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Committee to Review Adverse Effects of Vaccines; Institute of Medicine; Stratton K, Ford A, Rusch E, et al., editors. Adverse Effects of Vaccines: Evidence and Causality. Washington (DC): National Academies Press (US); 2011 Aug 25.

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Adverse Effects of Vaccines: Evidence and Causality.

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Appendix DCausality Conclusion Tables

TABLE D-1Causality Conclusions Organized by Chapter and Adverse Event

ChapterVaccineAdverse EventEpidemiologic AssessmentMechanistic AssessmentCausality Conclusion
4MMRMeasles Inclusion Body EncephalitisInsufficientStrong (measles; in individuals with demonstrated immunodeficiencies)Convincingly Supportsa (in individuals with demonstrated immunodeficiencies)
Lacking (mumps or rubella)
4MMREncephalitisLimitedWeakInadequate
4MMREncephalopathyLimitedWeakInadequate
4MMRFebrile SeizuresHigh (increase)IntermediateConvincingly Supports
4MMRAfebrile SeizuresLimitedLackingInadequate
4MMRMeningitisbModerate (null)Weak (mumps)Inadequate
Lacking (measles or rubella)
4MMRAtaxiaInsufficientWeak (measles or mumps)Inadequate
Lacking (rubella)
4MMRAutismHigh (null)LackingFavors Rejection
4MMRAcute Disseminated EncephalomyelitisInsufficientWeakInadequate
4MMRTransverse MyelitisInsufficientWeakInadequate
4MMROptic NeuritisbLimitedWeakInadequate
4MMRNeuromyelitis OpticabInsufficientWeak (rubella)Inadequate
Lacking (measles or mumps)
4MMRMultiple Sclerosis Onset in AdultsLimitedLackingInadequate
4MMRMultiple Sclerosis Onset in ChildrenLimitedLackingInadequate
4MMRGuillain-Barré syndromeInsufficientWeakInadequate
4MMRChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
4MMROpsoclonus Myoclonus SyndromeInsufficientLackingInadequate
4MMRBrachial NeuritisInsufficientLackingInadequate
4MMRAnaphylaxisInsufficientStrongConvincingly Supports
4MMRTransient Arthralgia in WomenModerate (increase) (rubella)Intermediate (rubella)Favors Acceptancec
Insufficient (measles or mumps)Lacking (measles or mumps)
4MMRTransient Arthralgia in ChildrenModerate (increase)Weak (rubella)Favors Acceptance
Lacking (measles or mumps)
4MMRChronic Arthralgia in WomenLimited (rubella)Low-Intermediate (rubella)Inadequate
Insufficient (measles or mumps)Lacking (measles or mumps)
4MMRChronic Arthritis in WomenLimited (rubella)Low-Intermediate (rubella)Inadequate
Insufficient (measles or mumps)Lacking (measles or mumps)
4MMRChronic Arthropathy in ChildrenInsufficientWeak (rubella)Inadequate
Lacking (measles or mumps)
4MMRArthropathy in MenLimitedWeak (rubella)Inadequate
Lacking (measles or mumps)
4MMRType 1 DiabetesHigh (null)LackingFavors Rejection
4MMRHepatitisInsufficientWeakInadequate
4MMRChronic Fatigue SyndromeInsufficientLackingInadequate
4MMRFibromyalgiaInsufficientLackingInadequate
4MMRHearing LossInsufficientLow-Intermediate (measles or mumps)Inadequate
Lacking (rubella)
5VaricellaDisseminated Oka VZV without Other Organ InvolvementInsufficientStrongConvincingly Supports
5VaricellaDisseminated Oka VZV with Subsequent Infection Resulting in Pneumonia, Meningitis, or HepatitisLimited (subsequent infection resulting in pneumonia)Strong (in individuals with demonstrated immunodeficiencies)Convincingly Supports (in individuals with demonstrated immunodeficiencies)
Insufficient (subsequent infection resulting in meningitis or hepatitis)
5VaricellaVaccine Strain Viral Reactivation without Other Organ InvolvementInsufficientStrongConvincingly Supports
5 VaricellaVaccine Strain Viral Reactivation with Subsequent Infection resulting in Meningitis or EncephalitisLimited (subsequent infection resulting in encephalitis)StrongConvincingly Supports
Insufficient (subsequent infection resulting in meningitis)
5VaricellaEncephalopathyInsufficientLackingInadequate
5VaricellaSeizuresLimitedWeakInadequate
5VaricellaCerebellar AtaxiaInsufficientWeakInadequate
5VaricellaAcute Disseminated EncephalomyelitisInsufficientWeakInadequate
5VaricellaTransverse MyelitisInsufficientWeakInadequate
5VaricellaGuillain-Barré syndromeInsufficientWeakInadequate
5VaricellaSmall Fiber NeuropathybInsufficientLackingInadequate
5VaricellaAnaphylaxisLimitedStrongConvincingly Supports
5VaricellaOnset or Exacerbation ArthropathyInsufficientLackingInadequate
5VaricellaStrokebLimitedWeakInadequate
5VaricellaThrombocytopeniaInsufficientWeakInadequate
6InfluenzaEncephalitisInsufficientWeakInadequate
6InfluenzaEncephalopathyInsufficientWeakInadequate
6InfluenzaSeizuresbModerate (null)LackingInadequate
6InfluenzaAcute Disseminated EncephalomyelitisInsufficientWeakInadequate
6InfluenzaTransverse MyelitisInsufficientWeakInadequate
6InfluenzaOptic NeuritisbLimitedWeakInadequate
6InfluenzaNeuromyelitis OpticaInsufficientLackingInadequate
6InfluenzaMultiple Sclerosis Onset in AdultsLimitedLackingInadequate
6InfluenzaMultiple Sclerosis Relapse in AdultsLimitedLackingInadequate
6InfluenzaGuillain-Barré syndromeModerate (null)WeakInadequate
6InfluenzaChronic Inflammatory Disseminated PolyneuropathyInsufficientWeakInadequate
6InfluenzaInactivated Influenza Vaccine and Bell's PalsyHigh (null)LackingFavors Rejection
6InfluenzaBrachial NeuritisInsufficientLackingInadequate
6InfluenzaSmall Fiber NeuropathyInsufficientLackingInadequate
6InfluenzaAnaphylaxisLimitedStrongConvincingly Supports
6InfluenzaInactivated Influenza Vaccine and Asthma Exacerbation or Reactive Airway Disease Episodes in Children and AdultsHigh (null)WeakFavors Rejection
6InfluenzaLive Attenuated Influenza Vaccine or Asthma Exacerbation or Reactive Airway Disease Episodes in Children Younger Than 5 Years of AgeModerate (null)WeakInadequate
6InfluenzaLive Attenuated Influenza Vaccine or Asthma Exacerbation or Reactive Airway Disease Episodes in Persons 5 Years of Age or OlderModerate (null)WeakInadequate
6InfluenzaOnset or Exacerbation of Systemic Lupus ErythematosusLimited (exacerbation)LackingInadequate
Insufficient (onset)
6InfluenzaOnset or Exacerbation of VasculitisLimited (exacerbation)Weak (exacerbation)Inadequate
Insufficient (onset)Lacking (onset)
6InfluenzaPolyarteritis NodosaInsufficientLackingInadequate
6InfluenzaOnset or Exacerbation of ArthropathyInsufficientWeakInadequate
6InfluenzaStrokeModerate (decrease)LackingInadequate
6InfluenzaMyocardial InfarctionModerate (decrease)Weak (Live Attenuated Influenza Vaccine)Inadequate
Lacking (Inactivated Influenza Vaccine)
6InfluenzaFibromyalgiaInsufficientLackingInadequate
6InfluenzaAll-Cause MortalitybModerate (decrease)Weak (Live Attenuated Influenza Vaccine)Inadequate
Lacking (Inactivated Influenza Vaccine)
6InfluenzaOculorespiratory SyndromeModerate (increase)dIntermediatedFavors Acceptanced
 Hepatitis AAcute Disseminated EncephalomyelitisInsufficientWeakInadequate
 Hepatitis ATransverse MyelitisInsufficientWeakInadequate
7Hepatitis AMultiple SclerosisInsufficientLackingInadequate
7Hepatitis AGuillain-Barré syndromeInsufficientWeakInadequate
 Hepatitis AChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
7Hepatitis ABell's PalsyInsufficientLackingInadequate
yHepatitis AAnaphylaxisInsufficientWeakInadequate
7Hepatitis AAutoimmune HepatitisInsufficientWeakInadequate
8Hepatitis BEncephalitisInsufficientLackingInadequate
8Hepatitis BEncephalopathyInsufficientLackingInadequate
8Hepatitis BSeizuresLimitedLackingInadequate
8Hepatitis BAcute Disseminated EncephalomyelitisInsufficientLow-IntermediateInadequate
8Hepatitis BTransverse MyelitisInsufficientWeakInadequate
8Hepatitis BOptic NeuritisbLimitedLackingInadequate
8Hepatitis BNeuromyelitis OpticaInsufficientLackingInadequate
8Hepatitis BMultiple Sclerosis Onset in AdultsLimitedLackingInadequate
8Hepatitis BMultiple Sclerosis Onset in ChildrenLimitedLackingInadequate
8Hepatitis BMultiple Sclerosis Relapse in AdultsLimitedLackingInadequate
8Hepatitis BMultiple Sclerosis Relapse in ChildrenLimitedLackingInadequate
8Hepatitis BFirst Demyelinating Event in AdultsModerate (null)Low-IntermediateInadequate
8Hepatitis BFirst Demyelinating Event in ChildrenLimitedLackingInadequate
8Hepatitis BGuillain-Barré syndromeInsufficientLackingInadequate
8Hepatitis BChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
8Hepatitis BBrachial NeuritisInsufficientLackingInadequate
8Hepatitis BAnaphylaxisInsufficientStrong (in yeast-sensitive individuals)Convincingly Supports (in yeast-sensitive individuals)
8Hepatitis BErythema NodosumbInsufficientWeakInadequate
8Hepatitis BOnset or Exacerbation of Systemic Lupus ErythematosusLimited (onset)WeakInadequate
Insufficient (exacerbation)
8Hepatitis BOnset or Exacerbation of VasculitisInsufficientLow-IntermediateInadequate
8Hepatitis BOnset or Exacerbation of Polyarteritis NodosaInsufficientWeakInadequate
8Hepatitis BOnset or Exacerbation of Psoriatic ArthritisInsufficientLackingInadequate
8Hepatitis BOnset or Exacerbation of Reactive ArthritisInsufficientWeakInadequate
8Hepatitis BOnset and Exacerbation of Rheumatoid ArthritisLimited (exacerbation)WeakInadequate
Insufficient (onset)
8Hepatitis BOnset or Exacerbation of Juvenile Idiopathic ArthritisInsufficientWeakInadequate
8Hepatitis BType 1 DiabetesModerate (null)LackingInadequate
8Hepatitis BFibromyalgiaInsufficientLackingInadequate
9HPVAcute Disseminated EncephalomyelitisInsufficientLackingInadequate
9HPVTransverse MyelitisInsufficientLackingInadequate
9HPVNeuromyelitis OpticaInsufficientLackingInadequate
9HPVMultiple SclerosisInsufficientLackingInadequate
9HPVGuillain-Barré syndromeInsufficientLackingInadequate
9HPVChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
9HPVBrachial NeuritisInsufficientLackingInadequate
9HPVAmyotrophic Lateral SclerosisInsufficientLackingInadequate
9HPVAnaphylaxisInsufficientIntermediateFavors Acceptance
9HPVTransient ArthralgiaLimitedLackingInadequate
9HPVPancreatitisInsufficientLackingInadequate
9HPVThromboembolic EventsInsufficientLackingInadequate
9HPVHypercoagulable StatesInsufficientLackingInadequate
10DT, TT, or aP containingEncephalitisLimitedWeakInadequate
10DT, TT, or aP containingEncephalopathyLimitedWeakInadequate
10DT, TT, or aP containingInfantile SpasmsLimited (diphtheria toxoid or tetanus toxoid)LackingInadequate
Insufficient (acellular pertussis)
10DT, TT, or aP containingSeizuresLimitedIIIInadequate
10DT, TT, or aP containingAtaxiaInsufficientLackingInadequate
10DT, TT, or aP containingAutismInsufficientLackingInadequate
10DT, TT, or aP containingAcute Disseminated EncephalomyelitisInsufficientWeak (tetanus toxoid)Inadequate
Lacking (diphtheria toxoid or acellular pertussis)
10DT, TT, or aP containingTransverse MyelitisInsufficientLackingInadequate
10DT, TT, or aP containingOptic NeuritisbLimited (diphtheria toxoid or tetanus toxoid)LackingInadequate
Insufficient (acellular pertussis)
10DT, TT, or aP containingMultiple Sclerosis Onset in AdultsLimited (diphtheria toxoid or tetanus toxoid)LackingInadequate
Insufficient (acellular pertussis)
10DT, TT, or aP containingMultiple Sclerosis Relapse in AdultsLimited (tetanus toxoid)LackingInadequate
Insufficient (diphtheria toxoid or acellular pertussis)
10DT, TT, or aP containingMultiple Sclerosis Relapse in ChildrenLimited (diphtheria toxoid or tetanus toxoid)LackingInadequate
Insufficient (acellular pertussis)
10DT, TT, or aP containingGuillain-Barré syndromeInsufficientLackingInadequate
10DT, TT, or aP containingChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
10DT, TT, or aP containingOpsoclonus Myoclonus SyndromeInsufficientLackingInadequate
10DT, TT, or aP containingBell's PalsyLimited (acel hilar pertussis)Weak (diphtheria toxoid or tetanus toxoid)Inadequate
Insufficient (diphtheria toxoid or tetanus toxoid)Lacking (acellular pertussis)
10TT containingAnaphylaxisInsufficientStrongConvincingly Supports
10DT and aP containingAnaphylaxisInsufficientLackingInadequate
10DT, TT, or aP containingChronic UrticariaInsufficientLackingInadequate
10DT, TT, or aP containingSerum SicknessInsufficientWeak (diphtheria toxoid or tetanus toxoid)Inadequate
Lacking (acellular pertussis)
10DT, TT, or aP containingArthropathyLimited (diphtheria toxoid or tetanus toxoid)LackingInadequate
Insufficient (acellular pertussis)
10DT, TT, or aP containingType 1 DiabetesHigh (null)LackingFavors Rejection
10DT, TT, or aP containingMyocarditisInsufficientWeak (diphtheria toxoid)Inadequate
Lacking (tetanus toxoid or acellular pertussis)
10DT, TT, or aP containingFibromyalgiaInsufficientLackingInadequate
10DT, TT, or aP containingSudden Infant Death SyndromeInsufficientLackingInadequate
10DT, TT, or aP containingImmune Thrombocytopenic PurpuraInsufficientLackingInadequate
11MeningococcalEncephalitisLimitedLackingInadequate
11MeningococcalEncephalopathyLimitedLackingInadequate
11MeningococcalAcute Disseminated EncephalomyelitisInsufficientLackingInadequate
11MeningococcalTransverse MyelitisInsufficientLackingInadequate
11MeningococcalMultiple SclerosisInsufficientLackingInadequate
11MeningococcalGuillain-Barré syndromeLimitedLackingInadequate
11MeningococcalChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
11MeningococcalAnaphylaxisInsufficientStrongConvincingly Supports
11MeningococcalChronic HeadacheInsufficientLackingInadequate
12Injection-Related EventComplex Regional Pain SyndromeInsufficientLow-IntermediateInadequate
12Injection-Related EventDeltoid BursitisLimitedStrongConvincingly Supports
12Injection-Related EventSyncopeInsufficientStrongConvincingly Supports

