Created at Source Raw Value Validated value
Nov. 6, 2020, 11:45 p.m. oms

1) Serious Adverse Events-SAE (It will measure as: -Occurrence of the SAE (Yes; No); - Duration (Time from start date until end date of event); -Description of the event; Result (Recovered; Recovered with squeals; Persists; Death; Unknown); - Causality (Causal association consistent with vaccination; Undetermined; Inconsistent causal association with vaccination; not classifiable). Measurement time: daily for 28 days after each dose.

1) Serious Adverse Events-SAE (It will measure as: -Occurrence of the SAE (Yes; No); - Duration (Time from start date until end date of event); -Description of the event; Result (Recovered; Recovered with squeals; Persists; Death; Unknown); - Causality (Causal association consistent with vaccination; Undetermined; Inconsistent causal association with vaccination; not classifiable). Measurement time: daily for 28 days after each dose.