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Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

Index

[Page numbers followed by italic letter n or t refer to footnotes or tables.]

A

Acellular pertussis vaccine

development, 529

formulations, 530

summary of evidence and causality conclusions, 585–588t

Acute disseminated encephalomyelitis definition, 635

DTaP vaccine and, 546–547, 586t

hepatitis A vaccine and, 423–424, 431t

hepatitis B vaccine and, 440–442, 491t

human papillomavirus vaccine and, 507–508, 521t

influenza vaccine and, 308–309, 402t

mechanism(s) that may contribute to symptoms of, 154, 271, 308, 423–424, 441, 507, 547, 604

meningococcal vaccine and, 603–604, 611t

MMR vaccine and, 153–154, 219t

varicella zoster vaccine and, 271, 284t

Acute motor axonal neuropathy (AMAN), 71–72

Adjuvants, 59

mechanism of action, 59

See also Alum; ASO4

Adverse events, generally

animal models, 89–91

brain development alterations, 85–89

definition, 1n, 30n

frequency and rate determinations, 629–632

injection-related, 78–81, 615–624, 625t

limitations of data sources and findings, 629–633

mechanisms of, 57, 65, 67–68, 72–73, 74, 76

methodology for evaluation of evidence, 10–14, 40–48

prior reviews, 1–2, 29–30, 39

recognized risk, 28

reporting requirements, 29

scope of review, 2–10, 30–36

seriousness of, 632

susceptibility, 24, 54, 82–84

See also Causality

Advisory Committee on Immunization Practices

DTaP vaccination recommendations, 530

hepatitis B vaccination recommendations, 437

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

human papillomavirus vaccination recommendations, 506–507

influenza vaccination recommendations, 295–296

meningococcal vaccination recommendations, 601

MMR vaccination recommendations, 108, 242

varicella vaccination recommendations, 242

Age

as adverse event risk factor, 24, 84

human papillomavirus infection risk, 505–506

Alterations in brain development. SeeBiological mechanisms, pathophysiologies, and susceptibilities with the potential to contribute to adverse events

Alum, 59

American Academy of Family Physicians, 437, 530

American Academy of Pediatrics, 437, 530

Amyotrophic lateral sclerosis

definition, 635

human papillomavirus vaccine and, 513–515

mechanism(s) that may contribute to symptoms of, 514

Anaphylaxis

causes, 65, 66, 632

complement-mediated, 65–66

definition, 635

DTaP vaccine and, 563–565, 587t

hepatitis A vaccine and, 428–429, 431t

hepatitis B vaccine and, 18, 20t, 468–469, 492t

human papillomavirus vaccine and, 21t, 515–516, 521t

immunoglobulin E-mediated hypersensitivity in, 64–65

influenza vaccine and, 18, 20t, 341–345, 403t

limitations of data sources, 631–632

mechanism(s) that may contribute to symptoms of, 64–66

meningococcal vaccine and, 18, 20t,608–610, 611t

MMR vaccine and, 18, 20t, 169–174, 219t, 631–632

recognized risks, 28

susceptibility to, 83–84

tetanus toxoid vaccine and, 18, 20t, 565, 587t

varicella zoster vaccine and, 18, 20t, 275–278, 284t

Animal models

application of evidence from, 89–91

contribution to the weight of mechanistic evidence, 14, 45, 47

disease processes affecting the brain, 86

influenza vaccine and Guillain-Barré syndrome, 333–334

MMR vaccine and hearing loss, 153

Antibodies and autoantibodies. See Biological mechanisms, pathophysiologies, and susceptibilities with the potential to contribute to adverse events

Antigen persistence. See Biological mechanisms, pathophysiologies, and susceptibilities with the potential to contribute to adverse events

Antigen-presenting cells, 58, 59

Antigenic drift, 293

Antigenic shift, 293

Arthralgia

chronic, in women, MMR vaccine and, 190–195, 220t

definition, 635

mechanism(s) that may contribute to symptoms of, 181, 185, 194, 517

transient, human papillomavirus vaccine and, 516–517, 521t

transient, in children, MMR vaccine and, 18, 21t, 182–190, 220t

transient, in women, MMR vaccine and, 18, 21t, 174–181, 219t

Arthritis, chronic

definition, 635

mechanism(s) that may contribute to symptoms of, 198

in women, MMR vaccine and, 195–199, 220t

Arthritis, juvenile idiopathic

definition, 641

hepatitis B vaccine and, 485–488, 493t

mechanism(s) that may contribute to symptoms of, 488

MMR vaccine and, transient arthralgia in children, 184

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

Arthritis, psoriatic

definition, 643

hepatitis B vaccine, onset or exacerbation of, 479–480, 492t

Arthritis, reactive

definition, 643

hepatitis B vaccine and, 480–482, 493t

mechanism(s) that may contribute to symptoms of, 481–482

Arthritis, rheumatoid

definition, 644

hepatitis B vaccine, onset or exacerbation of, 482–485, 493t

immune complexes and, 67

mechanism(s) that may contribute to symptoms of, 485

Arthropathy

chronic, in children, MMR vaccine and, 199–200, 220t,

definition, 635

DTaP vaccine and, 567–571, 588t

influenza vaccine, onset or exacerbation of, 384–385, 403t

mechanism(s) that may contribute to symptoms of, 200, 202, 279, 385, 571

in men, MMR vaccine and, 201–204, 220t

varicella vaccine, onset or exacerbation of, 278–279, 284t

ASO4, 59

Assessment of causality

DTaP vaccine

acute disseminated encephalomyelitis, 546–547

anaphylaxis, 563–565

arthropathy, 567–571

ataxia, 544–545

autism, 545–546

Bell’s Palsy, 561–562

chronic inflammatory disseminated polyneuropathy, 558–560

chronic urticaria, 565–566

encephalitis and encephalopathy, 534–537

fibromyalgia, 581

Guillain-Barré syndrome, 557–558

immune thrombocytopenic purpura, 582–584

infantile spasms, 537–539

multiple sclerosis onset in adults, 550–553

multiple sclerosis relapse in adults, 554–555

multiple sclerosis relapse in children, 555–557

myocarditis, 579–580

opsoclonus myoclonus syndrome, 560–561

optic neuritis, 549–550

seizures, 539–544

serum sickness, 566–567

sudden infant death syndrome, 581–582

summary of evidence and causality conclusions, 22t, 585–588t, 683–687t

transverse myelitis, 547–548

type 1 diabetes, 22t, 571–579

hepatitis A vaccine

acute disseminated encephalomyelitis, 423–424

anaphylaxis, 428–429

autoimmune hepatitis, 429–430

Bell’s palsy, 427–428

chronic inflammatory disseminated polyneuropathy, 427

Guillain-Barré syndrome, 426

multiple sclerosis, 425

summary of evidence and causality conclusions, 4311, 680–681t

transverse myelitis, 424–425

hepatitis B vaccine

acute disseminated encephalomyelitis, 440–442

anaphylaxis, 468–469

brachial neuritis, 467–468

chronic inflammatory disseminated polyneuropathy, 466–467

encephalitis and encephalopathy, 437–438

erythema nodosum, 469–471

fibromyalgia, 490

first demyelinating event in adults, 458–464

first demyelinating event in children, 464–465

Guillain-Barré syndrome, 465–466

juvenile idiopathic arthritis, onset or exacerbation, 485–488

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

multiple sclerosis onset in adults, 447–450, 451–453t

sclerosis onset in children, 454–455

multiple sclerosis relapse in adults, 455–456

multiple sclerosis relapse in children, 457–458

neuromyelitis optica, 446–447

optic neuritis, 443–446

polyarteritis nodosa, onset or exacerbation, 477–479

psoriatic arthritis, onset or exacerbation, 479–480

reactive arthritis, onset or exacerbation, 480–482

rheumatoid arthritis, onset or exacerbation, 482–485

seizures, 438–440

summary of evidence and causality conclusions, 20t, 491–493t, 681–683t

systemic lupus erythematosus, onset or exacerbation, 471–473

transverse myelitis, 442–443

type 1 diabetes, 488–490

vasculitis, onset or exacerbation, 473–477

human papillomavirus vaccine

acute disseminated encephalomyelitis, 507–508

amyotrophic lateral sclerosis, 513–515

anaphylaxis, 515–516

brachial neuritis, 512–513

chronic inflammatory disseminated polyneuropathy, 512

Guillain-Barré syndrome, 511–512

hypercoagulable states, 520

multiple sclerosis, 510

neuromyelitis optica, 509

pancreatitis, 517–518

summary of evidence and causality conclusions, 21t, 521t, 683t

thromboembolic events, 519–520

transient arthralgia, 516–517

transverse myelitis, 508

influenza vaccine

acute disseminated encephalomyelitis, 308–309

all-cause mortality, 390–391

anaphylaxis, 341–345

arthropathy, onset or exacerbation, 384–385

asthma exacerbation or reactive airway disease episodes in children and adults, inactivated influenza vaccine, 345–356

asthma exacerbation or reactive airway disease episodes in children younger than 5 years of age, live attenuated influenza vaccine, 356–366

asthma exacerbation or reactive airway disease episodes in persons 5 years of age or older, live attenuated influenza vaccine, 366–373

