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OCR for page 839
Index
[Page numbers followed by italic letter n or Adjuvants, 59
t refer to footnotes or tables.] mechanism of action, 59
See also Alum; ASO4
Adverse events, generally
A animal models, 89–91
brain development alterations, 85–89
Acellular pertussis vaccine definition, 1n, 30n
development, 529 frequency and rate determinations,
formulations, 530 629–632
summary of evidence and causality injection-related, 78–81, 615–624, 625t
conclusions, 585–588t limitations of data sources and findings,
Acute disseminated encephalomyelitis 629–633
definition, 635 mechanisms of, 57, 65, 67–68, 72–73,
DTaP vaccine and, 546–547, 586t 74, 76
hepatitis A vaccine and, 423–424, 431t methodology for evaluation of evidence,
hepatitis B vaccine and, 440–442, 491t 10–14, 40–48
human papillomavirus vaccine and, prior reviews, 1–2, 29–30, 39
507–508, 521t recognized risk, 28
influenza vaccine and, 308–309, 402t reporting requirements, 29
mechanism(s) that may contribute to scope of review, 2–10, 30–36
symptoms of, 154, 271, 308, seriousness of, 632
423–424, 441, 507, 547, 604 susceptibility, 24, 54, 82–84
meningococcal vaccine and, 603–604, See also Causality
611t Advisory Committee on Immunization
MMR vaccine and, 153–154, 219t Practices
varicella zoster vaccine and, 271, 284t DTaP vaccination recommendations, 530
Acute motor axonal neuropathy (AMAN), hepatitis B vaccination recommendations,
71–72 437
839
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840 INDEX
human papillomavirus vaccination susceptibility to, 83–84
recommendations, 506–507 tetanus toxoid vaccine and, 18, 20t, 565,
influenza vaccination recommendations, 587t
295–296 varicella zoster vaccine and, 18, 20t,
meningococcal vaccination 275–278, 284t
recommendations, 601 Animal models
MMR vaccination recommendations, application of evidence from, 89-91
108, 242 contribution to the weight of mechanistic
varicella vaccination recommendations, evidence, 14, 45, 47
242 disease processes affecting the brain, 86
Age influenza vaccine and Guillain-Barré
as adverse event risk factor, 24, 84 syndrome, 333–334
human papillomavirus infection risk, MMR vaccine and hearing loss, 153
505–506 Antibodies and autoantibodies. See
Alterations in brain development. See Biological mechanisms,
Biological mechanisms, pathophysiologies, and
pathophysiologies, and susceptibilities with the potential
susceptibilities with the potential to contribute to adverse events
to contribute to adverse events Antigen persistence. See Biological
Alum, 59 mechanisms, pathophysiologies,
American Academy of Family Physicians, and susceptibilities with the
437, 530 potential to contribute to adverse
American Academy of Pediatrics, 437, 530 events
Amyotrophic lateral sclerosis Antigen-presenting cells, 58, 59
definition, 635 Antigenic drift, 293
human papillomavirus vaccine and, Antigenic shift, 293
513–515 Arthralgia
mechanism(s) that may contribute to chronic, in women, MMR vaccine and,
symptoms of, 514 190–195, 220t
Anaphylaxis definition, 635
causes, 65, 66, 632 mechanism(s) that may contribute to
complement-mediated, 65–66 symptoms of, 181, 185, 194, 517
definition, 635 transient, human papillomavirus vaccine
DTaP vaccine and, 563–565, 587t and, 516–517, 521t
hepatitis A vaccine and, 428–429, 431t transient, in children, MMR vaccine and,
hepatitis B vaccine and, 18, 20t, 18, 21t, 182–190, 220t
468–469, 492t transient, in women, MMR vaccine and,
human papillomavirus vaccine and, 21t, 18, 21t, 174–181, 219t
515–516, 521t Arthritis, chronic
immunoglobulin E-mediated definition, 635
hypersensitivity in, 64–65 mechanism(s) that may contribute to
influenza vaccine and, 18, 20t, 341–345, symptoms of, 198
403t in women, MMR vaccine and, 195–199,
limitations of data sources, 631–632 220t
mechanism(s) that may contribute to Arthritis, juvenile idiopathic
symptoms of, 64–66 definition, 641
meningococcal vaccine and, 18, 20t, hepatitis B vaccine and, 485–488, 493t
608–610, 611t mechanism(s) that may contribute to
MMR vaccine and, 18, 20t, 169–174, symptoms of, 488
219t, 631–632 MMR vaccine and, transient arthralgia in
recognized risks, 28 children, 184
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841
INDEX
Arthritis, psoriatic multiple sclerosis onset in adults,
definition, 643 550–553
hepatitis B vaccine, onset or exacerbation multiple sclerosis relapse in adults,
of, 479–480, 492t 554–555
Arthritis, reactive multiple sclerosis relapse in children,
definition, 643 555–557
hepatitis B vaccine and, 480–482, 493t myocarditis, 579–580
mechanism(s) that may contribute to opsoclonus myoclonus syndrome,
symptoms of, 481–482 560–561
Arthritis, rheumatoid optic neuritis, 549–550
definition, 644 seizures, 539–544
hepatitis B vaccine, onset or exacerbation serum sickness, 566–567
of, 482–485, 493t sudden infant death syndrome,
immune complexes and, 67 581–582
mechanism(s) that may contribute to summary of evidence and causality
symptoms of, 485 conclusions, 22t, 585–588t,
Arthropathy 683–687t
chronic, in children, MMR vaccine and, transverse myelitis, 547–548
199–200, 220t type 1 diabetes, 22t, 571–579
definition, 635 hepatitis A vaccine
DTaP vaccine and, 567–571, 588t acute disseminated encephalomyelitis,
influenza vaccine, onset or exacerbation 423–424
of, 384–385, 403t anaphylaxis, 428–429
mechanism(s) that may contribute to autoimmune hepatitis, 429–430
symptoms of, 200, 202, 279, Bell’s palsy, 427–428
385, 571 chronic inflammatory disseminated
in men, MMR vaccine and, 201–204, polyneuropathy, 427
220t Guillain-Barré syndrome, 426
varicella vaccine, onset or exacerbation multiple sclerosis, 425
of, 278–279, 284t summary of evidence and causality
ASO4, 59 conclusions, 431t, 680–681t
Assessment of causality transverse myelitis, 424–425
DTaP vaccine hepatitis B vaccine
acute disseminated encephalomyelitis, acute disseminated encephalomyelitis,
546–547 440–442
anaphylaxis, 563–565 anaphylaxis, 468–469
arthropathy, 567–571 brachial neuritis, 467–468
ataxia, 544–545 chronic inflammatory disseminated
autism, 545–546 polyneuropathy, 466–467
Bell’s Palsy, 561–562 encephalitis and encephalopathy,
chronic inflammatory disseminated 437–438
polyneuropathy, 558–560 erythema nodosum, 469–471
chronic urticaria, 565–566 fibromyalgia, 490
encephalitis and encephalopathy, first demyelinating event in adults,
534–537 458–464
fibromyalgia, 581 first demyelinating event in children,
Guillain-Barré syndrome, 557–558 464–465
immune thrombocytopenic purpura, Guillain-Barré syndrome, 465–466
582–584 juvenile idiopathic arthritis, onset or
infantile spasms, 537–539 exacerbation, 485–488
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842 INDEX