NOTE: The measles-mumps-rubella; human papillomavirus; and diphtheria toxoid–, tetanus toxoid-, and acellular pertussis-containing vaccines have been abbreviated in the following ways: MMR; HPV; and DT, TT, and aP containing.

a

The committee attributes causation to the measles component of the vaccine.

b

Although not originally charged to the committee by the sponsor, the committee considered this adverse event in its review of the literature.

c

The committee attributes causation to the rubella component of the vaccine.

d

The committee attributes causation to two particular vaccines used in three particular years in Canada.

TABLE D-2Causality Conclusions Organized by Adverse Event and Chapter

ChapterVaccineAdverse EventEpidemiologic AssessmentMechanistic AssessmentCausality Conclusion
5VaricellaDisseminated Oka VZV without Other Organ InvolvementInsufficientStrongConvincingly Supports
5VaricellaDisseminated Oka VZV with Subsequent Infection Resulting in Pneumonia, Meningitis, or HepatitisLimited (subsequent infection resulting in pneumonia)Strong (in individuals with demonstrated immunodeficiencies)Convincingly Supports (in individuals with demonstrated immunodeficiencies)
Insufficient (subsequent infection resulting in meningitis or hepatitis)
5VaricellaVaccine Strain Viral Reactivation without Other Organ InvolvementInsufficientStrongConvincingly Supports
5VaricellaVaccine Strain Viral Reactivation with Subsequent Infection resulting in Meningitis or EncephalitisLimited (subsequent infection resulting in encephalitis)StrongConvincingly Supports
Insufficient (subsequent infection resulting in meningitis)
4MMRMeasles Inclusion Body EncephalitisInsufficientStrong (measles; in individuals with demonstrated immunodeficiencies)Convincingly Supportsa (in individuals with demonstrated immunodeficiencies)
Lacking (mumps or rubella)
4MMREncephalitisLimitedWeakInadequate
6InfluenzaEncephalitisInsufficientWeakInadequate
8Hepatitis BEncephalitisInsufficientLackingInadequate
10DT, TT, or aP containingEncephalitisLimitedWeakInadequate
11MeningococcalEncephalitisLimitedLackingInadequate
4MMREncephalopathyLimitedWeakInadequate
5VaricellaEncephalopathyInsufficientLackingInadequate
6InfluenzaEncephalopathyInsufficientWeakInadequate
8Hepatitis BEncephalopathyInsufficientLackingInadequate
10DT, TT, or aP containingEncephalopathyLimitedWeakInadequate
11MeningococcalEncephalopathyLimitedLackingInadequate
10DT, TT, or aP containingInfantile SpasmsLimited (diphtheria toxoid or tetanus toxoid)LackingInadequate
Insufficient (acellular pertussis)
4MMRFebrile SeizuresHigh (increase)IntermediateConvincingly Supports
4MMRAfebrile SeizuresLimitedLackingInadequate
5VaricellaSeizuresLimitedWeakInadequate
6InfluenzaSeizuresbModerate (null)LackingInadequate
8Hepatitis BSeizuresLimitedLackingInadequate
10DT, TT, or aP containingSeizuresLimitedWeak (acellular pertussis)Inadequate
Lacking (diphtheria toxoid or tetanus toxoid)
4MMRMeningitisbModerate (null)Weak (mumps)Inadequate
Lacking (measles or rubella)
5VaricellaCerebellar AtaxiaInsufficientWeakInadequate
4MMRAtaxiaInsufficientWeak (measles or mumps)Inadequate
Lacking (rubella)
10DT, TT, or aP containingAtaxiaInsufficientLackingInadequate
4MMRAutismHigh (null)LackingFavors Rejection
10DT, TT, or aP containingAutismInsufficientLackingInadequate
4MMRAcute Disseminated EncephalomyelitisInsufficientWeakInadequate
5VaricellaAcute Disseminated EncephalomyelitisInsufficientWeakInadequate
6InfluenzaAcute Disseminated EncephalomyelitisInsufficientWeakInadequate
7Hepatitis AAcute Disseminated EncephalomyelitisInsufficientWeakInadequate
8Hepatitis BAcute Disseminated EncephalomyelitisInsufficientLow-IntermediateInadequate
9HPVAcute Disseminated EncephalomyelitisInsufficientLackingInadequate
10DT, TT, or aP containingAcute Disseminated EncephalomyelitisInsufficientWeak (tetanus toxoid)Inadequate
Lacking (diphtheria toxoid or acellular pertussis)
11MeningococcalAcute Disseminated EncephalomyelitisInsufficientLackingInadequate
4MMRTransverse MyelitisInsufficientWeakInadequate
5VaricellaTransverse MyelitisInsufficientWeakInadequate
6InfluenzaTransverse MyelitisInsufficientWeakInadequate
7Hepatitis ATransverse MyelitisInsufficientWeakInadequate
8Hepatitis BTransverse MyelitisInsufficientWeakInadequate
9HPVTransverse MyelitisInsufficientLackingInadequate
10DT, TT, or aP containingTransverse MyelitisInsufficientLackingInadequate
11MeningococcalTransverse MyelitisInsufficientLackingInadequate
4MMROptic NeuritisbLimitedWeakInadequate
6InfluenzaOptic NeuritisbLimitedWeakInadequate
8Hepatitis BOptic NeuritisbLimitedLackingInadequate
10DT, TT, or aP containingOptic NeuritisbLimited (diphtheria toxoid or tetanus toxoid)LackingInadequate
Insufficient (acellular pertussis)
4MMRNeuromyelitis OpticabInsufficientWeak (rubella)Inadequate
Lacking (measles or mumps)
6InfluenzaNeuromyelitis OpticaInsufficientLackingInadequate
8Hepatitis BNeuromyelitis OpticaInsufficientLackingInadequate
9HPVNeuromyelitis OpticaInsufficientLackingInadequate
4MMRMultiple Sclerosis Onset in AdultsLimitedLackingInadequate
6InfluenzaMultiple Sclerosis Onset in AdultsLimitedLackingInadequate
8Hepatitis BMultiple Sclerosis Onset in AdultsLimitedLackingInadequate
10DT, TT, or aP containingMultiple Sclerosis Onset in AdultsLimited (diphtheria toxoid or tetanus toxoid)LackingInadequate
Insufficient acellular pertussis)
4MMRMultiple Sclerosis Onset in ChildrenLimitedLackingInadequate
8Hepatitis BMultiple Sclerosis Onset in ChildrenLimitedLackingInadequate
6InfluenzaMultiple Sclerosis Relapse in AdultsLimitedLackingInadequate
8Hepatitis BMultiple Sclerosis Relapse in AdultsLimitedLackingInadequate
10DT, TT, or aP containingMultiple Sclerosis Relapse in AdultsLimited (tetanus toxoid)LackingInadequate
Insufficient (diphtheria toxoid or acellular pertussis)
8Hepatitis BMultiple Sclerosis Relapse in ChildrenLimitedLackingInadequate
10DT, TT, or aP containingMultiple Sclerosis Relapse in ChildrenLimited (diphtheria toxoid or tetanus toxoid)LackingInadequate
Insufficient (acellular pertussis)
7Hepatitis AMultiple SclerosisInsufficientLackingInadequate
9HPVMultiple SclerosisInsufficientLackingInadequate
11MeningococcalMultiple SclerosisInsufficientLackingInadequate
8Hepatitis BFirst Demyelinating Event in AdultsModerate (null)Low-IntermediateInadequate
8Hepatitis BFirst Demyel ina ting Event in ChildrenLimitedLackingInadequate
4MMRGuillain-Barré syndromeInsufficientWeakInadequate
5VaricellaGuillain-Barré syndromeInsufficientWeakInadequate
6InfluenzaGuillain-Barré syndromeModerate (null)WeakInadequate
7Hepatitis AGuillain-Barré syndromeInsufficientWeakInadequate
8Hepatitis BGuillain-Barré syndromeInsufficientLackingInadequate
9HPVGuillain-Barré syndromeInsufficientLackingInadequate
10DT, TT, or aP containingGuillain-Barré syndromeInsufficientLackingInadequate
