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From page 451... ... 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 Expects 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, 104108 hepatitis B vaccination, 217-218, 220-221, 223, 224-226, 228, 229-230, 306 Hib vaccination, 239-241, 242, 244-246, 247, 248-249, 250-260 451 individual differences, 307 mandated reporting, 2, 49 measles-mumps -rubella vaccination, 127, 131-134, 144, 164, 165-167, 172-175 measles vaccination, 16, 17, 123129, 136-140, 147-148, 149150, 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, 104108 See also Deaths; specific adverse event Read the entire page →
From page 452... ... 452 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-Barre 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, 175176, 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, 100110, 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 INDEX 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, 223227 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 Read the entire page →
From page 453... ... 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-Barre 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 Read the entire page →
From page 454... ... 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 Read the entire page →
From page 455... ... INDEX 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, 219222, 306 measles and, 147-148 multiple sclerosis, 36, 219, 220221, 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; GuillainBarre syndrome; Transverse myelitis Diabetes mellitus clinical description, 153 epidemiology, 153 measles vaccination and, 154, 156159 mumps vaccination and, 154- 159, 306 viral infection and, 153- 154, 155156 Diagnosis acute disseminated encephalomyelitis, 36 anaphylaxis, 60-61, 230 aseptic meningitis, 130 brachial neuritis, 54 encephalopathy, 48-50 Guillain-Barre syndrome, 37-39, 40-42, 45-46 Hib disease, 239 455 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-Barre 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 encephalomyelitis and, 83 anaphylaxis and, 100- 110 arthritis and, 95-97 biologic effects, 70-72 brachial neuritis and, 16 demyelinating diseases and, 83-86 Read the entire page →
From page 456... ... 456 development of, 69 Encephalopathy and, 72-78 erythema multiforme and, 98-99 fatalities from, 109, 110 Guillain-Barre 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-pertussistetanus vaccination; Diphtheriatetanus 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 INDEX 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-Barre 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, ~ See also Residual seizure disorder Erythema multiforme clinical description, 98 diphtheria-tetanus vaccination and, 99 hepatitis B vaccination and, 225 Read the entire page →
From page 457... ... 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 encephalomyelitis, 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-Barre 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, 246 457 clinical description, 37-39, 45, 86, 151, 200, 216, 243-244 diagnosis, 39, 40-42, 45-46 diphtheria vaccination and, 16, 8790, 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, 216219, 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 influenzas type b (Hib) , 62, 97, 236 See also Hib disease, early-onset Haemophilus influenzas 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-Barre syndrome and, 244246 thrombocytopenia and, 247-250 transverse myelitis and, 241-243 See also Hib conjugate vaccines Read the entire page →
From page 458... ... Immune system 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-Barre syndrome and, 216 219 immunization schedules, 213-214, 215 multiple sclerosis and, 220 polyarteritis and, 227 research needs, 306 sudden infant death syndrome and, 122 231, 299, 300-301 transverse myelitis and, 221, 222, 306 Hib. See Haemophilus influenzas 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-Barre syndrome and, 245, 246 immunization schedules, 237-238 See also Haemophilus influenzas 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 INDEX Hypersensitivity delayed-type, 62 diphtheria vaccination, 71 -72, 100 nonanaphylactic, 60, 229 Schick test, 71-72 I anaphylaxis, 59-61 deficiency, 64-65, 195, 291, 294, 295, 296-297, 299 disease-causing reactions in, classification of, 59 in Guillain-Barre 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 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 influence type b, 237-238, 276 hepatitis B Read the entire page →
From page 459... ... . Immunosuppressive measles encephalopathy, 129 measles vaccine-strain viral infection, 17, 291 subacute sclerosing panencephalitis and, 51-52 vaccine strain infection, risk modifying factors, 295 Measles -mumps-rubella vaccination, 5 64-65, 146, 148 Meningitis 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, 250 459 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-Barre 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 panen cephalitis, 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 . Read the entire page →
From page 460... ... . 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 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 causality, 163 clinical description, 160 measles vaccination and, 160, 163 mumps vaccination and, 160- 163 p Pancreatitis, 155 Read the entire page →
From page 461... ... . myelitis 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-Barre syndrome, 203, 204, 217 hepatitis B vaccination in anaphy laxis, 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-Barre 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 Read the entire page →
From page 462... ... , 16, 109-110 diphtheria vaccination and, 109110, 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 Read the entire page →
From page 463... ... 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 Read the entire page →
From page 464... ... 464 INDEX development of, 279 encephalopathy in, 75, 128 erythema multiforms in, 99 Guillain-Barre 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 Viral infection 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 diabetes mellitus and, 155- 156 Guillain-Barre syndrome and, 39 vaccine-strain, 17, 177, 190-195, 291, 295, 296-297 Read the entire page →

From page 451...