Bell’s palsy, 335–337, 338–339t

brachial neuritis, 340

chronic inflammatory disseminated polyneuropathy, 334–335

encephalitis and encephalopathy, 296, 299–301

fibromyalgia, 389

Guillain-Barré syndrome, 321–334

multiple sclerosis onset in adults, 314–318

multiple sclerosis relapse in adults, 318–321

myocardial infarction, 387–389

neuromyelitis optica, 314

oculorespiratory syndrome, 391–401

optic neuritis, 310–313

polyarteritis nodosa, 383–384

seizures, 301–304, 305–307t

small fiber neuropathy, 340–341

stroke, 386–387

summary of evidence and causality conclusions, 20–22t, 402–404t, 678–680t

systemic lupus erythematosus, onset or exacerbation, 373–379

transverse myelitis, 309–310

vasculitis, onset or exacerbation, 379–383

injection-related adverse events

complex regional pain syndrome, 615–617

deltoid bursitis, 618–620

summary of evidence and causality conclusions, 21t, 625t, 687–688t,

syncope, 620–624

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

meningococcal vaccine

acute disseminated encephalomyelitis, 603–604

anaphylaxis, 608–610

chronic headache, 610

chronic inflammatory disseminated polyneuropathy, 607–608

encephalitis and encephalopathy, 602–603

Guillain-Barré syndrome, 606–607

multiple sclerosis, 605–606

summary of evidence and causality conclusions, 20t, 611t, 687t

transverse myelitis, 604–605

MMR vaccine

acute disseminated encephalomyelitis, 153–154

afebrile seizures, 133–137

anaphylaxis, 169–174

arthropathy in men, 201–204

ataxia, 143–144

autism, 145–153

brachial neuritis, 168–169

chronic arthralgia in women, 190–195

chronic arthritis in women, 195–199

chronic arthropathy in children, 199–200

chronic fatigue syndrome, 212–213

chronic inflammatory disseminated polyneuropathy, 166–167

encephalitis and encephalopathy, 111–119

febrile seizures, 119–132

fibromyalgia, 213–214

Guillain-Barré syndrome, 165–166

hearing loss, 214–217

hepatitis, 211–212

measles inclusion body encephalitis, 108–110

meningitis, 137–143

multiple sclerosis onset in adults, 159–164

multiple sclerosis onset in children, 164–165

neuromyelitis optica, 158–159

opsoclonus myoclonus syndrome, 167–168

optic neuritis, 156–158

summary of evidence and causality conclusions, 20–22t, 218–221t, 674–677t

transient arthralgia in children, 182–190

transient arthralgia in women, 174–181

transverse myelitis, 154–156

type 1 diabetes, 204–211

prior reviews, 1–2, 29–30, 39

process

categorization of findings, 14–18, 23–24, 48–53

contradictory evidence, 23

framework for, 10–18, 23–24, 42–53

weight-of-evidence evaluations, 10–14, 42–48

varicella zoster vaccine

acute disseminated encephalomyelitis, 271

anaphylaxis, 275–278

arthropathy, onset or exacerbation, 278–279

cerebellar ataxia, 269–270

disseminated Oka VZV with subsequent infection resulting in pneumonia, meningitis, or hepatitis, 249–256

disseminated Oka VZV without other organ involvement, 242–249

encephalopathy, 267–268

Guillain-Barré syndrome, 273–274

seizures, 268–269

small fiber neuropathy, 274–275

stroke, 279–280

summary of evidence and causality conclusions, 19–20t, 283–284t, 677–678t

thrombocytopenia, 281–282

transverse myelitis, 272–273

vaccine strain viral reactivation with subsequent infection resulting in meningitis or encephalitis, 261–267

vaccine strain viral reactivation without other organ involvement, 256–261

See also Causality

Asthma and reactive airway disease episodes

definition, 635

inactivated influenza vaccine and, 22t, 23, 345–356, 403t

live attenuated influenza vaccine and, 356–373, 403t

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

mechanism(s) that may contribute to symptoms of, 356, 366, 369, 373

Ataxia

definition, 636

DTaP vaccine and, 544–545, 585t

mechanism(s) that may contribute to symptoms of, 144

MMR vaccine and, 143–144, 218t

Attribution elements, 13, 46

Autism

definition, 636

diagnosis and biological mechanism, 57, 85–89

DTaP vaccine and, 545–546, 585t

MMR vaccine and, 21t, 23, 145–153, 218t

See also Biological mechanisms, pathophysiologies, and susceptibilities with the potential to contribute to adverse events

Autoimmune hepatitis

definition, 636

hepatitis A vaccine and, 429–430, 431t

mechanism(s) that may contribute to symptoms of, 430

Autoreactivity. See Biological mechanisms, pathophysiologies, and susceptibilities with the potential to contribute to adverse events

B

B cell response to antigen exposure, 57–58, 60, 63

Bell’s palsy

definition, 636

DTaP vaccine and, 561–562, 587t

hepatitis A vaccine and, 427–428, 431t

influenza vaccine and, 21t, 23, 335–337, 338–339t, 402t

Benefits of vaccination, 27

Biological mechanisms, pathophysiologies, and susceptibilities with the potential to contribute to adverse events

alterations in brain development, 85–86

autism, 86–89

coagulation and hypercoagulable states, 81–82

immune mediated mechanisms, 59–76

antigen persistence, 73–74

autoreactivity, 75

bystander activation, 75

complement activation, 62–64

effector functions of antibodies and autoantibodies, 60–62

effector functions of T cells, 59–60

epitope spreading, 74–75

hyperresponsiveness, 75

hypersensitivity reactions, 64–66

complement mediated hypersensitivity, 65–6

immunoglobulin E hypersensitivity, 64–65

immune complexes, 66–68

increased cytokines, 75–76

molecular mimicry, 70–73

superantigens, 76

tissue responses (fever and seizure), 68–70

increased susceptibility, 82–84

injection-related adverse events complex regional pain syndrome, 78–80

deltoid bursitis, 80

syncope, 80–81

latency between antigen exposure and peak adaptive immune response, 57–59

viral activity, 76–78

direct or primary infection, 76–77

persistent infection, 77

viral reactivation, 77–78

Bordatella pertussis

bacteria description, 528

clinical description, 529, 643

complications, 529

encephalitis and encephalopathy and, 529, 536

seizures and, 529, 544

transmission, 529

vaccine development and recommendations, 529, 530

See also Diphtheria toxoid, tetanus toxoid, and acellular pertussis antigen-containing (DTaP) vaccines

Brachial neuritis

definition, 636

hepatitis B vaccine and, 467–468, 492t

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

human papillomavirus vaccine and, 512–513, 521t

influenza vaccine and, 340, 402t

mechanism(s) that may contribute to symptoms of, 168, 340, 468, 513

MMR vaccine and, 168–169, 219t

Brain development, alterations, 85–86

Bystander activation. See Biological mechanisms, pathophysiologies, and susceptibilities with the potential to contribute to adverse events

C

Campylobacter jejuni, 72, 333, 423, 426

Canada, 18, 392–401

Cardiopulmonary disease, complications of influenza infection, 294–295

Case-control study

definition, 636

studies contributing to the weight of epidemiologic evidence, 111–112, 114–115t, 137–138, 140t, 147–148, 151–152t, 156, 160, 162–163t, 164, 201, 203t, 204–206, 208–210t, 310–311, 312t, 315, 317t, 443–444, 445t, 448, 452t, 454, 458–459, 461t, 464, 471, 488–489, 534–535, 537, 549, 550–551, 552t, 567–568, 569–570t, 572–573, 575–577t

Case-crossover study

definition, 636

studies contributing to the weight of epidemiologic evidence, 120–121, 125t, 138–139, 141t, 301–302, 305–306t, 318–319, 320t, 348–349, 354–355t, 393–394, 398t, 455–456, 554

Case-only study, definition, 637

Case reports, 12–13, 46–47, 52, 53

definition, 637

Case series, definition, 637

Causality

adverse effects versus adverse events, 1n

categories and explanations of, 14–24, 48–53

evidence convincingly supports, 15, 17–18, 49, 50–52

evidence favoring acceptance of, 15, 18–23, 49, 52–53

evidence favoring rejection of, 15, 23, 49, 53, 389n

evidence inadequate to accept or reject, 15, 23–24, 49, 53

DTaP vaccine

acute disseminated encephalomyelitis, 547

anaphylaxis, 565

arthropathy, 571

ataxia, 545

autism, 546

Bell’s Palsy, 562

chronic inflammatory disseminated polyneuropathy, 560

chronic urticaria, 566

encephalitis and encephalopathy, 537

fibromyalgia, 581

Guillain-Barré syndrome, 558

immune thrombocytopenic purpura, 584

infantile spasms, 539

multiple sclerosis onset in adults, 553

multiple sclerosis relapse in adults, 555

multiple sclerosis relapse in children, 557

myocarditis, 580

opsoclonus myoclonus syndrome, 561

optic neuritis, 550

seizures, 544

serum sickness, 567

sudden infant death syndrome, 582

summary of evidence and causality conclusions, 22t, 585–588t, 683–687t

transverse myelitis, 548

type 1 diabetes, 579

finding of no causal relationship, 15, 49

hepatitis A vaccine

acute disseminated encephalomyelitis, 424

anaphylaxis, 429

autoimmune hepatitis, 430

Bell’s palsy, 428

chronic inflammatory disseminated polyneuropathy, 427

Guillain-Barré syndrome, 426

multiple sclerosis, 425

summary of evidence and causality conclusions, 431t, 680–681t

transverse myelitis, 425

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

hepatitis B vaccine

acute disseminated encephalomyelitis, 442

anaphylaxis, 469

brachial neuritis, 468

chronic inflammatory disseminated polyneuropathy, 467

encephalitis and encephalopathy, 438

erythema nodosum, 471

fibromyalgia, 490

first demyelinating event in adults, 463

first demyelinating event in children, 465

Guillain-Barré syndrome, 466

juvenile idiopathic arthritis, onset or exacerbation, 488

multiple sclerosis onset in adults, 450

multiple sclerosis onset in children, 455

multiple sclerosis relapse in adults, 456

multiple sclerosis relapse in children, 458

neuromyelitis optica, 447

optic neuritis, 446

polyarteritis nodosa, onset or exacerbation, 479

psoriatic arthritis, onset or exacerbation, 480

reactive arthritis, onset or exacerbation, 482

rheumatoid arthritis, onset or exacerbation, 485

seizures, 440

summary of evidence and causality conclusions, 20t, 491–493t, 681–683t

systemic lupus erythematosus, onset or exacerbation, 473

transverse myelitis, 443

type 1 diabetes, 490

vasculitis, onset or exacerbation, 477

human papillomavirus vaccine

acute disseminated encephalomyelitis, 508

amyotrophic lateral sclerosis, 515

anaphylaxis, 516

brachial neuritis, 513

chronic inflammatory disseminated polyneuropathy, 512

Guillain-Barré syndrome, 512

hypercoagulable states, 520

multiple sclerosis, 510

neuromyelitis optica, 509

pancreatitis, 518

summary of evidence and causality conclusions, 21t, 521t, 683t

thromboembolic events, 520

transient arthralgia, 517

transverse myelitis, 508

influenza vaccine

acute disseminated encephalomyelitis, 309

all-cause mortality, 391

anaphylaxis, 345

arthropathy, onset or exacerbation, 385

asthma exacerbation or reactive airway disease episodes in children and adults, inactivated influenza vaccine, 356