11MeningococcalGuillain-Barré syndromeLimitedLackingInadequate
4MMRChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
6InfluenzaChronic Inflammatory Disseminated PolyneuropathyInsufficientWeakInadequate
7Hepatitis AChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
8Hepatitis BChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
9HPVChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
10DT, TT, or aP containingChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
11MeningococcalChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
4MMROpsoclonus Myoclonus SyndromeInsufficientLackingInadequate
10DT, TT, or aP containingOpsoclonus Myoclonus SyndromeInsufficientLackingInadequate
7Hepatitis ABell's PalsyInsufficientLackingInadequate
10DT, TT, or aP containingBell's PalsyLimited (acellular pertussis)Weak (diphtheria toxoid or tetanus toxoid)Inadequate
Insufficient (diphtheria toxoid or tetanus toxoid)Lacking (acellular pertussis)
6InfluenzaInactivated Influenza Vaccine and Bell's PalsyHigh (null)LackingFavors Rejection
4MMRBrachial NeuritisInsufficientLackingInadequate
6InfluenzaBrachial NeuritisInsufficientLackingInadequate
8Hepatitis BBrachial NeuritisInsufficientLackingInadequate
9HPVBrachial NeuritisInsufficientLackingInadequate
9HPVAmyotrophic Lateral SclerosisInsufficientLackingInadequate
5VaricellaSmall Fiber NeuropathybInsufficientLackingInadequate
6InfluenzaSmall Fiber NeuropathyInsufficientLackingInadequate
4MMRAnaphylaxisInsufficientStrongConvincingly Supports
5VaricellaAnaphylaxisLimitedStrongConvincingly Supports
6InfluenzaAnaphylaxisLimitedStrongConvincingly Supports
7Hepatitis AAnaphylaxisInsufficientWeakInadequate
8Hepatitis BAnaphylaxisInsufficientStrong (in yeast-sensitive individuals)Convincingly Supports (in yeast-sensitive individuals)
9HPVAnaphylaxisInsufficientIntermediateFavors Acceptance
10DT and aP containingAnaphylaxisInsufficientLackingInadequate
10TT containingAnaphylaxisInsufficientStrongConvincingly Supports
11MeningococcalAnaphylaxisInsufficientStrongConvincingly Supports
10DT, TT, or aP containingChronic UrticariaInsufficientLackingInadequate
10DT, TT, or aP containingSerum SicknessInsufficientWeak (diphtheria toxoid or tetanus toxoid)Inadequate
Lacking (acellular pertussis)
6InfluenzaInactivated Influenza Vaccine and Asthma Exacerbation or Reactive Airway Disease Episodes in Children and AdultsHigh (null)WeakFavors Rejection
6InfluenzaLive Attenuated Influenza Vaccine or Asthma Exacerbation or Reactive Airway Disease Episodes in Children Younger Than 5 Years of AgeModerate (null)WeakInadequate
6InfluenzaLive Attenuated Influenza Vaccine or Asthma Exacerbation or Reactive Airway Disease Episodes in Persons 5 Years of Age or OlderModerate (null)WeakInadequate
8Hepatitis BErythema NodosumbInsufficientWeakInadequate
6InfluenzaOnset or Exacerbation of Systemic Lupus ErythematosusLimited (exacerbation)LackingInadequate
Insufficient (onset)
8Hepatitis BOnset or Exacerbation of Systemic Lupus ErythematosusLimited (onset)WeakInadequate
Insufficient (exacerbation)
6InfluenzaOnset or Exacerbation of VasculitisLimited (exacerbation)Weak (exacerbation)Inadequate
Insufficient (onset)Lacking (onset)
8Hepatitis BOnset or Exacerbation of VasculitisInsufficientLow-IntermediateInadequate
6InfluenzaPolyarteritis NodosaInsufficientLackingInadequate
8Hepatitis BOnset or Exacerbation of Polyarteritis NodosaInsufficientWeakInadequate
8Hepatitis BOnset or Exacerbation of Psoriatic ArthritisInsufficientLackingInadequate
8Hepatitis BOnset or Exacerbation of Reactive ArthritisInsufficientWeakInadequate
8Hepatitis BOnset and Exacerbation of Rheumatoid ArthritisLimited (exacerbation)WeakInadequate
Insufficient (onset)
8Hepatitis BOnset or Exacerbation of Juvenile Idiopathic ArthritisInsufficientWeakInadequate
4MMRTransient Arthralgia in WomenModerate (increase) (rubella)Intermediate (rubella)Favors Acceptancec
Insufficient (measles or mumps)Lacking (measles or mumps)
4MMRTransient Arthralgia in ChildrenModerate (increase)Weak (rubella)Favors Acceptance
Lacking (measles or mumps)
9HPVTransient ArthralgiaLimitedLackingInadequate
4MMRChronic Arthralgia in WomenLimited (rubella)Low-Intermediate (rubella)Inadequate
Insufficient (measles or mumps)Lacking (measles or mumps)
4MMRChronic Arthritis in WomenLimited (rubella)Low-Intermediate (rubella)Inadequate
Insufficient (measles or mumps)Lacking (measles or mumps)
4MMRChronic Arthropathy in ChildrenInsufficientWeak (rubella)Inadequate
Lacking (measles or mumps)
4MMRArthropathy in MenLimitedWeak (rubella)Inadequate
Lacking (measles or mumps)
5VaricellaOnset or Exacerbation ArthropathyInsufficientLackingInadequate
6InfluenzaOnset or Exacerbation of ArthropathyInsufficientWeakInadequate
10DT, TT, or aP containingArthropathyLimited (diphtheria toxoid or tetanus toxoid)LackingInadequate
Insufficient (acellular pertussis)
4MMRType 1 DiabetesHigh (null)LackingFavors Rejection
8Hepatitis BType 1 DiabetesModerate (null)LackingInadequate
10DT, TT, or aP containingType 1 DiabetesHigh (null)LackingFavors Rejection
7Hepatitis AAutoimmune HepatitisInsufficientWeakInadequate
10DT, TT, or aP containingMyocarditisInsufficientWeak (diphtheria toxoid)Inadequate
Lacking (tetanus toxoid or acellular pertussis)
9HPVPancreatitisInsufficientLackingInadequate
4MMRHepatitisInsufficientWeakInadequate
9HPVThromboembolic EventsInsufficientLackingInadequate
5VaricellaStrokebLimitedWeakInadequate
6InfluenzaStrokeModerate (decrease)LackingInadequate
9HPVHypercoagulable StatesInsufficientLackingInadequate
6InfluenzaMyocardial InfarctionModerate (decrease)Weak (Live Attenuated Influenza Vaccine)Inadequate
Lacking (Inactivated Influenza Vaccine)
4MMRChronic Fatigue SyndromeInsufficientLackingInadequate
11MeningococcalChronic HeadacheInsufficientLackingInadequate
4MMRFibromyalgiaInsufficientLackingInadequate
6InfluenzaFibromyalgiaInsufficientLackingInadequate
8Hepatitis BFibromyalgiaInsufficientLackingInadequate
10DT, TT, or aP containingFibromyalgiaInsufficientLackingInadequate
10DT, TT, or aP containingSudden Infant Death SyndromeInsufficientLackingInadequate
4MMRHearing LossInsufficientLow-Intermediate (measles or mumps)Inadequate
Lacking (rubella)
6InfluenzaAll-Cause MortalitybModerate {decrease)Weak (Live Attenuated Influenza Vaccine)Inadequate
Lacking (Inactivated Influenza Vaccine)
6InfluenzaOculorespiratory SyndromeModerate (increase)dIntermediatedFavors Acceptanced
5VaricellaThrombocytopeniaInsufficientWeakInadequate
10DT, TT, or aP containingImmune Thrombocytopenic PurpuraInsufficientLackingInadequate
12Injection-Related EventComplex Regional Pain SyndromeInsufficientLow-IntermediateInadequate
12Injection-Related EventDeltoid BursitisLimitedStrongConvincingly Supports
12Injection-Related EventSyncopeInsufficientStrongConvincingly Supports

