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 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.
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