic anemia, 4, 48, 158-159 hypsarrhythmia, 8, 67, 77-82, 98 infantile spasms, 8, 57, 67-77, 100, 101, 103, 112 juvenile diabetes, 4, 160-161 learning disabilities, 4, 163-164 peripheral mononeuropathy, 4, 157 protracted crying and screaming, 4, 8, 87, 165-169 Reye syndrome, 8, 170-171 shock, 8, 87, 98, 172-177 sudden infant death syndrome, 8, 33, 46, 51, 52, 128-141, 322, 339, 340, 342 thrombocytopenia, 8, 178-179 "Pertussis vaccine-induced encephalopathy," 87, 117 Pervasive developmental disorders, 151 Petechiae, 125, 178, 199, 200 Physicians, 49 Platelet-activating factor, 144 Platelet counts, 177-178, 199, 200 Pneumonitis, 125 Polio, 321 Polio vaccine, oral (OPV), 68, 71, 84, 93, 153, 155, 158, 163, 170, 171, 178, 321 Polyneuritis, 21, 154 Polyneuropathy, 154, 155, 197 Polyradiculitis, 154 Positron tomography, 66 Power calculations, 37, 56-58, 337-340 Pregnancy antibody transmission in, 145 complications, 151 intrauterine infections, 66 rubella transmission in, 19, 20, 22, 327 Primates, 333 Progressive neurologic deterioration, 67 Proteins, 149, 150 cerebral spinal fluid, 155 pertussis toxin, 16 Protracted crying and screaming case reports, 165-166 controlled studies, 166-168 human studies, 165-168 pertussis vaccination and, 4, 8, 87, 165, 168-169 Psychomotor retardation, 65, 67 Public Health Service (PHS), 49-50 Q Quadrigen vaccine, 321

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Page 365 R Rabbits, 333 Radiculoneuritis, vii, 46, 191, 287 case reports, 55, 198-199 epidemiology, 197-198 human studies, 198 rubella vaccination and,
8, 55, 197, 198-199 Rashes, 4, 46, 152 aluminum salts and, 153, 347 rubella, 20 Rats, 148, 333 Reading disability, 161 "Recall bias," 103 Regan-Lowe technique, 11 Relative risk, 42, 287-288 arthritis, 196 aseptic meningitis, 84 encephalopathy and seizures, 97, 98, 101, 103-104, 105, 106, 108, 110, 111-112, 113, 115, 117, 118, 345 infantile spasms, 72, 73-74, 75, 76 and inference of causality, 4, 34, 51-52, 53, 58, 59-62 shock and HHE, 175, 176 sudden infant death syndrome, 51, 131, 138, 140 Renal failure, 148, 347 Report of the Task Force on Pertussis and Pertussis Immunization (AAP), vii Research needs, 8, 206-207 Respiratory complications, pertussis, 11 Reye syndrome, 169-170, 288 case reports, 170-171 controlled studies, 170 epidemiology, 170 human studies, 170-171 in NCES data, 100, 103, 105, 107, 112, 170 pertussis vaccination and, 8, 171 Rheumatism, 187, 188 Risk-benefit analysis, 1-2, 38 Risk estimates. See Relative risk Rubella (German measles), 288, 327 arthritis following, 187, 191, 193 complications, 20 diagnosis, 20 epidemiology, 19-22 radiculoneuritis following, 197, 199 thrombocytopenic purpura, 199 Rubella panencephalitis, 21 Rubella vaccine, 1, 22, 39, 55, 289 animal models, 40, 41 development of, 22-23, 326-329 exposure, 3 Rubella vaccine, adverse events, v, vi, vii, 2, 8, 23-24, 32, 38, 46, 52, 71, 328 arthritis, 8, 21, 24, 55, 187, 188-197, 328, 329 radiculoneuritis, 8, 55, 198-199 thrombocytopenic purpura, 8, 55, 200-201 Rubella virus, 21, 22, 23 S Salk polio vaccine, 321 Sauer, Louis, 19, 321 Seizure disorders, 90, 108 Seizures, 42, 43, 87-88, 177 aseptic meningitis and, 82 infantile spasms and, 65, 66, 67, 75-76 in NCES data, 100, 101, 103, 105, 106, 112 pertussis vaccination and, 87, 93-94, 95-97, 118 See also Afebrile seizures; Febrile seizures Shock, 16, 116, 145, 146, 171-172 case reports, 172-173, 177 controlled studies, 173-177 human studies, 172-176 pertussis vaccination and, 8, 87, 98, 172, 176-177 Sleep apnea, 126 Smallpox vaccine, 68 Social Security Act (1965), 327 Socioeconomic status, 44, 104, 137, 140, 164 Spastic diplegia, 67

