FOI release

FOI 21/108 - FOI Covid-19 Vaccine Adverse Drug Reaction (ADR) Reporting

Published 24 March 2021

Thank you for your email dated 29th January 2021. We are pleased to inform you that data on reported adverse reactions to the COVID-19 vaccines is now published on our website. You can access the information through the following link: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions

Please note, this information will be updated weekly and you can register for our email alerting service using the link below: https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency/email-signup

To provide reassurance as to the ongoing benefit and risk assessment of available vaccines and assist the public with the interest of the available data in detail, the MHRA intends to publish suspected reactions reported in association with available COVID-19 vaccines in an interactive format as iDAPs. The use of iDAPs will enable users to view the data by categories of their choice such as age, sex and seriousness of reports. We have your contact information and to help assist we will send you a link to the interactive ADR data report once it has been published. You can be assured that we continue to adhere to the highest standards of safety with available COVID-19 vaccines.

Finally, information relating to the total number of people who tested positive for COVID-19 after being vaccinated is not held by the MHRA.

I hope the information provided is helpful; however, 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. Please remember to quote the reference number above in any future communications. Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF

Yours sincerely

FOI Team Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU