Freedom of Information request about any cases of haematemesis reported due to gastrointestinal bleeding in males or females after Flu Vaccination (FOI-21-405)
Published 28 June 2021
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Thank you for your email dated 9 th April 2021, where you requested information on;
• Any cases of haematemesis reported due to gastrointestinal bleeding in males or females after Flu Vaccination.
Further to your request I can confirm up to and including 04/05/2021 we have received a total of five Adverse Drug Reaction (ADR) reports of the inactivated influenza vaccine in association with haematemesis. None of these five reports were associated with gastrointestinal bleeding.
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. Vaccines encompass a wide variety of products with different indications, different ingredients and different mechanisms of action and as such safety for each vaccine is considered individually rather than as a group. If appropriate, regulatory action would be taken if any serious risks were confirmed.
When considering the 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. The fact that symptoms occur after use of a vaccine or medicine, and are reported via the Yellow Card Scheme, does not in itself mean that they are proven to have been caused by it. 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 or compare the safety profile of different vaccines. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular medicine, 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.
As the data does not necessarily refer to proven side effects, you should refer to the NHS website for details on the possible side effects of each vaccine here https://www.nhs.uk/conditions/vaccinations/fluinfluenza-vaccine/.
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.
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