multiple sclerosis onset in adults, arthropathy, onset or exacerbation,
447–450, 451–453t 384–385
multiple sclerosis onset in children, asthma exacerbation or reactive airway
454–455 disease episodes in children and
multiple sclerosis relapse in adults, adults, inactivated influenza
455–456 vaccine, 345–356
multiple sclerosis relapse in children, asthma exacerbation or reactive airway
457–458 disease episodes in children
neuromyelitis optica, 446–447 younger than 5 years of age, live
optic neuritis, 443–446 attenuated influenza vaccine,
polyarteritis nodosa, onset or 356–366
exacerbation, 477–479 asthma exacerbation or reactive airway
psoriatic arthritis, onset or disease episodes in persons
exacerbation, 479–480 5 years of age or older, live
reactive arthritis, onset or attenuated influenza vaccine,
exacerbation, 480–482 366–373
rheumatoid arthritis, onset or Bell’s palsy, 335–337, 338–339t
exacerbation, 482–485 brachial neuritis, 340
seizures, 438–440 chronic inflammatory disseminated
summary of evidence and causality polyneuropathy, 334–335
conclusions, 20t, 491–493t, encephalitis and encephalopathy, 296,
681–683t 299–301
systemic lupus erythematosus, onset or fibromyalgia, 389
exacerbation, 471–473 Guillain-Barré syndrome, 321–334
transverse myelitis, 442–443 multiple sclerosis onset in adults,
type 1 diabetes, 488–490 314–318
vasculitis, onset or exacerbation, multiple sclerosis relapse in adults,
473–477 318–321
human papillomavirus vaccine myocardial infarction, 387–389
acute disseminated encephalomyelitis, neuromyelitis optica, 314
507–508 oculorespiratory syndrome, 391–401
amyotrophic lateral sclerosis, 513–515 optic neuritis, 310–313
anaphylaxis, 515–516 polyarteritis nodosa, 383–384
brachial neuritis, 512–513 seizures, 301–304, 305–307t
chronic inflammatory disseminated small fiber neuropathy, 340–341
polyneuropathy, 512 stroke, 386–387
Guillain-Barré syndrome, 511–512 summary of evidence and causality
hypercoagulable states, 520 conclusions, 20–22t, 402–404t,
multiple sclerosis, 510 678–680t
neuromyelitis optica, 509 systemic lupus erythematosus, onset or
pancreatitis, 517–518 exacerbation, 373–379
summary of evidence and causality transverse myelitis, 309–310
conclusions, 21t, 521t, 683t vasculitis, onset or exacerbation,
thromboembolic events, 519–520 379–383
transient arthralgia, 516–517 injection-related adverse events
transverse myelitis, 508 complex regional pain syndrome,
influenza vaccine 615–617
acute disseminated encephalomyelitis, deltoid bursitis, 618–620
308–309 summary of evidence and causality
all-cause mortality, 390–391 conclusions, 21t, 625t, 687–688t
anaphylaxis, 341–345 syncope, 620–624
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843
INDEX
meningococcal vaccine transient arthralgia in children,
acute disseminated encephalomyelitis, 182–190
603–604 transient arthralgia in women,
anaphylaxis, 608–610 174–181
chronic headache, 610 transverse myelitis, 154–156
chronic inflammatory disseminated type 1 diabetes, 204–211
polyneuropathy, 607–608 prior reviews, 1–2, 29–30, 39
encephalitis and encephalopathy, process
602–603 categorization of findings, 14–18,
Guillain-Barré syndrome, 606–607 23–24, 48–53
multiple sclerosis, 605–606 contradictory evidence, 23
summary of evidence and causality framework for, 10–18, 23–24, 42–53
conclusions, 20t, 611t, 687t weight-of-evidence evaluations, 10–14,
transverse myelitis, 604–605 42–48
MMR vaccine varicella zoster vaccine
acute disseminated encephalomyelitis, acute disseminated encephalomyelitis,
153–154 271
afebrile seizures, 133–137 anaphylaxis, 275–278
anaphylaxis, 169–174 arthropathy, onset or exacerbation,
arthropathy in men, 201–204 278–279
ataxia, 143–144 cerebellar ataxia, 269–270
autism, 145–153 disseminated Oka VZV with
brachial neuritis, 168–169 subsequent infection resulting
chronic arthralgia in women, 190–195 in pneumonia, meningitis, or
chronic arthritis in women, 195–199 hepatitis, 249–256
chronic arthropathy in children, disseminated Oka VZV without other
199–200 organ involvement, 242–249
chronic fatigue syndrome, 212–213 encephalopathy, 267–268
chronic inflammatory disseminated Guillain-Barré syndrome, 273–274
polyneuropathy, 166–167 seizures, 268–269
encephalitis and encephalopathy, small fiber neuropathy, 274–275
111–119 stroke, 279–280
febrile seizures, 119–132 summary of evidence and causality
fibromyalgia, 213–214 conclusions, 19–20t, 283–284t,
Guillain-Barré syndrome, 165–166 677–678t
hearing loss, 214–217 thrombocytopenia, 281–282
hepatitis, 211–212 transverse myelitis, 272–273
measles inclusion body encephalitis, vaccine strain viral reactivation with
108–110 subsequent infection resulting
meningitis, 137–143 in meningitis or encephalitis,
multiple sclerosis onset in adults, 261–267
159–164 vaccine strain viral reactivation
multiple sclerosis onset in children, without other organ involvement,
164–165 256–261
neuromyelitis optica, 158–159 See also Causality
opsoclonus myoclonus syndrome, Asthma and reactive airway disease episodes
167–168 definition, 635
optic neuritis, 156–158 inactivated influenza vaccine and, 22t,
summary of evidence and causality 23, 345–356, 403t
conclusions, 20–22t, 218–221t, live attenuated influenza vaccine and,
674–677t 356–373, 403t
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844 INDEX
mechanism(s) that may contribute to antigen persistence, 73–74
symptoms of, 356, 366, 369, 373 autoreactivity, 75
Ataxia bystander activation, 75
definition, 636 complement activation, 62–64
DTaP vaccine and, 544–545, 585t effector functions of antibodies and
mechanism(s) that may contribute to autoantibodies, 60–62
symptoms of, 144 effector functions of T cells, 59–60
MMR vaccine and, 143–144, 218t epitope spreading, 74–75
Attribution elements, 13, 46 hyperresponsiveness, 75
Autism hypersensitivity reactions, 64–66
definition, 636 complement mediated
diagnosis and biological mechanism, 57, hypersensitivity, 65–6
85–89 immunoglobulin E hypersensitivity,
DTaP vaccine and, 545–546, 585t 64–65
MMR vaccine and, 21t, 23, 145–153, immune complexes, 66–68
218t increased cytokines, 75–76
See also Biological mechanisms, molecular mimicry, 70–73
pathophysiologies, and superantigens, 76
susceptibilities with the potential tissue responses (fever and seizure),
to contribute to adverse events 68–70
Autoimmune hepatitis increased susceptibility, 82–84
definition, 636 injection-related adverse events
hepatitis A vaccine and, 429–430, 431t complex regional pain syndrome,
mechanism(s) that may contribute to 78–80
symptoms of, 430 deltoid bursitis, 80
Autoreactivity. See Biological mechanisms, syncope, 80–81
pathophysiologies, and latency between antigen exposure and
susceptibilities with the potential peak adaptive immune response,
to contribute to adverse events 57–59
viral activity, 76–78
direct or primary infection, 76–77
B persistent infection, 77
viral reactivation, 77–78
B cell response to antigen exposure, 57–58, Bordatella pertussis
60, 63 bacteria description, 528
Bell’s palsy clinical description, 529, 643
definition, 636 complications, 529
DTaP vaccine and, 561–562, 587t encephalitis and encephalopathy and,
hepatitis A vaccine and, 427–428, 431t 529, 536
influenza vaccine and, 21t, 23, 335–337, seizures and, 529, 544
338–339t, 402t transmission, 529
Benefits of vaccination, 27 vaccine development and
Biological mechanisms, pathophysiologies, recommendations, 529, 530
and susceptibilities with the See also Diphtheria toxoid, tetanus
potential to contribute to adverse toxoid, and acellular pertussis
events
antigen-containing (DTaP)
alterations in brain development, 85–86 vaccines
autism, 86–89 Brachial neuritis
coagulation and hypercoagulable states, definition, 636
81–82 hepatitis B vaccine and, 467–468, 492t
immune mediated mechanisms, 59–76
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845
INDEX
human papillomavirus vaccine and, evidence favoring acceptance of, 15,
512–513, 521t 18–23, 49, 52–53
influenza vaccine and, 340, 402t evidence favoring rejection of, 15, 23,
mechanism(s) that may contribute to 49, 53, 389n
symptoms of, 168, 340, 468, 513 evidence inadequate to accept or reject,
MMR vaccine and, 168–169, 219t 15, 23–24, 49, 53
Brain development, alterations, 85–86 DTaP vaccine
Bystander activation. See Biological acute disseminated encephalomyelitis,
mechanisms, pathophysiologies, 547
and susceptibilities with the anaphylaxis, 565
potential to contribute to adverse arthropathy, 571
events ataxia, 545
autism, 546
Bell’s Palsy, 562
C chronic inflammatory disseminated
polyneuropathy, 560
Campylobacter jejuni, 72, 333, 423, 426 chronic urticaria, 566
Canada, 18, 392–401 encephalitis and encephalopathy, 537
Cardiopulmonary disease, complications of fibromyalgia, 581
influenza infection, 294–295 Guillain-Barré syndrome, 558
Case-control study immune thrombocytopenic purpura,
definition, 636 584
studies contributing to the weight of infantile spasms, 539
epidemiologic evidence, 111–112, multiple sclerosis onset in adults, 553
114–115t, 137–138, 140t, multiple sclerosis relapse in adults, 555
147–148, 151–152t, 156, 160, multiple sclerosis relapse in children, 557
162–163t, 164, 201, 203t, 204– myocarditis, 580
206, 208–210t, 310–311, 312t, opsoclonus myoclonus syndrome, 561
315, 317t, 443–444, 445t, 448, optic neuritis, 550
452t, 454, 458–459, 461t, 464, seizures, 544
471, 488–489, 534–535, 537, serum sickness, 567
549, 550–551, 552t, 567–568, sudden infant death syndrome, 582
569–570t, 572–573, 575–577t summary of evidence and causality
Case-crossover study conclusions, 22t, 585–588t,
definition, 636 683–687t
studies contributing to the weight of transverse myelitis, 548
epidemiologic evidence, 120–121, type 1 diabetes, 579
125t, 138–139, 141t, 301–302, finding of no causal relationship, 15, 49
305–306t, 318–319, 320t, hepatitis A vaccine
348–349, 354–355t, 393–394, acute disseminated encephalomyelitis,
398t, 455–456, 554 424
Case-only study, definition, 637 anaphylaxis, 429
Case reports, 12–13, 46–47, 52, 53 autoimmune hepatitis, 430
definition, 637 Bell’s palsy, 428
Case series, definition, 637 chronic inflammatory disseminated
Causality
polyneuropathy, 427
adverse effects versus adverse events, 1n Guillain-Barré syndrome, 426
categories and explanations of, 14–24, multiple sclerosis, 425
48–53 summary of evidence and causality
evidence convincingly supports, 15, conclusions, 431t, 680–681t
17–18, 49, 50–52 transverse myelitis, 425
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846 INDEX
hepatitis B vaccine multiple sclerosis, 510
acute disseminated encephalomyelitis, neuromyelitis optica, 509
442 pancreatitis, 518
anaphylaxis, 469 summary of evidence and causality
brachial neuritis, 468 conclusions, 21t, 521t, 683t
chronic inflammatory disseminated thromboembolic events, 520
polyneuropathy, 467 transient arthralgia, 517
encephalitis and encephalopathy, 438 transverse myelitis, 508
erythema nodosum, 471 influenza vaccine
fibromyalgia, 490 acute disseminated encephalomyelitis,
first demyelinating event in adults, 463 309
first demyelinating event in children, all-cause mortality, 391
465 anaphylaxis, 345
Guillain-Barré syndrome, 466 arthropathy, onset or exacerbation, 385
juvenile idiopathic arthritis, onset or asthma exacerbation or reactive airway
exacerbation, 488 disease episodes in children and
multiple sclerosis onset in adults, 450 adults, inactivated influenza
multiple sclerosis onset in children, vaccine, 356
455 asthma exacerbation or reactive airway
multiple sclerosis relapse in adults, 456 disease episodes in children
multiple sclerosis relapse in children, younger than 5 years of age, live
458 attenuated influenza vaccine, 366
neuromyelitis optica, 447 asthma exacerbation or reactive airway
optic neuritis, 446 disease episodes in persons
polyarteritis nodosa, onset or 5 years of age or older, live
exacerbation, 479 attenuated influenza vaccine, 373
psoriatic arthritis, onset or Bell’s palsy, 337
exacerbation, 480 brachial neuritis, 340
reactive arthritis, onset or chronic inflammatory disseminated
exacerbation, 482 polyneuropathy, 335
rheumatoid arthritis, onset or encephalitis, 299
exacerbation, 485 encephalopathy, 301
seizures, 440 fibromyalgia, 389
summary of evidence and causality Guillain-Barré syndrome, 334
conclusions, 20t, 491–493t, multiple sclerosis onset in adults, 318
681–683t multiple sclerosis relapse in adults, 321
systemic lupus erythematosus, onset or myocardial infarction, 389
exacerbation, 473 neuromyelitis optica, 314
transverse myelitis, 443 oculorespiratory syndrome, 401
type 1 diabetes, 490 optic neuritis, 313
vasculitis, onset or exacerbation, 477 polyarteritis nodosa, 384
human papillomavirus vaccine seizures, 304
acute disseminated encephalomyelitis, small fiber neuropathy, 341
508 stroke, 386
amyotrophic lateral sclerosis, 515 summary of evidence and causality
anaphylaxis, 516 conclusions, 20–22t, 402–404t,
brachial neuritis, 513 678–680t
chronic inflammatory disseminated systemic lupus erythematosus, onset or
polyneuropathy, 512 exacerbation, 379
Guillain-Barré syndrome, 512 transverse myelitis, 310
hypercoagulable states, 520 vasculitis, onset or exacerbation, 383
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847
INDEX
injection-related adverse events optic neuritis, 158
complex regional pain syndrome, 617 summary of evidence and causality
deltoid bursitis, 620 conclusions, 20–22t, 218–221t,
summary of evidence and causality 674–677t
conclusions, 21t, 625t, 678–680t transient arthralgia in children, 190
syncope, 624 transient arthralgia in women, 181
limitations of data sources and findings, transverse myelitis, 156
629–633 type 1 diabetes, 211
meningococcal vaccine summary of evidence and causality
acute disseminated encephalomyelitis, conclusions, 19–22t, 674–748t
604 DTaP vaccine and, 585–588t
anaphylaxis, 610 hepatitis A vaccine and, 431t
chronic headache, 610 hepatitis B vaccine and, 491–493t
chronic inflammatory disseminated human papillomavirus vaccine and,
polyneuropathy, 608 521t
encephalitis and encephalopathy, 603 influenza vaccine and, 402–404t
Guillain-Barré syndrome, 607 injection related adverse events and,
multiple sclerosis, 606 625t
summary of evidence and causality meningococcal vaccine and, 611t
conclusions, 20t, 611t, 687t MMR vaccine and, 218–221t
transverse myelitis, 605 varicella vaccine and, 283–284t
MMR vaccine varicella zoster vaccine
acute disseminated encephalomyelitis, acute disseminated encephalomyelitis,
154 271
afebrile seizures, 137 anaphylaxis, 278
anaphylaxis, 174 arthropathy, onset or exacerbation,
arthropathy in men, 204 279
ataxia, 144 cerebellar ataxia, 270
autism, 153 disseminated Oka VZV with
brachial neuritis, 169 subsequent infection resulting
chronic arthralgia in women, 195 in pneumonia, meningitis, or
chronic arthritis in women, 199 hepatitis, 256
chronic arthropathy in children, 200 disseminated Oka VZV without other
chronic fatigue syndrome, 213 organ involvement, 249
chronic inflammatory disseminated encephalopathy, 268
polyneuropathy, 167 Guillain-Barré syndrome, 274
encephalitis, 118 seizures, 269
encephalopathy, 119 small fiber neuropathy, 275
febrile seizures, 132 stroke, 280
fibromyalgia, 214 summary of evidence and causality
Guillain-Barré syndrome, 166 conclusions, 19–20t, 283–284t,
hearing loss, 217 677–678t
hepatitis, 212 thrombocytopenia, 282
measles inclusion body encephalitis, transverse myelitis, 273
110 vaccine strain viral reactivation with
meningitis, 143 subsequent infection resulting in
multiple sclerosis onset in adults, 164 meningitis or encephalitis, 267
multiple sclerosis onset in children, vaccine strain viral reactivation
165 without other organ involvement,
neuromyelitis optica, 159 261
opsoclonus myoclonus syndrome, 168 See also Assessment of causality
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848 INDEX
Centers for Disease Control and Prevention, Cohort studies
2, 29, 30 contributing to the weight of
Cephalic tetanus, 527–528 epidemiologic evidence, 322–323,
Cerebellar ataxia 328t, 374, 375, 376t, 377t,
definition, 637 438–439, 535, 540, 542t, 561,
mechanism(s) that may contribute to 574, 578t
symptoms of, 270 definition, 637–638
varicella zoster vaccine and, 269–270, prospective cohort studies contributing
284t to the weight of epidemiologic
Chemotherapy, 73, 82, 241, 246–248, 253, evidence, 374, 376–377t,
254–255, 260, 264, 265 482–483
Chronic fatigue syndrome retrospective cohort studies contributing
definition, 637 to the weight of epidemiologic
MMR vaccine and, 212–213, 221t evidence, 111, 114t, 120,
Chronic inflammatory disseminated 121–122, 125–127t, 133–134,
polyneuropathy 135–136t, 138, 140–141t, 146,
definition, 637 151t, 174–175, 177–178t, 183,
DTaP vaccine and, 558–560, 587t 184, 187t, 189t, 190, 192t,
hepatitis A vaccine and, 427, 431t 195, 197t, 201, 203t, 206,
hepatitis B vaccine and, 466–467, 492t 210t, 250–251, 262, 268, 275,
human papillomavirus vaccine and, 512, 279, 303, 307t, 323, 325–326,
521t 329t, 331–332t, 336–337, 339t,
influenza vaccine and, 334–335, 402t 341, 358–359, 363–364t, 367,
mechanism(s) that may contribute to 371–372t, 379, 381t, 390,
symptoms of, 167, 335, 427, 457, 540–541, 543t, 555–556,
467, 512, 560, 608 573–574, 577t, 606–607, 618
meningococcal vaccine and, 607–608, 611t Compensation for adverse events
MMR vaccine and, 166–167, 219t for effects of vaccines not on Vaccine
Chronic urticaria Injury Table, 29, 30
definition, 637 legislation in support of, 1, 28, 29
DTaP vaccine and, 565–566, 587t Complement activation. See Biological
mechanism(s) that may contribute to mechanisms, pathophysiologies,
symptoms of, 565 and susceptibilities with the
potential to contribute to adverse
Clostridium tetani
bacteria description, 527 events
Bell’s palsy and, 562 Complement-mediated hypersensitivity.
clinical description, 527, 645 See Biological mechanisms,
complications, 527–528 pathophysiologies, and
incidence, 528 susceptibilities with the potential
transmission, 527 to contribute to adverse events
vaccine development and Complex regional pain syndrome
recommendations, 528, 530 definition, 638
See also Diphtheria toxoid, tetanus injection-related, 78–80, 615–617, 625t
toxoid, and acellular pertussis See also Biological mechanisms,
antigen-containing (DTaP) pathophysiologies, and
vaccines susceptibilities with the potential
Coagulation and hypercoagulable states. to contribute to adverse events
See Biological mechanisms, Confounding variables, definition, 638
pathophysiologies, and Consumer education, legislation in support
susceptibilities with the potential of, 1, 28–29
to contribute to adverse events Contradictory evidence, 23, 53
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849
INDEX
Convulsion. See Febrile seizures; Seizures molecular mimicry, 71
mumps and, 105, 211
Corynebacterium diphtheriae
bacteria description, 525 Diabetes mellitus, insulin-dependent. See
Bell’s palsy and, 562 Diabetes, type 1
clinical description, 525–526, 638–639 Diphtheria toxoid, tetanus toxoid, and
complications, 526 acellular pertussis antigen-
encephalitis and encephalopathy and, containing (DTaP) vaccines
526, 536 acute disseminated encephalomyelitis,
myocarditis and, 526, 580 546–547
transmission, 525 anaphylaxis, 563–565
vaccine development and arthropathy, 567–571
recommendations, 526, 530 ataxia, 544–545
See also Diphtheria toxoid, tetanus autism, 545–546
toxoid, and acellular pertussis Bell’s Palsy, 561–562
antigen-containing (DTaP) booster vaccinations, 530
vaccines as cause of adverse events. See Causality,
Countermeasures Injury Compensation DTaP vaccine
Program, 2n chronic inflammatory disseminated
Critical periods, 84 polyneuropathy, 558–560
Crossover experiment, definition, 638 chronic urticaria, 565–566
Cytokine storm, 75–76 development of, 526
effectiveness, 526, 528
encephalitis and encephalopathy,
D 534–537
fibromyalgia, 581
Defense Medical Surveillance System, formulations and dosages, 530, 531–533t
310–311, 312t, 444, 445t, 461t Guillain-Barré syndrome, 557–558
Deltoid bursitis immune thrombocytopenic purpura,
definition, 80, 638 582–584
injection of vaccine and, 18, 21t, infantile spasms, 537–539
618–620, 625t multiple sclerosis onset in adults,
