Freedom of Information request on the adverse reactions reported relating to Diphtheria, tetanus, pertussis, polio, Hib and hepatitis B, Meningococcal group B, Measles, mumps and rubella vaccinations (FOI 22/671)
Published 22 March 2023
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FOI 22/671
24 May 2022
Dear
Thank you for your enquiry dated the 1st May where you requested information regarding vaccine injury and suspected adverse reactions for the following vaccines:
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Diphtheria, tetanus, pertussis, polio, Hib and hepatitis B (6 in 1)
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Meningococcal group B (MenB)
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Measles, mumps and rubella (MMR)
When considering the provided spontaneous Adverse Drug Reaction (ADR) data, it is important to be aware of the following points:
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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 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.
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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. 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. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time. For these reasons the enclosed data should not be used as a basis for determining incidence of side effects.
The MHRA continuously monitors the safety of medicines and vaccines through a variety of pharmacovigilance processes including the Yellow Card scheme. The Yellow Card scheme collects reports of suspected side effects and not vaccine injuries, therefore only reports of suspected side effects have been included within our response. 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. 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: MHRA Products - Home for details on the possible side effects of the vaccines.
Further to your request, the total number of UK, spontaneous suspected ADR reports for each vaccine is listed below:
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Diphtheria, tetanus, pertussis, polio, Hib and hepatitis B (6 in 1) - 585
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Meningococcal group B (MenB) – 2,935
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Measles, mumps and rubella (MMR) – 7,693
Please also find attached a Vaccine Analysis Print (VAP) for each requested vaccine which contains information on all UK spontaneous suspected ADR reports received through the Yellow Card scheme for that vaccine up to and including 17/05/2022. Please refer to the enclosed information sheet for guidelines on how to interpret the VAPs. Please note that the attached VAPs contain ADR reports for each brand of vaccine available as well as reports in which the brand of the vaccine was not provided.
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