asthma exacerbation or reactive airway disease episodes in children younger than 5 years of age, live attenuated influenza vaccine, 366

asthma exacerbation or reactive airway disease episodes in persons 5 years of age or older, live attenuated influenza vaccine, 373

Bell’s palsy, 337

brachial neuritis, 340

chronic inflammatory disseminated polyneuropathy, 335

encephalitis, 299

encephalopathy, 301

fibromyalgia, 389

Guillain-Barré syndrome, 334

multiple sclerosis onset in adults, 318

multiple sclerosis relapse in adults, 321

myocardial infarction, 389

neuromyelitis optica, 314

oculorespiratory syndrome, 401

optic neuritis, 313

polyarteritis nodosa, 384

seizures, 304

small fiber neuropathy, 341

stroke, 386

summary of evidence and causality conclusions, 20–22t, 402–404t, 678–680t

systemic lupus erythematosus, onset or exacerbation, 379

transverse myelitis, 310

vasculitis, onset or exacerbation, 383

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

injection-related adverse events

complex regional pain syndrome, 617

deltoid bursitis, 620

summary of evidence and causality conclusions, 21t, 625t, 678–680t,

syncope, 624

limitations of data sources and findings, 629–633

meningococcal vaccine

acute disseminated encephalomyelitis, 604

anaphylaxis, 610

chronic headache, 610

chronic inflammatory disseminated polyneuropathy, 608

encephalitis and encephalopathy, 603

Guillain-Barré syndrome, 607

multiple sclerosis, 606

summary of evidence and causality conclusions, 20t, 611t, 687t

transverse myelitis, 605

MMR vaccine

acute disseminated encephalomyelitis, 154

afebrile seizures, 137

anaphylaxis, 174

arthropathy in men, 204

ataxia, 144

autism, 153

brachial neuritis, 169

chronic arthralgia in women, 195

chronic arthritis in women, 199

chronic arthropathy in children, 200

chronic fatigue syndrome, 213

chronic inflammatory disseminated polyneuropathy, 167

encephalitis, 118

encephalopathy, 119

febrile seizures, 132

fibromyalgia, 214

Guillain-Barré syndrome, 166

hearing loss, 217

hepatitis, 212

measles inclusion body encephalitis, 110

meningitis, 143

multiple sclerosis onset in adults, 164

multiple sclerosis onset in children, 165

neuromyelitis optica, 159

opsoclonus myoclonus syndrome, 168

optic neuritis, 158

summary of evidence and causality conclusions, 20–22t, 218–221t, 674–677t

transient arthralgia in children, 190

transient arthralgia in women, 181

transverse myelitis, 156

type 1 diabetes, 211

summary of evidence and causality conclusions, 19–221, 674–748t

DTaP vaccine and, 585–588t

hepatitis A vaccine and, 431t

hepatitis B vaccine and, 491–493t

human papillomavirus vaccine and, 521t

influenza vaccine and, 402–404t

injection related adverse events and, 625t

meningococcal vaccine and, 611t

MMR vaccine and, 218–221t

varicella vaccine and, 283–284t

varicella zoster vaccine

acute disseminated encephalomyelitis, 271

anaphylaxis, 278

arthropathy, onset or exacerbation, 279

cerebellar ataxia, 270

disseminated Oka VZV with subsequent infection resulting in pneumonia, meningitis, or hepatitis, 256

disseminated Oka VZV without other organ involvement, 249

encephalopathy, 268

Guillain-Barré syndrome, 274

seizures, 269

small fiber neuropathy, 275

stroke, 280

summary of evidence and causality conclusions, 19–20t, 283–284t, 677–678t,

thrombocytopenia, 282

transverse myelitis, 273

vaccine strain viral reactivation with subsequent infection resulting in meningitis or encephalitis, 267

vaccine strain viral reactivation without other organ involvement, 261

See also Assessment of causality

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

Centers for Disease Control and Prevention, 2, 29, 30

Cephalic tetanus, 527–528

Cerebellar ataxia

definition, 637

mechanism(s) that may contribute to symptoms of, 270

varicella zoster vaccine and, 269–270, 284t

Chemotherapy, 73, 82, 241, 246–248, 253, 254–255, 260, 264, 265

Chronic fatigue syndrome

definition, 637

MMR vaccine and, 212–213, 221t

Chronic inflammatory disseminated polyneuropathy

definition, 637

DTaP vaccine and, 558–560, 587t

hepatitis A vaccine and, 427, 431t

hepatitis B vaccine and, 466–467, 492t

human papillomavirus vaccine and, 512, 521t

influenza vaccine and, 334–335, 402t

mechanism(s) that may contribute to symptoms of, 167, 335, 427, 467, 512, 560, 608

meningococcal vaccine and, 607–608, 611t

MMR vaccine and, 166–167, 219t

Chronic urticaria

definition, 637

DTaP vaccine and, 565–566, 587t

mechanism(s) that may contribute to symptoms of, 565

Clostridium tetani

bacteria description, 527

Bell’s palsy and, 562

clinical description, 527, 645

complications, 527–528

incidence, 528

transmission, 527

vaccine development and recommendations, 528, 530

See also Diphtheria toxoid, tetanus toxoid, and acellular pertussis antigen-containing (DTaP) vaccines

Coagulation and hypercoagulable states. See Biological mechanisms, pathophysiologies, and susceptibilities with the potential to contribute to adverse events

Cohort studies

contributing to the weight of epidemiologic evidence, 322–323, 328t, 374, 375, 3761, 377t, 438–439, 535, 540, 542t, 561, 574, 578t,

definition, 637–638

prospective cohort studies contributing to the weight of epidemiologic evidence, 374, 376–377t,482–483

retrospective cohort studies contributing to the weight of epidemiologic evidence, 111, 114t, 120, 121–122, 125–127t, 133–134, 135–136t, 138, 140–141t, 146, 151t, 174–175, 177–178t, 183, 184, 187t, 189t, 190, 192t, 195, 197t, 201, 203t, 206, 210t, 250–251, 262, 268, 275, 279, 303, 307t, 323, 325–326, 329t, 331–332t, 336–337, 339t, 341, 358–359, 363–364t, 367, 371–372t, 379, 381t, 390, 457, 540–541, 543t, 555–556, 573–574, 577t, 606–607, 618

Compensation for adverse events

for effects of vaccines not on Vaccine Injury Table, 29, 30

legislation in support of, 1, 28, 29

Complement activation. See Biological mechanisms, pathophysiologies, and susceptibilities with the potential to contribute to adverse events

Complement-mediated hypersensitivity. See Biological mechanisms, pathophysiologies, and susceptibilities with the potential to contribute to adverse events

Complex regional pain syndrome

definition, 638

injection-related, 78–80, 615–617, 625t

See also Biological mechanisms, pathophysiologies, and susceptibilities with the potential to contribute to adverse events

Confounding variables, definition, 638

Consumer education, legislation in support of, 1, 28–29

Contradictory evidence, 23, 53

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

Convulsion. See Febrile seizures; Seizures

Corynebacterium diphtheriae

bacteria description, 525

Bell’s palsy and, 562

clinical description, 525–526, 638–639

complications, 526

encephalitis and encephalopathy and, 526, 536

myocarditis and, 526, 580

transmission, 525

vaccine development and recommendations, 526, 530

See also Diphtheria toxoid, tetanus toxoid, and acellular pertussis antigen-containing (DTaP) vaccines

Countermeasures Injury Compensation Program, 2n

Critical periods, 84

Crossover experiment, definition, 638

Cytokine storm, 75–76

D

Defense Medical Surveillance System, 310–311, 312t, 444, 445t, 461t

Deltoid bursitis

definition, 80, 638

injection of vaccine and, 18, 21t, 618–620, 625t

See also Biological mechanisms, pathophysiologies, and susceptibilities with the potential to contribute to adverse events

