Freedom of Information request on the total number of Yellow Card reports to date since 2021 (FOI 21/1219)
Published 31 May 2022
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FOI 21/1219
9th December 2021
Dear
Thank you for your email dated 4th November 2021 in which you requested, under the Freedom of Information Act, the total number of Yellow Card reports received to date in 2021.
As you may be aware the Yellow Card Scheme is the UK system for collecting and monitoring information on suspected Adverse Drug Reactions (ADRs). The Scheme is run by the Medicines and Healthcare products Regulatory Agency (MHRA) and currently relies on voluntary reporting of suspected ADRs by health professionals and patients. There is also a legal obligation for pharmaceutical companies to report serious ADRs associated with their products to the MHRA. The purpose of the Scheme is to provide an early warning that the safety of a product may require further investigation.
In response to your request, I am pleased to confirm that as of 23rd November 2021, the MHRA have received a total of 26,819 Yellow Card reports. Please note that these reports have been received directly via the Yellow Card Scheme and will not include reports from pharmaceutical companies. I must emphasise that the total number of Yellow Card reports provided does not include Yellow Card reports pertaining to suspected side-effects following COVID-19 vaccination. As previously provided, these data can be found on the weekly summary of Yellow Card reporting, which can be accessed via the following link: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting
Please note that the number of reports received via the Yellow Card Scheme does not directly equate to the number of people who suffer adverse reactions to drugs or vaccines for a number of reasons. ADR reporting rates may be influenced by the seriousness of reactions, their ease of recognition, extent of use of a particular drug or vaccine, promotion and publicity about a drug/vaccine and awareness of the Yellow Card Scheme. Since the launch of the national immunisation campaign for COVID-19 vaccines, the Yellow Card Scheme has benefited from an increased spotlight and as such the MHRA has seen an increase in reports received for non-COVID-19-related drugs and vaccines.
I hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.
Yours sincerely,
FOI Team,
Vigilance and Risk Management of Medicines Division