Freedom of Information request on the number of cases reported to the Yellow Card Scheme in 2019 and 2020 (FOI 21-533)
Published 13 August 2021
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18th June 2021 FOI 21/533
Dear
Thank you for your email dated 20th May, where you asked for information on the following:
“How many cases were reported to the Yellow Card Scheme in 2019 and, if possible in 2020?”
In relation to your request I can confirm that in 2019 we received 43,776 Yellow Card reports and in 2020 we received 40,764. Pease see the link to the 2019 CHM annual report https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/902455/HM R_CHM_BPC_Annual_report_2019.pdf This will provide further information on the number of reports received in 2019 as well as an overview of the trends in Adverse Drug Reaction (ADR) reporting to the Yellow Card scheme. Please be aware the 2020 CHM annual report is currently being finalised and will soon be published.
When considering spontaneous Adverse Drug Reaction (ADR) data, it is important to be aware of the following points:
• A reported reaction does not necessarily mean it has been caused by the medicine or vaccine, only that the reporter had a suspicion it may have. The fact that symptoms and events occur after use of a vaccine, and are reported via the Yellow Card Scheme, does not in itself mean that they are proven to have been caused by the medicine or vaccine, underlying or concurrent illnesses may be responsible and such events can also be coincidental.
• It is also important to 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 medicines or vaccines and therefore cannot be used to determine the incidence of a reaction. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use, and may be stimulated by promotion and publicity. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time.
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