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From page 839...
... 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
From page 840...
... 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)
From page 841...
... 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
From page 842...
... 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
From page 843...
... 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
From page 844...
... 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)
From page 845...
... 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
From page 846...
... 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
From page 847...
... 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
From page 848...
... 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)
From page 849...
... 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)
From page 850...
... See Diphtheria toxoid, tetanus- autism, 545 toxoid, and acellular pertussis Bell's Palsy, 561–562 antigen-containing vaccines chronic inflammatory disseminated polyneuropathy, 558 chronic urticaria, 565 E encephalitis and encephalopathy, 534–535 Egg sensitivity, 83, 170–172, 277, 342–343, fibromyalgia, 581 344, 632 Guillain-Barré syndrome, 557 Embolism, definition, 639 immune thrombocytopenic purpura, Encephalitis and encephalopathy 582–583 autism and, 85, 88–89 infantile spasms, 537–538 as Bordetella pertussis infection multiple sclerosis onset in adults, complication, 529, 536 550–553 as Corynebacterium diphtheriae infection multiple sclerosis relapse in adults, 554 complication, 526, 536 multiple sclerosis relapse in children, definition, 639 555–556 DTaP vaccine and, 534–537, 585t myocarditis, 579 genetic risk, 84, 85, 88–89 opsoclonus myoclonus syndrome, 560 hepatitis B vaccine and, 437–438, 491t optic neuritis, 549 as influenza infection complication, 299 seizures, 539–541, 542–543t influenza vaccine and, 296, 299–301, 402t serum sickness, 566 as measles infection complication, 77, sudden infant death syndrome, 103, 117, 118 581–582 mechanism(s) that may contribute to summary of evidence and causality symptoms of, 117, 119, 266, conclusions, 22t, 585–588t, 267, 299, 300, 537, 603 683–687t meningococcal vaccine and, 602–603, transverse myelitis, 547–548 611t type 1 diabetes, 571–579 MMR vaccine and, 111–119, 218t for evaluation of causality, 39–40 as mumps infection complication, 105, hepatitis A vaccine 117, 118 acute disseminated encephalomyelitis, as rubella infection complication, 77, 423 106–107, 117 anaphylaxis, 428 varicella vaccine and, 262–263, 265–266, autoimmune hepatitis, 429 267–268, 283t Bell's palsy, 427
From page 851...
... 851 INDEX chronic inflammatory disseminated human papillomavirus vaccine polyneuropathy, 427 acute disseminated encephalomyelitis, Guillain-Barré syndrome, 426 507 multiple sclerosis, 425 amyotrophic lateral sclerosis, 513 summary of evidence and causality anaphylaxis, 515 conclusions, 431t, 680–681t brachial neuritis, 512–513 transverse myelitis, 424 chronic inflammatory disseminated hepatitis B vaccine polyneuropathy, 512 acute disseminated encephalomyelitis, Guillain-Barré syndrome, 511 440 hypercoagulable states, 520 anaphylaxis, 468 multiple sclerosis, 510 brachial neuritis, 467 neuromyelitis optica, 509 chronic inflammatory disseminated pancreatitis, 517–518 polyneuropathy, 466–467 summary of evidence and causality encephalitis and encephalopathy, 437 conclusions, 21t, 521t, 683t erythema nodosum, 469 thromboembolic events, 519 fibromyalgia, 490 transient arthralgia, 516–517 first demyelinating event in adults, transverse myelitis, 508 458–460, 461–462t influenza vaccine first demyelinating event in children, acute disseminated encephalomyelitis, 464–465 308 Guillain-Barré syndrome, 465–466 all-cause mortality, 390 juvenile idiopathic arthritis, onset or anaphylaxis, 341–342 exacerbation, 485–486 arthropathy, onset or exacerbation, multiple sclerosis, onset in adults, 384 447–450, 451–453t asthma exacerbation or reactive airway multiple sclerosis, onset in children, disease episodes in children and 454 adults, inactivated influenza multiple sclerosis, relapse in adults, vaccine, 345–350, 351–355t 455–456 asthma exacerbation or reactive airway multiple sclerosis, relapse in children, disease episodes in children 457 younger than 5 years of age, live neuromyelitis optica, 446 attenuated influenza vaccine, optic neuritis, 443–444, 445t 356–361, 362–365t polyarteritis nodosa, onset or asthma exacerbation or reactive airway exacerbation, 477 disease episodes in persons psoriatic arthritis, onset or 5 years of age or older, live exacerbation, 479–480 attenuated influenza vaccine, reactive arthritis, onset or 366–369, 370–372t exacerbation, 480 Bell's palsy, 335–337, 338–339t rheumatoid arthritis, onset or brachial neuritis, 340 exacerbation, 482–483 chronic inflammatory disseminated seizures, 438–439 polyneuropathy, 334 summary of evidence and causality encephalitis and encephalopathy, 296 conclusions, 20t, 491–493t, fibromyalgia, 389 681–683t Guillain-Barré syndrome, 321–327, systemic lupus erythematosus onset or 328–332t exacerbation, 471–472 multiple sclerosis, onset in adults, transverse myelitis, 442 314–316, 317t type 1 diabetes, 488–489 multiple sclerosis, relapse in adults, vasculitis, onset or exacerbation, 473 318–319, 320t
From page 852...