Demyelination, definition, 638

Department of Health and Human Services

National Vaccine Program Office, 29

prior reviews of adverse events, 1–2, 29–30

Developmental problems, brain development, 85–89

Diabetes, type 1

definition, 641

DTaP vaccine and, 22t, 571–579, 588t

evidence favoring rejection of vaccine causality, 23

hepatitis B vaccine and, 488–490, 493t

mechanism(s) that may contribute to symptoms of, 211, 489, 571

MMR vaccine and, 22t, 204–211, 220t

molecular mimicry, 71

mumps and, 105, 211

Diabetes mellitus, insulin-dependent. See Diabetes, type 1

Diphtheria toxoid, tetanus toxoid, and acellular pertussis antigen-containing (DTaP) vaccines

acute disseminated encephalomyelitis, 546–547

anaphylaxis, 563–565

arthropathy, 567–571

ataxia, 544–545

autism, 545–546

Bell’s Palsy, 561–562

booster vaccinations, 530

as cause of adverse events. See Causality, DTaP vaccine

chronic inflammatory disseminated polyneuropathy, 558–560

chronic urticaria, 565–566

development of, 526

effectiveness, 526, 528

encephalitis and encephalopathy, 534–537

fibromyalgia, 581

formulations and dosages, 530, 531–533t

Guillain-Barré syndrome, 557–558

immune thrombocytopenic purpura, 582–584

infantile spasms, 537–539

multiple sclerosis onset in adults, 550–553

multiple sclerosis relapse in adults, 554–555

multiple sclerosis relapse in children, 555–557

myocarditis, 579–580

opsoclonus myoclonus syndrome, 560–561

optic neuritis, 10, 36, 549–550

prior reviews into adverse events, 1–2, 30

seizures, 539–544

serum sickness, 566–567

sudden infant death syndrome, 581–582

transverse myelitis, 547–548

type 1 diabetes, 23, 571–579

summary of evidence and causality conclusions, 20t, 22t, 585–588t, 683–687t

vaccination rates, 530

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

with whole cell pertussis component, 2, 30, 84, 529, 530

See also Acellular pertussis vaccine; Pertussis vaccine, whole cell; Tetanus toxoid-containing vaccines

Double blind controlled crossover study

studies contributing to the weight of epidemiologic evidence, 182–183, 186t

Double blind randomized controlled crossover trial

studies contributing to the weight of epidemiologic evidence, 345–346, 347, 351–352t, 353t

DTaP. See Diphtheria toxoid, tetanus-toxoid, and acellular pertussis antigen-containing vaccines

E

Egg sensitivity, 83, 170–172, 277, 342–343, 344, 632

Embolism, definition, 639

Encephalitis and encephalopathy autism and, 85, 88–89

as Bordetella pertussis infection complication, 529, 536

as Corynebacterium diphtheriae infection complication, 526, 536

definition, 639

DTaP vaccine and, 534–537, 585t

genetic risk, 84, 85, 88–89

hepatitis B vaccine and, 437–438, 491t

as influenza infection complication, 299

influenza vaccine and, 296, 299–301, 402t

as measles infection complication, 77, 103, 117, 118

mechanism(s) that may contribute to symptoms of, 117, 119, 266, 267, 299, 300, 537, 603

meningococcal vaccine and, 602–603, 611t

MMR vaccine and, 111–119, 218t

as mumps infection complication, 105, 117, 118

as rubella infection complication, 77, 106–107, 117

varicella vaccine and, 262–263, 265–266, 267–268, 283t

as varicella zoster virus complication, 266

See also Measles inclusion body encephalitis

Encephalomyelitis, acute disseminated. See Acute disseminated encephalomyelitis

Epidemiologic evidence

categorization of causality based on, 10, 12, 14–18, 23–24, 42–45, 48–53

DTaP vaccine

acute disseminated encephalomyelitis, 546

anaphylaxis, 563

arthropathy, 567–578, 569–570t,

ataxia, 544–545

autism, 545

Bell’s Palsy, 561–562

chronic inflammatory disseminated polyneuropathy, 558

chronic urticaria, 565

encephalitis and encephalopathy, 534–535

fibromyalgia, 581

Guillain-Barré syndrome, 557

immune thrombocytopenic purpura, 582–583

infantile spasms, 537–538

multiple sclerosis onset in adults, 550–553

multiple sclerosis relapse in adults, 554

multiple sclerosis relapse in children, 555–556

myocarditis, 579

opsoclonus myoclonus syndrome, 560

optic neuritis, 549

seizures, 539–541, 542–543t

serum sickness, 566

sudden infant death syndrome, 581–582

summary of evidence and causality conclusions, 22t, 585–588t, 683–687t

transverse myelitis, 547–548

type 1 diabetes, 571–579

for evaluation of causality, 39–40

hepatitis A vaccine

acute disseminated encephalomyelitis, 423

anaphylaxis, 428

autoimmune hepatitis, 429

Bell’s palsy, 427

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

chronic inflammatory disseminated polyneuropathy, 427

Guillain-Barré syndrome, 426

multiple sclerosis, 425

summary of evidence and causality conclusions, 431t, 680–681t

transverse myelitis, 424

hepatitis B vaccine

acute disseminated encephalomyelitis, 440

anaphylaxis, 468

brachial neuritis, 467

chronic inflammatory disseminated polyneuropathy, 466–467

encephalitis and encephalopathy, 437

erythema nodosum, 469

fibromyalgia, 490

first demyelinating event in adults, 458–460,461–462t

first demyelinating event in children, 464–465

Guillain-Barré syndrome, 465–466

juvenile idiopathic arthritis, onset or exacerbation, 485–486

multiple sclerosis, onset in adults, 447–450, 451–453t

multiple sclerosis, onset in children, 454

multiple sclerosis, relapse in adults, 455–456

multiple sclerosis, relapse in children, 457

neuromyelitis optica, 446

optic neuritis, 443–444, 445t

polyarteritis nodosa, onset or exacerbation, 477

psoriatic arthritis, onset or exacerbation, 479–480

reactive arthritis, onset or exacerbation, 480

rheumatoid arthritis, onset or exacerbation, 482–483

seizures, 438–439

summary of evidence and causality conclusions, 20t, 491–493t, 681–683t

systemic lupus erythematosus onset or exacerbation, 471–472

transverse myelitis, 442

type 1 diabetes, 488–489

vasculitis, onset or exacerbation, 473

human papillomavirus vaccine

acute disseminated encephalomyelitis, 507

amyotrophic lateral sclerosis, 513

anaphylaxis, 515

brachial neuritis, 512–513

chronic inflammatory disseminated polyneuropathy, 512

Guillain-Barré syndrome, 511

hypercoagulable states, 520

multiple sclerosis, 510

neuromyelitis optica, 509

pancreatitis, 517–518

summary of evidence and causality conclusions, 21t, 521t, 683t

thromboembolic events, 519

transient arthralgia, 516–517

transverse myelitis, 508

influenza vaccine

acute disseminated encephalomyelitis, 308

all-cause mortality, 390

anaphylaxis, 341–342

arthropathy, onset or exacerbation, 384

asthma exacerbation or reactive airway disease episodes in children and adults, inactivated influenza vaccine, 345–350, 351–355t

asthma exacerbation or reactive airway disease episodes in children younger than 5 years of age, live attenuated influenza vaccine, 356–361, 362–365t

asthma exacerbation or reactive airway disease episodes in persons 5 years of age or older, live attenuated influenza vaccine, 366–369, 370–372t

Bell’s palsy, 335–337, 338–339t

brachial neuritis, 340

chronic inflammatory disseminated polyneuropathy, 334

encephalitis and encephalopathy, 296

fibromyalgia, 389

Guillain-Barré syndrome, 321–327, 328–332t

multiple sclerosis, onset in adults, 314–316, 317t

multiple sclerosis, relapse in adults, 318–319, 320t

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

myocardial infarction, 387–388

neuromyelitis optica, 314

oculorespiratory syndrome, 391–398

optic neuritis, 310–311, 312t

polyarteritis nodosa, 383

seizures, 301–304, 305–307t

small fiber neuropathy, 340–341

stroke, 386

summary of evidence and causality conclusions, 20–221, 402–404t, 678–680t

systemic lupus erythematosus, onset or exacerbation, 373–375, 376–377t

transverse myelitis, 309

vasculitis, onset or exacerbation, 379–380, 381t

injection-related outcomes

complex regional pain syndrome, 615

deltoid bursitis, 618

summary of evidence and causality conclusions, 21t, 625t, 687–688t,

syncope, 620

limitations of current data, 630

meningococcal vaccine

acute disseminated encephalomyelitis, 603–604

anaphylaxis, 608–609

chronic headache, 610

chronic inflammatory disseminated polyneuropathy, 607–608

encephalitis and encephalopathy, 602–603

Guillain-Barré syndrome, 606–607

multiple sclerosis, 605

summary of evidence and causality conclusions, 20t, 611t, 687t

transverse myelitis, 604

MMR vaccine

acute disseminated encephalomyelitis, 153

afebrile seizures, 133–134, 135–136t

anaphylaxis, 169

arthropathy in men, 201–202, 203t

ataxia, 143

autism, 145–148, 149–152t

brachial neuritis, 168

chronic arthralgia in women, 190–191, 192t

chronic arthritis in women, 195–196, 197t

chronic arthropathy in children, 199

chronic fatigue syndrome, 212–213

chronic inflammatory disseminated polyneuropathy, 166–167

encephalitis and encephalopathy, 111–113, 114–115t

febrile seizures, 119–124, 125–130t,

fibromyalgia, 213

Guillain-Barré syndrome, 165

hearing loss, 214

hepatitis, 211

measles inclusion body encephalitis, 108

meningitis, 137–139, 140–141t

multiple sclerosis, onset in adults, 159–161,162–163t

multiple sclerosis, onset in children, 164

neuromyelitis optica, 158

opsoclonus myoclonus syndrome, 167

optic neuritis, 156

summary of evidence and causality conclusions, 20–22t, 218–221t, 674–677t

transient arthralgia in children, 182–185,186–189t

transient arthralgia in women, 174–176, 177–179t

transverse myelitis, 154

type 1 diabetes, 204–207, 208–210t

varicella zoster vaccine

acute disseminated encephalomyelitis, 271

anaphylaxis, 275

arthropathy, onset or exacerbation, 278

cerebellar ataxia, 269–270

disseminated Oka VZV with subsequent infection resulting in pneumonia, meningitis, or hepatitis, 250–251