See also Biological mechanisms, 550–553
pathophysiologies, and multiple sclerosis relapse in adults,
susceptibilities with the potential 554–555
to contribute to adverse events multiple sclerosis relapse in children,
Demyelination, definition, 638 555–557
Department of Health and Human Services myocarditis, 579–580
National Vaccine Program Office, 29 opsoclonus myoclonus syndrome,
prior reviews of adverse events, 1–2, 560–561
29–30 optic neuritis, 10, 36, 549–550
Developmental problems, brain prior reviews into adverse events, 1–2,
development, 85–89 30
Diabetes, type 1 seizures, 539–544
definition, 641 serum sickness, 566–567
DTaP vaccine and, 22t, 571–579, 588t sudden infant death syndrome, 581–582
evidence favoring rejection of vaccine
transverse myelitis, 547–548
causality, 23 type 1 diabetes, 23, 571–579
hepatitis B vaccine and, 488–490, 493t summary of evidence and causality
mechanism(s) that may contribute to conclusions, 20t, 22t, 585–588t,
symptoms of, 211, 489, 571 683–687t
MMR vaccine and, 22t, 204–211, 220t vaccination rates, 530
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Infant mortality, historical evolution, 27 chronic inflammatory disseminated
Infantile spasms polyneuropathy, 334–335
definition, 640 development of, 295
DTaP vaccine and, 537–539, 585t encephalitis and encephalopathy, 296,
Influenza infection 299–301
acute disseminated encephalomyelitis, fibromyalgia, 389
308 formulations, 295
all-cause mortality, 391 Guillain-Barré syndrome, 321–334
asthma exacerbation and, 295, 356, 366, H1N1, 2n
369 multiple sclerosis onset in adults,
clinical description, 294–295, 641 314–318
complications, 294–295 multiple sclerosis relapse in adults,
encephalitis and, 299 318–321
Guillain-Barré syndrome, 333 myocardial infarction, 387–389
mutagenesis, 293 neuromyelitis optica, 314
myocardial infarction, 388 oculorespiratory syndrome, 18, 391–401,
nomenclature, 293–294 632
onset or exacerbation of arthropathy and, optic neuritis, 18, 36, 310–313
385 polyarteritis nodosa, 383–384
transmission, 294 recommendations for administration,
transverse myelitis and, 309 295–296
vaccine development and seizures, 2, 36, 301–304, 305–307t
recommendations, 295–296 small fiber neuropathy, 340–341
virus description, 293–294 stroke, 386–387
Influenza vaccine summary of evidence and causality
acute disseminated encephalomyelitis, conclusions, 20–22t, 402–404t,
308–309 678–680t
all-cause mortality, 390–391 systemic lupus erythematosus onset or
anaphylaxis, 18, 341–345 exacerbation, 373–379
arthropathy, onset or exacerbation, transverse myelitis, 309–310
384–385 trivalent, definition, 295–296
asthma exacerbation or reactive airway vaccination rates, 296
disease episodes in children and vasculitis, onset or exacerbation,
adults, inactivated influenza 379–383
vaccine, 23, 345–356 Injection of vaccine,
asthma exacerbation or reactive airway as cause of adverse event, evidence
disease episodes in children convincingly supporting, 18
younger than 5 years of age, live as cause of adverse events. See Causality,
attenuated influenza vaccine, injection-related adverse events
356–366 complex regional pain syndrome, 78–80,
asthma exacerbation or reactive airway 615–617
disease episodes in persons deltoid bursitis, 80, 618–620, 632
5 years of age or older, live summary of evidence and causality
attenuated influenza vaccine, conclusions, 21t, 625t,
366–373 687–688t
Bell’s palsy, 23, 335–337, 338–339t syncope, 80–81, 620–624, 632
brachial neuritis, 340 Institute of Medicine, 1–2, 29–30, 39
Campylobacter jejuni contamination, 333
as cause of adverse events. See Causality,
influenza vaccine
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INDEX
L opsoclonus myoclonus syndrome,
167–168
Latency between antigen exposure and optic neuritis, 2–10, 36, 156–158
peak adaptive immune response. prior reviews into adverse events, 1–2, 30
See Biological mechanisms, rubella virus strain, 107
pathophysiologies, and summary of evidence and causality
susceptibilities with the potential conclusions, 20–22t, 218–221t,
to contribute to adverse events 674–677t
Lockjaw, 527 transient arthralgia in children, 18,
182–190
transient arthralgia in women, 174–181
M transverse myelitis, 154–156
type 1 diabetes, 23, 204–211
Manufacturers of vaccine, legislative relief
Measles, mumps, rubella, and varicella
from tort liablity, 1, 28
vaccine, 108, 242
Measles, mumps, and rubella (MMR)
Measles inclusion body encephalitis
vaccine
definition, 641
acute disseminated encephalomyelitis,
mechanism(s) that may contribute to
153–154
symptoms of, 110
afebrile seizures, 133–137
MMR vaccine and, 18, 20t, 108–110,
anaphylaxis, 18, 169–174, 631–632
218t
arthropathy in men, 201–204
Measles infection
ataxia, 143–144
acute disseminated encephalomyelitis, 154
autism, 23, 88, 145–153
ataxia and, 144
brachial neuritis, 168–169
clinical description, 103, 641
causality conclusions. See Causality,
complications, 103
MMR vaccine
encephalitis and, 103, 117
chronic arthralgia in women, 190–195
encephalopathy and, 118
chronic arthritis in women, 195–199
febrile seizures and, 132
chronic arthropathy in children, 199–200
Guillain-Barré syndrome and, 166
chronic fatigue syndrome, 212–213
hearing loss and, 216
chronic inflammatory disseminated
hepatitis and, 104, 212
polyneuropathy, 166–167
measles inclusion body encephalitis and,
cytokine imbalance and, 76
110
encephalitis and encephalopathy,
optic neuritis and, 157
111–119
transmission, 103
febrile seizures, 18, 119–132, 630
transverse myelitis and, 155
fibromyalgia, 213–214
vaccine development and
formulation, 107–108
recommendations, 104, 108
Guillain-Barré syndrome, 165–166
virus description, 103
hearing loss, 214–217
See also Measles, mumps, and rubella
hepatitis, 211–212
(MMR) vaccine
measles inclusion body encephalitis, 18,
Mechanistic evidence
108–110
categorization of causality based on,
measles virus strain, 104
12–14, 45–48
meningitis, 10, 36, 137–143
DTaP vaccine
multiple sclerosis onset in adults,
acute disseminated encephalomyelitis,
159–164
546–547
multiple sclerosis onset in children,
anaphylaxis, 563–565
164–165
arthropathy, 571
mumps virus strain, 106
ataxia, 545
neuromyelitis optica, 10, 36, 158–159
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autism, 546 first demyelinating event in adults,
Bell’s Palsy, 562 460, 463
chronic inflammatory disseminated first demyelinating event in children,
polyneuropathy, 559–560 465
chronic urticaria, 565–566 Guillain-Barré syndrome, 466
encephalitis and encephalopathy, juvenile idiopathic arthritis, onset or
536–537 exacerbation, 486–488
fibromyalgia, 581 multiple sclerosis onset in adults, 450
Guillain-Barré syndrome, 557–558 multiple sclerosis onset in children,