... 852 INDEX myocardial infarction, 387–388 chronic fatigue syndrome, 212–213 neuromyelitis optica, 314 chronic inflammatory disseminated oculorespiratory syndrome, 391–398 polyneuropathy, 166–167 optic neuritis, 310–311, 312t encephalitis and encephalopathy, polyarteritis nodosa, 383 111–113, 114–115t seizures, 301–304, 305–307t febrile seizures, 119–124, 125–130t small fiber neuropathy, 340–341 fibromyalgia, 213 stroke, 386 Guillain-Barré syndrome, 165 summary of evidence and causality hearing loss, 214 conclusions, 20–22t, 402–404t, hepatitis, 211 678–680t measles inclusion body encephalitis, systemic lupus erythematosus, onset or 108 exacerbation, 373–375, 376–377t meningitis, 137–139, 140–141t transverse myelitis, 309 multiple sclerosis, onset in adults, vasculitis, onset or exacerbation, 159–161, 162–163t 379–380, 381t multiple sclerosis, onset in children, injection-related outcomes 164 complex regional pain syndrome, 615 neuromyelitis optica, 158 deltoid bursitis, 618 opsoclonus myoclonus syndrome, 167 summary of evidence and causality optic neuritis, 156 conclusions, 21t, 625t, 687–688t summary of evidence and causality syncope, 620 conclusions, 20–22t, 218–221t, limitations of current data, 630 674–677t meningococcal vaccine transient arthralgia in children, acute disseminated encephalomyelitis, 182–185, 186–189t 603–604 transient arthralgia in women, anaphylaxis, 608–609 174–176, 177–179t chronic headache, 610 transverse myelitis, 154 chronic inflammatory disseminated type 1 diabetes, 204–207, 208–210t polyneuropathy, 607–608 varicella zoster vaccine encephalitis and encephalopathy, acute disseminated encephalomyelitis, 602–603 271 Guillain-Barré syndrome, 606–607 anaphylaxis, 275 multiple sclerosis, 605 arthropathy, onset or exacerbation, summary of evidence and causality 278 conclusions, 20t, 611t, 687t cerebellar ataxia, 269–270 transverse myelitis, 604 disseminated Oka VZV with MMR vaccine subsequent infection resulting acute disseminated encephalomyelitis, in pneumonia, meningitis, or 153 hepatitis, 250–251 afebrile seizures, 133–134, 135–136t disseminated Oka VZV without other anaphylaxis, 169 organ involvement, 243 arthropathy in men, 201–202, 203t encephalopathy, 267 ataxia, 143 Guillain-Barré syndrome, 273 autism, 145–148, 149–152t seizures, 268 brachial neuritis, 168 small fiber neuropathy, 274 chronic arthralgia in women, 190–191, stroke, 279–280 192t summary of evidence and causality chronic arthritis in women, 195–196, conclusions, 19t, 20t, 283–284t, 197t 677–678t chronic arthropathy in children, 199 thrombocytopenia, 281
From page 853...
