Unlikely was defined as AE occurring
after vaccination, literature did not establish or refute a causal
relationship, and other causes were more likely or had not been
excluded. Finally, unrelated was an event that occurred prior to vaccination,
there was evidence in literature that the vaccine did not
cause the event, a co-existing disease/condition, drug, or vaccine
might have caused the event, or the clinical syndrome was not consistent
with causation.
Unlikely was defined as AE occurringafter vaccination, literature did not establish or refute a causalrelationship, and other causes were more likely or had not beenexcluded. Finally, unrelated was an event that occurred prior to vaccination,there was evidence in literature that the vaccine did notcause the event, a co-existing disease/condition, drug, or vaccinemight have caused the event, or the clinical syndrome was not consistentwith causation.
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