immune thrombocytopenic purpura, 455
583 multiple sclerosis relapse in adults, 456
infantile spasms, 538 multiple sclerosis relapse in children,
multiple sclerosis onset in adults, 553 457–458
multiple sclerosis relapse in adults, neuromyelitis optica, 446–447
554–555 optic neuritis, 444, 446
multiple sclerosis relapse in children, polyarteritis nodosa, onset or
556–557 exacerbation, 477–479
myocarditis, 580 psoriatic arthritis, onset or
opsoclonus myoclonus syndrome, 561 exacerbation, 480
optic neuritis, 549–550 reactive arthritis, onset or
seizures, 541, 544 exacerbation, 480–482
serum sickness, 566–567 rheumatoid arthritis, onset or
sudden infant death syndrome, 582 exacerbation, 483–485
summary of evidence and causality seizures, 439
conclusions, 22t, 585–588t, summary of evidence and causality
683–687t conclusions, 20t, 491–493t,
transverse myelitis, 548 681–683t
type 1 diabetes, 579 systemic lupus erythematosus,
hepatitis A vaccine 472–473
acute disseminated encephalomyelitis, transverse myelitis, 442–443
423–424 type 1 diabetes, 489
anaphylaxis, 428–429 vasculitis, onset or exacerbation,
autoimmune hepatitis, 429–430 473–476
Bell’s palsy, 428 human papillomavirus vaccine
chronic inflammatory disseminated acute disseminated encephalomyelitis,
polyneuropathy, 427 507
Guillain-Barré syndrome, 426 amyotrophic lateral sclerosis, 514
multiple sclerosis, 425 anaphylaxis, 515–516
summary of evidence and causality brachial neuritis, 513
conclusions, 431t, 680–681t chronic inflammatory disseminated
transverse myelitis, 424 polyneuropathy, 512
hepatitis B vaccine Guillain-Barré syndrome, 511
acute disseminated encephalomyelitis, hypercoagulable states, 520
440–441 multiple sclerosis, 510
anaphylaxis, 468–469 neuromyelitis optica, 509
brachial neuritis, 467–468 pancreatitis, 518
chronic inflammatory disseminated summary of evidence and causality
polyneuropathy, 467 conclusions, 21t, 521t, 683t
encephalitis and encephalopathy, 438 thromboembolic events, 519
erythema nodosum, 470 transient arthralgia, 517
fibromyalgia, 490 transverse myelitis, 508
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INDEX
influenza vaccine injection-related outcomes
acute disseminated encephalomyelitis, complex regional pain syndrome,
308 615–617
all-cause mortality, 390–391 deltoid bursitis, 618–620
anaphylaxis, 342–344 summary of evidence and causality
arthropathy, onset or exacerbation, conclusions, 21t, 625t, 687–688t
384–385 syncope, 620–624
asthma exacerbation or reactive airway meningococcal vaccine
disease episodes in children and acute disseminated encephalomyelitis,
adults, inactivated influenza 604
vaccine, 350, 356 anaphylaxis, 609
asthma exacerbation or reactive airway chronic headache, 610
disease episodes in children chronic inflammatory disseminated
younger than 5 years of age, live polyneuropathy, 608
attenuated influenza vaccine, 361, encephalitis and encephalopathy, 603
366 Guillain-Barré syndrome, 607
asthma exacerbation or reactive airway multiple sclerosis, 605–606
disease episodes in persons summary of evidence and causality
5 years of age or older, live conclusions, 20t, 611t, 687t
attenuated influenza vaccine, 369, transverse myelitis, 605
373 MMR vaccine
Bell’s palsy, 337 acute disseminated encephalomyelitis,
brachial neuritis, 340 153–154
chronic inflammatory disseminated afebrile seizures, 134, 137
polyneuropathy, 334–335 anaphylaxis, 169–174
encephalitis and encephalopathy, arthropathy in men, 202
299–300 ataxia, 143–144
fibromyalgia, 389 autism, 148, 153
Guillain-Barré syndrome, 327, brachial neuritis, 168–169
333–334 chronic arthralgia in women, 191,
multiple sclerosis onset in adults, 316 193–194
multiple sclerosis relapse in adults, chronic arthritis in women, 196, 198
319, 321 chronic arthropathy in children,
myocardial infarction, 388 199–200
neuromyelitis optica, 314 chronic fatigue syndrome, 213
oculorespiratory syndrome, 399–401 chronic inflammatory disseminated
optic neuritis, 311, 313 polyneuropathy, 167
polyarteritis nodosa, 383–384 encephalitis and encephalopathy,
seizures, 304 116–119
small fiber neuropathy, 341 febrile seizures, 124, 131–132
stroke, 386–387 fibromyalgia, 213
summary of evidence and causality Guillain-Barré syndrome, 165–166
conclusions, 20–22t, 401–404t, hearing loss, 214–217
678–680t hepatitis, 212
systemic lupus erythematosus, onset or measles inclusion body encephalitis,
exacerbation, 375, 378–379 109–110
transverse myelitis, 309 meningitis, 139, 142–143
vasculitis, onset or exacerbation, 380, multiple sclerosis onset in adults, 161
382–383 multiple sclerosis onset in children,
165
neuromyelitis optica, 158–159
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opsoclonus myoclonus syndrome, Meningococcal disease, 599–600
167–168 as cause of adverse events. See Causality,
optic neuritis, 156–157 meningococcal vaccine
summary of evidence and causality See Neisseria meningitides
conclusions, 20–22t, 218–221t, Meningococcal vaccine
674–677t acute disseminated encephalomyelitis,
transient arthralgia in children, 185, 603–604
190 anaphylactic reactions, 18
transient arthralgia in women, 176, anaphylaxis, 608–610
180–181 chronic headache, 610
transverse myelitis, 154–156 chronic inflammatory disseminated
type 1 diabetes, 207, 211 polyneuropathy, 607–608
varicella zoster vaccine development, 600–601
acute disseminated encephalomyelitis, encephalitis and encephalopathy,
271 602–603
anaphylaxis, 276–278 formulations, 601
arthropathy, onset or exacerbation, Guillain-Barré syndrome, 606–607
278–279 multiple sclerosis, 605–606
cerebellar ataxia, 270 summary of evidence and causality
disseminated Oka VZV with conclusions, 20t, 611t, 687t
subsequent infection resulting transverse myelitis, 604–605
in pneumonia, meningitis, or vaccination rate, 601–602
hepatitis, 251–256 Meningococcemia, 599
disseminated Oka VZV without other Meningoencephalitis
organ involvement, 243–249 definition, 641
encephalopathy, 267 influenza vaccine and, 299
Guillain-Barré syndrome, 273–274 MMR. See Measles, mumps, and rubella
seizures, 269 vaccine
small fiber neuropathy, 274–275 Molecular mimicry. See Biological
stroke, 280 mechanisms, pathophysiologies,
summary of evidence and causality and susceptibilities with the
conclusions, 19–20t, 283–284t, potential to contribute to adverse
677–678t events
thrombocytopenia, 281–282 Mortality
transverse myelitis, 272–273 infant, 27
vaccine strain viral reactivation with influenza vaccine and all-cause mortality,
subsequent infection resulting 390–391
in meningitis or encephalitis, Multiple sclerosis
263–266 definition, 641
vaccine strain viral reactivation DTaP vaccine and, 550–557, 586–587t
without other organ involvement, hepatitis A vaccine and, 425, 431t
