FOI release

Freedom of Information request on adverse reactions to named vaccines (FOI 21-259)

Published 28 May 2021

Thank you for your email dated 15th March 2021, whereby you requested the following information:

1. How many ADR reports were sent in the UK during a) 2020 and b) 2021 so far for people who had taken the flu vaccine?
2. Of these, in how many cases did the recipient die shortly after taking the flu vaccine? Please provide an age breakdown.
3. How many ADR reports were sent in the UK during a) 2020 and b) 2021 so far for people who had taken the HPV vaccine?
4. Of these, in how many cases did the recipient die shortly after taking the HPV vaccine?
5. How many ADR reports were sent in the UK during a) 2020 and b) 2021 so far for people who had taken the MMR vaccine?
6. Of these, in how many cases did the recipient die shortly after taking the MMR vaccine?

In your request you mention that you would like to compare the data provided below to that seen in the ADR summary published each week for COVID-19 vaccines, however this comparison is not possible for a number of reasons. There are a range of factors that can lead to increased reporting of one vaccine over another, for instance socio-demographic factors of vaccine recipients or whether or not they have been encouraged by information, or a healthcare professional, to make a report. No robust inferences can be drawn from such comparisons.

Overall, the number and nature of suspected adverse reactions reported so far is not unusual for an immunisation programme and the data published and analysed by the MHRA tell us that the safety of the COVID-19 vaccines is as expected based on the robust clinical trial data that supported the authorisations.

The general safety profiles of the COVID-19 vaccines authorised in the UK are broadly similar to other types of routinely-used vaccines. Our robust regulatory work continues to reinforce that the safety profile of the vaccines remains positive and the benefits continue to far outweigh any known side-effects.

When considering the below spontaneous Adverse Drug Reaction (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 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. 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.

Please find Table 1 below which shows the total number of UK spontaneous suspect adverse reaction reports in association with the inactivated influenza, human papilloma virus (HPV) and measles mumps and rubella (MMR) vaccines received in 2020 and 2021, as of the 6th April 2021. Please also find Table 2 which displays an age breakdown of influenza vaccine ADR reports associated with a fatal outcome received between 01/01/2020 and 06/04/2021. Please note that data has been provided for the inactivated injectable flu vaccine only.

Table 1: UK spontaneous suspected ADR reports for influenza, HPV and MMR vaccines received by the MHRA in 2020 and 2021.

Vaccine	2020	2021	Fatal Reports
Flu Vaccine	1339	319	7
HPV Vaccine	147	37	3
MMR Vaccine	299	73	1

Please note that the fatal reports are included in totals for the years.

Table 2: UK spontaneous suspected fatal ADR reports for influenza vaccines by patient age.

Vaccine

20

2021

Fatal Reports

Vaccine	41-50	51-60	61-70	71-80	81-90	Total Deaths
Flu vaccine	1	1	2	1	2	7

As with any serious suspected ADR, reports with a fatal outcome are fully evaluated by the MHRA, including an assessment of post-mortem details if available, to consider whether the vaccine (or medicine) may have caused the event, or whether the event and fatal outcome were likely to be purely coincidental and due to underlying illness. Any emerging evidence relating to possible risks associated with vaccines and medicines, would be carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks were confirmed.

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