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Adverse Events Reviewed
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Conclusion
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DPT Vaccine
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RA 27/3 Rubella Vaccine
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1. No evidence bearing on a causal relationc
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Autism
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2. Evidence insufficient to indicate a causal relationd
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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
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Radiculoneuritis and other neuropathies
Thrombocytopenic purpura
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3. Evidence does not Indicate a causal relatione
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Infantile spasms
Hypsarrythmia
Reye syndrome
Sudden infant death syndrome
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4. Evidence is consistent with a causal relationf
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Acute encephalopathyg
Shock and "unusual shocklike state"
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Chronic arthritis
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5. Evidence indicates a causal relationh
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Anaphylaxis
Protracted, inconsolable crying
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Acute arthritis
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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.
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bRA 27/3 MMR, Trivalent measles-mumps-rubella vaccine containing the RA 27/3 rubella strain,
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cNo category of evidence was found bearing on a judgment about causation (all categories of evidence left blank in Table 1-1).
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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).
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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).
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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).
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gDefined in controlled studies reviewed as encephalopathy, encephalitis, or encephalomyelitis.
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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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