FOI release

Freedom of Information request on blood clots following the COVID-19 vaccines (FOI 21/993)

Published 17 January 2022

17th September 2021

FOI 21/993

Dear

Thank you for your email on 25th August asking if the MHRA could confirm five reported cases of blood clots following COVID-19 vaccinations at the Medway Maritime Hospital in one week.

Firstly, I can confirm the MHRA is responsible for monitoring the safety of COVID-19 vaccines on an ongoing basis to ensure their benefits continue to outweigh any risks. The Yellow Card scheme allows anybody to submit reports of suspected side effects, including patients and healthcare professionals alike. This scheme is one way the MHRA carries out COVID-19 vaccine safety surveillance, and you can find out more information on our proactive pharmacovigilance strategy and how we monitor safety here.

Further to your request, the MHRA has the functionality to collect outcome information on suspected adverse reactions, including those where the patient was hospitalised, when reports are submitted to us via our electronic reporting systems. However, it is important to note that reporters are not required to tell us if patients have been hospitalised or disclose the hospital name in order to submit a valid report on our system. Therefore, the MHRA can receive valid reports without knowing where the patient is receiving treatment. Additionally, reporters can submit reports without providing the date on which the suspected reaction started or an onset time following the administration of the vaccine. As this information is not mandatory, we might not be able to accurately identify the number of cases of a specific reaction over one week. It is essential to note that reporters can submit Yellow Cards at any time, from the same day of the suspected reaction to many years later. Hence, we cannot use the report submission date as the time the suspected adverse reaction occurred. Therefore, for the reasons mentioned above, we cannot confirm if there were five reported cases of blood clots following COVID-19 vaccinations at the Medway Maritime Hospital in one week.

The MHRA is not required to hold information on where patients are admitted, as this information is confidential and could potentially identify patients if known. When provided, hospital names are removed from the summary section of the report to ensure patient and reporter confidentiality is upheld. If you would like a more general overview of Yellow Card reporting trends on COVID-19 vaccinations, the MHRA publishes a weekly summary of our analysis of Yellow Cards concerning COVID-19 vaccines, which you can find here. This summary includes comments on specific reactions, such as cases of thrombo-embolic events with concurrent low platelets in the United Kingdom.

We would like to apologise for not being able to confirm the requested information, as you were directed to the MHRA after initial contact with Public Health England. NHS Digital is a national body responsible for collecting, processing, and using data from across the NHS and social care; therefore, they may be better placed to answer your data query. NHS Digital can be contacted via email at [email protected]

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 this response’s date and can be addressed to this email address.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division