Index

A

Acceptance of causal relation, 16, 32-33

evidence for, 22, 30-31

Acquired immune deficiency syndrome, 294

Acute disseminated encephalomyelitis, 34, 35, 36, 37, 45, 47, 83, 84, 85, 86

See also Encephalomyelitis

Adverse Effects of Pertussis and Rubella Vaccines,4, 59

executive summary, 310-317

Adverse events

causal assessment of, 23-24, 25-26

data sources, 4-5, 17

diphtheria vaccination, 16, 17, 73, 74-77, 78-81, 83-85, 87-88, 90 , 91-92, 94-97, 98-99, 100, 104-108

hepatitis B vaccination, 217-218, 220-221, 223, 224-226, 228, 229-230, 306

Hib vaccination, 239-241, 242, 244-246, 247, 248-249, 250-260

individual differences, 307

mandated reporting, 2, 49

measles-mumps-rubella vaccination, 127, 131-134, 144, 164, 165-167, 172-175

measles vaccination, 16, 17, 123-129, 136-140, 147-148, 149-150, 151-152, 156, 160, 164, 165-168, 170, 171-172, 198-199

mumps vaccination, 131-134, 144, 146, 154-158, 161-162, 164, 165-168

polio vaccination, 17, 190-194, 198-199, 200-203

rabies vaccination, 44

research needs, 307-308

risk-modifying factors, 3

rubella vaccination, 4-5

swine flu vaccination, 42-44

tetanus vaccination, 16, 17, 70-71, 73-77, 78-81, 83-85, 87-88, 90 , 91-92, 94-97, 98-99, 100, 104-108

See also Deaths;

specific adverse event



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Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality Index A Acceptance of causal relation, 16, 32-33 evidence for, 22, 30-31 Acquired immune deficiency syndrome, 294 Acute disseminated encephalomyelitis, 34, 35, 36, 37, 45, 47, 83, 84, 85, 86 See also Encephalomyelitis Adverse Effects of Pertussis and Rubella Vaccines,4, 59 executive summary, 310-317 Adverse events causal assessment of, 23-24, 25-26 data sources, 4-5, 17 diphtheria vaccination, 16, 17, 73, 74-77, 78-81, 83-85, 87-88, 90 , 91-92, 94-97, 98-99, 100, 104-108 hepatitis B vaccination, 217-218, 220-221, 223, 224-226, 228, 229-230, 306 Hib vaccination, 239-241, 242, 244-246, 247, 248-249, 250-260 individual differences, 307 mandated reporting, 2, 49 measles-mumps-rubella vaccination, 127, 131-134, 144, 164, 165-167, 172-175 measles vaccination, 16, 17, 123-129, 136-140, 147-148, 149-150, 151-152, 156, 160, 164, 165-168, 170, 171-172, 198-199 mumps vaccination, 131-134, 144, 146, 154-158, 161-162, 164, 165-168 polio vaccination, 17, 190-194, 198-199, 200-203 rabies vaccination, 44 research needs, 307-308 risk-modifying factors, 3 rubella vaccination, 4-5 swine flu vaccination, 42-44 tetanus vaccination, 16, 17, 70-71, 73-77, 78-81, 83-85, 87-88, 90 , 91-92, 94-97, 98-99, 100, 104-108 See also Deaths; specific adverse event

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Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality Advisory Committee on Immunization Practices, 121, 189, 213, 238, 278 Afebrile seizures, 53, 78, 144 Age-related effects hepatitis B vaccination response, 214 in Hib vaccinations, 236-237, 240 Age-specific incidence, 17 in Guillain-Barré syndrome, 46-47 Aids to Interpretation of the Vaccine Injury Table, 48-49, 50 American Academy of Pediatrics, 121, 176, 189, 213, 238 Analytic bias, 21 Anaphylaxis, 26 causality, 16, 17, 108, 109, 175-176, 205, 230-231, 262-263 clinical description, 59-61, 100, 170, 204, 228, 261 diphtheria vaccination and, 17, 100-110, 288, 290 fatal outcomes, 170, 231, 261, 288, 290, 292, 294-295, 300 hepatitis B vaccination and, 17, 228-231, 300 Hib vaccination and, 262-263 measles-mumps-rubella vaccination and, 17, 170-176, 292 measles vaccination and, 16, 175, 292 mumps vaccination and, 176 polio vaccination and, 204-205 risk-modifying factors, 109, 176, 231 tetanus vaccination and, 17, 100-110, 290 Antibody-antigen reaction in anaphylaxis, 60-61 in arthritis, 95 Arthus type, 61-62 in delayed-type hypersensitivity, 62 in hepatitis B serum-like sickness, 223-224, 227 in hepatitis B vaccine-induced anaphylaxis, 228-229 in Hib vaccination, 240-241, 251-253 in measles, 121-122 in normal tissue, 61 normative, 63 in tetanus vaccination, 70-71, 101 Arthralgia, 94, 222, 224, 226 Arthritis, 17 causality, 97, 226-227 clinical description, 94, 222 diphtheria-tetanus vaccination and, 95-97 epidemiology, 222 hepatitis B vaccination and, 223-227 Arthropathy, 222, 223, 224 Arthus reaction, 59, 61-62 in tetanus vaccination, 70-71 Aseptic meningitis, 49, 306 causality, 134-135 clinical description, 130 incidence, 130 mumps vaccination and, 130-135 Attributable risk, 27 B B cells, 240, 241 Bayesian analysis, 25 Bias analytic, 21 information, 21 systematic, 21 Biologic gradient, 21 Biologic plausibility, 5, 22 anaphylaxis, 101-104, 170-171, 228-229, 230, 262 arthritis, 95, 97, 223-224, 227 aseptic meningitis, 131, 134 demonstrated. 28 demyelinating diseases, 47-48, 84, 199, 220 diabetes mellitus, 155-156, 159 early-onset Hib disease, 251-252 encephalopathy, 73, 77, 123, 129 erythema multiforme, 98 evidentiary role of, 5, 28, 31, 32-33

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Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality Guillain-Barré syndrome, 87, 151, 216, 219, 244, 246 immunosuppression, 64 multiple sclerosis, 36, 220 neuropathy, 90-91 optic neuritis, 147-148 orchitis, 160-161, 163 poliomyelitis, 191 residual seizure disorder, 79, 142 sensorineural deafness, 146 subacute sclerosing panencephalitis, 136 thrombocytopenia, 164-165, 248 transverse myelitis, 149, 196, 199, 242 Brachial neuritis, 54-55 causality, 16, 93-94 diphtheria-tetanus vaccination and, 16, 90, 91, 92, 93-94 C Campylobacter jejuni, 39 Canada, 131, 132, 144, 161, 166, 173 Case-control studies, 29 Case reports and uncontrolled studies, 5 absence of, 22 anaphylaxis, 104-108, 171-175, 229, 262 arthritis, 95-97, 224-226 aseptic meningitis, 131-134 brachial neuritis, 91-92 data sources, 23, 28-29 demyelinating diseases, 84-85, 221 diabetes mellitus, 156-158 early-onset Hib disease, 253-254, 256-260 encephalopathy, 74-75, 123-129 erythema multiforme, 98-99 evaluation of, 23-26 fatal outcomes, 275, 287-289, 291-294, 296-298, 300, 301 Guillain-Barré syndrome, 87-88 infantile spasms, 81 mononeuropathy, 91 multiple sclerosis, 221 optic neuritis, 85, 148, 221 orchitis, 161-162 poliomyelitis, 190, 191-194 residual seizure disorder, 79-81, 142-145 role of, 22 sensorineural deafness, 146 subacute sclerosing panencephalitis, 136-138 thrombocytopenia, 165-167, 248-249 transverse myelitis, 149-150, 198-199, 242 Causality anaphylaxis, 16, 17, 108, 109, 110, 175-176, 205, 230-231, 262-263 arthritis/arthropathy, 97, 226-227 aseptic meningitis, 134-135 brachial neuritis, 16, 93-94 Can It? assessment, 20-23 categories of, 16-17, 32-33 combination vaccines, 5 definitions, 19-20 demyelinating diseases, 47-48, 85-86, 222 diabetes mellitus, 159 Did It? assessment, 20, 23-26 early-onset Hib disease, 260-261 encephalopathy, 16, 77-78, 129-130 erythema multiforme, 99 evidence for determination of, 5, 22-23, 27-33 fatal outcomes, 16, 17, 109-110, 205-206, 231, 263, 276-277, 277-278, 289-290, 294-295, 298-299, 300-301, 302 focal lesions, 36-37 Guillain-Barré syndrome, 16, 17, 88-89, 109, 110, 153, 203-204, 219 , 246 Haemophilus influenzae type b, 16, 17 infantile spasms, 16, 17, 82 Koch's postulates, 19 measles vaccine-strain viral infection, 17, 176-177, 291, 294-295 mononeuropathy, 54, 93, 94

