Report Type:
In the reporter’s opinion (if a HCP) was the event:
Serious Criteria:
Hospitalisation Dates:
Event Outcome
Event abated after the suspect product was discontinued or dose reduced:
Event reappeared after reintroduction of the suspect product
Postmortem Performed:
If yes, please provide postmortem results (if known)
Gender:
If female, Pregnant?
Relevant Lab Data
Relevant Medical History
History of Allergies
Action Taken:
Reporter Causality Assessment:
Concomitant Meds
Reporter Position:
Permission to contact reporter for additional information:
Permission to contact Health Care Professional (HCP), if different from Reporter:
If this procedure is printed copy it shall become obsolete after 24hrs.