Freedom of Information request on the annual number of UK spontaneous, suspected ADR reports and deaths for flu vaccines for the last ten years (2010 to 2020) for over 65s only (FOI 21/755)
Published 27 April 2022
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9th August 2021 FOI 21/755
Dear
Thank you for your email dated 8th July 2021, where you requested:
Please provide the annual number of UK spontaneous, suspected ADR reports and deaths for flu vaccines for the last ten years (2010 to 2020) for over 65s only. If you are not able to provide the number for flu vaccines alone, all vaccines (excluding COVID-19) will suffice.
Further to your request, I can confirm that the MHRA has received 2558 spontaneous UK suspected Adverse Drug Reaction (ADR) reports concerning administration of the inactivated injectable influenza vaccine in patients aged 65 and over, received between 01/01/2010 and 31/12/2020 (data extracted on 22/07/2021). Of these 2558 spontaneous ADR reports, there have been 39 reports associated with a fatal outcome. Please see the drug analysis print (DAP) attached for a breakdown of the reported reactions. Please also refer to the enclosed information sheet for guidelines on how to interpret the DAP.
Regarding the annual number of ADR reports that you have requested, I have provided a breakdown for each year in Table 1:
Table 1: Total number of UK spontaneous suspected ADR reports associated with the administration of the inactivated injectable influenza vaccine per year, with a breakdown of fatal reports
| Year report received | Total number of ADR reports | Number of fatal cases |
|---|---|---|
| 2010 | 103 | 3 |
| 2011 | 91 | 7 |
| 2012 | 64 | 5 |
| 2013 | 118 | 3 |
| 2014 | 143 | 1 |
| 2015 | 183 | 0 |
| 2016 | 160 | 0 |
| 2017 | 246 | 3 |
| 2018 | 617 | 3 |
| 2019 | 464 | 10 |
| 2020 | 369 | 4 |
| Total | 2558 | 39 |
When considering the 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 vaccines are given in the UK alone, and when any vaccine is administered to very large numbers of people, some recipients will inevitably experience illness following vaccination. The fact that symptoms or 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 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. Therefore, Yellow Card data cannot be used to determine the incidence of a reaction or to compare the side effect profiles of different medicines or vaccines. 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. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time.
Any emerging evidence relating to possible risks associated with vaccines and medicines, is carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks were confirmed. As these data do not necessarily refer to proven side effects, you should refer to the product information which can be found here: https://products.mhra.gov.uk/ for details on the possible side effects of the inactivated injectable influenza vaccine.
Details of the current UK immunisation schedule can be found here: https://www.gov.uk/government/publications/the-complete-routine-immunisation-schedule.
The MHRA continuously monitors the safety of vaccines through a variety of pharmacovigilance processes including the Yellow Card scheme. As part of our signal detection processes all adverse reaction reports received by the Yellow Card scheme are individually assessed and cumulative information reviewed at regular intervals. Please note that there has been no causal association established between the fatal reports and vaccination with the influenza vaccines.
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