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Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality multiple sclerosis, 36, 222 multivalent vaccines, 4 optic neuritis, 85, 86, 148-149, 222 orchitis, 163 plausibility, 5 poliomyelitis, 194-195 research needs, 17 residual seizure disorder, 81-82, 145 sensorineural deafness, 147 subacute sclerosing panencephalitis, 140-142 sudden infant death syndrome, 16, 109, 110, 287, 289, 290, 299, 300 , 301, 302 thrombocytopenia, 17, 168-169, 176-177, 205, 249-250 transverse myelitis, 85, 86, 150-151, 199-200, 222, 243 Will It? assessment, 20, 26-27 Centers for Disease Control and Prevention, 2, 28, 150, 190, 191-193, 195, 217, 274, 279, 297, 307 Clinical trials, 5 hepatitis B vaccines, 214-216, 218 Hib vaccines, 243, 246, 249, 254-260, 262 measles vaccine, 129, 140, 145, 162 rabies vaccine, 35-36 research needs in, 308 role of, 30 Coding Symbols for Thesaurus of Adverse Reaction Terms, 279 Cohort studies, 29 Combination vaccination, 5 Hib vaccines, 5, 237, 239-240 immune system reactions and, 62-65 research needs, 307 Committee to Review the Adverse Consequences of Pertussis and Rubella Vaccines, 3, 4-5, 16, 31-32, 310-317 Compensation for vaccine-related injury, 2 Contamination of vaccine, 275-276 Controlled observational studies, 5 anaphylaxis, 262 diabetes mellitus, 158 early-onset Hib disease, 254, 256-260 encephalopathy, 75-77, 129 Guillain-Barré syndrome, 201-203, 246 orchitis, 162 research needs in, 308 residual seizure disorder, 81 role of, 29 subacute sclerosing panencephalitis, 138-140 sudden infant death syndrome, 287 thrombocytopenia, 167-168, 249 transverse myelitis, 243 Coxsackie virus, 155-156 Cutter incident, 275 Cytomegalovirus, 39 D Data sources, 3-5, 16, 23, 28, 322-323 electronic databases, 318-321 research needs, 307-308 Vaccine Adverse Event Reporting System as, 278-286 Deafness. See Sensorineural deafness Deaths classification of, 274-278 data sources, 274 DPT vaccination and, 109, 287-290 DT vaccination and, 109, 110, 289-290 hepatitis B vaccination and, 231, 300-301 Hib vaccination and, 263, 301-302 measles fatality rate, 118 measles-mumps-rubella vaccination and, 176-177 measles vaccination and, 17, 176, 177, 294-295 meningitis fatality rate, 236 mumps vaccination and, 117, 176, 294-295

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Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality polio vaccination and, 17, 205-206, 296-299 research needs, 307 tetanus vaccination and, 109, 110, 290 Vaccine Adverse Event Reporting System data, 282-286 See also Sudden infant death syndrome Demonstrated plausibility, 5 Demyelinating diseases, 17, 34-36 biologic plausibility, 84 causality, 47, 85-86 clinical description, 83 diphtheria vaccination and, 85-86 hepatitis b vaccination and, 219-222, 306 measles and, 147-148 multiple sclerosis, 36, 219, 220-221, 222, 241, 306 optic neuritis, 36, 37, 83, 85, 86, 147-149, 220, 221, 222, 306 tetanus vaccination and, 85-86 See also Acute disseminated encephalomyelitis; Guillain-Barré syndrome; Transverse myelitis Diabetes mellitus clinical description, 153 epidemiology, 153 measles vaccination and, 154, 156-159 mumps vaccination and, 154-159, 306 viral infection and, 153-154, 155-156 Diagnosis acute disseminated encephalo-myelitis, 36 anaphylaxis, 60-61, 230 aseptic meningitis, 130 brachial neuritis, 54 encephalopathy, 48-50 Guillain-Barré syndrome, 37-39, 40-42, 45-46 Hib disease, 239 immunologic reaction classifications, 59 measles, 118 mononeuropathy, 54 neuropathy, 90 residual seizure disorder, 78 seizures, 53 subacute sclerosing panencephalitis, 51 vaccine-associated poliomyelitis, 191 Didymitis. See Orchitis Diphtheria, 68-69 Diphtheria-pertussis-tetanus vaccination, 4, 5, 63-64, 96, 101, 107 , 150, 237, 293 encephalopathy and, 73 in fatal outcomes, 287-290 immunization schedules, 69-70 sudden infant death syndrome and, 109, 276, 287, 289, 295, 296 See also Diphtheria vaccination; Tetanus vaccination Diphtheria-tetanus vaccination, 4, 72 anaphylactic reactions, 101, 107-108 brachial neuritis and, 93, 94 as cause of death, 109, 110, 289-290, 296 deaths and, 287-289 encephalopathy and, 74-78 Guillain-Barré syndrome and, 88-89 immunization schedule, 70 mononeuropathy and, 93, 94 seizures and, 79-82 sudden infant death syndrome and, 289 Td vs., 73 See also Diphtheria vaccination Diphtheria vaccination, 2 acute disseminated encephalo-myelitis and, 83 anaphylaxis and, 100-110 arthritis and, 95-97 biologic effects, 70-72 brachial neuritis and, 16 demyelinating diseases and, 83-86

