Pharmacovigilance data overview 

The Yellow Card Scheme, managed by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), is a system for collecting and monitoring information on suspected adverse drug reactions (ADRs) and medical device incidents. Reports can be submitted by healthcare professionals, patients, and caregivers, making it a valuable source of real-world safety data. Once submitted, each report is reviewed and stored in a central database, where it contributes to ongoing safety monitoring, signal detection, and regulatory decision-making aimed at protecting public health.

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The Yellow Card data uses MedDRA (Medical Dictionary for Regulatory Activities), an internationally recognised system for classifying medical terms. MedDRA standardises how side effects are recorded and analysed across countries and healthcare systems. It is organised as a hierarchy, where each adverse drug reaction (ADR) belongs to broader categories that can be grouped into even larger classifications. For example, "migraine" is a type of "headache", which in turn falls under "nervous system disorders". In OpenPV, ADRs are coded using the Preferred Term (PT) — a standard, specific description used to ensure consistency in reporting and analysis Other data available in UK Yellow Card Scheme relate to severity of ADR, gender, age, who reported the ADR. In OpenPV, all reactions are included (regardless of severity and whether the drug in question was part of a combination or single formulation. 

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The data in OpenPV relates to all reported, suspected adverse drug reactions for a drug (either as a single constituent or as part of a multiple constitutent formulation).  This includes reports from members of the public as well as healthcare professionals, at any time point. No filter was applied based on severity (fatal vs. non-fatal).