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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 shock-like state"

Chronic arthritis

5. Evidence indicates a causal relationh 

Anaphylaxis
Protracted, inconsolable crying

Acute arthritis

a Evidence 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.

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

c No category of evidence was found bearing on a judgment about causation (all categories of evidence left blank in Table 1-1).

d Relevant 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).

e The 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).

f The 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).

g Defined in controlled studies reviewed as encephalopathy, encephalitis, or encephalomyelitis.

h The 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 those 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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