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Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality development of, 69 encephalopathy and, 72-78 erythema multiforme and, 98-99 fatalities from, 109, 110 Guillain-Barré syndrome and, 87-90 hypersensitivity reaction, 71-72 immunization schedule, 71 infantile spasms and, 16, 81-82 lot-specific reactions, 77, 305 mutant toxins, 305 neuropathy and, 90, 91-92, 93-94 research needs, 305 residual seizure disorder and, 78-82 response phases, 251 sudden infant death syndrome and, 109, 110 See also Diphtheria-pertussis-tetanus vaccination; Diphtheria-tetanus vaccination; Td vaccination Disseminated intravascular coagulation, 248 Dose-response effects, 21 DPT. See Diphtheria-pertussis-tetanus vaccination DPT: A Shot in the Dark,1 "DPT: Vaccine Roulette,"; 1 Dysgammaglobulinemia, 291, 295 E Ecologic studies, 29 Egg allergy, 170-171, 173-174, 176 Encephalitis encephalopathy and, 48, 122 epidemiology, 49, 122 measles vaccination and, 292, 293 mumps vaccination and, 123 See also Encephalopathy Encephalomyelitis, 26, 34, 35-36, 45 See also Demyelinating diseases; Encephalopathy Encephalopathy, 16 causality, 16, 77-78, 129-130 clinical description, 72, 122 definition, 48-50, 122 diphtheria vaccination and, 73-78 encephalitis and, 48, 122 epidemiology, 72, 122 immunosuppressive measles, 129 measles vaccination and, 123-130 subacute sclerosing panencephalitis, 51-52 tetanus vaccination and, 73-78 vaccine-related fatal outcomes, 293 Epidemiologic studies, 20, 29 combining, 30-31 evidentiary role of, 21, 22-23, 27, 32-34 types of, 27-28, 29 See also Clinical trials; Controlled observational studies Epidemiology age-specific incidence, 17 arthropathy, 222 aseptic meningitis, 49, 130 bacterial meningitis, 236 brachial neuritis, 55 diabetes mellitus, 153 encephalitis, 49 encephalopathy, 72, 122 epilepsy, 142 Guillain-Barré syndrome, 46-47, 86, 151, 200, 216, 244 hepatitis B chronic carriers, 211 Hib disease, 236 insulin-dependent diabetes mellitus, 153 research needs, 307-308 subacute sclerosing panencephalitis, 52, 135-136 thrombocytopenia, 163-164, 247 transverse myelitis, 37, 83, 85, 149, 196, 220, 241 vaccine-associated polio, 191-193, 195 Epilepsy, 78, 80, 142 seizures in, 53 See also Residual seizure disorder Erythema multiforme clinical description, 98 diphtheria-tetanus vaccination and, 99 hepatitis B vaccination and, 225

