Freedom of Information request (FOI 22/985)
Published 17 January 2024
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FOI 22/985
26th September 2022
Dear
Thank you for your email dated 16th September 2022.
Please refer to the product information for a list of recognised side effects for the Pfizer BioNTech vaccine Patient Information Leaflet Comirnaty 30 micrograms/dose concentrate for age 12+ (purple cap) - GOV.UK (www.gov.uk), and the Vaccine Analysis Prints for a list of all the suspected ADRs received Vaccine_Analysis_Print_Pfizer_BioNTech_COVID-19_vaccine_24.08.2022.pdf (publishing.service.gov.uk)
Vaccine Analysis Prints contain a complete listing of all suspected adverse reactions that have been reported to the MHRA via the Yellow Card scheme for the COVID-19 Vaccine Pfizer/BioNTech, the COVID-19 Vaccine AstraZeneca, the COVID-19 Vaccine Moderna and where the brand of the vaccine was not specified. This includes all reports received from healthcare professionals, members of the public, and pharmaceutical companies.
This information does not represent an overview of the potential side effects associated with the vaccines. A list of the recognised adverse effects of COVID-19 vaccines is provided in the information for healthcare professionals and the recipient information here. These can also be found on the Coronavirus Yellow Card reporting site. Conclusions on the safety and risks of the vaccines cannot be made on the data shown in the Print alone.
When viewing the vaccine analysis print you should remember that:
- reporters are asked to submit Yellow Card reports even if they only have a suspicion that the medicine or vaccine may have caused the adverse reaction. The existence of an adverse reaction report in the print does not necessarily mean that the vaccine has caused the suspected reaction.
- it may be difficult to tell the difference between something that has occurred naturally and a suspected adverse reaction. Sometimes these events can be part of the condition being treated rather than being caused by the vaccine.
- many factors have to be considered when assessing whether the vaccine has caused a reported adverse reaction. When monitoring the safety of vaccines and medicines, MHRA staff carry out careful analysis of these factors.
For a medicine or vaccine to be considered safe, the expected benefits will be greater than the risk of having harmful reactions. It is important to note that most people take medicines and vaccines without having any serious side effects.
Kind regards,
FOI Team
Safety & Surveillance Group