FOI release

Freedom of Information request on cardiomyopathy reports following the Astrazeneca COVID-19 vaccine (21/953)

Published 25 February 2022

9th September 2021

FOI 21/953

Dear

Thank you for your e-mail dated 19th August 2021 where you requested:

“Information under the Freedom of Information Act regarding details of 3 fatalities which have been registered with you regarding cardiomyopathy and AstraZeneca vaccine.”

I can confirm that as per the Vaccine Analysis Prints for COVID-19 Vaccine AstraZeneca, as of 25/08/2021 there have been 13 reported cases of cardiomyopathy, 13 reported cases of congestive cardiomyopathy, 4 cases of stress cardiomyopathy, 3 cases of hypertrophic cardiomyopathy and 1 case of peripartum cardiomyopathy. 3 of these total cases are reported to have had a fatal outcome. Of these 3 cases, one of them is the case that was reported by yourself.

Of these 3 reports, 2 concern female patients and the third a patient of unknown sex. Patient age ranges between unknown to 64 years. All patients were reported to have suffered a fatal reaction of either dilated cardiomyopathy or cardiomyopathy. No post-mortem or coroner report is on file for any of the 3 cases. The MHRA has not currently identified any signals regarding cardiomyopathies and the COVID-19 Vaccine AstraZeneca.

When considering spontaneous Adverse Drug Reaction (ADR) 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. As the COVID-19 immunisation campaign schedule is rolled out across the UK, each vaccine is administered to very large numbers of people, and 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.

• 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 vaccine, and may be stimulated by promotion and publicity about a vaccine. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time.

Please note that in the context of fatal reports, it is not within the remit of the MHRA to define or confirm the cause of death when a Yellow Card is submitted to us. As mentioned above, a reported reaction does not necessarily mean it has been caused by the vaccine, only that the reporter had a suspicion it may have. If the reporter has provided details of the post-mortem report or clinically reported cause of death, we use this information to classify and assess the case. If this official information is not provided, the suspected cause of death as provided by the reporter is then used to classify the case. It is the responsibility of the healthcare professional to define and provide details of the cause of death, as they are trained to do so and are knowledgeable about the patient’s medical history and complications. Therefore, please note that inclusion of a Yellow Card report within our database and within the weekly summary of Yellow Card reporting, is not necessarily proof of an evidential link between the vaccine and suspected side effect, just that the reporter had a suspicion it may have contributed.

Yours Sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division