EMA Reports Record Numbers of Adverse Drug Reactions in 2021

The European Medicines Agency (EMA) said its EudraVigilance system for tracking suspected adverse reactions to medicines last year logged the highest number of cases ever, driven by COVID-19 vaccine reporting.

The agency said that more than 3.5 million individual case safety reports were recorded. The EudraVigilance database currently holds more than 22.3 million individual case safety reports relating to 12.9 million suspected adverse drug reactions. Adverse reactions can lead to several individual case safety reports, including the initial report and follow-ups.

More than 25 percent of the adverse event reports in 2021 discussed by the agency’s Pharmacovigilance Risk Assessment Committee were related to COVID-19 vaccines, the agency said.