Vigibase

VigiBase is the World Health Organization's global database of individual case safety reports (ICSRs) concerning adverse drug reactions. It is maintained by the Uppsala Monitoring Centre (UMC) in Sweden as part of the WHO Programme for International Drug Monitoring. The database aggregates reports submitted by national pharmacovigilance centers and other partners from member countries, enabling international data sharing on medicines and vaccines. Each record typically includes details such as the drug involved, the adverse reaction, patient demographics, seriousness criteria, and outcome.

Data in VigiBase are standardized using the Medical Dictionary for Regulatory Activities (MedDRA) terminology and subjected to quality checks. The database supports signal detection and safety monitoring through statistical analyses and data mining, helping regulators, researchers, and health professionals identify potential safety signals that may require further evaluation. VigiBase data inform regulatory actions, safety communications, and guideline development, and it supports pharmacovigilance research and post-marketing surveillance worldwide.

Access to VigiBase is generally restricted to WHO member countries and approved researchers or institutions under data-sharing agreements. The UMC maintains governance and data protection standards. While each report does not establish causality on its own, the aggregation of reports across many medicines and populations enables robust pharmacovigilance and collaborative safety assessments across jurisdictions.