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Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality Erythema nodosum, 225 Evidence algorithms in assessment of, 24 Bayesian analysis of, 25 in Can It? assessment, 20-23 for causality, 16-17, 30-33 clinical trials as, 30 controlled studies as, 29 in Did It? assessment, 23-26 encephalopathy, 49 meta-analysis, 30-31 types of, 5, 27-31 uncontrolled studies as, 28-29 See also Data sources Experimental allergic encephalo-myelitis, 35 Experimental allergic neuritis, 35-36 Experimental studies, 30 See also Clinical trials F Febrile seizures, 53, 78, 79, 80, 144, 145 Fevers, 53 Finland, 166, 201-203, 257 Food and Drug Administration, U.S., 2, 28, 249, 274, 279, 283 Formaldehyde, 67, 68 G Gamma globulin, 119 Gender differences in hepatitis b vaccine-induced anaphylaxis, 228 in SSPE incidence, 52 Genetic factors, in diabetes susceptibility, 153-154 Germany, 74-75, 92, 126, 134, 138, 152, 157-158, 159, 161-162, 166 , 172-173, 194, 288, 292, 298 Guillain-Barré syndrome, 16, 17, 26, 35 antecedent events, 39-45, 86 biologic plausibility, 47-48, 87, 200, 216, 244 causality, 17, 88-89, 109, 110, 153, 203-204, 219, 246 clinical description, 37-39, 45, 86, 151, 200, 216, 243-244 diagnosis, 39, 40-42, 45-46 diphtheria vaccination and, 16, 87-90, 109, 110, 286 DPT vaccination and, 288 DT vaccination and, 290 electrodiagnostic criteria, 38-39, 43 epidemiology, 46-47, 86, 151, 200, 216, 244 fatal outcomes, 109, 110, 205, 206, 288, 290, 296, 298-299, 307 hepatitis B vaccination and, 216-219, 306 Hib vaccination and, 244-246 measles vaccination and, 151-153 pathogenesis, 45-46 polio vaccination and, 200-206 rabies vaccination and, 44 research needs, 306-307 risk-modifying factors, 89-90, 204 swine flu vaccination and, 42-44 synonyms, 34 Td vaccination and, 290 tetanus vaccination and, 16, 87-90, 109, 110, 286, 306 H Haemophilus influenzae type b (Hib), 62, 97, 236 See also Hib disease, early-onset Haemophilus influenzae type b vaccine anaphylaxis and, 262-263 anti-PRP antibodies produced by, 240-241 biologic effects of, 239-241 death and, 263, 301, 302 development of, 236-238 early-onset Hib disease and, 17, 250-256 Guillain-Barré syndrome and, 244-246 thrombocytopenia and, 247-250 transverse myelitis and, 241-243 See also Hib conjugate vaccines

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Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality Health and Human Services, U.S. Department of, 2 Hepatitis B arthritis and, 223-224 chronic carriers, 211 clinical description, 211 fatality rate, 211 polyarteritis and, 224 Hepatitis B vaccination, 4 anaphylaxis and, 17, 228-231, 300 arthritis and, 17, 223-227 biologic effects of, 213-216 death and, 231, 300-301 demyelinating diseases and, 17, 219-222 development of, 212-213 Guillain-Barré syndrome and, 216-219 immunization schedules, 213-214, 215 multiple sclerosis and, 220 polyarteritis and, 227 research needs, 306 sudden infant death syndrome and, 231, 299, 300-301 transverse myelitis and, 221, 222, 306 Hib. See Haemophilus influenzae type b Hib conjugate vaccines, 305 as cause of death, 263, 302 cytopenia and, 247-248 development of, 237-238 early-onset Hib disease and, 16, 256-261, 302 Guillain-Barré syndrome and, 245, 246 immunization schedules, 237-238 See also Haemophilus influenzae type b vaccine Hib disease, early-onset causality, 16, 17, 260-261, 263, 302 clinical description, 250 fatal outcomes, 263, 302 Hib vaccination and, 250-260 risk-modifying factors, 261 Human immunodeficiency virus, 39, 294, 295 Hungary, 191 Hypersensitivity delayed-type, 62 diphtheria vaccination, 71-72, 100 nonanaphylactic, 60, 229 Schick test, 71-72 I Immune system anaphylaxis, 59-61 deficiency, 64-65, 195, 291, 294, 295, 296-297, 299 disease-causing reactions in, classification of, 59 in Guillain-Barré syndrome, 37-38, 44-46 measles vaccination and, 64-65, 294, 295 polio vaccination and, 195, 296-297 response to hepatitis B vaccine, 213-214 response to Hib vaccines, 240-241 response to measles vaccine, 121-122 response to mumps vaccine, 122 response to tetanus toxoid, 95 as risk-modifying factor, 299 type II reaction, 59, 61 type III reaction, 59, 61-62 type IV reaction, 62 vaccine effects in, 62-65 See also Antibody-antigen reaction Immunization schedules diphtheria, 70 diphtheria-pertussis-tetanus, 69-70, 276 Haemophilus influenzae type b, 237-238, 276 hepatitis B, 213, 214-215, 276 mumps, 121 poliomyelitis, 188-189 tetanus, 70 Immunosuppressive measles encephalopathy, 129 Infantile spasms, 16, 17, 53, 78 diphtheria vaccination and, 81, 82 tetanus vaccination and, 81, 82

