Freedom of Information request on adverse drug reactions associated with COVID-19 vaccines (FOI 21-363)
Published 28 June 2021
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6th May 2021 FOI 21/363
Thank you for contacting the MHRA regarding the reports we have received concerning a specific type of blood clot in the brain, known as cerebral venous sinus thrombosis (CVST) and other blood clotting cases (thromboembolic events) occurring together with low levels of platelets (thrombocytopenia).
Under the Freedom of Information (FOI) act, you have requested to be provided with the following:
Please could you provide the following information regarding reported adverse reactions to AstraZeneca Covid-19 vaccine?
Specifically in relation to the 30 reported cases of blood clots (22 CVST & 8 Thrombocytopenia). 1. Ages 2. Biological Sex 3. Race 4. Reported after 1st or 2nd dose 5. Previous confirmed tested positive for natural Covid-19 infection 6. Pre-existing medical conditions and/or medications
The MHRA publishes a weekly summary of Yellow Card reporting which can be found on this link: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirusvaccine-summary-of-yellow-card-reporting. In this publication, you will find the specific information you have requested surrounding these case reports, including a breakdown of the age and sex of these patients as well as the number of reports which indicate the first or second dose of the vaccine being given.
Yellow Card data is releasable to members of the public provided that patient and reporter confidentiality is maintained. Under the Freedom of Information Act (FOIA) 2000 data is releasable as category 1b, patient ethnicity does not fall within this category.
However, for reports of thromboembolic events with concurrent thrombocytopenia (low platelets) that the MHRA has received, the majority are reported in white British patients. This correlates with the overall Yellow Card reporting profile across all reports and all COVID-19 vaccines. It is important to note that this does not infer which ethnicities experience a greater number of side effects or are more susceptible to adverse reactions when taking COVID-19 vaccines due to many factors; including that the number of doses administered to each ethnic group is not included in MHRA data or the incidence of the events occurring naturally regardless of vaccination between ethnic groups.
The MHRA does not collect information exclusively on COVID infections; this information is only asked for when a possible reaction to a COVID-19 vaccination is reported via the Yellow Card scheme. Further information on COVID infections can be found on the Daily Summary and you can request additional information from Public Health England (PHE). Regarding the information on COVID infection in relation to Yellow Card reports of thrombus, this information is not available across all reports; however, MHRA works across the healthcare system to consider the totality of the data in the case reports when evaluating the evidence.
Unfortunately, we are unable to provide details of past medical history for individual cases. Because of the way this information is captured within our database, this would require manual extraction of the information from each individual report. Please be reassured that any information provided regarding a patient’s past medical history or concurrent conditions is taken into account during the routine assessment of all cases that we receive.
Please refer to our statement for further information on individuals potentially more at risk of blood clots because of their medical conditions: https://www.gov.uk/government/publications/coronavirus-covid-19- vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting.
Dr June Raine, MHRA Chief Executive said: “Over 44 million doses of vaccines against COVID-19 have now been administered in the UK, saving thousands of lives through the biggest vaccination programme that has ever taken place in this country. “No effective medicine or vaccine is without risk. These specific kinds of blood clots with low platelets reported following COVID-19 Vaccine AstraZeneca remain extremely rare and unlikely to occur. The benefits of the vaccine continue to outweigh the risks for most people. “It is still vitally important that people come forward for their vaccination when invited to do so. “We ask anyone who suspects they have experienced a side effect linked with their COVID-19 vaccine to report it to the Coronavirus Yellow Card website.”
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