VigiMed: Brazilian Adverse Drug Event Reports (2018–2025)

Individual Case Safety Reports (ICSRs) from VigiMed, the Brazilian national pharmacovigilance database, are consolidated in this collection covering 2018 to 2025. Extracted by Ana Carolina Jacoby (CIARS) using an automated ETL pipeline, the data includes patient demographics and MedDRA-coded adverse reactions. The records are provided in Parquet format to support high-performance analytical queries.

Use Cases

• Analyzing clinical outcomes of adverse drug reactions using MedDRA-coded reaction details
• Mining drug safety signals by correlating active ingredients with reported seriousness levels
• Studying longitudinal trends in Brazilian pharmacovigilance from 2018 to 2025

Strengths

• Uses MedDRA terminology for standardized clinical coding
• Automated ETL pipeline via GitHub Actions ensures reproducibility
• Optimized Parquet format for high-performance analytical queries

Limitations

• Relies on spontaneous reporting, which is subject to underreporting and reporting bias
• De-identification removes specific sensitive personal data which may limit certain demographic analyses

Provenance

Source

VigiMed (ANVISA)

Collection Method

Automated extraction via GitHub Actions from the national pharmacovigilance database

Time Range

2018-2025

Freshness

Updated through 2025; last extraction performed in March 2026.

Geography

Brazil