disseminated Oka VZV without other organ involvement, 243

encephalopathy, 267

Guillain-Barré syndrome, 273

seizures, 268

small fiber neuropathy, 274

stroke, 279–280

summary of evidence and causality conclusions, 19t, 20t, 283–284t, 677–678t

thrombocytopenia, 281

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

transverse myelitis, 272

vaccine strain viral reactivation with subsequent infection resulting in meningitis or encephalitis, 262–263

vaccine strain viral reactivation without other organ involvement, 256–257

weight-of-evidence evaluations, 10, 12, 42–45

Epilepsy, myoclonic, definition, 642

Epitope spreading. See Biological mechanisms, pathophysiologies, and susceptibilities with the potential to contribute to adverse events Erythema nodosum

definition, 639

hepatitis B vaccine and, 10, 36, 469–471, 492t

mechanism(s) that may contribute to symptoms of, 470

F

Febrile seizures

clinical significance, 630

definition, 639

influenza infection, 294

mechanism(s) that may contribute to symptoms of, 132

MMR vaccine and, 18, 20t, 119–132, 218t, 630

tissue responses, 68–70

Fibromyalgia

DTaP vaccine and, 581, 588t

hepatitis

hepatitis B vaccine and, 490, 493t

influenza vaccine and, 389, 404t

MMR vaccine and, 213–214, 221t

First demyelinating event

hepatitis B vaccine and, in adults, 458–460, 461–462t, 491t

hepatitis B vaccine and, in children, 464–465, 492t

mechanism(s) that may contribute to symptoms of, 463, 465

Food and Drug Administration, 29

Food hypersensitivity reactions, 65, 171–173

See also Egg sensitivity; Gelatin

G

Gelatin, 83, 171–173, 276–277, 342–344, 632

Gender differences

as susceptibility factor, 84

General Practice Research Database, 147, 151t, 315, 317t, 323–325, 329–330t, 336, 338t, 344, 346, 352t, 386, 387–388, 448–449, 452t, 551, 552t

Genetic risk factors

autism, 87–88

febrile seizures, 69–70

neuronal development, 85, 86

susceptibility to adverse events, 24, 83–84

German measles. See Rubivirus (rubella infection)

Guillain-Barré syndrome

acute motor axonal neuropathy in, 71–72

definition, 639

DTaP vaccine and, 557–558, 587t

evaluation of adverse event data, 47

hepatitis A vaccine and, 426, 431t

hepatitis B vaccine and, 465–466, 492t

human papillomavirus vaccine and, 511–512, 521t

influenza vaccine and, 321–334, 402t

mechanism(s) that may contribute to symptoms of, 166, 274, 334, 426, 466, 511, 558, 607

meningococcal vaccine and, 606–607, 611t

MMR vaccine and, 165–166, 219t

swine influenza vaccine and, 321n

varicella zoster vaccine and, 273–274, 284t

H

H1N1 vaccine, 2n, 30

H5N1 vaccine, 294

Haemophilus influenzae type B vaccine, 2, 30

Health Resources and Services Administration, 2, 29, 30, 36

Hearing loss

definition, 639

mechanism(s) that may contribute to symptoms of, 217

MMR vaccine and, 214–217, 221t

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

Hemagglutinin surface proteins, 294

Hepatitis, as an adverse event of vaccination

definition, 639

mechanism(s) that may contribute to symptoms of, 212, 256

MMR vaccine and, 211–212, 221t

varicella vaccine and, 251, 254–256, 283t

Hepatitis A infection

acute disseminated encephalomyelitis and, 423

autoimmune hepatitis and, 421–422, 430

clinical description, 421–422, 640

complications, 421–422

Guillain-Barré syndrome and, 426

transmission, 422

transverse myelitis and, 424

vaccine development, 422

virus description, 421

Hepatitis A vaccine

acute disseminated encephalomyelitis, 423–424

anaphylaxis, 428–429

autoimmune hepatitis, 429–430

Bell’s palsy, 427–428

as cause of adverse events. See Causality, hepatitis A vaccine

chronic inflammatory disseminated polyneuropathy, 427

development, 422

formulations, 422–423

Guillain-Barré syndrome, 426

multiple sclerosis, 425

summary of evidence and causality conclusions, 431t, 680–681t

transverse myelitis, 424–425

Hepatitis B infection

clinical description, 435–436, 640

complications, 435–436

onset or exacerbation of juvenile idiopathic arthritis and, 435, 487

onset or exacerbation of polyarteritis nodosa and, 435, 478–479

onset or exacerbation of rheumatoid arthritis and, 435, 484

onset or exacerbation of vasculitis and, 435, 476

transmission, 435

vaccine development and recommendations, 436–437

virus description, 435

Hepatitis B vaccine

acute disseminated encephalomyelitis, 440–442

anaphylactic reactions, 18

anaphylaxis, 468–469

brachial neuritis, 467–468

as cause of adverse events. See Causality, hepatitis B vaccine

chronic inflammatory disseminated polyneuropathy, 466–467

cytokine imbalance and, 76

development, 436

encephalitis and encephalopathy, 437–438

erythema nodosum, 10, 36, 469–471

fibromyalgia, 490

first demyelinating event in adults, 458–464

first demyelinating event in children, 464–465

formulations, 436–437

Guillain-Barré syndrome, 465–466

immune complex-mediated effects, 68

injection-related adverse events, 616

juvenile idiopathic arthritis, onset or exacerbation, 485–488

multiple sclerosis onset in adults, 447–450, 451–453t

multiple sclerosis onset in children, 454–455

multiple sclerosis relapse in adults, 455–456

multiple sclerosis relapse in children, 457–458

neuromyelitis optica, 446–447

optic neuritis, 10, 36, 443–446

polyarteritis nodosa, onset or exacerbation, 477–479

prior reviews into adverse events, 2, 30

psoriatic arthritis, onset or exacerbation, 479–480

reactive arthritis, onset or exacerbation, 480–482

rheumatoid arthritis, onset or exacerbation, 482–485

seizures, 438–440

summary of causality studies and conclusions, 20t, 491–493t, 681–683t

systemic lupus erythematosus onset or exacerbation, 471–473

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

transverse myelitis, 442–443

type 1 diabetes, 488–490

vasculitis, onset or exacerbation, 473–477

Herd immunity, 28

Herpes zoster

cause, 240

definition, 640

mechanism(s) that may contribute to symptoms of, 261

rate, 631

varicella vaccine and, 256–267, 283t

Human papillomavirus infection clinical description, 506, 640

complications, 506

nomenclature, 505

transmission, 505

vaccine development and recommendations, 506–507

virus description, 505, 640

Human papillomavirus vaccine

acute disseminated encephalomyelitis, 507–508

amyotrophic lateral sclerosis, 513–515

anaphylaxis, 18, 515–516

brachial neuritis, 512–513

as cause of adverse events. See Causality, human papillomavirus vaccine

chronic inflammatory disseminated polyneuropathy, 512

current formulations, 506

cytokine imbalance and, 76

development, 506

Guillain-Barré syndrome, 511–512

hypercoagulable states, 520

multiple sclerosis, 510

neuromyelitis optica, 509

pancreatitis, 517–518

prevalence of use, 507

recommendations for, 506–507

summary of evidence and causality conclusions, 21t, 521t, 683t

thromboembolic

thromboembolic events, 519–520

transient arthralgia, 516–517

transverse myelitis, 508

Hypercoagulable states

definition, 640

mechanism

human papillomavirus vaccine and, 520, 521t

mechanism(s) that may contribute to symptoms of, 520

Hyperresponsiveness. See Biological mechanisms, pathophysiologies, and susceptibilities with the potential to contribute to adverse events

Hypersensitivity reactions. See Biological mechanisms, pathophysiologies, and susceptibilities with the potential to contribute to adverse events

I

Immune complexes. See Biological mechanisms, pathophysiologies, and susceptibilities with the potential to contribute to adverse events

Immune thrombocytopenic purpura

definition, 640

DTaP vaccine and, 582–584, 588t

mechanism(s) that may contribute to symptoms of, 583

Immunocompromised individuals complications of varicella zoster infection, 240

influenza vaccine recommendations in, 296

measles inclusion body encephalitis and MMR vaccine, 109–110

meningococcal disease, 600

treatment of varicella zoster infection in, 241

varicella vaccine and, 241–242, 244–249, 252–256, 258–262, 264–265, 630–631

Immunoglobulin E hypersensitivity. See Biological mechanisms, pathophysiologies, and susceptibilities with the potential to contribute to adverse events

Increased cytokines. See Biological mechanisms, pathophysiologies, and susceptibilities with the potential to contribute to adverse events

Increased susceptibility. See Biological mechanisms, pathophysiologies, and susceptibilities with the potential to contribute to adverse events

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

Infant mortality, historical evolution, 27

Infantile spasms

definition, 640

DTaP vaccine and, 537–539, 585t

Influenza infection

acute disseminated encephalomyelitis, 308

all-cause mortality, 391

asthma exacerbation and, 295, 356, 366, 369

clinical description, 294–295, 641

complications, 294–295

encephalitis and, 299

Guillain-Barré syndrome, 333

mutagenesis, 293

myocardial infarction, 388

nomenclature, 293–294

onset or exacerbation of arthropathy and, 385

transmission, 294

transverse myelitis and, 309

vaccine development and recommendations, 295–296

virus description, 293–294

Influenza vaccine

acute disseminated encephalomyelitis, 308–309

all-cause mortality, 390–391

anaphylaxis, 18, 341–345

arthropathy, onset or exacerbation, 384–385

asthma exacerbation or reactive airway disease episodes in children and adults, inactivated influenza vaccine, 23, 345–356

asthma exacerbation or reactive airway disease episodes in children younger than 5 years of age, live attenuated influenza vaccine, 356–366

asthma exacerbation or reactive airway disease episodes in persons 5 years of age or older, live attenuated influenza vaccine, 366–373

