FOI release

Freedom of Information request on side effects of Covid-19 vaccine AstraZeneca (FOI 21-385)

Published 28 June 2021

Thank you for your email dated 9 th April 2021, where you asked:

“Can we have side effects broken down by time like number of weeks from first dose of astrazeneca vaccine. I would like to know how many blood clots have been reported after 10 weeks from first vaccination in particular or any other side affects after 10 weeks of vaccination. Also if someone reported paraoxmyl high bp events along with palpitations.”

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/coronavirus-vaccine-summary-of-yellow-card-reporting. In this publication, you will find a breakdown of the age and sex of these patients and the number of reports of high blood pressure following vaccination. Although this condition remains extremely rare there appears to be a higher risk in people shortly after the first dose of the AstraZeneca (AZ) vaccine. This is seen slightly more often in younger people and tends to occur between 4 days and 2 weeks following vaccination. For the majority of reports received the time from receiving a vaccination to when the events occurred were within 4 days to 2 weeks; however, some reports do include an event onset later than 2 weeks whilst others have not been provided. It is important to note that when submitting a Yellow Card, reporters may report the time to onset as the time when the first symptoms began, the time at which an admission occurred or a diagnosis. The MHRA consider all ADR reports in our ongoing analysis regardless of time to onset and look at a range of risk windows in our statistical analysis; we never exclude a case. 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