NOTE: The measles-mumps-rubella; human papillomavirus; and diphtheria toxoid–, tetanus toxoid-, and acellular pertussis-containing vaccines have been abbreviated in the following ways: MMR; HPV; and DT, TT, and aP containing.

a

The committee attributes causation to the measles component of the vaccine.

b

Although not originally charged to the committee by the sponsor, the committee considered this adverse event in its review of the literature.

c

The committee attributes causation to the rubella component of the vaccine.

d

The committee attributes causation to two particular vaccines used in three particular years in Canada.

TABLE D-3Causality Conclusions Organized by Causality Conclusion, Adverse Event, and Chapter

ChapterVaccineAdverse EventEpidemiologic AssessmentMechanistic AssessmentCausality Conclusion
5VaricellaDisseminated Oka VZV without Other Organ InvolvementInsufficientStrongConvincingly Supports
5VaricellaDisseminated Oka VZV with Subsequent Infection Resulting in Pneumonia, Meningitis, or HepatitisLimited (subsequent infection resulting in pneumonia)Strong (in individuals with demonstrated immunodeficiencies)Convincingly Supports (in individuals with demonstrated immunodeficiencies)
Insufficient (subsequent infection resulting in meningitis or hepatitis)
5VaricellaVaccine Strain Viral Reactivation without Other Organ InvolvementInsufficientStrongConvincingly Supports
5VaricellaVaccine Strain Viral Reactivation with Subsequent Infection resulting in Meningitis or EncephalitisLimited (subsequent infection resulting in encephalitis)StrongConvincingly Supports
Insufficient (subsequent infection resulting in meningitis)
4MMRMeasles Inclusion Body EncephalitisInsufficientStrong (measles; in individuals with demonstrated immunodehc iencies)Convincingly Supportsa (in individuals with demonstrated immunodeficiencies)
Lacking (mumps or rubella)
4MMRFebrile SeizuresHigh (increase)IntermediateConvincingly Supports
4MMRAnaphylaxisInsufficientStrongConvincingly Supports
5VaricellaAnaphylaxisLimitedStrongConvincingly Supports
6InfluenzaAnaphylaxisLimitedStrongConvincingly Supports
8Hepatitis BAnaphylaxisInsufficientStrong (in yeast-sensitive individuals)Convincingly Supports (in yeast-sensitive individuals)
10TT containingAnaphylaxisInsufficientStrongConvincingly Supports
11MeningococcalAnaphylaxisInsufficientStrongConvincingly Supports
12Injection-Related EventDeltoid BursitisLimitedStrongConvincingly Supports
12Injection-Related EventSyncopeInsufficientStrongConvincingly Supports
9HPVAnaphylaxisInsufficientIntermediateFavors Acceptance
4MMRTransient Arthralgia in WomenModerate (increase) (rubella)Intermediate (rubella)Favors Acceptanceb
Insufficient (measles or mumps)Lacking (measles or mumps)
4MMRTransient Arthralgia in ChildrenModerate (increase)Weak (rubella)Favors Acceptance
Lacking (measles or mumps)
6InfluenzaOculorespiratory SyndromeModerate (increase)cIntermediatecFavors Acceptancec
4MMRAutismHigh (null)LackingFavors Rejection
6InfluenzaInactivated Influenza Vaccine and Bell's PalsyHigh (null)LackingFavors Rejection
6InfluenzaInactivated Influenza Vaccine and Asthma Exacerbation or Reactive Airway Disease Episodes in Children and AdultsHigh (null)WeakFavors Rejection
4MMRType 1 DiabetesHigh (null)LackingFavors Rejection
10DT, TT, or aP containingType 1 DiabetesHigh (null)LackingFavors Rejection
4MMREncephalitisLimitedWeakInadequate
6InfluenzaEncephalitisInsufficientWeakInadequate
8Hepatitis BEncephalitisInsufficientLackingInadequate
10DT, TT, or aP containingEncephalitisLimitedWeakInadequate
11MeningococcalEncephalitisLimitedLackingInadequate
4MMREncephalopathyLimitedWeakInadequate
5VaricellaEncephalopathyInsufficientLackingInadequate
6InfluenzaEncephalopathyInsufficientWeakInadequate
8Hepatitis BEncephalopathyInsufficientLackingInadequate
10DT, TT, or aP containingEncephalopathyLimitedWeakInadequate
11MeningococcalEncephalopathyLimitedLackingInadequate
10DT, TT, or aP containingInfantile SpasmsLimited (diphtheria toxoid or tetanus toxoid)LackingInadequate
Insufficient (acellular pertussis)
4MMRAfebrile SeizuresLimitedLackingInadequate
5VaricellaSeizuresLimitedWeakInadequate
6InfluenzaSeizuresdMjxlerate (null)LackingInadequate
8Hepatitis BSeizuresLimitedLackingInadequate
10DT, TT, or aP containingSeizuresLimitedWeak (acellular pertussis)Inadequate
Lacking (diphtheria toxoid or tetanus toxoid)
4MMRMeningitisModerate (null)Weak (mumps)Inadequate
Lacking (measles or rubella)
5VaricellaCerebellar AtaxiaInsufficientWeakInadequate
4MMRAtaxiaInsufficientWeak (measles or mumps)Inadequate
Lacking (rubella)
10DT, TT, or aP containingAtaxiaInsufficientLackingInadequate
10DT, TT, or aP containingAutismInsufficientLackingInadequate
4MMRAcute Disseminated EncephalomyelitisInsufficientWeakInadequate
5VaricellaAcute Disseminated EncephalomyelirisInsufficientWeakInadequate
6InfluenzaAcute Disseminated EncephalomyelitisInsufficientWeakInadequate
 Hepatitis AAcute Disseminated EncephalomyelirisInsufficientWeakInadequate
8Hepatitis BAcute Disseminated EncephalomyelirisInsufficientLow-IntermediateInadequate
9HPVAcute Disseminated EncephalomyelirisInsufficientLackingInadequate
10DT, TT, or aP containingAcute Disseminated EncephalomyelirisInsufficientWeak (tetanus toxoid)Inadequate
Lacking (diphtheria toxoid or acellular pertussis)
11MeningococcalAcute Disseminated EncephalomyelirisInsufficientLackingInadequate
4MMRTransverse MyelitisInsufficientWeakInadequate
5VaricellaTransverse MyelitisInsufficientWeakInadequate
6InfluenzaTransverse MyelitisInsufficientWeakInadequate
 Hepatitis ATransverse MyelitisInsufficientWeakInadequate
8Hepatitis BTransverse MyelitisInsufficientWeakInadequate
9HPVTransverse MyelitisInsufficientLackingInadequate
10DT, TT, or aP containingTransverse MyelitisInsufficientLackingInadequate
11MeningococcalTransverse MyelitisInsufficientLackingInadequate
4MMROptic NeuritisdLimitedWeakInadequate
6InfluenzaOptic NeuritisdLimitedWeakInadequate
8Hepatitis BOptic NeuritisdLimitedLackingInadequate
10DT, TT, or aP containingOptic NeuritisdLimited (diphtheria toxoid or tetanus toxoid)LackingInadequate
Insufficient (acellular pertussis)
4MMRNeuromyelitis OptiradInsufficientWeak (rubella)Inadequate
Lacking (measles or mumps)
6InfluenzaNeuromyelitis OpticaInsufficientLackingInadequate
8Hepatitis BNeuromyelitis OpticaInsufficientLackingInadequate
9HPVNeuromyelitis OpticaInsufficientLackingInadequate
4MMRMultiple Sclerosis Onset in AdultsLimitedLackingInadequate
6InfluenzaMultiple Sclerosis Onset in AdultsLimitedLackingInadequate
8Hepatitis BMultiple Sclerosis Onset in AdultsLimitedLackingInadequate
10DT, TT, or aP containingMultiple Sclerosis Onset in AdultsLimited (diphtheria toxoid or tetanus toxoid)LackingInadequate
Insufficient (acellular pertussis)
4MMRMultiple Sclerosis Onset in ChildrenLimitedLackingInadequate
8Hepatitis BMultiple Sclerosis Onset in ChildrenLimitedLackingInadequate
6InfluenzaMultiple Sclerosis Relapse in AdultsLimitedLackingInadequate
8Hepatitis BMultiple Sclerosis Relapse in AdultsLimitedLackingInadequate
10DT, TT, or aP containingMultiple Sclerosis Relapse in AdultsLimited (tetanus toxoid)LackingInadequate
Insufficient (diphtheria toxoid or acellular pertussis)
8Hepatitis BMultiple Sclerosis Relapse in ChildrenLimitedLackingInadequate
10DT, TT, or aP containingMultiple Sclerosis Relapse in ChildrenLimited (diphtheria toxoid or tetanus toxoid)LackingInadequate
Insufficient (acellular pertussis)
7Hepatitis AMultiple SclerosisInsufficientLackingInadequate
9HPVMultiple SclerosisInsufficientLackingInadequate
11MeningococcalMultiple SclerosisInsufficientLackingInadequate
8Hepatitis BFirst Demyelinating Event in AdultsModerate (null)Low-IntermediateInadequate
8Hepatitis BFirst Demyelinating Event in ChildrenLimitedLackingInadequate
4MMRGuillain-Barré syndromeInsufficientWeakInadequate
5VaricellaGuillain-Barré syndromeInsufficientWeakInadequate
6InfluenzaGuillain-Barré syndromeModerate (null)WeakInadequate
7Hepatitis AGuillain-Barré syndromeInsufficientWeakInadequate
8Hepatitis BGuillain-Barré syndromeInsufficientLackingInadequate
9HPVGuillain-Barré syndromeInsufficientLackingInadequate
10DT, TT, or aP containingGuillain-Barré syndromeInsufficientLackingInadequate
11MeningococcalGuillain-Barré syndromeLimitedLackingInadequate
4MMRChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
6InfluenzaChronic Inflammatory DisseminatedInsufficientWeakInadequate
7Hepatitis AChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
8Hepatitis BChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
9HPVChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
10DT, TT, or aP containingChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
11MeningococcalChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
4MMROpsoclonus Myoclonus SyndromeInsufficientLackingInadequate
10DT, TT, or aP containingOpsoclonus Myoclonus SyndromeInsufficientLackingInadequate
7Hepatitis ABell's PalsyInsufficientLackingInadequate
10DT, TT, or aP containingBell's PalsyLimited (acellular pertussis)Weak (diphtheria toxoid or tetanus toxoid)Inadequate
Insufficient (diphtheria toxoid or tetanus toxoid)Lacking (acellular pertussis)
4MMRBrachial NeuritisInsufficientLackingInadequate
6InfluenzaBrachial NeuritisInsufficientLackingInadequate
8Hepatitis BBrachial NeuritisInsufficientLackingInadequate
9HPVBrachial NeuritisInsufficientLackingInadequate
9HPVAmyotrophic Lateral SclerosisInsufficientLackingInadequate
5VaricellaSmall Fiber NeuropathydInsufficientLackingInadequate
6InfluenzaSmall Fiber NeuropathyInsufficientLackingInadequate
7Hepatitis AAnaphylaxisInsufficientWeakInadequate
10DT and aP containingAnaphylaxisInsufficientLackingInadequate
10DT, TT, or aP containingChronic UrticariaInsufficientLackingInadequate
10DT, TT, or aP containingSerum SicknessInsufficientWeak (diphtheria toxoid or tetanus toxoid)Inadequate
Lacking (acellular pertussis)
6InfluenzaLive Attenuated Influenza Vaccine or Asthma Exacerbation or Reactive Airway Disease Episodes in Children Younger Than 5 Years of AgeModerate (null)WeakInadequate
6InfluenzaLive Attenuated Influenza Vaccine or Asthma Exacerbation or Reactive Airway Disease Episodes in Persons 5 Years of Age or OlderModerate (null)WeakInadequate
8Hepatitis BErythema NodosumdInsufficientWeakInadequate
6InfluenzaOnset or Exacerbation of Systemic Lupus ErythematosusLimited (exacerbation)LackingInadequate
Insufficient (onset)
8Hepatitis BOnset or Exacerbation of Systemic Lupus ErythematosusLimited (onset)WeakInadequate
Insufficient (exacerbation)
6InfluenzaOnset or Exacerbation of VasculitisLimited (exacerbation)Weak (exacerbation)Inadequate
Insufficient (onset)Lacking (onset)
8Hepatitis BOnset or Exacerbation of VasculitisInsufficientLow-IntermediateInadequate
6InfluenzaPolyarteritis NodosaInsufficientLackingInadequate
8Hepatitis BOnset or Exacerbation of Polyarteritis NodosaInsufficientWeakInadequate
8Hepatitis BOnset or Exacerbation of Psoriatic ArthritisInsufficientLackingInadequate
8Hepatitis BOnset or Exacerbation of Reactive ArthritisInsufficientWeakInadequate
8Hepatitis BOnset and Exacerbation of Rheumatoid ArthritisLimited (exacerbation)WeakInadequate
Insufficient (onset)
8Hepatitis BOnset or Exacerbation of Juvenile Idiopathic ArthritisInsufficientWeakInadequate
9HPVTransient ArthralgiaLimitedLackingInadequate
4MMRChronic Arthralgia in WomenLimited (rubella)Low-Intermediate (rubella)Inadequate
Insufficient (measles or mumps)Lacking (measles or mumps)
4MMRChronic Arthritis in WomenLimited (rubella)Low-Intermediate (rubella)Inadequate
Insufficient (measles or mumps)Lacking (measles or mumps)
4MMRChronic Arthropathy in ChildrenInsufficientWeak (rubella)Inadequate
Lacking (measles or mumps)
4MMRArthropathy in MenLimitedWeak (rubella)Inadequate
Lacking (measles or mumps)
5VaricellaOnset or Exacerbation ArthropathyInsufficientLackingInadequate
6InfluenzaOnset or Exacerbation of ArthropathyInsufficientWeakInadequate
10DT, TT, or aP containingArthropathyLimited (diphtheria toxoid or tetanus toxoid)LackingInadequate
Insufficient (acellular pertussis)
8Hepatitis BType 1 DiabetesModerate (null)LackingInadequate
7Hepatitis AAutoimmune HepatitisInsufficientWeakInadequate
10DT, TT, or aP containingMyocarditisInsufficientWeak (diphtheria toxoid)Inadequate
Lacking (tetanus toxoid or acellular pertussis)
9HPVPancreatitisInsufficientLackingInadequate
4MMRHepatitisInsufficientWeakInadequate
9HPVThromboembolic EventsInsufficientLackingInadequate
5VaricellaStrokedLimitedWeakInadequate
6InfluenzaStrokeModerate (decrease)LackingInadequate
9HPVHypercoagulable StatesInsufficientLackingInadequate
6InfluenzaMyocardial InfarctionModerate (decrease)Weak (Live Attenuated influenza Vaccine)Inadequate
Lacking (Inactivated Influenza Vaccine)
4MMRChronic Fatigue SyndromeInsufficientLackingInadequate
11MeningococcalChronic HeadacheInsufficientLackingInadequate
4MMRFibromyalgiaInsufficientLackingInadequate
6InfluenzaFibromyalgiaInsufficientLackingInadequate
8Hepatitis BFibromyalgiaInsufficientLackingInadequate
10DT, TT, or aP containingFibromyalgiaInsufficientLackingInadequate
10DT, TT, or aP containingSudden Infant Death SyndromeInsufficientLackingInadequate
4MMRHearing LossInsufficientLow-Intermediate (measles or mumps)Inadequate
Lacking (rubella)
6InfluenzaAll-Cause MortalitydModerate (decrease)Weak (Live Attenuated Influenza Vaccine)Inadequate
Lacking (Inactivated Influenza Vaccine)
5VaricellaThrombocytopeniaInsufficientWeakInadequate
10DT, TT, or aP containingImmune Thrombocytopenic PurpuraInsufficientLackingInadequate
12Injection-Related EventComplex Regional Pain SyndromeInsufficientLow-IntermediateInadequate

