Freedom of Information request on data concerning any adverse reactions observed to COVID vaccine treatment through our Yellow Card Scheme (FOI 21/1088)
Published 27 April 2022
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26th October 2021 FOI 21/1088
Dear
Thank you for your FOI request dated 27th September. The MHRA is collecting data concerning any adverse reactions observed to vaccine treatment through our Yellow Card Scheme. We are regularly publishing Yellow Card data associated with COVID-19 vaccinations. Yellow Card data for drugs is routinely published on the Yellow Card website, with vaccine data available on request. However, for COVID-19 vaccinations we are proactively publishing details of adverse drug reactions received, including MHRA assessment of the data to provide context. Please note this data is updated weekly.
https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions The Yellow Card scheme is a mechanism by which anybody can voluntarily report any suspected adverse reactions or side effects to the vaccine. It is very important to note that a Yellow Card report does not necessarily mean the vaccine caused that reaction or event. We ask for any suspicions to be reported, even if the reporter isn’t sure if it was caused by the vaccine. Reports to the scheme are known as suspected adverse drug reactions (ADRs). Many suspected ADRs reported on a Yellow Card do not have any relation to the vaccine or medicine and it is often coincidental that they both occurred around the same time. The reports are continually reviewed to detect possible new side effects that may require regulatory action, and to differentiate these from things that would have happened regardless of the vaccine or medicine being administered, for instance due to underlying or undiagnosed illness. It is therefore important that the suspected ADRs described in this report are not interpreted as being proven side effects of COVID-19 vaccines. A list of the possible side effects of COVID-19 Pfizer/BioNTech, COVID-19 Vaccine AstraZeneca vaccineand COVID-19 Vaccine Moderna are provided in the product information document for healthcare professionals and the UK recipient information. These can also be found on the Coronavirus Yellow Card reporting site.
Kind regards,
FOI Team Vigilance and Risk Management of Medicines Division Medicines and Healthcare Products Regulatory Agency