National Academies Press: OpenBook
« Previous: Bibliography
Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×

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

Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×

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

Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×

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

Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×

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

Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×

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

Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×

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

Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×

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

Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×

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

Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×

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

Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×

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

Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×

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

Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×

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

Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×

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

Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×

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

Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×
Page 451
Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×
Page 452
Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×
Page 453
Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×
Page 454
Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×
Page 455
Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×
Page 456
Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×
Page 457
Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×
Page 458
Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×
Page 459
Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×
Page 460
Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×
Page 461
Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×
Page 462
Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×
Page 463
Suggested Citation:"Index." Institute of Medicine. 1994. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. doi: 10.17226/2138.
×
Page 464
Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality Get This Book
×
Buy Paperback | $120.00
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

Childhood immunization is one of the major public health measures of the 20th century and is now receiving special attention from the Clinton administration. At the same time, some parents and health professionals are questioning the safety of vaccines because of the occurrence of rare adverse events after immunization.

This volume provides the most thorough literature review available about links between common childhood vaccines--tetanus, diphtheria, measles, mumps, polio, Haemophilus influenzae b, and hepatitis B--and specific types of disorders or death.

The authors discuss approaches to evidence and causality and examine the consequences--neurologic and immunologic disorders and death--linked with immunization. Discussion also includes background information on the development of the vaccines and details about the case reports, clinical trials, and other evidence associating each vaccine with specific disorders.

This comprehensive volume will be an important resource to anyone concerned about the immunization controversy: public health officials, pediatricians, attorneys, researchers, and parents.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!