NOTE: The measles-mumps-rubella; human papillomavirus; and diphtheria toxoid–, tetanus toxoid-, and acellular pertussis-containing vaccines have been abbreviated in the following ways: MMR; HPV; and DT, TT, and aP containing.

a

The committee attributes causation to the measles component of the vaccine.

b

The committee attributes causation to the rubella component of the vaccine.

c

The committee attributes causation to two particular vaccines used in three particular years in Canada.

d

Although not originally charged to the committee by the sponsor, the committee considered this adverse event in its review of the literature.

TABLE D-4Causality Conclusions Organized by Epidemiologic Assessment, Adverse Event, and Chapter

ChapterVaccineAdverse EventEpidemiologic AssessmentMechanistic AssessmentCausality Conclusion
4MMRFebrile SeizuresHigh (increase)IntermediateConvincingly Supports
4MMRAutismHigh (null)LackingFavors Rejection
6InfluenzaInactivated Influenza Vaccine and Bell's PalsyHigh (null)LackingFavors Rejection
6InfluenzaInactivated Influenza Vaccine and Asthma Exacerbation or Reactive Airway Disease Episodes in Children and AdultsHigh (null)WeakFavors Rejection
4MMRType 1 DiabetesHigh (null)LackingFavors Rejection
10DT, TT, or aP containingType 1 DiabetesHigh (null)LackingFavors Rejection
4MMRTransient Arthralgia in WomenModerate (increase) (rubella)Intermediate (rubella)Favors Acceptanceb
Insufficient (measles or mumps)Lacking (measles or mumps)
4MMRTransient Arthralgia in ChildrenModerate (increase)Weak (rubella)Favors Acceptance
Lacking (measles or mumps)
6InfluenzaOculorespiratory SyndromeModerate (increase)bIntermediatebFavors Acceptanceb
6InfluenzaSeizurescModerate (null)LackingInadequate
4MMRMeningitiscModerate (null)Weak (mumps)Inadequate
Lacking (measles or rubella)
8Hepatitis BFirst Dcmyclinating Event in AdultsModerate (null)Low-IntermediateInadequate
6InfluenzaGuillain-Barrc syndromeModerate (null)WeakInadequate
6InfluenzaLive Attenuated Influenza Vaccine or Asthma Exacerbation or Reactive Airway Disease Episodes in Children Younger Than 5 Years of AgeModerate (null)WeakInadequate
6InfluenzaLive Attenuated Influenza Vaccine or Asthma Exacerbation or Reactive Airway Disease Episodes in Persons 5 Years of Age or OlderModerate (null)WeakInadequate
8Hepatitis BType 1 DiabetesModerate (null)LackingInadequate
6InfluenzaStrokeModerate (decrease)LackingInadequate
6InfluenzaMyocardial InfarctionModerate (decrease)Weak (Live Attenuated Influenza Vaccine)Inadequate
Lacking (Inactivated Influenza Vaccine)
6InfluenzaAll-Cause MortalitycModerate (decrease)Weak (Live Attenuated Influenza Vaccine)Inadequate
Lacking (Inactivated Influenza Vaccine)
5VaricellaDisseminated Oka VZV with Subsequent Infection Resulting in Pneumonia, Meningitis, or HepatitisLimited (subsequent infection resulting in pneumonia)Strong (in individuals with demonstrated immunodeficiencies)Convincingly Supports (in individuals with demonstrated immunodeficiencies)
Insufficient (subsequent infection resulting in meningitis or hepatitis)
5VaricellaVaccine Strain Viral Reactivation with Subsequent Infection Resulting in Meningitis or EncephalitisLimited (subsequent infection resulting in encephalitis)StrongConvincingly Supports
Insufficient (subsequent infection resulting in meningitis)
4MMREncephalitisLimitedWeakInadequate
10DT, TT, or aP containingEncephalitisLimitedWeakInadequate
11MeningococcalEncephalitisLimitedLackingInadequate
4MMREncephalopathyLimitedWeakInadequate
10DT, TT, or aP containingEncephalopathyLimitedWeakInadequate
11MeningococcalEncephalopathyLimitedLackingInadequate
10DT, TT, or aP containingInfantile SpasmsLimited (diphtheria toxoid or tetanus toxoid)LackingInadequate
Insufficient (accllular pertussis)
4MMRAfebrile SeizuresLimitedLackingInadequate
5VaricellaSeizuresLimitedWeakInadequate
8Hepatitis BSeizuresLimitedLackingInadequate
10DT, TT, or aP containingSeizuresLimitedWeak (accllular pertussis)Inadequate
Lacking (diphtheria toxoid or tetanus toxoid)
4MMROptic NeuritiscLimitedWeakInadequate
bInfluenzaOptic NeuritiscLimitedWeakInadequate
8Hepatitis BOptic NeuritiscLimitedLackingInadequate
10DT, TT, or aP containingOptic NeuritiscLimited (diphtheria toxoid or tetanus toxoid)LackingInadequate
Insufficient (accllular pertussis)
4MMRMultiple Sclerosis Onset in AdultsLimitedLackingInadequate
6InfluenzaMultiple Sclerosis Onset in AdultsLimitedLackingInadequate
8Hepatitis BMultiple Sclerosis Onset in AdultsLimitedLackingInadequate
10DT, TT, or aP containingMultiple Sclerosis Onset in AdultsLimited (diphtheria toxoid or tetanus toxoid)LackingInadequate
Insufficient (accllular pertussis)
4MMRMultiple Sclerosis Onset in ChildrenLimitedLackingInadequate
8Hepatitis BMultiple Sclerosis Onset in ChildrenLimitedLackingInadequate
6InfluenzaMultiple Sclerosis Relapse in AdultsLimitedLackingInadequate
8Hepatitis BMultiple Sclerosis Relapse in AdultsLimitedLackingInadequate
10DT, TT, or aP containingMultiple Sclerosis Relapse in AdultsLimited (tetanus toxoid)LackingInadequate
Insufficient (diphtheria toxoid or accllular pertussis)
8Hepatitis BMultiple Sclerosis Relapse in ChildrenLimitedLackingInadequate
10DT, TT, or aP containingMultiple Sclerosis Relapse in ChildrenLimited (diphtheria toxoid or tetanus toxoid)LackingInadequate
Insufficient (accllular pertussis)
8Hepatitis BFirst Dcmyclinating Event in ChildrenLimitedLackingInadequate
11MeningococcalGuillain-Barrc syndromeLimitedLackingInadequate
10DT, TT, or aP containingBell's PalsyLimited (accllular pertussis)Weak (diphtheria toxoid or tetanus toxoid)Inadequate
Insufficient (diphtheria toxoid or tetanus toxoid)Lacking (accllular pertussis)
5VaricellaAnaphylaxisLimitedStrongConvincingly Supports
6InfluenzaAnaphylaxisLimitedStrongConvincingly Supports
6InfluenzaOnset or Exacerbation of Systemic Lupus ErythematosusLimited (exacerbation)LackingInadequate
Insufficient (onset)
8Hepatitis BOnset or Exacerbation of Systemic Lupus ErythematosusLimited (onset)WeakInadequate
Insufficient (exacerbation)
6InfluenzaOnset or Exacerbation of VasculitisLimited (exacerbation)Weak (exacerbation)Inadequate
Insufficient (onset)Lacking (onset)
8Hepatitis BOnset and Exacerbation of Rheumatoid ArthritisllllWeakInadequate
9HPVTransient ArthralgiaLimitedLackingInadequate
4MMRChronic Arthralgia in WomenLimited (rubella)Low-Intermediate (rubella)Inadequate
Insufficient (measles or mumps)Lacking (measles or mumps)
4MMRChronic Arthritis in WomenLimited (rubella)Low-Intermediate (rubella)Inadequate
Insufficient (measles or mumps)Lacking (measles or mumps)
4MMRArthropathy in MenLimitedWeak (rubella)Inadequate
Lacking (measles or mumps)
10DT, TT, or aP containingArthropathyLimited (diphtheria toxoid or tetanus toxoid)LackingInadequate
Insufficient (accllular pertussis)
5VaricellaStrokecLimitedWeakInadequate
121 njection- Related EventDeltoid BursitisLimitedStrongConvincingly Supports
5VaricellaDisseminated Oka VZV without Other Organ InvolvementInsufficientStrongConvincingly Supports
5VaricellaVaccine Strain Viral Reactivation without Other Organ InvolvementInsufficientStrongConvincingly Supports
4MMRMeasles Inclusion Body EncephalitisInsufficientStrong(measles; in with demon immunodef Lacking)Convincingly Supportsd
6InfluenzaEncephalitisInsufficientWeakInadequate
8Hepatitis BEncephalitisInsufficientLackingInadequate
5VaricellaEncephalopathyInsufficientLackingInadequate
6InfluenzaEncephalopathyInsufficientWeakInadequate
8Hepatitis BEncephalopathyInsufficientLackingInadequate
5VaricellaCerebellar AtaxiaInsufficientWeakInadequate
4MMRAtaxiaInsufficientWeak (measles or iInadequate
Lacking (rubella)
10DT, TT, or aP containingAtaxiaInsufficientLackingInadequate
10DT, TT, or aP containingAutismInsufficientLackingInadequate
4MMRAcute Disseminated EncephalomyelitisInsufficientWeakInadequate
5VaricellaAcute Disseminated EncephalomyelitisInsufficientWeakInadequate
6InfluenzaAcute Disseminated EncephalomyelitisInsufficientWeakInadequate
7Hepatitis AAcute Disseminated EncephalomyelitisInsufficientWeakInadequate
8Hepatitis BAcute Disseminated EncephalomyelitisInsufficientLow-IntermediateInadequate
9HPVAcute Disseminated EncephalomyelitisInsufficientLackingInadequate
10DT, TT, or aP containingAcute Disseminated EncephalomyelitisInsufficientWeak (tetanus toxoid)Inadequate
Lacking (diphtheria toxoid or acellular pertussis)
11MeningococcalAcute Disseminated EncephalomyelitisInsufficientLackingInadequate
4MMRTransverse MyelitisInsufficientWeakInadequate
5VaricellaTransverse MyelitisInsufficientWeakInadequate
6InfluenzaTransverse MyelitisInsufficientWeakInadequate
7Hepatitis ATransverse MyelitisInsufficientWeakInadequate
8Hepatitis BTransverse MyelitisInsufficientWeakInadequate
9HPVTransverse MyelitisInsufficientLackingInadequate
10DT, TT, or aP containingTransverse MyelitisInsufficientLackingInadequate
11MeningococcalTransverse MyelitisInsufficientLackingInadequate
4MMRNeuromyelitis OpticacInsufficientWeak (rubella)Inadequate
Lacking (measles or mumps)
6InfluenzaNeuromyelitis OpticaInsufficientLackingInadequate
8Hepatitis BNeuromyelitis OpticaInsufficientLackingInadequate
9HPVNeuromyelitis OpticaInsufficientLackingInadequate
 Hepatitis AMultiple SclerosisInsufficientLackingInadequate
9HPVMultiple SclerosisInsufficientLackingInadequate
11MeningococcalMultiple SclerosisInsufficientLackingInadequate
4MMRGuillain-Barrc syndromeInsufficientWeakInadequate
5VaricellaGuillain-Barrc syndromeInsufficientWeakInadequate
7Hepatitis AGuillain-Barrc syndromeInsufficientWeakInadequate
8Hepatitis BGuillain-Barrc syndromeInsufficientLackingInadequate
9HPVGuillain-Barrc syndromeInsufficientLackingInadequate
10DT, TT, or aP containingGuillain-Barrc syndromeInsufficientLackingInadequate
4MMRChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
6InfluenzaChronic Inflammatory Disseminated PolyneuropathyInsufficientWeakInadequate
 Hepatitis AChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
8Hepatitis BChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
9HPVChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
10DT, TT, or aP containingChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
11MeningococcalChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
4MMROpsoclonus Myoclonus SyndromeInsufficientLackingInadequate
10DT, TT, or aP containingOpsoclonus Myoclonus SyndromeInsufficientLackingInadequate
/Hepatitis ABell's PalsyInsufficientLackingInadequate
4MMRBrachial NeuritisInsufficientLackingInadequate
6InfluenzaBrachial NeuritisInsufficientLackingInadequate
8Hepatitis BBrachial NeuritisInsufficientLackingInadequate
9HPVBrachial NeuritisInsufficientLackingInadequate
9HPVAmyotrophic Lateral SclerosisInsufficientLackingInadequate
5VaricellaSmall Fiber NcuropathycInsufficientLackingInadequate
6InfluenzaSmall Fiber NeuropathyInsufficientLackingInadequate
4MMRAnaphylaxisInsufficientStrongConvincingly Supports
7Hepatitis AAnaphylaxisInsufficientWeakInadequate
8Hepatitis BAnaphylaxisInsufficientStrong (in yeast-sensitive individuals)Convincingly Supports (in yeast-sensitive individuals)
9HPVAnaphylaxisInsufficientIntermediateFavors Acceptance
10TT containingAnaphylaxisInsufficientStrongConvincingly Supports
10DT and aP containingAnaphylaxisInsufficientLackingInadequate
11MeningococcalAnaphylaxisInsufficientStrongConvincingly Supports
10DT, TT, or aP containingChronic UrticariaInsufficientLackingInadequate
10DT, TT, or aP containingSerum SicknessInsufficientWeak (diphtheria toxoid or tetanus toxoid)Inadequate
Lacking (accllular pertussis)
8Hepatitis BErythema NodosumcInsufficientWeakInadequate
8Hepatitis BOnset or Exacerbation of VasculitisInsufficientLow-IntermediateInadequate
6InfluenzaPolyarteritis NodosaInsufficientLackingInadequate
8Hepatitis BOnset or Exacerbation of Polyarteritis NodosaInsufficientWeakInadequate
8Hepatitis BOnset or Exacerbation of Psoriatic ArthritisInsufficientLackingInadequate
8Hepatitis BOnset or Exacerbation of Reactive ArthritisInsufficientWeakInadequate
8Hepatitis BOnset or Exacerbation of Juvenile Idiopathic ArthritisInsufficientWeakInadequate
4MMRChronic Arthropathy in ChildrenInsufficientWeak (rubella)Inadequate
Lacking (measles or mumps)
5VaricellaOnset or Exacerbation ArthropathyInsufficientLackingInadequate
6InfluenzaOnset or Exacerbation of ArthropathyInsufficientWeakInadequate
7Hepatitis AAutoimmune HepatitisInsufficientWeakInadequate
10DT, TT, or aP containingMyocarditisInsufficientWeak (diphtheria toxoid)Inadequate
Lacking (tetanus toxoid or accllular pertussis)
9HPVPancreatitisInsufficientLackingInadequate
4MMRHepatitisInsufficientWeakInadequate
9HPVThromboembolic EventsInsufficientLackingInadequate
9HPVHypercoagulable StatesInsufficientLackingInadequate
4MMRChronic Fatigue SyndromeInsufficientLackingInadequate
11MeningococcalChronic HeadacheInsufficientLackingInadequate
4MMRFibromyalgiaInsufficientLackingInadequate
6InfluenzaFibromyalgiaInsufficientLackingInadequate
8Hepatitis BFibromyalgiaInsufficientLackingInadequate
10DT, TT, or aP containingFibromyalgiaInsufficientLackingInadequate
10DT, TT, or aP containingSudden Infant Death SyndromeInsufficientLackingInadequate
4MMRHearing LossInsufficientLow-Intermediate (measles or mumps)Inadequate
Lacking (rubella)
5VaricellaThrombocytopeniaInsufficientWeakInadequate
10DT, TT, or aP containingImmune Thrombocytopenic PurpuraInsufficientLackingInadequate
12Injcction- Related EventComplex Regional Pain SyndromeInsufficientLow-IntermediateInadequate
12Injcction- Related EventSyncopeInsufficientStrongConvincingly Supports

NOTE: The measles-mumps-rubella; human papillomavirus; and diphtheria toxoid–, tetanus toxoid-, and acellular pertussis-containing vaccines have been abbreviated in the following ways: MMR; HPV; and DT, TT, and aP containing.

a

The committee attributes causation to the rubella component of the vaccine.

b

The committee attributes causation to two particular vaccines used in three particular years in Canada.

c

Although not originally charged to the committee by the sponsor, the committee considered this adverse event in its review of the literature.

d

The committee attributes causation to the measles component of the vaccine.

TABLE D-5Causality Conclusions Organized by Mechanistic Assessment, Adverse Event, and Chapter

ChapterVaccineAdverse EventEpidemiologic AssessmentMechanistic AssessmentCausality Conclusion
5VaricellaDisseminated Oka VZV without Other Organ InvolvementInsufficientStrongConvincingly Supports
5VaricellaDisseminated Oka VZV with Subsequent Infection Resulting in Pneumonia, Meningitis, or HepatitisLimited (subsequent infection resulting in pneumonia)Strong (in individuals with demonstrated immunodeficiencies)Convincingly Supports (in individuals with demonstrated immunodeficiencies)
5VaricellaVaccine Strain Viral Reactivation without Other Organ InvolvementInsufficientStrongConvincingly Supports
5VaricellaVaccine Strain Viral Reactivation with Subsequent Infection resulting in Meningitis or EncephalitisLimited (subsequent infection resulting in encephalitis)StrongConvincingly Supports
Insufficient (subsequent infection resulting in meningitis)
4MMRMeasles Inclusion Body EncephalitisInsufficientStrong (measles; in individuals with demonstrated immunodeficiencies)Convincingly Supportsa (in individuals with demonstrated immunodeficiencies)
Lacking (mumps or rubella)
4MMRAnaphylaxisInsufficientStrongConvincingly Supports
5VaricellaAnaphylaxisLimitedStrongConvincingly Supports
6InfluenzaAnaphylaxisLimitedStrongConvincingly Supports
8Hepatitis BAnaphylaxisInsufficientStrong (in yeast-sensitive individuals)Convincingly Supports (in yeast-sensitive individuals)
10TT containingAnaphylaxisInsufficientStrongConvincingly Supports
11MeningococcalAnaphylaxisInsufficientStrongConvincingly Supports
12Injection- Related EventDeltoid BursitisLimitedStrongConvincingly Supports
12Injection- Related EventSyncopeInsufficientStrongConvincingly Supports
4MMRFebrile SeizuresHigh (increase)IntermediateConvincingly Supports
9HPVAnaphylaxisInsufficientIntermediateFavors Acceptance
4MMRTransient ArthralgiaModerate (increase) (rubella)Intermediate (rubella)Favors Acceptancec
Insufficient (measles or mumps)Lacking (measles or mumps)
6InfluenzaOculorespiratory SyndromeModerate (increase)IntermediateFavors Acceptance'
8Hepatitis BAcute DisseminatedEncephalomyelitisLow-IntermediateInadequate
8Hepatitis BFirst DcmyclinatingEvent in AdultsLow-IntermediateInadequate
8Hepatitis BOnset or Exacerbation of VasculitisInsufficientLow-IntermediateInadequate
4MMRChronic Arthralgia in WomenLimited (rubella)Low-Intermediate (rubella)Inadequate
Insufficient (measles or mumps)Lacking (measles or mumps)
4MMRphronic Arthritis in WomenLimited (rubella)Low-Intermediate (rubella)Inadequate
Insufficient (measles or mumps)Lacking (measles or mumps)
4MMRHearing LossInsufficientLow-Intermediate (measles or mumps)Inadequate
Lacking (rubella)
12Injection- Related EventComplex Regional Pain SyndromeInsufficientLow-IntermediateInadequate
4MMREncephalitisLimitedWeakInadequate
6InfluenzaEncephalitisInsufficientWeakInadequate
10DT, TT, or aP containingEncephalitisLimitedWeakInadequate
4MMREncephalopathyLimitedWeakInadequate
6InfluenzaEncephalopathyInsufficientWeakInadequate
10DT, TT, or aP containingEncephalopathyLimitedWeakInadequate
5VaricellaSeizuresLimitedWeakInadequate
10DT, TT, or aP containingSeizuresLimitedWeak (accllular pertussis)Inadequate
Lacking (diphtheria toxoid or tetanus toxoid)
4MMRMeningitisModerate (null)Weak (mumps)Inadequate
Lacking (measles or rubella)
5VaricellaCerebellar AtaxiaInsufficientWeakInadequate
4MMRAtaxiaInsufficientWeak (measles or mumps)Inadequate
Lacking (rubella)
4MMRAcute Disseminated EncephalomyelitisInsufficientWeakInadequate
5VaricellaAcute Disseminated EncephalomyelitisInsufficientWeakInadequate
6InfluenzaAcute Disseminated EncephalomyelitisInsufficientWeakInadequate
7Hepatitis AAcute Disseminated EncephalomyelitisInsufficientWeakInadequate
10DT, TT, or aP containingAcute Disseminated EncephalomyelitisInsufficientWeak (tetanus toxoid)Inadequate
Lacking (diphtheria toxoid or accllular pertussis)
4MMRTransverse MyelitisInsufficientWeakInadequate
5VaricellaTransverse MyelitisInsufficientWeakInadequate
6InfluenzaTransverse MyelitisInsufficientWeakInadequate
7Hepatitis ATransverse MyelitisInsufficientWeakInadequate
8Hepatitis BTransverse MyelitisInsufficientWeakInadequate
4MMROptic Neuritis1dLimitedWeakInadequate
6InfluenzaOptic NeuritisdLimitedWeakInadequate
4MMRNeuromyelitis OpticadInsufficientWeak (rubella)Inadequate
Lacking (measles or mumps)
4MMRGuillain-Barrc syndromeInsufficientWeakInadequate
5VaricellaGuillain-Barrc syndromeInsufficientWeakInadequate
6InfluenzaGuillain-Barrc syndromeModerate (null)WeakInadequate
7Hepatitis AGuillain-Barrc syndromeInsufficientWeakInadequate
6InfluenzaChronic Inflammatory Disseminated PolyneuropathyInsufficientWeakInadequate
10DT, TT, or aP containingBell's PalsyLimited (accllular pertussis)Weak (diphtheria toxoid or tetanus toxoid)Inadequate
Insufficient (diphtheria toxoid or tetanus toxoid)Lacking (accllular pertussis)
7Hepatitis AAnaphylaxisInsufficientWeakInadequate
10DT, TT, or aP containingSerum SicknessInsufficientWeak (diphtheria toxoid or tetanus toxoid)Inadequate
Lacking (accllular pertussis)
6InfluenzaInactivated Influenza Vaccine and Asthma Exacerbation or Reactive Airway Disease Episodes in Children and AdultsHigh (null)WeakFavors Rejection
6InfluenzaLive Attenuated Influenza Vaccine or Asthma Exacerbation or Reactive Airway Disease Episodes in Children Younger Than 5 Years of AgeModerate (null)WeakInadequate
6InfluenzaLive Attenuated Influenza Vaccine or Asthma Exacerbation or Reactive Airway Disease Episodes in Persons 5 Years of Age or OlderModerate (null)WeakInadequate
8Hepatitis BErythema NodosumdInsufficientWeakInadequate
8Hepatitis BOnset or Exacerbation of Systemic Lupus ErythematosusLimited (onset)WeakInadequate
Insufficient (exacerbation)
6InfluenzaOnset or Exacerbation of VasculitisLimited (exacerbation)Weak (exacerbation)Inadequate
Insufficient (onset)Lacking (onset)
8Hepatitis BOnset or Exacerbation of Polyarteritis NodosaInsufficientWeakInadequate
8Hepatitis BOnset or Exacerbation of Reactive ArthritisInsufficientWeakInadequate
8Hepatitis BOnset and Exacerbation of Rheumatoid ArthritisLimited (exacerbation)WeakInadequate
Insufficient (onset)
8Hepatitis BOnset or Exacerbation of Juvenile Idiopathic ArthritisInsufficientWeakInadequate
4MMRTransient Arthralgia in ChildrenModerate (increase)Weak (rubella)Favors Acceptance
Lacking (measles or mumps)
4MMRChronic Arthropathy in ChildrenInsufficientWeak (rubella)Inadequate
Lacking (measles or mumps)
4MMRArthropathy in MenLimitedWeak (rubella)Inadequate
