TABLE 10-6, Summary of Epidemiologic Assessments, Mechanistic Assessments, and Causality Conclusions for Diphtheria Toxoid (DT)–, Tetanus Toxoid (TT)–, and Acellular Pertussis (aP)–Containing Vaccines - Adverse Effects of Vaccines

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TABLE 10-6Summary of Epidemiologic Assessments, Mechanistic Assessments, and Causality Conclusions for Diphtheria Toxoid (DT)–, Tetanus Toxoid (TT)–, and Acellular Pertussis (aP)–Containing Vaccines

Vaccine	Adverse Event	Epidemiologic Assessment	Studies Contributing to the Epidemiologic Assessment	Mechanistic Assessment	Cases Contributing to the Mechanistic Assessment	Causality Conclusion
DT, TT, or aP containing	Encephalitis	Limited	2	Weak	1	Inadequate
DT, TT, or aP containing	Encephalopathy	Limited	2	Weak	1	Inadequate
DT, TT, or aP containing	Infantile Spasms	Limited (diphtheria toxoid or tetanus toxoid)	1	Lacking	None	Inadequate
DT, TT, or aP containing	Infantile Spasms	Insufficient (accllutar pertussis)	None	Lacking	None	Inadequate
DT, TT, or aP containing	Seizures	Limited	3	Weak (accllular pertussis)	None	Inadequate
DT, TT, or aP containing	Seizures	Limited	3	Lacking (diphtheria toxoid or tetanus toxoid)	None	Inadequate
DT, TT, or aP containing	Ataxia	Insufficient	None	Lacking	None	Inadequate
DT, TT, or aP containing	Autism	Insufficient	None	Lacking	None	Inadequate
DT, TT, or aP containing	Acute Disseminated Encephalomyelitis	Insufficient	None	Weak (tetanus toxoid)	1	Inadequate
DT, TT, or aP containing	Acute Disseminated Encephalomyelitis	Insufficient	None	Lacking (diphtheria toxoid or acellular pertussis)	None	Inadequate
DT, TT, or aP containing	Transverse Myelitis	Insufficient	None	Lacking	None	Inadequate
DT, TT, or aP containing	Optic Neuritis^*	Limited (diphtheria toxoid or tetanus toxoid)	1	Lacking	None	Inadequate
DT, TT, or aP containing	Optic Neuritis^*	Insufficient (acellular pertussis)	None	Lacking	None	Inadequate
DT, TT, or aP containing	Multiple Sclerosis Onset in Adults	Limited (diphtheria toxoid or tetanus toxoid)	2	Lacking	None	Inadequate
DT, TT, or aP containing	Multiple Sclerosis Onset in Adults	Insufficient (acellular pertussis)	None	Lacking	None	Inadequate
DT, TT, or aP containing	Multiple Sclerosis Relapse in Adults	Limited (tetanus toxoid)	1	Lacking	None	Inadequate
DT, TT, or aP containing	Multiple Sclerosis Relapse in Adults	Insufficient (diphtheria toxoid or acellular pertussis)	None	Lacking	None	Inadequate
DT, TT, or aP containing	Multiple Sclerosis Relapse in Children	Limited (DT or TT)	1	Lacking	None	Inadequate
DT, TT, or aP containing	Multiple Sclerosis Relapse in Children	Limited (DT or TT)	Insufficient (acellular pertussis)	Lacking	None	Inadequate
DT, TT, or aP containing	Guillain-Barré Syndrome	Insufficient	None	Lacking	None	Inadequate
DT, TT, or aP containing	Chronic Inflammatory Disseminated Polyneuropathy	Insufficient	None	Lacking	None	Inadequate
DT, TT, or aP containing	Opsoclonus Myoclonus Syndrome	Insufficient	None	Lacking	None	Inadequate
DT, TT, or aP containing	Bell's Palsy	Limited (acellular pertussis)	1	Weak (diphtheria toxoid or tetanus toxoid)	None	Inadequate
DT, TT, or aP containing	Bell's Palsy	Insufficient (diphtheria toxoid or tetanus toxoid)	None	Lacking (acellular pertussis)	None	Inadequate
TT	Anaphylaxis	Insufficient	None	Strong	6	Convincingly Supports
DToraP	Anaphylaxis	Insufficient	None	Lacking	None	Inadequate
DT, TT, or aP containing	Chronic Urticaria	Insufficient	None	Lacking	None	Inadequate
DT, TT, or aP containing	Serum Sickness	Insufficient	None	Weak (diphtheria toxoid or tetanus toxoid	1	Inadequate
DT, TT, or aP containing	Serum Sickness	Insufficient	None	Lacking (acellular pertussis)	None	Inadequate
DT, TT, or aP containing	Arthropathy	Limited (diphtheria toxoid or tetanus toxoid)	2	Lacking	None	Inadequate
DT, TT, or aP containing	Arthropathy	Insufficient (acellular pertussis)	None	Lacking	None	Inadequate
DT, TT, or aP containing	Type 1 Diabetes	High (null)	5	Lacking	None	Favors Rejection
DT, TT, or aP containing	Myocarditis	Insufficient	None	Weak (diphtheria toxoid)	None	Inadequate
DT, TT, or aP containing	Myocarditis	Insufficient	None	Lacking (tetanus toxoid or acellular pertussis)	None	Inadequate
DT, TT, or aP containing	Fibromyalgia	Insufficient	None	Lacking	None	Inadequate
DT, TT, or aP containing	Sudden Infant Death Syndrome	Insufficient	None	Lacking	None	Inadequate
DT, TT, or aP containing	Immune Thrombocytopenic Purpura	Insufficient	None	Lacking	None	Inadequate

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

From: 10, Diphtheria Toxoid–, Tetanus Toxoid–, and Acellular Pertussis–Containing 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.

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