Freedom of Information request on the adverse reactions reported for pseudolymphoma following the COVID-19 vaccine (FOI 22/627)
Published 27 March 2023
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-6-june-2022/freedom-of-information-request-on-the-adverse-reactions-reported-for-pseudolymphoma-following-the-covid-19-vaccine-foi-22627
8th June 2022
FOI 22/627
Dear
Thank you for your follow up email dated 21st April 2022 related to FOI 22/601, where you requested FOI Category 1b data for Yellow Card data concerning the 12 reported cases of pseudolymphoma associated with the Pfizer/BioNTech vaccine and 4 reported cases associated with the AstraZeneca formulation.
The attached FOI Category 1b data for Yellow Card data includes the following:
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Aggregated patient age
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Aggregated patient sex (number of males and females)
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Suspect drug(s)
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Dose of suspect drug
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Route of administration
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Duration of treatment
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Suspected adverse drug reaction(s)
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Outcome of reaction
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Reaction onset times
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Patient medical history
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Year of receipt
When considering the attached spontaneous ADR data, it is important to be aware of the following points:
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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 data does not necessarily mean that the vaccine has caused the suspected reaction.
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The reaction outcome provided is the outcome at the time the Yellow Card report was submitted and should not be considered as the final outcome.
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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.
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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.
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.
The expected benefits of the vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known side effects. As with all vaccines and medicines, the safety of COVID-19 vaccines is continuously monitored and benefits and possible risks remain under review.
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