Freedom of Information request on the number of yellow card reports submitted by healthcare professionals relating to adverse reactions following a COVID-19 vaccination (FOI 22/732)
Published 21 December 2023
© Crown copyright 2023
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-20-june-2022/freedom-of-information-request-on-the-number-of-yellow-card-reports-submitted-by-healthcare-professionals-relating-to-adverse-reactions-following-a-co
FOI 22/732
21st June 2022
Dear
Thank you for your email dated 29th May 2022, where you requested the total number of Yellow Card reports submitted by healthcare professionals for all COVID-19 vaccines.
The MHRA has received 70,120 UK spontaneous suspected Adverse Drug Reaction (ADR) reports (Yellow Cards) associated with COVID-19 vaccines (COVID-19 Pfizer/BioNTech Vaccine, COVID-19 Vaccine AstraZeneca, COVID-19 Vaccine Moderna, COVID-19 Vaccine brand unspecified) directly from healthcare professionals up to and including 12th June 2022. Reports submitted by pharmaceutical companies to the MHRA have not been included in these data.
When considering the above figure, it is important to note that healthcare professionals can submit Yellow Cards on behalf of themselves. Furthermore, a report can sometimes have more than one reporter as it may have been submitted by both a patient and their healthcare professional.
It is also important to be aware that a report of a suspected ADR to the Yellow Card scheme does not necessarily mean that it was caused by the vaccine, only that the reporter has a suspicion it may have been. Underlying or previously undiagnosed illness unrelated to vaccination can also be factors in such reports. The relative number and nature of reports should therefore not be used to compare the safety of the different vaccines.
Furthermore, 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, and may be stimulated by promotion and publicity about a drug or vaccine.
As you may be aware, further details on Yellow Cards reported in relation to COVID-19 vaccinations is available in our summary of Yellow Card reporting, which you can find here: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adversereactions/coronavirus-vaccine-summary-of-yellow-card-reporting.
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