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Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality Infants, measles vaccine-associated thrombocytopenia in, 167-168 Information bias, 21 Injection technique, injury from, 54, 90-91, 93, 293-294 Italy, 75-77, 143, 191 J Japan, 126, 131, 132-133, 138, 143, 293 K Koch's postulates of causality, 19 L Leukemia, 129, 291, 294 M Mandated reporting, 2, 49 Measles, 2, 5 clinical features, 118 fatality rates, 118 immunosuppressive measles encephalopathy, 129 measles vaccine-strain viral infection, 17, 291 subacute sclerosing panencephalitis and, 51-52 vaccine strain infection, riskmodifying factors, 295 Measles-mumps-rubella vaccination, 5, 64-65, 146, 148 anaphylaxis and, 17, 170-176, 177 aseptic meningitis and, 131-134 death and, 176-177, 292-295 diabetes mellitus and, 156-157, 158 egg allergy and, 170-171, 173-174, 176 encephalopathy and, 127, 129, 130 Hib vaccines and, 239, 240, 249, 250 orchitis and, 161-162 residual seizure disorder and, 144 thrombocytopenia and, 164, 165-167, 169-170, 249, 250 Measles vaccination anaphylaxis and, 170-172, 175-176, 177-178 Beckenham strain, 143, 294 Biken-CAM strain, 126, 293 biologic effects, 64, 121-122 death and, 17, 176-177, 294, 295 development of, 118-120 diabetes mellitus and, 154, 156, 159 Edmonston strain, 119, 120, 123, 292 encephalopathy and, 123-130 Enders strain, 128 Guillain-Barré syndrome and, 151-153 more-attenuated strain, 119-120, 152 optic neuritis and, 147-149 orchitis and, 160, 163 research needs, 306 residual seizure disorder and, 142-145 Schwarz strain, 120, 126, 129, 143, 149, 292, 293, 294 sensorineural deafness and, 146-147 strains of, 119-120 subacute sclerosing panencephalitis, 135-142 thrombocytopenia and, 164-169, 176-177 transverse myelitis and, 149-151 vaccine-strain viral infection, 17, 177, 295 Wellcome strain, 128 See also Measles-mumps-rubella vaccination Meningitis epidemiology, 49, 236 See also Aseptic meningitis Monitoring System for Adverse Events Following Immunization, 28, 107, 109, 138, 152, 301, 323 arthritis in, 97 fatal outcomes in, 293, 298, 300 Guillain-Barré syndrome in, 88, 218 polio in, 193 sudden infant death syndrome in, 276-277, 296

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Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality Mononeuropathy, 54, 90, 91, 92, 93, 94 Multifactorial causality, 20 Multiple sclerosis, 219, 241 causality, 222 clinical description, 36 hepatitis b vaccination and, 220-222, 306 Multivalent vaccines, 5 Mumps, 2 aseptic meningitis and, 49 complications, 121 Mumps vaccination anaphylaxis and, 170, 176 aseptic meningitis and, 130-135 biologic effects, 122 as cause of anaphylaxis, 175-176, 177 death and, 176-177, 291, 294, 295 development of, 121 diabetes mellitus and, 154-159, 306 Jeryl Lynn strain, 121, 132, 133-134, 135 orchitis and, 160-163 research needs, 306 residual seizure disorder and, 142, 145 sensorineural deafness and, 146-147 thrombocytopenia and, 164-169, 176-177 Urabe strain, 121, 131-132, 133, 134, 135, 306 Myocarditis, 296 N National Childhood Encephalopathy Study (NCES), 75, 81, 82, 129 National Childhood Vaccine Injury Act, 2, 279 National Collaborative Perinatal Project. 80, 142 National Health Interview Survey, 94, 222 National Health Survey, 226 National Registry for Subacute Sclerosing Panencephalitis, 136, 137 , 140, 141 National Vaccine Injury Compensation Program, 2, 4, 49, 279 National Vaccine Program, 2 Necessary cause, 19 Neomycin sulfate, 174-175, 176 Neuralgic amyotrophy. See Brachial neuritis Neuritis brachial, 16, 54-55, 90, 91, 92, 93-94 experimental allergic, 35 optic, 36, 37, 83, 85, 86, 147-149, 220, 221, 222, 306 Neuropathy, 53-54, 90 New Zealand, 219, 226, 229 North West Thames study, 74, 79, 82, 143, 287 O Odds ratios brachial neuritis, 93-94 early-onset Hib disease, 261 encephalopathy, 75, 77 infantile spasms, 82 subacute sclerosing panencephalitis, 139 sudden infant death syndrome, 276, 295-296 See also Relative risk Optic neuritis, 36, 85 causality, 148-149, 222 clinical description, 37, 83, 147, 220 hepatitis b vaccination and, 221, 222, 306 measles vaccination and, 147-149 tetanus vaccination and, 85, 86 Orchitis causality, 163 clinical description, 160 measles vaccination and, 160, 163 mumps vaccination and, 160-163 P Pancreatitis, 155