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Page 366 States vaccination requirements,
v, 17, 321, 328 Statistical analysis, 37 Study of Neurological Illness in Children (SONIC), 74-75, 76, 112-113, 114, 300, 325, 338 Sudden infant death syndrome (SIDS), vii, 93, 288 case reports, 128-130, 138 controlled studies, 130-140 diagnosis, 125-126 epidemiology, 125, 126-127 human studies, 128-140 pertussis vaccination and, 8, 33, 46, 51, 52, 128, 140-141, 322, 339, 340, 342 SIDS Cooperative Epidemiologic Study, 126, 127, 136 Supplementary Pertussis Surveillance System (SPSS), 12, 13 Sweden, 80, 323 Switzerland, 23 Synovial membrane infection, 194, 196 T Tachycardia, 172 Tasaka, S., 22-23, 326-327 Task Force Report on Pertussis, 324 Tennessee Department of Health, 128 Tetanus vaccine, 54, 150, 154, 156, 157, 158 Thrombocytopenia, 21, 46, 177-178, 288 case reports, 178 epidemiology, 178 human studies, 178 pertussis vaccination and, 8, 178-179 Thrombocytopenic purpura, 46, 178, 288 case reports, 55, 200 epidemiology, 199 human studies, 200 rubella vaccination and, 8, 55, 200-201 Tokyo Women's Medical College, 68 Toxemia, 115, 333 ''Toxic effects," 89 Toxicity, 166-167, 335 Tuberous sclerosis, 66, 75-76 Tuberous Sclerosis Association of Great Britain, 75 Tumor necrosis factor, 145 Twins, 129, 146 U United Kingdom pertussis mortality in, 14 pertussis vaccination in, 19, 39, 44, 55, 321-322, 325 Reye syndrome incidence, 170 rubella incidence, 22 rubella vaccination in, 23 Vaccine Damage Payment Act, 323 See also National Childhood Encephalopathy Study (NCES) United States, 322 arthritis incidence, 188 DPT vaccination in, 17, 19, 39, 54, 69, 128, 321, 348 Guillain-Barrè syndrome incidence, 155 infantile spasms incidence, 66 juvenile diabetes incidence, 159 pertussis incidence, 13, 14 Reye syndrome incidence, 170, 171 rubella incidence, 22, 23, 327 rubella vaccination in, 23, 24, 55, 199, 328 sudden infant death syndrome deaths, 128-129, 140 U.S. Congress, v, 325, 328 U.S. Department of Health and Human Services (DHHS), 324 University of California, Los Angeles, 323 University of Illinois Medical Center, 81 "Unusual shock-like state," 8 Urticaria, 146, 172 V Vaccination, v, 1, 9n.2, 47, 288-289 immunization schedules, 54-55

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54, 55, 117 vaccine exposure, 3, 32-33, 34 See also Adverse events Vaccine Adverse Event Reporting System (VAERS), 49-50 Vaccine Compensation Amendments (1987), v Vaccine Damage Payment Act (U.K.), 323 Vaccine Supply and Innovation (IOM), vii Vasculitis, 148 Viral encephalitis, 82, 103, 105, 107 W Waxman, Henry, 324 Wechsler Intelligence Scale for Children, 97, 175 Weller, Thomas H., 22, 23, 327 West syndrome, 65 Whites arthritis incidence, 188 juvenile diabetes in, 159-160 pertussis incidence, 13 Whooping cough. See Pertussis Wilkins, Jeanette, 295 World Health Organization (WHO), 13 WRC-TV, 19, 93, 323 Wyeth Laboratories, Inc., 322, 324