TABLE 1-2 Summary of Conclusions by Adverse Event for DPTa and RA 27/3 MMRb Vaccines

 

Adverse Events Reviewed

 

Conclusion

DPT Vaccine

RA 27/3 Rubella Vaccine

1. No evidence bearing on a causal relationc

Autism

 

2. Evidence insufficient to indicate a causal relationd

Aseptic meningitis Chronic neurologic damage Erythema multiforme or other rash

Guillain-Barré syndrome

Hemolytic anemia

Juvenile diabetes

Learning disabilities and attention-deficit disorder

Peripheral mononeuropathy Thrombocytopenia

Radiculoneuritis and other neuropathies

Thrombocytopenic purpura

3. Evidence does not Indicate a causal relatione

Infantile spasms

Hypsarrythmia

Reye syndrome

Sudden infant death syndrome

 

4. Evidence is consistent with a causal relationf

Acute encephalopathyg

Shock and "unusual shocklike state"

Chronic arthritis

5. Evidence indicates a causal relationh

Anaphylaxis

Protracted, inconsolable crying

Acute arthritis

aEvidence does not differentiate between DPT vaccine and the pertussis component of DPT vaccine except in the case of protracted, inconsolable crying where the evidence implicates the pertussis component specifically.

bRA 27/3 MMR, Trivalent measles-mumps-rubella vaccine containing the RA 27/3 rubella strain,

cNo category of evidence was found bearing on a judgment about causation (all categories of evidence left blank in Table 1-1).

dRelevant evidence in one or more categories was identified but was judged to be insufficient to indicate whether or not a causal relation exists (no category of evidence checked as supporting causation in Table 1-1; exceptions are this designation under biologic plausibility for erythema multiforme and hemolytic anemia).

eThe available evidence, on balance, does not indicate a causal relation (one or more categories of evidence checked as not supporting causation in Table 1-1, with evidence supporting causation being either absent or outweighed by the other evidence).

fThe available evidence, on balance, tends to support a causal relation (one or more categories of evidence checked as supporting causation in Table 1-1, with evidence checked as insufficient or not supporting causation being absent or outweighed by the other evidence).

gDefined in controlled studies reviewed as encephalopathy, encephalitis, or encephalomyelitis.

hThe available evidence, on balance, supports a causal relation, and the evidence is more persuasive than that for conclusion 4 above (the categories of evidence are coded similarly to thos in conclusion 4, with evidence checked as insufficient or not supporting causation in Table 1-1 being absent or less than for 4).



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