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



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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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856 INDEX 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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857 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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858 INDEX 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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859 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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860 INDEX 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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861 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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862 INDEX 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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863 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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864 INDEX 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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865 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

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