TABLE S-2Summary of Causality Conclusionsa

ChapterVaccineAdverse EventEpidemiologic AssessmentStudies Contributing to the Epidemiologic AssessmentMechanistic AssessmentCases Contributing to the Mechanistic AssessmentCausality Conclusion
5VaricellaDisseminated Oka VZV without Other Organ InvolvementInsufficientNoneStrong_bConvincingly Supports
5VaricellaDisseminated Oka VZV with Subsequent Infection Resulting in Pneumonia, Meningitis, or HepatitisLimited (subsequent infection resulting in pneumonia)1Strong (in individuals with demonstrated immuno-deficiencies)9Convincingly Supportsc
Insufficient (subsequent infection resulting in meningitis or hepatitis)None
5VaricellaVaccine Strain Viral Reactivation without Other Organ InvolvementInsufficientNoneStrong_bConvincingly Supports
5VaricellaVaccine Strain Viral Reactivation with Subsequent Infection Resulting in Meningitis or EncephalitisLimited (subsequent infection resulting in encephalitis)1Strong6Convincingly Supports
Insufficient (subsequent infection resulting in meningitis)None
4MMRMeasles Inclusion Body EncephalitisInsufficientNoneStrong (measles; in individuals with demonstrated immunodeficiencies)1Convincingly Supportsc,d
Lacking (mumps or rubella)None
4MMRFebrile SeizuresHigh (increase)7Intermediate12Convincingly Supports
4MMRAnaphylaxisInsufficientNoneStrong43eConvincingly Supports
5VaricellaAnaphylaxisLimited1Strong76fConvincingly Supports
6InfluenzaAnaphylaxisLimited1Strong22Convincingly Supports
8Hepatitis BAnaphylaxisInsufficientNoneStrong (in yeast-sensitive individuals)10Convincingly Supportsg
10Tetanus ToxoidAnaphylaxisInsufficientNoneStrong6Convincingly Supports
11MeningococcalAnaphylaxisInsufficientNoneStrong1Convincingly Supports
12Injection-Related EventDeltoid BursitisLimited1Strong36Convincingly Supports
12Injection-Related EventSyncopeInsufficientNoneStrong35bConvincingly Supports
9HPVAnaphylaxisInsufficientNoneIntermediate36Favors Acceptance
4MMRTransient Arthralgia in WomenModerate (increase) (rubella)4Intermediate (rubella)13Favors Acceptancei
Insufficient (measles or mumps)NoneLacking (measles or mumps)None
4MMRTransient Arthralgia in ChildrenModerate (increase)7Weak (rubella)NoneFavors Acceptance
Lacking (measles or mumps)None
6InfluenzaOculorespiratory SyndromeModerate (increase)3Intermediate_jFavors Acceptancek
4MMRAutismHigh (null)4LackingNoneFavors Rejection
6InfluenzaInactivated Influenza Vaccine and Bell's palsyHigh (null)2LackingNoneFavors Rejection
6InfluenzaInactivated Influenza Vaccine and Asthma Exacerbation or Reactive Airway Disease Episodes in Children and AdultsHigh (null)9Weak6Favors Rejection
4MMRType 1 DiabetesHigh (null)5LackingNoneFavors Rejection
10DT, TT, or aP containingType 1 DiabetesHigh (null)5LackingNoneFavors Rejection
a

All other causality conclusions are the evidence is inadequate to accept or reject a causal relationship.

b

Due to the use of the same surveillance systems in some publications it is likely that some of the cases were presented more than once; thus, it is difficult to determine the number of unique cases.

c

The committee attributes causation to individuals with demonstrated immunodeficiencies.

d

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

e

Some cases were from passive surveillance systems; however, it is not possible to know how many represent unique cases or were reported elsewhere.

f

In addition, at least 30 cases were reported to passive surveillance systems; however, it is not possible to know how many represent unique cases or were reported elsewhere.

g

The committee attributes causation to yeast-sensitive individuals.

h

In addition, hundreds of cases have been reported to passive surveillance systems; however, it is not possible to known how many represent unique cases or were reported elsewhere.

i

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

j

Due to the use of the same sample population in some studies it is likely that some of the cases were presented in more than one publication; thus, it is difficult to determine the number of unique cases.

k

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

From: Summary

Cover of Adverse Effects of Vaccines
Adverse Effects of Vaccines: Evidence and Causality.
Committee to Review Adverse Effects of Vaccines; Institute of Medicine; Stratton K, Ford A, Rusch E, et al., editors.
Washington (DC): National Academies Press (US); 2011 Aug 25.
Copyright 2012 by the National Academy of Sciences. All rights reserved.

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