Lacking (measles or mumps)
6InfluenzaOnset or Exacerbation of ArthropathyInsufficientWeakInadequate
7Hepatitis AAutoimmune HepatitisInsufficientWeakInadequate
10DT, TT, or aP containingMyocarditisInsufficientWeak (diphtheria toxoid)Inadequate
Lacking (tetanus toxoid or acellular pertussis)
4MMRHepatitisInsufficientWeakInadequate
5VaricellaStrokedLimitedWeakInadequate
6InfluenzaMyocardial InfarctionModerate (decrease)Weak (Live Attenuated Influenza Vaccine)Inadequate
Lacking (Inactivated Influenza Vaccine)
6InfluenzaAll-Cause MortalitydModerate (decrease)Weak (Live Attenuated Influenza Vaccine)Inadequate
Lacking (Inactivated Influenza Vaccine)
5VaricellaThrombocytopeniaInsufficientWeakInadequate
8Hepatitis BEncephalitisInsufficientLackingInadequate
11MeningococcalEncephalitisLimitedLackingInadequate
5VaricellaEncephalopathyInsufficientLackingInadequate
8Hepatitis BEncephalopathyInsufficientLackingInadequate
11MeningococcalEncephalopathyLimitedLackingInadequate
10DT, TT, or aP containingInfantile SpasmsLimited (diphtheria toxoid or tetanus toxoid)LackingInadequate
Insufficient (accllular pertussis)
4MMRAfebrile SeizuresLimitedLackingInadequate
6InfluenzaSeizuresdModerate (null)LackingInadequate
8Hepatitis BSeizuresLimitedLackingInadequate
10DT, TT, or aP containingAtaxiaInsufficientLackingInadequate
4MMRAutismHigh (null)LackingFavors Rejection
10DT, TT, or aP containingAutismInsufficientLackingInadequate
9HPVAcute Disseminated EncephalomyelitisInsufficientLackingInadequate
11MeningococcalAcute Disseminated EncephalomyelitisInsufficientLackingInadequate
9HPVTransverse MyelitisInsufficientLackingInadequate
10DT, TT, or aP containingTransverse MyelitisInsufficientLackingInadequate
11MeningococcalTransverse MyelitisInsufficientLackingInadequate
8Hepatitis BOptic NeuritisdLimitedLackingInadequate
10DT, TT, or aP containingOptic NeuritisdLimited (diphtheria toxoid or tetanus toxoid)LackingInadequate
Insufficient (accllular pertussis)
6InfluenzaNeuromyelitis OpticaInsufficientLackingInadequate
8Hepatitis BNeuromyelitis OpticaInsufficientLackingInadequate
9HPVNeuromyelitis OpticaInsufficientLackingInadequate
4MMRMultiple Sclerosis Onset in AdultsLackingLimitedInadequate
6InfluenzaMultiple Sclerosis Onset in AdultsLimitedLackingInadequate
8Hepatitis BMultiple Sclerosis Onset in AdultsLackingLimitedLacking
10DT, TT, or aP containingMultiple Sclerosis Onset in AdultsLimited (diphtheria toxoid or tetanus toxoid)LackingInadequate
Insufficient (accllular pertussis)
4MMRMultiple Sclerosis Onset in ChildrenLimitedLackingInadequate
8Hepatitis BMultiple Sclerosis Onset in ChildrenLimitedLackingInadequate
6InfluenzaMultiple Sclerosis Relapse in AdultsLimitedLackingInadequate
8Hepatitis BMultiple Sclerosis Relapse in AdultsLimitedLackingInadequate
10DT, TT, or aP containingMultiple Sclerosis Relapse in AdultsLimited (tetanus toxoid)LackingInadequate
Insufficient (diphtheria toxoid or accllular pertussis)
8Hepatitis BMultiple Sclerosis Relapse in ChildrenLimitedLackingInadequate
10DT, TT, or aP containingMultiple Sclerosis Relapse in ChildrenLimited (diphtheria toxoid or tetanus toxoid)LackingInadequate
Insufficient (accllular pertussis)
7Hepatitis AMultiple SclerosisInsufficientLackingInadequate
9HPVMultiple SclerosisInsufficientLackingInadequate
11MeningococcalMultiple SclerosisInsufficientLackingInadequate
8Hepatitis BFirst Dcmyclinating Event in ChildrenLimitedLackingInadequate
8Hepatitis BGuillain-Barrc syndromeInsufficientLackingInadequate
9HPVGuillain-Barrc syndromeInsufficientLackingInadequate
10DT, TT, or aP containingGuillain-Barrc syndromeInsufficientLackingInadequate
11MeningococcalGuillain-Barrc syndromeLimitedLackingInadequate
4MMRChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
7Hepatitis AChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
8Hepatitis BChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
9HPVChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
10DT, TT, or aP containingChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
11MeningococcalChronic Inflammatory Disseminated PolyneuropathyInsufficientLackingInadequate
4MMROpsoclonus Myoclonus SyndromeInsufficientLackingInadequate
10DT, TT, or aP containingOpsoclonus Myoclonus SyndromeInsufficientLackingInadequate
6InfluenzaInactivated Influenza Vaccine and Bell's PalsyHigh (null)LackingFavors Rejection
7Hepatitis ABell's PalsyInsufficientLackingInadequate
4MMRBrachial NeuritisInsufficientLackingInadequate
6InfluenzaBrachial NeuritisInsufficientLackingInadequate
8Hepatitis BBrachial NeuritisInsufficientLackingInadequate
9HPVBrachial NeuritisInsufficientLackingInadequate
9HPVAmyotrophic Lateral SclerosisInsufficientLackingInadequate
5VaricellaSmall Fiber NeuropathydInsufficientLackingInadequate
6InfluenzaSmall Fiber NeuropathyInsufficientLackingInadequate
10DT and aP containingAnaphylaxisInsufficientLackingInadequate
10DT, TT, or aP containingChronic UrticariaInsufficientLackingInadequate
6InfluenzaOnset or Exacerbation of Systemic Lupus ErythematosusLimited (exacerbation)LackingInadequate
Insufficient (onset)
6InfluenzaPolyarteritis NodosaInsufficientLackingInadequate
8Hepatitis BOnset or Exacerbation of Psoriatic ArthritisInsufficientLackingInadequate
9HPVTransient ArthralgiaLimitedLackingInadequate
5VaricellaOnset or Exacerbation ArthropathyInsufficientLackingInadequate
l0DT, TT, or aP containingArthropathyLimited (diphtheria toxoid or tetanus toxoid)LackingInadequate
Insufficient (accllular pertussis)
4MMRType 1 DiabetesHigh (null)LackingFavors Rejection
8Hepatitis BType 1 DiabetesModerate (null)LackingInadequate
10DT, TT, or aP containingType 1 DiabetesHigh (null)LackingFavors Rejection
9HPVPancreatitisInsufficientLackingInadequate
9HPVThromboembolic EventsInsufficientLackingInadequate
6InfluenzaStrokeModerate (decrease)LackingInadequate
9HPVHypercoagulable StatesInsufficientLackingInadequate
4MMRChronic Fatigue SyndromeInsufficientLackingInadequate
11MeningococcalChronic HeadacheInsufficientLackingInadequate
4MMRFibromyalgiaInsufficientLackingInadequate
6InfluenzaFibromyalgiaInsufficientLackingInadequate
8Hepatitis BFibromyalgiaInsufficientLackingInadequate
10DT, TT, or aP containingFibromyalgiaInsufficientLackingInadequate
10DT, TT, or aP containingSudden Infant Death SyndromeInsufficientLackingInadequate
10DT, TT, or aP containingImmune Thrombocytopenic PurpuraInsufficientLackingInadequate

NOTE: The measles-mumps-rubella; human papillomavirus; and diphtheria toxoid–, tetanus toxoid-, and acellular pertussis-containing vaccines have been abbreviated in the following ways: MMR; HPV; and DT, TT, and aP containing.

a

The committee attributes causation to the measles component of the vaccine.

b

The committee attributes causation to the rubella component of the vaccine.

c

The committee attributes causation to two particular vaccines used in three particular years in Canada.

d

Although not originally charged to the committee by the sponsor, the committee considered this adverse event in its review of the literature.

Copyright 2012 by the National Academy of Sciences. All rights reserved.
Bookshelf ID: NBK190029

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