Bell’s palsy, 23, 335–337, 338–339t

brachial neuritis, 340

Campylobacter jejuni contamination, 333

as cause of adverse events. See Causality, influenza vaccine chronic inflammatory disseminated polyneuropathy, 334–335

development of, 295

encephalitis and encephalopathy, 296, 299–301

fibromyalgia, 389

formulations, 295

Guillain-Barré syndrome, 321–334

H1N1, 2n

multiple sclerosis onset in adults, 314–318

multiple sclerosis relapse in adults, 318–321

myocardial infarction, 387–389

neuromyelitis optica, 314

oculorespiratory syndrome, 18, 391–401, 632

optic neuritis, 18, 36, 310–313

polyarteritis nodosa, 383–384

recommendations for administration, 295–296

seizures, 2, 36, 301–304, 305–307t

small fiber neuropathy, 340–341

stroke, 386–387

summary of evidence and causality conclusions, 20–221, 402–404t, 678–680t

systemic lupus erythematosus onset or exacerbation, 373–379

transverse myelitis, 309–310

trivalent, definition, 295–296

vaccination rates, 296

vasculitis, onset or exacerbation, 379–383

Injection of vaccine,

as cause of adverse event, evidence convincingly supporting, 18

as cause of adverse events. See Causality, injection-related adverse events

complex regional pain syndrome, 78–80, 615–617

deltoid bursitis, 80, 618–620, 632

summary of evidence and causality conclusions, 21t, 625t, 687–688t

syncope, 80–81, 620–624, 632

Institute of Medicine, 1–2, 29–30, 39

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

L

Latency between antigen exposure and peak adaptive immune response. See Biological mechanisms, pathophysiologies, and susceptibilities with the potential to contribute to adverse events

Lockjaw, 527

M

Manufacturers of vaccine, legislative relief from tort liablity, 1, 28

Measles, mumps, and rubella (MMR) vaccine

acute disseminated encephalomyelitis, 153–154

afebrile seizures, 133–137

anaphylaxis, 18, 169–174, 631–632

arthropathy in men, 201–204

ataxia, 143–144

autism, 23, 88, 145–153

brachial neuritis, 168–169

causality conclusions. See Causality, MMR vaccine

chronic arthralgia in women, 190–195

chronic arthritis in women, 195–199

chronic arthropathy in children, 199–200

chronic fatigue syndrome, 212–213

chronic inflammatory disseminated polyneuropathy, 166–167

cytokine imbalance and, 76

encephalitis and encephalopathy, 111–119

febrile seizures, 18, 119–132, 630

fibromyalgia, 213–214

formulation, 107–108

Guillain-Barré syndrome, 165–166

hearing loss, 214–217

hepatitis, 211–212

measles inclusion body encephalitis, 18, 108–110

measles virus strain, 104

meningitis, 10, 36, 137–143

multiple sclerosis onset in adults, 159–164

multiple sclerosis onset in children, 164–165

mumps virus strain, 106

neuromyelitis optica, 10, 36, 158–159

opsoclonus myoclonus syndrome, 167–168

optic neuritis, 2–10, 36, 156–158

prior reviews into adverse events, 1–2, 30

rubella virus strain, 107

summary of evidence and causality conclusions, 20–221, 218–221t, 674–677t

transient arthralgia in children, 18, 182–190

transient arthralgia in women, 174–181

transverse myelitis, 154–156

type 1 diabetes, 23, 204–211

Measles, mumps, rubella, and varicella vaccine, 108, 242

Measles inclusion body encephalitis

definition, 641

mechanism(s) that may contribute to symptoms of, 110

MMR vaccine and, 18, 20t, 108–110, 218t

Measles infection

acute disseminated encephalomyelitis, 154

ataxia and, 144

clinical description, 103, 641

complications, 103

encephalitis and, 103, 117

encephalopathy and, 118

febrile seizures and, 132

Guillain-Barré syndrome and, 166

hearing loss and, 216

hepatitis and, 104, 212

measles inclusion body encephalitis and, 110

optic neuritis and, 157

transmission, 103

transverse myelitis and, 155

vaccine development and recommendations, 104, 108

virus description, 103

See also Measles, mumps, and rubella (MMR) vaccine

Mechanistic evidence

categorization of causality based on, 12–14,45–48

DTaP vaccine

acute disseminated encephalomyelitis, 546–547

anaphylaxis, 563–565

arthropathy, 571

ataxia, 545

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

autism, 546

Bell’s Palsy, 562

chronic inflammatory disseminated polyneuropathy, 559–560

chronic urticaria, 565–566

encephalitis and encephalopathy, 536–537

fibromyalgia, 581

Guillain-Barré syndrome, 557–558

immune thrombocytopenic purpura, 583

infantile spasms, 538

multiple sclerosis onset in adults, 553

multiple sclerosis relapse in adults, 554–555

multiple sclerosis relapse in children, 556–557

myocarditis, 580

opsoclonus myoclonus syndrome, 561

optic neuritis, 549–550

seizures, 541, 544

serum sickness, 566–567

sudden infant death syndrome, 582

summary of evidence and causality conclusions, 22t, 585–588t, 683–687t

transverse myelitis, 548

type 1 diabetes, 579

hepatitis A vaccine

acute disseminated encephalomyelitis, 423–424

anaphylaxis, 428–429

autoimmune hepatitis, 429–430

Bell’s palsy, 428

chronic inflammatory disseminated polyneuropathy, 427

Guillain-Barré syndrome, 426

multiple sclerosis, 425

summary of evidence and causality conclusions, 4311, 680–681t

transverse myelitis, 424

hepatitis B vaccine

acute disseminated encephalomyelitis, 440–441

anaphylaxis, 468–469

brachial neuritis, 467–468

chronic inflammatory disseminated polyneuropathy, 467

encephalitis and encephalopathy, 438

erythema nodosum, 470

fibromyalgia, 490

first demyelinating event in adults, 460, 463

first demyelinating event in children, 465

Guillain-Barré syndrome, 466

juvenile idiopathic arthritis, onset or exacerbation, 486–488

multiple sclerosis onset in adults, 450

multiple sclerosis onset in children, 455

multiple sclerosis relapse in adults, 456

multiple sclerosis relapse in children, 457–458

neuromyelitis optica, 446–447

optic neuritis, 444, 446

polyarteritis nodosa, onset or exacerbation, 477–479

psoriatic arthritis, onset or exacerbation, 480

reactive arthritis, onset or exacerbation, 480–482

rheumatoid arthritis, onset or exacerbation, 483–485

seizures, 439

summary of evidence and causality conclusions, 20t, 491–493t, 681–683t

systemic lupus erythematosus, 472–473

transverse myelitis, 442–443

type 1 diabetes, 489

vasculitis, onset or exacerbation, 473–476

human papillomavirus vaccine

acute disseminated encephalomyelitis, 507

amyotrophic lateral sclerosis, 514

anaphylaxis, 515–516

brachial neuritis, 513

chronic inflammatory disseminated polyneuropathy, 512

Guillain-Barré syndrome, 511

hypercoagulable states, 520

multiple sclerosis, 510

neuromyelitis optica, 509

pancreatitis, 518

summary of evidence and causality conclusions, 21t, 521t, 683t

thromboembolic events, 519

transient arthralgia, 517

transverse myelitis, 508

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

influenza vaccine

acute disseminated encephalomyelitis, 308

all-cause mortality, 390–391

anaphylaxis, 342–344

arthropathy, onset or exacerbation, 384–385

asthma exacerbation or reactive airway disease episodes in children and adults, inactivated influenza vaccine, 350, 356

asthma exacerbation or reactive airway disease episodes in children younger than 5 years of age, live attenuated influenza vaccine, 361, 366

asthma exacerbation or reactive airway disease episodes in persons 5 years of age or older, live attenuated influenza vaccine, 369, 373

Bell’s palsy, 337

brachial neuritis, 340

chronic inflammatory disseminated polyneuropathy, 334–335

encephalitis and encephalopathy, 299–300

fibromyalgia, 389

Guillain-Barré syndrome, 327, 333–334

multiple sclerosis onset in adults, 316

multiple sclerosis relapse in adults, 319, 321

myocardial infarction, 388

neuromyelitis optica, 314

oculorespiratory syndrome, 399–401

optic neuritis, 311, 313

polyarteritis nodosa, 383–384

seizures, 304

small fiber neuropathy, 341

stroke, 386–387

summary of evidence and causality conclusions, 20–221, 401–404t, 678–680t

systemic lupus erythematosus, onset or exacerbation, 375, 378–379

transverse myelitis, 309

vasculitis, onset or exacerbation, 380, 382–383

injection-related outcomes

complex regional pain syndrome, 615–617

deltoid bursitis, 618–620

summary of evidence and causality conclusions, 21t, 625t, 687–688t,

syncope, 620–624

meningococcal vaccine

acute disseminated encephalomyelitis, 604

anaphylaxis, 609

chronic headache, 610

chronic inflammatory disseminated polyneuropathy, 608

encephalitis and encephalopathy, 603

Guillain-Barré syndrome, 607

multiple sclerosis, 605–606

summary of evidence and causality conclusions, 20t, 611t, 687t

transverse myelitis, 605

MMR vaccine

acute disseminated encephalomyelitis, 153–154

afebrile seizures, 134, 137

anaphylaxis, 169–174

arthropathy in men, 202

ataxia, 143–144

autism, 148, 153

brachial neuritis, 168–169

chronic arthralgia in women, 191, 193–194

chronic arthritis in women, 196, 198

chronic arthropathy in children, 199–200

chronic fatigue syndrome, 213

chronic inflammatory disseminated polyneuropathy, 167

encephalitis and encephalopathy, 116–119

febrile seizures, 124, 131–132

fibromyalgia, 213

Guillain-Barré syndrome, 165–166

hearing loss, 214–217

hepatitis, 212

measles inclusion body encephalitis, 109–110

meningitis, 139, 142–143

multiple sclerosis onset in adults, 161

multiple sclerosis onset in children, 165

neuromyelitis optica, 158–159

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

opsoclonus myoclonus syndrome, 167–168

optic neuritis, 156–157

summary of evidence and causality conclusions, 20–22t, 218–221t, 674–677t

transient arthralgia in children, 185, 190

transient arthralgia in women, 176, 180–181

transverse myelitis, 154–156

type 1 diabetes, 207, 211

varicella zoster vaccine

acute disseminated encephalomyelitis, 271

anaphylaxis, 276–278

arthropathy, onset or exacerbation, 278–279

cerebellar ataxia, 270

disseminated Oka VZV with subsequent infection resulting in pneumonia, meningitis, or hepatitis, 251–256

