Freedom of Information request on the yellow card reports submitted by the NHS Ambulance service (FOI 22/370)
Published 31 May 2022
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FOI 22/370
11th February 2022
Dear
Thank you for your email dated 8th November 2021, where you asked for information on Yellow Card reports submitted by the NHS Ambulance Services by financial year, reporter type, suspect drug, suspect reaction, and postcode. Please accept my apologies for the delay in our response.
As per your request, please find enclosed a summary of the requested reports split by financial year, using the date they were first received by the MHRA. These tables contain the UK spontaneous suspected Adverse Drug Reaction (ADR) reports received through the Yellow Card scheme from the email addresses you provided since the beginning of the 2018/19 financial year (06/04/2018) up until the 31/01/2022. Postcode has been included in the spreadsheet where a postcode was provided by the reporter, but this is not a mandatory field when completing a Yellow Card report and so this is not available in every case. The postcode has been shortened in order to maintain reporter confidentiality. Data relating to the COVID-19 vaccines has not been provided within the response.
When considering the attached spontaneous data, it is important to be aware of the following points:
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A reported reaction does not necessarily mean it has been caused by the medicine or vaccine in question, only that the reporter had a suspicion it may have. The fact that symptoms occur after use of a vaccine or medicine, and are reported via the Yellow Card Scheme, does not in itself mean that they are proven to have been caused by it. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.
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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 and therefore cannot be used to determine the incidence of a reaction or compare the safety profile of different vaccines. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular medicine, and may be stimulated by promotion and publicity about a drug. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time.
As these data do not necessarily refer to proven side effects, you should refer to the product information which can be found here: https://www.medicines.org.uk/emc/ for details on the known possible side effects of any particular medicine or vaccine.
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