Report TypeIdentify report type: Initial, Follow-up, Final...
Case NumberExtract the case/report number...
Report DateExtract the report date. Return in YYYY-MM-DD form...
SeriousnessClassify seriousness: Serious, Non-Serious...
Seriousness CriteriaIf serious, list criteria met: Death, Life-Threate...
Patient IdentifierExtract the patient ID or initials (de-identified)...
Patient AgeExtract patient age with unit (years, months)...
Patient SexExtract patient sex: Male, Female, Unknown...
Product NameExtract the suspect drug/product name...
IndicationExtract the indication for use...
DoseExtract the dose and regimen...
RouteExtract the route of administration...
Start DateExtract drug start date. Return in YYYY-MM-DD form...
Stop DateExtract drug stop date if applicable. Return in YY...
Event TermExtract the adverse event term as reported...
MedDRA PTExtract the MedDRA Preferred Term if coded...
Event Onset DateExtract the event onset date. Return in YYYY-MM-DD...
Event OutcomeExtract outcome: Recovered, Recovering, Not Recove...
Causality AssessmentExtract causality: Related, Possibly Related, Unli...
Action TakenExtract action taken with drug: None, Dose Reduced...
NarrativeSummarize the case narrative...
Reporter TypeIdentify reporter type: Healthcare Professional, C...
Expedited ReportIs this an expedited/15-day report? Yes or No...