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Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Casuality (1994)
Institute of Medicine (IOM)

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Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality

DT/Td/T

Measlesa

Mumpsa

OPV/IPVb

Hepatitis B

H. influenzae typeb

Category 5: The Evidence Establishes a Causal Relation

Anaphylaxish

Thrombocytopenia (MMR)

 

Poliomyelitis in recipient or contact (OPV)

Anaphylaxis

 

 

Anaphylaxis (MMR)d

 

 

 

 

 

Death from measles vaccine-strain viral infectionc,i

 

Death from polio vaccine-strain viral infectionc,i

 

 

a If the data derive from a monovalent preparation, then in the committee's judgment the causal relation extends to multivalent preparations. If the data derive exclusively from MMR, that is so indicated by (MMR). In the absence of any data on the monovalent preparation, in the committee's judgment the causal relation determined for the multivalent preparations does not extend to the monovalent components.

b For some adverse events, the committee was charged with assessing the causal relation between the adverse event and only oral polio vaccine (OPV) (paralytic and nonparalytic poliomyelitis) or only inactivated polio vaccine (IPV) (anaphylaxis and thrombocytopenia). If the conclusions are different for OPV than for IPV for the other adverse events, that is so noted.

c This table lists weight-of-evidence determinations only for deaths that are classified as SIDS and deaths that are a consequence of vaccine-strain adverse event can be fatal, then in the committee's judgment the evidence favors the acceptance of (or establishes) a causal relation between the vaccine and death from the adverse event. Direct evidence regarding death in association with a vaccine-associated adverse event is limited to tetanus-diphtheria toxoid for adult use (Td) and Guillain-Barré syndrome, tetanus toxoid and anaphylaxis, and OPV and poliomyelitis. Direct evidence regarding death in association with a potentially fatal adverse event that itself is causally related to the vaccine is lacking for measles vaccine and anaphylaxis, MMR and anaphylaxis, OPV and Guillain-Barré syndrome, hepatitis B vaccine and anaphylaxis, and H. influenzae type b unconjugated PRP vaccine and early-onset H. influenzae type b disease in children age 18 months or older who receive their first Hib immunization with unconjugated PRP vaccine. See Chapter 10 for details.

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