... 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 Expects 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, 104108 hepatitis B vaccination, 217-218, 220-221, 223, 224-226, 228, 229-230, 306 Hib vaccination, 239-241, 242, 244-246, 247, 248-249, 250-260 451 individual differences, 307 mandated reporting, 2, 49 measles-mumps -rubella vaccination, 127, 131-134, 144, 164, 165-167, 172-175 measles vaccination, 16, 17, 123129, 136-140, 147-148, 149150, 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, 104108 See also Deaths; specific adverse event

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From page 452...

... 452 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-Barre 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, 175176, 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, 100110, 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 INDEX 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, 223227 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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From page 453...

... 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-Barre 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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From page 454...

... 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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From page 455...

... INDEX 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, 219222, 306 measles and, 147-148 multiple sclerosis, 36, 219, 220221, 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; GuillainBarre syndrome; Transverse myelitis Diabetes mellitus clinical description, 153 epidemiology, 153 measles vaccination and, 154, 156159 mumps vaccination and, 154- 159, 306 viral infection and, 153- 154, 155156 Diagnosis acute disseminated encephalomyelitis, 36 anaphylaxis, 60-61, 230 aseptic meningitis, 130 brachial neuritis, 54 encephalopathy, 48-50 Guillain-Barre syndrome, 37-39, 40-42, 45-46 Hib disease, 239 455 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-Barre 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 encephalomyelitis 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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From page 456...

... 456 development of, 69 Encephalopathy and, 72-78 erythema multiforme and, 98-99 fatalities from, 109, 110 Guillain-Barre 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-pertussistetanus vaccination; Diphtheriatetanus 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 INDEX 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-Barre 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, ~ See also Residual seizure disorder Erythema multiforme clinical description, 98 diphtheria-tetanus vaccination and, 99 hepatitis B vaccination and, 225

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From page 457...

... 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 encephalomyelitis, 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-Barre 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, 246 457 clinical description, 37-39, 45, 86, 151, 200, 216, 243-244 diagnosis, 39, 40-42, 45-46 diphtheria vaccination and, 16, 8790, 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, 216219, 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 influenzas type b (Hib) , 62, 97, 236 See also Hib disease, early-onset Haemophilus influenzas 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-Barre syndrome and, 244246 thrombocytopenia and, 247-250 transverse myelitis and, 241-243 See also Hib conjugate vaccines

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From page 458...

... Immune system 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-Barre syndrome and, 216 219 immunization schedules, 213-214, 215 multiple sclerosis and, 220 polyarteritis and, 227 research needs, 306 sudden infant death syndrome and, 122 231, 299, 300-301 transverse myelitis and, 221, 222, 306 Hib. See Haemophilus influenzas 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-Barre syndrome and, 245, 246 immunization schedules, 237-238 See also Haemophilus influenzas 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 INDEX Hypersensitivity delayed-type, 62 diphtheria vaccination, 71 -72, 100 nonanaphylactic, 60, 229 Schick test, 71-72 I anaphylaxis, 59-61 deficiency, 64-65, 195, 291, 294, 295, 296-297, 299 disease-causing reactions in, classification of, 59 in Guillain-Barre 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 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 influence type b, 237-238, 276 hepatitis B

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From page 459...

... . Immunosuppressive measles encephalopathy, 129 measles vaccine-strain viral infection, 17, 291 subacute sclerosing panencephalitis and, 51-52 vaccine strain infection, risk modifying factors, 295 Measles -mumps-rubella vaccination, 5 64-65, 146, 148 Meningitis 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, 250 459 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-Barre 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 panen cephalitis, 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 .

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From page 460...

... . 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 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 causality, 163 clinical description, 160 measles vaccination and, 160, 163 mumps vaccination and, 160- 163 p Pancreatitis, 155

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From page 461...

... . myelitis 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-Barre syndrome, 203, 204, 217 hepatitis B vaccination in anaphy laxis, 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-Barre 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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From page 462...

... , 16, 109-110 diphtheria vaccination and, 109110, 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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From page 463...

... 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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From page 464...

... 464 INDEX development of, 279 encephalopathy in, 75, 128 erythema multiforms in, 99 Guillain-Barre 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 Viral infection 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 diabetes mellitus and, 155- 156 Guillain-Barre syndrome and, 39 vaccine-strain, 17, 177, 190-195, 291, 295, 296-297

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Index Pages 451-464

Index
Pages 451-464