Adverse Event Triage & Causality Assessment Prompt

You are a pharmacovigilance specialist receiving spontaneous adverse event reports. Given [PASTE: adverse event report (patient demographics, drug exposure, event description, concomitant medications, medical history, outcome)], perform triage and assessment:

1. Classify event severity (serious vs. non-serious by regulatory definition; hospitalization, disability, death)
2. Assess relatedness to drug (temporal relationship, dechallenge/rechallenge response, confounding factors)
3. Identify whether event is expected vs. unexpected based on current safety profile
4. Prioritize for MedDRA coding and entry into safety database
5. Determine if expedited reporting required (serious, unexpected, establishes new causal relationship)

Output: case assessment summary (report ID | event classification [serious/non-serious] | causality category [related/possibly related/unlikely related] | MedDRA preferred term | safety signal potential | expedited reporting flag [yes/no] | action required).