disseminated Oka VZV without other organ involvement, 243–249

encephalopathy, 267

Guillain-Barré syndrome, 273–274

seizures, 269

small fiber neuropathy, 274–275

stroke, 280

summary of evidence and causality conclusions, 19–20t, 283–284t, 677–678t

thrombocytopenia, 281–282

transverse myelitis, 272–273

vaccine strain viral reactivation with subsequent infection resulting in meningitis or encephalitis, 263–266

vaccine strain viral reactivation without other organ involvement, 257–261

weight-of-evidence evaluations, 12–14, 45–48

Meningitis

definition, 641

mechanism(s) that may contribute to symptoms of, 143, 256, 266

MMR vaccine and, 10, 36, 137–143, 218t

varicella vaccine and, 19t, 251, 253, 255–256, 262, 263–267, 283t

Meningococcal disease, 599–600

as cause of adverse events. See Causality, meningococcal vaccine

See Neisseria meningitides

Meningococcal vaccine

acute disseminated encephalomyelitis, 603–604

anaphylactic reactions, 18

anaphylaxis, 608–610

chronic headache, 610

chronic inflammatory disseminated polyneuropathy, 607–608

development, 600–601

encephalitis and encephalopathy, 602–603

formulations, 601

Guillain-Barré syndrome, 606–607

multiple sclerosis, 605–606

summary of evidence and causality conclusions, 20t, 611t, 687t

transverse myelitis, 604–605

vaccination rate, 601–602

Meningococcemia, 599

Meningoencephalitis

definition, 641

influenza vaccine and, 299

MMR. See Measles, mumps, and rubella vaccine

Molecular mimicry. See Biological mechanisms, pathophysiologies, and susceptibilities with the potential to contribute to adverse events

Mortality

infant, 27

influenza vaccine and all-cause mortality, 390–391

Multiple sclerosis

definition, 641

DTaP vaccine and, 550–557, 586–587t

hepatitis A vaccine and, 425, 431t

hepatitis B vaccine and, 447–458, 491t

human vaccine and, 510, 521t

influenza vaccine and, 314–321, 402t

mechanism(s) that may contribute to symptoms of, 161, 165, 316, 321, 425, 450, 455, 456, 458, 510, 553, 555, 556, 606

meningococcal vaccine and, 605–606, 611t

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

MMR vaccine and, 159–165, 219t

molecular mimicry, 71

onset in adults

DTaP vaccine, 550–553, 586t

hepatitis B vaccine and, 447–450, 451–453t, 491t

influenza vaccine and, 314–318, 402t

MMR vaccine and, 159–164, 219t

oneset in children

hepatitis B vaccine and, 454–455, 491t

MMR vaccine and, 164–165, 219t

relapse in adults

DTaP vaccine, 554–555, 586t

hepatitis B vaccine and, 455–456, 491t

influenza vaccine and, 318–321, 402t

relapse in children DTaP vaccine, 555–557, 587t

hepatitis B vaccine and, 457–458, 491t

Mumps infection

acute disseminated encephalomyelitis, 154

ataxia and, 144

clinical description, 105, 641–642

complications, 105

encephalitis and, 105, 117

encephalopathy and, 118

febrile seizures and, 132

Guillain-Barré syndrome and, 166

meningitis and, 105, 142

hearing loss and, 105, 216

hepatitis and, 212

optic neuritis and, 157

transmission, 104–105

transverse myelitis and, 105, 155

type 1 diabetes and, 105, 211

vaccine development and recommendations, 105–106, 108

virus description, 104

See also Measles, mumps, and rubella (MMR) vaccine

Myocardial infarction

definition, 642

influenza vaccine and, 387–389, 404t

mechanism(s) that may contribute to symptoms of, 388

Myocarditis

definition, 642

DTaP vaccine and, 579–580, 588t

mechanism(s) that may contribute to symptoms of, 580

Myoclonic epilepsy, 84, 642

N

National Childhood Vaccine Injury Act, 1, 28–29

National Vaccine Injury Compensation Program

purpose, 29

scientific basis for adjudication under, 30

scope of coverage, 1–2, 2n, 30n

structure, 29

National Vaccine Program Office, 29

Neisseria meningitides

bacteria description, 599

clinical description, 599

complications, 599, 600

nomenclature, 600

transmission, 599

vaccine development and recommendations, 600–602

Nested case-control studies

definition, 642

studies contributing to the weight of epidemiologic evidence, 302–303, 306t, 315, 317t, 324–325, 330t, 447–449, 451t, 452t, 551, 552t

Neuraminidase surface proteins, 294

Neuritis, definition of, 642

Neuromyelitis optica

definition, 642

hepatitis B vaccine and, 446–447, 491t

human papillomavirus vaccine and, 509, 521t

influenza vaccine and, 314, 402t

mechanism(s) that may contribute to symptoms of, 158–159, 314, 447, 509

MMR vaccine and, 10, 36, 158–159, 219t

Neuropathy, definition of, 642

Northern California Kaiser Permanente Patients, 133–134, 135t, 175, 178t, 192t, 197t, 250, 268, 275, 438–439, 574, 578t, 618

Nurses’Health Study, 447–448, 451t

O

Oculorespiratory syndrome

definition, 642

influenza vaccine and, 18, 21t, 391–401, 404t, 632

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

mechanism(s) that may contribute to symptoms of, 400

Opsoclonus myoclonus syndrome

definition, 642–643

DTaP vaccine and, 560–561, 587t

mechanism(s) that may contribute to symptoms of, 168, 561

MMR vaccine and, 167–168, 219t

Optic neuritis

definition, 643

DTaP vaccine and, 549–550, 586t

hepatitis B vaccine and, 443–446, 491t

influenza vaccine and, 310–313, 402t

mechanism(s) that may contribute to symptoms of, 157, 313, 446, 550

MMR vaccine and, 156–158, 219t

scope of review into vaccine events, 2, 10, 36

Orthomyxoviridae, 293

P

Pancreatitis

definition, 643

human papillomavirus vaccine and, 517–518, 521t

mechanism(s) that may contribute to symptoms of, 518

Pertussis vaccine, acellular. See Acellular pertussis vaccine

Pertussis vaccine, whole cell

adverse event review, 1–2, 30, 530

development, 529

susceptibility to adverse events, 84

See also Diphtheria toxoid, tetanus-toxoid, and acellular pertussis antigen-containing (DTaP) vaccines

Pneumonia

definition, 643

influenza infection and, 294–295

meningococcal infection and, 599

varicella vaccine and, 250–253, 255–256, 283t

varicella vaccine and mechanism(s) contributing to symptoms of, 256

Polio vaccine, 2, 28, 30

Polyarteritis nodosa

definition, 643

hepatitis B infection and, 67

hepatitis B vaccine and onset or exacerbation of, 477–479, 492t

influenza vaccine and, 383–384, 403t

mechanism(s) that may contribute to symptoms of, 67, 383–384, 479

Pregnancy, rubella infection in, 106–107

Preventive interventions

accomplishments, 27

evolution of vaccination programs, 27

ProQuad, 107–108, 242

Psychogenic factors in complex regional pain syndrome, 79

Purpura. See Immune thrombocytopenic purpura

R

Randomized clinical trials, 43–44

Randomized controlled crossover trials, studies contributing to the weight of epidemiologic evidence, 392–393, 395–397t

Randomized controlled trials

contributing to the weight of epidemiologic evidence, 359–360, 365t, 367–368, 372t, 379–380, 381t

definition, 643

double blind randomized controlled trials contributing to the weight of epidemiologic evidence, 175–176, 178–179t, 183–184, 188t, 190, 192t, 195, 197t, 318, 320t, 345, 347–348, 351t, 353t, 354t, 357–358, 362t, 367, 370–371t, 373–374, 376t, 516–517

