This dataset is designed to mimic pharmacovigilance reports of adverse drug reactions (ADRs) and aims to support research, machine learning experiments, and algorithm development in drug safety monitoring. Case Safety Reports (ICSRs) are artificially generated, inspired by real-world pharmacovigilance systems such as FDA FAERS and EMA EudraVigilance.

This dataset particularly highlights the rarity and imbalance of severe ADRs: most reports are mild reactions, while severe and fatal results are relatively rare (severe/fatal totals approximately 4–51 TP3T), reflecting the underreporting and severity distribution bias common in post-market surveillance.

Data Fields:

• ReportID: A unique synthetic identifier for each report
• PatientAge: Patient's age at reaction time
• Gender: Patient's gender
• DrugName: The main suspected drug
• Dosage: The dosage of the main drug.
• DurationDays: Duration of exposure to the primary drug prior to reporting.
• Concomitant Drugs: Other medications taken concurrently
• ADR_Code: Synthetic MedDRA sample 8-bit code for the reported adverse reaction.
• Seriousness: Classification of ADR severity
• OnsetDays: Number of days from first dose to onset of adverse drug reactions (ADRs)