Freedom of Information request about data on all reactions reported via the Yellow Card scheme for influenza vaccines (FOI-21-420)
Published 28 June 2021
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Thank you for your email dated 15th April 2021, where you requested data on all reactions reported via the Yellow Card scheme for influenza vaccines.
Please find enclosed Drug Analysis Prints (DAPs), which list all reported, suspected reactions associated with influenza vaccines up to and including 28/02/2021. Two DAPs are provided, one for the live attenuated influenza vaccines (LAIVs) and the second for inactivated flu vaccines. LAIVs are mostly given to children, and the inactivated flu vaccines are typically administered to adults, especially the elderly. Please refer to the attached information sheet for guidelines on how to interpret the DAP.
When considering the attached spontaneous 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 vaccine, only that the reporter had a suspicion it may have. Each year, millions of doses of routine vaccinations are given in the UK alone, and when any vaccine is administered to large numbers of people, some recipients will inevitably experience illness following vaccination. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.
• Additionally, 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.
As this data does not necessarily refer to proven side effects, you should refer to the product information (Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL)) for details on the possible side effects of each influenza vaccine, which can be found here.
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 this response’s date and can be addressed to this email address.
Kind regards,
FOI Team
Vigilance and Risk Management of Medicines Division
Medicines and Healthcare Products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU