The UK's pharmacovigilance reporting system for adverse drug reactions including vaccines
The Yellow Card scheme is the UK's system for collecting information on suspected adverse reactions to medicines and vaccines. Operated by the Medicines and Healthcare products Regulatory Agency (MHRA), it is one of the world's longest-running pharmacovigilance systems, established in 1964 following the thalidomide tragedy.
Post-Brexit, the Yellow Card scheme operates independently of EudraVigilance, making it a distinct and important data source for UK-specific vaccine safety monitoring.
Established in 1964 by Professor Bill Inman following the thalidomide tragedy. One of the world's oldest pharmacovigilance systems. Named after the original yellow reporting cards distributed to doctors.
Healthcare professionals, patients, carers, and parents can all submit Yellow Card reports. This open reporting model maximises signal capture, particularly for patient experiences not captured through clinical encounters.
Yellow Card data is publicly searchable via the Yellow Card website. MHRA publishes regular drug safety updates and vaccine analysis prints (VAPs) with aggregated data.
Since the UK left the EU in 2021, MHRA operates independently from EMA. Yellow Card data is no longer shared with EudraVigilance, making it a separate and complementary data source for global surveillance.
UK MHRA. "Yellow Card Scheme." Medicines and Healthcare products Regulatory Agency. https://yellowcard.mhra.gov.uk
UK MHRA. "Coronavirus (COVID-19) Vaccine Analysis Print." Gov.uk. https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions
Hazell L, Shakir SA. "Under-reporting of adverse drug reactions: a systematic review." Drug Safety. 2006;29(5):385-396. https://doi.org/10.2165/00002018-200629050-00003
MHRA. "About the Yellow Card scheme." Gov.uk. https://www.gov.uk/report-reaction-medicine