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Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality Pertussis, 2, 3, 4, 63 recommended immunization schedules, 69-70 See also Diphtheria-pertussis-tetanus vaccination Pharmaceutical manufacturers, 2 P.L. 99-660, 3, 4, 279 Plausibility of causal relation, 5 Polio vaccination anaphylaxis and, 204-205 biologic effects, 189 death and, 17, 205-206, 298-299 development of, 187-189 Guillain-Barré syndrome and, 17, 200-204, 205, 206 immunization schedules, 189 immunodeficiency as risk factor in, 297 polio caused by, 17, 194-195, 205, 206, 296, 298-299 research needs, 306 risk-modifying factors in, 195 sudden infant death syndrome and, 205-206, 276, 295-296, 299 thrombocytopenia and, 204-205 transverse myelitis and, 196-200 vaccine strain viral infection, 17, 190-195, 205, 206, 296-299 Poliomyelitis, 2 aseptic meningitis and, 49 clinical description, 187, 189 forms of, 187, 189 polio vaccine and, 17, 190-195, 205, 206, 296-299 risk modifying factors, 195 Polyarteritis, 224, 227 Polysaccharide, polyribosylribitol phosphate (PRP), 236-237, 239, 240-241 in postimmunization period, 251-253 See also Haemophilus influenzae type b vaccination Postinfectious neuritis. See Guillain-Barré syndrome Postmarketing surveillance, 23, 307 Postvaccinal encephalomyelitis. See Acute disseminated encephalomyelitis Potential causality, 20-23 Predictive causality, 20, 26-27 Public Health Service, U.S., 4 R Rabies, 34-35, 44, 83 Randomized clinical trial, 30 Recombinant hepatitis B vaccines, 213, 214, 215-216, 223 Rejection of causal relation, 16, 32 evidence for, 22-23, 30-31 Relative risk, 20-21 brachial neuritis, 93-94 case control studies in estimating, 29 of death following measles vaccination, 292 fatal outcomes following DT/Td/tetanus vaccination, 109, 110, 287-290 Guillain-Barré syndrome, 203, 204, 217 hepatitis B vaccination in anaphylaxis, 230-231 Hib vaccination in Hib disease, 261 polio vaccination in SIDS, 295-296 sudden infant death syndrome, 109, 276, 296 Research needs, 17 data, 307-308 diphtheria vaccination, 305 disease registries, 308 Guillain-Barré syndrome, 306-307 hepatitis B vaccines, 222, 306 measles vaccines, 306 mortality data, 307 multiple vaccine administration, 307 mumps vaccines, 306 pertussis vaccines, 317 polio vaccines, 306 risk-modifying factors, 307

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Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality rubella vaccines, 317 tetanus toxoids, 305 Residual seizure disorder, 52-53 causality, 81-82, 145, 293 clinical description, 78, 142 diphtheria vaccination and, 78-82, 81-82 measles vaccination and, 142-145 mumps vaccination and, 142, 144, 145 tetanus vaccination and, 78-82 vaccine-related fatal outcomes, 293 Retrobulbar neuritis,37 ''Retrodictive'' causality, 20, 23-26 Reverse causality bias, 21 Reye syndrome, 76 Rheumatism, 222 Rheumatoid arthritis, 95, 227, 306 Risk-benefit comparisons, 3, 27 Risk difference, 27 Risk-modifying factors anaphylaxis, 109, 176, 231 definition, 3 early-onset Hib disease, 261 Guillain-Barré syndrome, 89-90, 204 measles vaccine-strain viral infection, 295 poliomyelitis, 195, 299 research needs, 307 thrombocytopenia, 169-170 Romania, 139-140, 191 Rubella, 2, 3, 4-5, 155, 156 S Sampling procedures, bias in, 21, 22 Schick test, 69, 71-72 Seizures, 52-53, 74 See also Residual seizure disorder Selection bias, 21 Semple vaccine, 44 Sensorineural deafness causality, 147 clinical description, 146 measles/mumps vaccine and, 146-147 SIDS. See Sudden infant death syndrome Spontaneous Reporting System, 28 SSPE. See Subacute sclerosing panencephalitis Stevens-Johnson syndrome, 98, 225 Strength of association, 21 Subacute sclerosing panencephalitis (SSPE), 51-52 causality, 140-142 clinical description, 135 epidemiology, 135-136 measles vaccination and, 135-142 vs. immunosuppressive measles encephalopathy, 129 Sudden infant death syndrome (SIDS), 16, 109-110 diphtheria vaccination and, 109-110, 287 DPT vaccination and, 109, 276, 289, 295, 296 DT vaccination and, 289 epidemiologic data, 276-277 hepatitis B vaccination and, 231, 299, 300-301 Hib vaccination and, 263, 301, 302 measles vaccination and, 291 mumps vaccination and, 291 polio vaccination and, 205-206, 276, 295-296, 299 tetanus vaccination and, 109-110, 287 Sufficient cause, 19 Sweden, 158, 159, 165-166, 172, 201 Swine flu vaccine, 42-44, 46 T T cells, 45, 84, 87, 240, 291 T-lymphocytes, 59 Td vaccination, 70, 72 anaphylactic reactions, 101-104, 107, 108 arthritis and, 96-97 brachial neuritis and, 93, 94 as cause of death, 109, 110, 290 diphtheria-tetanus vaccination vs., 73

