Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what methods (a) GPs and (b) other healthcare providers use to register adverse events following immunisation; and what recent assessment her Department has made of the effectiveness of those methods in accurately reflecting the (a) number and (b) type of adverse events following immunisation.

Since the start of the COVID-19 vaccines campaign, the Medicines and Healthcare products Regulatory Agency (MHRA) has been working in close collaboration across the healthcare system to ensure healthcare professionals and patients are aware of the Yellow Card scheme and how they can report to us. The Yellow Card scheme relies on voluntary reporting of suspected side effects or medical device incidents. The reporting of suspected adverse drug reactions (ADRs) is considered a healthcare professionals’ duty and is supported by their various regulators and their respective professional guidance.

Information on Yellow Card reporting has been included in National Health Service training materials, as well as the materials available to individuals both before and after vaccination. Both vaccine recipients and healthcare professionals are strongly encouraged to report any suspicion of a side effect to the MHRA. Additionally, the MHRA have worked to actively promote reporting on COVID-19 vaccines from the public, patients and healthcare with a targeted marketing campaign. Healthcare professionals can also report to the scheme via their clinical systems, reporting of ADRs to the Yellow Card Scheme is available in at least 93% of primary medical care practices in the United Kingdom.

The reporting rate for spontaneous adverse drug reactions (ADR) is variable and can depend on a multitude of factors. For the COVID-19 vaccines, MHRA assessments show that there is a higher-than-normal public awareness of Yellow Card reporting and therefore the reporting rate for these products is expected to be higher. The World Health Organization’s Uppsala Monitoring Centre latest annual report shows that globally, the UK is the third largest contributor of reports, behind the USA and Germany, and also one of the highest reporting countries per million inhabitants in its global database.