Rechallenge reports as an attribution element, 13, 46–47, 84

Research and development, vaccine, 28

Retrospective studies, 644

Rubivirus (rubella infection)

acute disseminated encephalomyelitis, 154

arthropathy in men and, 106, 202

chronic arthralgia in women and, 106, 194

chronic arthritis in women and, 106, 198

chronic arthropathy in children and, 106, 200

clinical description, 106–107, 644

encephalitis, 106, 117

Guillain-Barré syndrome and, 106, 166

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

hepatitis and, 212

optic neuritis and, 157

neuromyelitis optica, 158

transient arthralgia in children and, 106, 185

transient arthralgia in women and, 106, 181

transmission, 106

transverse myelitis and, 155

vaccine development and recommendations, 107, 108

virus description, 106

See also Measles, mumps, and rubella (MMR) vaccine

S

Seizures

afebrile, definition, 635

definition, 644

DTaP vaccine and, 537–544, 585t

hepatitis B vaccine and, 438–440, 491t

influenza infection and, 294

influenza vaccine and, 2, 36, 301–304, 305–307t, 402t

mechanism(s) that may contribute to symptoms of, 68–70, 132, 269, 304, 439, 544

MMR vaccine and, 18, 20t, 119–137, 218t

varicella vaccine and, 268–269, 283t

See also Febrile seizures; Infantile spasms

Self-controlled case-series study

definition, 644

studies contributing to the weight of epidemiologic evidence, 112, 115t, 121, 122–124, 128–130t, 145–146, 149–150t, 184, 188t, 323–324, 325, 329–330t, 336, 338t, 346, 352t, 386, 387–388, 449, 453t, 459, 462t, 539–540, 542t, 602

Sequential vaccination, 36

Serum sickness

definition, 644

DTaP vaccine and, 566–567, 587t

mechanism(s) that may contribute to symptoms of, 566–567

Shingles. See Herpes zoster

Shoulder pain and stiffness, 80

See also Deltoid bursitis

Small fiber neuropathy

definition, 644

influenza vaccine and, 340–341, 402t

mechanism(s) that may contribute to symptoms of, 274–275, 341

varicella vaccine and, 10, 36, 274–275, 284t

Smallpox, 27

Special Masters, 2, 29, 30

Streptococcal infection

immune complexes, 67

molecular mimicry, 71

superantigens, 76

Streptococcus pneumoniae, 61

Stroke

definition, 645

influenza vaccine and, 386–387, 403t

mechanism(s) that may contribute to symptoms of, 280, 386–387

varicella vaccine and, 10, 36, 279–280, 284t

Subunit vaccines, 59

Sudden infant death syndrome

definition, 645

DTaP vaccine and, 581–582, 588t

Superantigens. See Biological mechanisms, pathophysiologies, and susceptibilities with the potential to contribute to adverse events

Surveillance system for adverse events

definition and features, 645

legislation in support of, 1, 28–29

See also Vaccine Adverse Event Reporting System (VAERS)

Susceptible individuals and populations

application to adverse event review, 24, 54

hypersensitivity mechanisms, 64–66

predispositions in, 82–84

See also Genetic risk factors

Swine influenza vaccine, 321n

Syncope

clinical features, 80–81

definition, 645

injection-related adverse events, 620–624, 625t

mechanism(s) that may contribute to symptoms of, 623–624

as result of vaccine injection, 18

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

See also Biological mechanisms, pathophysiologies, and susceptibilities with the potential to contribute to adverse events

Systemic lupus erythematosus

definition, 645

hepatitis B vaccine and, 471–473, 492t

immune complexes in, 67

influenza vaccine and, 373–379, 403t

mechanism(s) that may contribute to symptoms of, 67, 378, 473

T

T cells. See Biological mechanisms, pathophysiologies, and susceptibilities with the potential to contribute to adverse events

Tetanospasm, 527

Tetanus infection, 527–528, 562, 645

Tetanus toxoid-containing vaccines

anaphylactic reactions, 18

development, 528

effectiveness, 528

non-whole cell pertussis, 1n, 2

summary of evidence and causality conclusions, 20t, 22t, 585–588t, 683–687t

See also Diphtheria toxoid, tetanus-toxoid, and acellular pertussis antigen-containing (DTaP) vaccines

Thrombocytopenia

definition, 645

mechanism(s) that may contribute to symptoms of, 282

varicella zoster vaccine and, 281–282, 284t

Thromboembolic events

definition, 645

human papillomavirus vaccine and, 519–520, 521t

mechanism(s) that may contribute to symptoms of, 519

Thromboembolism, definition of, 645

Time interval between vaccine administration and adverse event

case report evaluations, 13

Vaccine Injury Table reporting requirements, 29

Tissue responses. See Biological mechanisms, pathophysiologies, and susceptibilities with the potential to contribute to adverse events

Transverse myelitis

definition, 646

DTaP vaccine and, 547–548, 586t

hepatitis A vaccine and, 424–425, 431t

hepatitis B vaccine and, 442–443, 491t

human papillomavirus vaccine and, 508, 521t

influenza vaccine and, 309–310, 402t

mechanism(s) that may contribute to symptoms of, 155, 273, 309, 424, 443, 508, 548, 605

meningococcal vaccine and, 604–605, 611t

MMR vaccine and, 154–156, 219t

varicella zoster vaccine and, 272–273, 284t

Trismus, 527

Type 1 autoimmune chronic hepatitis, 421–422

U

Urticaria

definition, 646

See also Chronic urticaria

V

Vaccine Adverse Event Reporting System (VAERS), 29, 171–172, 215, 244–245, 257–258, 263, 276, 277, 281, 313, 335, 343–344, 382, 469, 474, 477, 515, 618–619, 622, 623, 631, 646

Vaccine information statement (VIS), 29

Vaccine Injury Table

purpose, 29

Vaccine Safety Datalink (VSD), 111–112, 121, 156, 160, 170, 205–206, 262, 279, 301, 302, 303, 310, 315, 326, 336, 342, 348–349, 428, 443, 448, 458–459, 488, 535, 540, 551, 573, 646

Vaccines, general

historical evolution, 27

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
×

mechanism of action, 28, 57–59

public health benefits, 28

recognized risks, 28

See also Adverse events, generally; specific vaccines

Varicella Vaccine Collaborative Study, 241–242

Varicella zoster vaccine

acute disseminated encephalomyelitis, 271

anaphylaxis, 18, 20t, 275–278

arthropathy, onset or exacerbation, 278–279

causality conclusions. See Causality, varicella zoster vaccine

as cause of adverse events. See Causality, varicella zoster vaccine

cerebellar ataxia, 269–270

development of, 241–242

disseminated Oka VZV with subsequent infection resulting in pneumonia, meningitis, or hepatitis, 249–256

disseminated Oka VZV without other organ involvement, 242–249

dosage, 242

encephalopathy, 267–268

Guillain-Barré syndrome, 273–274

in immunodeficient individuals, 241–242, 245–248, 255, 630–631

limitations of data sources, 631

seizures, 268–269

small fiber neuropathy, 10, 36, 274–275

stroke, 10, 36, 279–280

summary of evidence and causality conclusions, 19–20t, 283–284t, 677–678t

thrombocytopenia, 281–282

transverse myelitis, 272–273

vaccine strain viral reactivation with subsequent infection resulting in meningitis or encephalitis, 78, 261–267

vaccine strain viral reactivation without other organ involvement, 18, 78, 256–261

Varicella zoster virus infection

acute disseminated encephalomyelitis and, 271

cerebellar ataxia and, 240, 270

clinical description, 239–240, 646

complications, 239–241

disseminated Oka VZV without other organ involvement and, 239, 248

disseminated Oka VZV with subsequent infection resulting in pneumonia, meningitis, or hepatitis and, 239–240, 255

Guillain-Barré syndrome and, 240, 274

incidence, 240–241

stroke and, 280

thrombocytopenia, 239, 282

transmission, 239

transverse myelitis and, 240, 272

vaccine development and recommendations, 241–242

vaccine-strain viral reactivation with subsequent infection resulting in meningitis or encephalitis and, 240, 266

vaccine-strain viral reactivation without other organ involvement and, 240, 260

virus description, 239

Vasculitis

definition, 646

hepatitis B vaccine and onset or exacerbation of, 473–477, 492t

influenza vaccine and onset or exacerbation of, 379–383, 403t

mechanism(s) that may contribute to symptoms of, 383, 476

Viral activity. See Biological mechanisms, pathophysiologies, and susceptibilities with the potential to contribute to adverse events

W

Weight-of-evidence evaluations, 10–14, 42–48

Worldwide Adverse Event System, 244–245, 257, 258, 263, 277

Suggested Citation:"Index." Institute of Medicine. 2012. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. doi: 10.17226/13164.
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In 1900, for every 1,000 babies born in the United States, 100 would die before their first birthday, often due to infectious diseases. Today, vaccines exist for many viral and bacterial diseases. The National Childhood Vaccine Injury Act, passed in 1986, was intended to bolster vaccine research and development through the federal coordination of vaccine initiatives and to provide relief to vaccine manufacturers facing financial burdens. The legislation also intended to address concerns about the safety of vaccines by instituting a compensation program, setting up a passive surveillance system for vaccine adverse events, and by providing information to consumers. A key component of the legislation required the U.S. Department of Health and Human Services to collaborate with the Institute of Medicine to assess concerns about the safety of vaccines and potential adverse events, especially in children.

Adverse Effects of Vaccines reviews the epidemiological, clinical, and biological evidence regarding adverse health events associated with specific vaccines covered by the National Vaccine Injury Compensation Program (VICP), including the varicella zoster vaccine, influenza vaccines, the hepatitis B vaccine, and the human papillomavirus vaccine, among others. For each possible adverse event, the report reviews peer-reviewed primary studies, summarizes their findings, and evaluates the epidemiological, clinical, and biological evidence. It finds that while no vaccine is 100 percent safe, very few adverse events are shown to be caused by vaccines. In addition, the evidence shows that vaccines do not cause several conditions. For example, the MMR vaccine is not associated with autism or childhood diabetes. Also, the DTaP vaccine is not associated with diabetes and the influenza vaccine given as a shot does not exacerbate asthma.

Adverse Effects of Vaccines will be of special interest to the National Vaccine Program Office, the VICP, the Centers for Disease Control and Prevention, vaccine safety researchers and manufacturers, parents, caregivers, and health professionals in the private and public sectors.

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