Freedom of Information request (FOI 22/1013)
Published 17 January 2024
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31st October 2022
FOI 22/1013
Dear
Thank you for your email dated 3rd October 2022 following our response to FOI 22/923 where you clarify your request to ask for the following:
• Please can you inform me of the number of direct Yellow Card reports received, from 6th October 2021 to date, by the four groups of reporters below, but excluding suspected side-effects following COVID-19 vaccination.
Further to your request, I can confirm from 6th October 2021 to 15th September 2022 the MHRA have received 31,976 direct UK spontaneous Adverse Drug Reaction (ADR) reports excluding COVID-19 vaccine reports.
Table 1 below provides a breakdown of the number of direct UK spontaneous Yellow Card reports excluding COVID-19 vaccine reports according to the four reporter categories you requested.
| Reporter type | Total number of reports |
|---|---|
| Patient | 13968 |
| Doctor | 7296 |
| Nurse | 2581 |
| Pharmacist | 5236 |
Table 1: Total number of direct UK spontaneous suspected Yellow Card reports from 6th October 2021 to 15th September 2022.
Please note that within each of the reporter categories you specified, there are multiple possible qualifications. The qualifications that have been considered for each reporter category are stated below:
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Patients – patient, parent, carer, consumer or other non-health professional.
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Doctors – hospital doctor, general practitioner (GP), physician, dentist.
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Nurses – nurse, hospital nurse.
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Pharmacists – pharmacist, community pharmacist, hospital pharmacist, pre-registration pharmacist, pharmacy assistant.
When considering spontaneous ADR data, it is important to keep in mind the following points:
• A reported reaction does not necessarily mean it has been caused by the drug or vaccine, only that the reporter had a suspicion it may have. The fact that symptoms occur after use of a drug or vaccine, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by the drug 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 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 of a particular drug or vaccine and may be stimulated by promotion and publicity about a drug or vaccine. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time. For these reasons the above data should not be used as a basis for determining incidence of side effects. During assessment we take into account of the variable levels of reporting as part of our monitoring procedures.
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