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Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality encephalopathy and, 78 Guillain-Barré syndrome, 88-89 immunization schedule, 69-70, 70 mononeuropathy and, 93, 94 seizures and, 79, 81, 82 See also Diphtheria vaccination; Tetanus vaccination Testitis. See Orchitis Tetanospasmin, 78 Tetanus, 2, 4, 67, 78 Tetanus vaccination acute disseminated encephalomyelitis and, 84 anaphylaxis and, 17, 100-110 arthritis and, 95-97 biologic effects, 70-71, 95 brachial neuritis and, 16 as cause of death, 109, 110, 287-290 demyelinating diseases and, 83-86 development of, 67-68 encephalopathy and, 16, 73-78 erythema multiforme and, 98-99 Guillain-Barré syndrome and, 16, 86-90, 290 infantile spasms and, 16, 81, 82 lot-specific reactions, 305 neuropathy and, 90, 91-92, 93-94 optic neuritis and, 85-86 research needs, 305 residual seizure disorder and, 78-82 sudden infant death syndrome and, 16, 109, 110 transverse myelitis and, 84-86 See also Diphtheria-pertussistetanus vaccination; Td vaccination Theoretical plausibility, 5 Thimerosal, 68, 213, 229, 231 Thrombocytopenia, 17 causality, 168-169, 205, 249-250 clinical description, 163, 164, 205, 247 epidemiology, 163-164, 247 fatal outcomes, 294-295 Hib vaccinations and, 247-250 measles-mumps-rubella vaccine and, 17, 164, 167-170, 292, 294-295 measles vaccination and, 164-169 mumps vaccination and, 164-169 platelet destruction in, 168 polio vaccination and, 204-205 risk-modifying factors, 169-170 Thrombocytopenic purpura, 164, 166, 205, 247 Toxic shock syndrome, 172, 175, 176, 293-294 Transverse myelitis, 84-85 causality, 85, 86, 150-151, 199-200, 222, 243 clinical description, 36-37, 83, 149, 196, 219, 241 hepatitis b vaccination and, 221, 222, 306 Hib vaccinations and, 241-243 incidence, 37, 83, 85, 149, 150, 196, 220, 241 measles vaccine and, 149-151 polio vaccination and, 196-200 U Uncontrolled observational studies, 28-29. See also Case reports and uncontrolled studies Underreporting, in VAERS, 282-283 United Kingdom, 75, 126, 131, 140, 143, 145, 191, 193, 237-238, 294 See also National Childhood Encephalopathy Study; North West Thames study Urabe strain mumps vaccine, 121, 131-132, 133, 134, 135, 306 Urticaria, 60 V Vaccine Adverse Event Reporting System, 2, 28, 107, 274, 307 anaphylaxis in, 173, 175, 229, 230, 262, 300 arthritis in, 96-97, 224, 227

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Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality development of, 279 encephalopathy in, 75, 128 erythema multiforme in, 99 Guillain-Barré syndrome in, 88, 152, 153, 201, 218, 245, 288 limitations of, 279-283, 323 measles/mumps vaccination associated with deaths in, 293 meningitis in, 134 mortality data in, 282-286 optic neuritis in, 221 orchitis in, 162, 163 polio vaccinations associated with deaths in, 298 reporting procedures, 279 role of, 278, 279, 322-323 seizures in. 81 subacute sclerosing panencephalitis in, 138 sudden infant death syndrome in, 276-277, 283-286, 296, 299, 300, 301 thrombocytopenia in, 166-167, 169, 248, 250 transverse myelitis in, 84-85, 150, 198-199, 221, 241, 242, 243 underreporting in, 282-283 Vaccine Injury Table, 48-49, 50, 60, 278, 280-281 Vaccine Safety Committee, 3, 4-5, 16, 278 Viral infection diabetes mellitus and, 155-156 Guillain-Barré syndrome and, 39 vaccine-strain, 17, 177, 190-195, 291, 295, 296-297