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