257–261 hepatitis B vaccine and, 447–458, 491t
weight-of-evidence evaluations, 12–14, human papillomavirus vaccine and, 510,
45–48 521t
Meningitis influenza vaccine and, 314–321, 402t
definition, 641 mechanism(s) that may contribute to
mechanism(s) that may contribute to symptoms of, 161, 165, 316,
symptoms of, 143, 256, 266 321, 425, 450, 455, 456, 458,
MMR vaccine and, 10, 36, 137–143, 218t 510, 553, 555, 556, 606
varicella vaccine and, 19t, 251, 253, meningococcal vaccine and, 605–606,
255–256, 262, 263–267, 283t 611t
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INDEX
N
MMR vaccine and, 159–165, 219t
molecular mimicry, 71
National Childhood Vaccine Injury Act, 1,
onset in adults
28–29
DTaP vaccine, 550–553, 586t
National Vaccine Injury Compensation
hepatitis B vaccine and, 447–450,
Program
451–453t, 491t
purpose, 29
influenza vaccine and, 314–318, 402t
scientific basis for adjudication under, 30
MMR vaccine and, 159–164, 219t
scope of coverage, 1–2, 2n, 30n
onset in children
structure, 29
hepatitis B vaccine and, 454–455, 491t
National Vaccine Program Office, 29
MMR vaccine and, 164–165, 219t
Neisseria meningitides
relapse in adults
bacteria description, 599
DTaP vaccine, 554–555, 586t
clinical description, 599
hepatitis B vaccine and, 455–456,
complications, 599, 600
491t
nomenclature, 600
influenza vaccine and, 318–321, 402t
transmission, 599
relapse in children
vaccine development and
DTaP vaccine, 555–557, 587t
recommendations, 600–602
hepatitis B vaccine and, 457–458, 491t
Nested case-control studies
Mumps infection
definition, 642
acute disseminated encephalomyelitis, 154
studies contributing to the weight of
ataxia and, 144
epidemiologic evidence, 302–303,
clinical description, 105, 641–642
306t, 315, 317t, 324–325, 330t,
complications, 105
447–449, 451t, 452t, 551, 552t
encephalitis and, 105, 117
Neuraminidase surface proteins, 294
encephalopathy and, 118
Neuritis, definition of, 642
febrile seizures and, 132
Neuromyelitis optica
Guillain-Barré syndrome and, 166
definition, 642
meningitis and, 105, 142
hepatitis B vaccine and, 446–447, 491t
hearing loss and, 105, 216
human papillomavirus vaccine and, 509,
hepatitis and, 212
521t
optic neuritis and, 157
influenza vaccine and, 314, 402t
transmission, 104–105
mechanism(s) that may contribute to
transverse myelitis and, 105, 155
symptoms of, 158–159, 314, 447,
type 1 diabetes and, 105, 211
509
vaccine development and
MMR vaccine and, 10, 36, 158–159, 219t
recommendations, 105–106, 108
Neuropathy, definition of, 642
virus description, 104
Northern California Kaiser Permanente
See also Measles, mumps, and rubella
Patients, 133–134, 135t, 175,
(MMR) vaccine
178t, 192t, 197t, 250, 268, 275,
Myocardial infarction
438–439, 574, 578t, 618
definition, 642
Nurses’ Health Study, 447–448, 451t
influenza vaccine and, 387–389, 404t
mechanism(s) that may contribute to
symptoms of, 388
O
Myocarditis
definition, 642 Oculorespiratory syndrome
DTaP vaccine and, 579–580, 588t definition, 642
mechanism(s) that may contribute to influenza vaccine and, 18, 21t, 391–401,
symptoms of, 580 404t, 632
Myoclonic epilepsy, 84, 642
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mechanism(s) that may contribute to influenza vaccine and, 383–384, 403t
symptoms of, 400 mechanism(s) that may contribute to
Opsoclonus myoclonus syndrome symptoms of, 67, 383–384, 479
definition, 642–643 Pregnancy, rubella infection in, 106–107
DTaP vaccine and, 560–561, 587t Preventive interventions
mechanism(s) that may contribute to accomplishments, 27
symptoms of, 168, 561 evolution of vaccination programs, 27
MMR vaccine and, 167–168, 219t ProQuad, 107–108, 242
Optic neuritis Psychogenic factors in complex regional
definition, 643 pain syndrome, 79
DTaP vaccine and, 549–550, 586t Purpura. See Immune thrombocytopenic
hepatitis B vaccine and, 443–446, 491t purpura
influenza vaccine and, 310–313, 402t
mechanism(s) that may contribute to
R
symptoms of, 157, 313, 446, 550
MMR vaccine and, 156–158, 219t
Randomized clinical trials, 43–44
scope of review into vaccine events, 2,
Randomized controlled crossover trials,
10, 36
studies contributing to the weight of
Orthomyxoviridae, 293
epidemiologic evidence, 392–393,
395–397t
Randomized controlled trials
P
contributing to the weight of
Pancreatitis epidemiologic evidence, 359–360,
definition, 643 365t, 367–368, 372t, 379–380,
human papillomavirus vaccine and, 381t
517–518, 521t definition, 643
mechanism(s) that may contribute to double blind randomized controlled trials
symptoms of, 518 contributing to the weight of
Pertussis vaccine, acellular. See Acellular epidemiologic evidence, 175–176,
pertussis vaccine 178–179t, 183–184, 188t, 190,
Pertussis vaccine, whole cell 192t, 195, 197t, 318, 320t,
adverse event review, 1–2, 30, 530 345, 347–348, 351t, 353t, 354t,
development, 529 357–358, 362t, 367, 370–371t,
susceptibility to adverse events, 84 373–374, 376t, 516–517
See also Diphtheria toxoid, tetanus-toxoid, Rechallenge reports
and acellular pertussis antigen- as an attribution element, 13, 46–47, 84
containing (DTaP) vaccines Research and development, vaccine, 28
Pneumonia Retrospective studies, 644
definition, 643 Rubivirus (rubella infection)
influenza infection and, 294–295 acute disseminated encephalomyelitis,
meningococcal infection and, 599 154
varicella vaccine and, 250–253, 255–256, arthropathy in men and, 106, 202
283t chronic arthralgia in women and, 106,
varicella vaccine and mechanism(s) 194
contributing to symptoms of, 256 chronic arthritis in women and, 106, 198
Polio vaccine, 2, 28, 30 chronic arthropathy in children and, 106,
Polyarteritis nodosa 200
definition, 643 clinical description, 106–107, 644
hepatitis B infection and, 67 encephalitis, 106, 117
hepatitis B vaccine and onset or Guillain-Barré syndrome and, 106, 166
exacerbation of, 477–479, 492t
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INDEX
hepatitis and, 212 Shoulder pain and stiffness, 80
optic neuritis and, 157 See also Deltoid bursitis
neuromyelitis optica, 158 Small fiber neuropathy
transient arthralgia in children and, 106, definition, 644
185 influenza vaccine and, 340–341, 402t
transient arthralgia in women and, 106, mechanism(s) that may contribute to
181 symptoms of, 274–275, 341
transmission, 106 varicella vaccine and, 10, 36, 274–275,
transverse myelitis and, 155 284t
vaccine development and Smallpox, 27
recommendations, 107, 108 Special Masters, 2, 29, 30
virus description, 106 Streptococcal infection
See also Measles, mumps, and rubella immune complexes, 67
(MMR) vaccine molecular mimicry, 71
superantigens, 76
Streptococcus pneumoniae, 61
S Stroke
definition, 645
Seizures influenza vaccine and, 386–387, 403t