... that may contribute to symptoms of, 166, 274, 334, symptoms of, 132 426, 466, 511, 558, 607 MMR vaccine and, 18, 20t, 119–132, meningococcal vaccine and, 606–607, 218t, 630 611t tissue responses, 68–70 MMR vaccine and, 165–166, 219t Fibromyalgia swine influenza vaccine and, 321n DTaP vaccine and, 581, 588t varicella zoster vaccine and, 273–274, 284t hepatitis B vaccine and, 490, 493t influenza vaccine and, 389, 404t H MMR vaccine and, 213–214, 221t First demyelinating event H1N1 vaccine, 2n, 30 hepatitis B vaccine and, in adults, H5N1 vaccine, 294 458–460, 461–462t, 491t Haemophilus influenzae type B vaccine, 2, hepatitis B vaccine and, in children, 30 464–465, 492t Health Resources and Services mechanism(s) that may contribute to Administration, 2, 29, 30, 36 symptoms of, 463, 465 Hearing loss Food and Drug Administration, 29 definition, 639 Food hypersensitivity reactions, 65, mechanism(s)
From page 854...
... See Causality, Hepatitis A infection hepatitis B vaccine acute disseminated encephalomyelitis chronic inflammatory disseminated and, 423 polyneuropathy, 466–467 autoimmune hepatitis and, 421–422, 430 cytokine imbalance and, 76 clinical description, 421–422, 640 development, 436 complications, 421–422 encephalitis and encephalopathy, Guillain-Barré syndrome and, 426 437–438 transmission, 422 erythema nodosum, 10, 36, 469–471 transverse myelitis and, 424 fibromyalgia, 490 vaccine development, 422 first demyelinating event in adults, virus description, 421 458–464 Hepatitis A vaccine first demyelinating event in children, acute disseminated encephalomyelitis, 464–465 423–424 formulations, 436–437 anaphylaxis, 428–429 Guillain-Barré syndrome, 465–466 autoimmune hepatitis, 429–430 immune complex-mediated effects, 68 Bell's palsy, 427–428 injection-related adverse events, 616 as cause of adverse events. See Causality, juvenile idiopathic arthritis, onset or hepatitis A vaccine exacerbation, 485–488 chronic inflammatory disseminated multiple sclerosis onset in adults, polyneuropathy, 427 447–450, 451–453t development, 422 multiple sclerosis onset in children, formulations, 422–423 454–455 Guillain-Barré syndrome, 426 multiple sclerosis relapse in adults, multiple sclerosis, 425 455–456 summary of evidence and causality multiple sclerosis relapse in children, conclusions, 431t, 680–681t 457–458 transverse myelitis, 424–425 neuromyelitis optica, 446–447 Hepatitis B infection optic neuritis, 10, 36, 443–446 clinical description, 435–436, 640 polyarteritis nodosa, onset or complications, 435–436 exacerbation, 477–479 onset or exacerbation of juvenile prior reviews into adverse events, 2, 30 idiopathic arthritis and, 435, 487 psoriatic arthritis, onset or exacerbation, onset or exacerbation of polyarteritis 479–480 nodosa and, 435, 478–479 reactive arthritis, onset or exacerbation, onset or exacerbation of rheumatoid 480–482 arthritis and, 435, 484 rheumatoid arthritis, onset or onset or exacerbation of vasculitis and, exacerbation, 482–485 435, 476 seizures, 438–440 transmission, 435 summary of causality studies and vaccine development and conclusions, 20t, 491–493t, recommendations, 436–437 681–683t virus description, 435 systemic lupus erythematosus onset or exacerbation, 471–473
From page 855...
... See Causality, influenza vaccine recommendations in, human papillomavirus vaccine 296 chronic inflammatory disseminated measles inclusion body encephalitis and polyneuropathy, 512 MMR vaccine, 109–110 current formulations, 506 meningococcal disease, 600 cytokine imbalance and, 76 treatment of varicella zoster infection in, development, 506 241 Guillain-Barré syndrome, 511–512 varicella vaccine and, 241–242, 244–249, hypercoagulable states, 520 252–256, 258–262, 264–265, multiple sclerosis, 510 630–631 neuromyelitis optica, 509 Immunoglobulin E hypersensitivity. pancreatitis, 517–518 See Biological mechanisms, prevalence of use, 507 pathophysiologies, and recommendations for, 506–507 susceptibilities with the potential summary of evidence and causality to contribute to adverse events conclusions, 21t, 521t, 683t Increased cytokines.
From page 856...
... See Causality, influenza vaccine
From page 857...
... 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
From page 858...
... 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
From page 859...
... 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
From page 860...
... 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)
From page 861...
... 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)
From page 862...
... 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)
From page 863...
... 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)
From page 864...
... 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)
From page 865...
... 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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