afebrile, definition, 635 mechanism(s) that may contribute to
definition, 644 symptoms of, 280, 386–387
DTaP vaccine and, 537–544, 585t varicella vaccine and, 10, 36, 279–280,
hepatitis B vaccine and, 438–440, 491t 284t
influenza infection and, 294 Subunit vaccines, 59
influenza vaccine and, 2, 36, 301–304, Sudden infant death syndrome
305–307t, 402t definition, 645
mechanism(s) that may contribute to DTaP vaccine and, 581–582, 588t
symptoms of, 68–70, 132, 269, Superantigens. See Biological mechanisms,
304, 439, 544 pathophysiologies, and
MMR vaccine and, 18, 20t, 119–137, susceptibilities with the potential
218t to contribute to adverse events
varicella vaccine and, 268–269, 283t Surveillance system for adverse events
See also Febrile seizures; Infantile spasms definition and features, 645
Self-controlled case-series study legislation in support of, 1, 28–29
definition, 644 See also Vaccine Adverse Event Reporting
studies contributing to the weight of System (VAERS)
epidemiologic evidence, 112, Susceptible individuals and populations
115t, 121, 122–124, 128–130t, application to adverse event review, 24,
145–146, 149–150t, 184, 188t, 54
323–324, 325, 329–330t, 336, hypersensitivity mechanisms, 64–66
338t, 346, 352t, 386, 387–388, predispositions in, 82–84
449, 453t, 459, 462t, 539–540, See also Genetic risk factors
542t, 602 Swine influenza vaccine, 321n
Sequential vaccination, 36 Syncope
Serum sickness clinical features, 80–81
definition, 644
definition, 645
DTaP vaccine and, 566–567, 587t injection-related adverse events, 620–624,
mechanism(s) that may contribute to 625t
symptoms of, 566–567 mechanism(s) that may contribute to
Shingles. See Herpes zoster symptoms of, 623–624
as result of vaccine injection, 18
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See also Biological mechanisms, Tissue responses. See Biological
pathophysiologies, and mechanisms, pathophysiologies,
susceptibilities with the potential and susceptibilities with the
to contribute to adverse events potential to contribute to adverse
Systemic lupus erythematosus events
definition, 645 Transverse myelitis
hepatitis B vaccine and, 471–473, 492t definition, 646
immune complexes in, 67 DTaP vaccine and, 547–548, 586t
influenza vaccine and, 373–379, 403t hepatitis A vaccine and, 424–425, 431t
mechanism(s) that may contribute to hepatitis B vaccine and, 442–443, 491t
symptoms of, 67, 378, 473 human papillomavirus vaccine and, 508,
521t
influenza vaccine and, 309–310, 402t
T mechanism(s) that may contribute to
symptoms of, 155, 273, 309,
T cells. See Biological mechanisms, 424, 443, 508, 548, 605
pathophysiologies, and meningococcal vaccine and, 604–605,
susceptibilities with the potential 611t
to contribute to adverse events MMR vaccine and, 154–156, 219t
Tetanospasm, 527 varicella zoster vaccine and, 272–273,
Tetanus infection, 527–528, 562, 645 284t
Tetanus toxoid-containing vaccines Trismus, 527
anaphylactic reactions, 18 Type 1 autoimmune chronic hepatitis,
development, 528 421–422
effectiveness, 528
non-whole cell pertussis, 1n, 2
summary of evidence and causality U
conclusions, 20t, 22t, 585–588t,
683–687t Urticaria
See also Diphtheria toxoid, tetanus- definition, 646
toxoid, and acellular pertussis See also Chronic urticaria
antigen-containing (DTaP)
vaccines
V
Thrombocytopenia
definition, 645
Vaccine Adverse Event Reporting System
mechanism(s) that may contribute to
(VAERS), 29, 171–172, 215,
symptoms of, 282
244–245, 257–258, 263, 276,
varicella zoster vaccine and, 281–282,
277, 281, 313, 335, 343–344,
284t
382, 469, 474, 477, 515,
Thromboembolic events
618–619, 622, 623, 631, 646
definition, 645
Vaccine information statement (VIS), 29
human papillomavirus vaccine and,
Vaccine Injury Table
519–520, 521t
purpose, 29
mechanism(s) that may contribute to
Vaccine Safety Datalink (VSD), 111–112,
symptoms of, 519
121, 156, 160, 170, 205–206,
Thromboembolism, definition of, 645
262, 279, 301, 302, 303, 310,
Time interval between vaccine
315, 326, 336, 342, 348–349,
administration and adverse event
428, 443, 448, 458–459, 488,
case report evaluations, 13
535, 540, 551, 573, 646
Vaccine Injury Table reporting
Vaccines, general
requirements, 29
historical evolution, 27
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INDEX
mechanism of action, 28, 57–59 cerebellar ataxia and, 240, 270
public health benefits, 28 clinical description, 239–240, 646
recognized risks, 28 complications, 239–241
See also Adverse events, generally; disseminated Oka VZV without other
organ involvement and, 239, 248
specific vaccines
Varicella Vaccine Collaborative Study, disseminated Oka VZV with subsequent
241–242 infection resulting in pneumonia,
Varicella zoster vaccine meningitis, or hepatitis and,
acute disseminated encephalomyelitis, 239–240, 255
271 Guillain-Barré syndrome and, 240, 274
anaphylaxis, 18, 20t, 275–278 incidence, 240–241
arthropathy, onset or exacerbation, stroke and, 280
278–279 thrombocytopenia, 239, 282
causality conclusions. See Causality, transmission, 239
varicella zoster vaccine transverse myelitis and, 240, 272
as cause of adverse events. See Causality, vaccine development and
varicella zoster vaccine recommendations, 241–242
cerebellar ataxia, 269–270 vaccine-strain viral reactivation with
development of, 241–242 subsequent infection resulting in
disseminated Oka VZV with subsequent meningitis or encephalitis and,
infection resulting in pneumonia, 240, 266
meningitis, or hepatitis, 249–256 vaccine-strain viral reactivation without
disseminated Oka VZV without other other organ involvement and,
organ involvement, 242–249 240, 260
dosage, 242 virus description, 239
encephalopathy, 267–268 Vasculitis
Guillain-Barré syndrome, 273–274 definition, 646
in immunodeficient individuals, 241–242, hepatitis B vaccine and onset or
245–248, 255, 630–631 exacerbation of, 473–477, 492t
limitations of data sources, 631 influenza vaccine and onset or
seizures, 268–269 exacerbation of, 379–383, 403t
small fiber neuropathy, 10, 36, 274–275 mechanism(s) that may contribute to
stroke, 10, 36, 279–280 symptoms of, 383, 476
summary of evidence and causality Viral activity. See Biological mechanisms,
conclusions, 19–20t, 283–284t, pathophysiologies, and
677–678t susceptibilities with the potential
thrombocytopenia, 281–282 to contribute to adverse events
transverse myelitis, 272–273
vaccine strain viral reactivation with
W
subsequent infection resulting in
meningitis or encephalitis, 78,
Weight-of-evidence evaluations, 10–14,
261–267
42–48
vaccine strain viral reactivation without
Worldwide Adverse Event System, 244–245,
other organ involvement, 18, 78,
257, 258, 263, 277
256–261
Varicella zoster virus infection
acute disseminated encephalomyelitis
and, 271
OCR for page 866
