FOI release

Freedom of Information request on COVID19, Influenza and Other Vaccine Adverse Reaction Data – Past 20 years (FOI 21-038)

Published 24 March 2021

Thank you of your Freedom of Information (FOI) request dated 14th January 2021 where you requested adverse reaction information over the last 20 years for the following:

All brands of COVID 19 vaccines

All other vaccines

All vaccines on the childhood schedule

Influenza vaccines for adults

I can confirm that the MHRA collects reports of suspected adverse reactions to medicines and vaccines via the Yellow Card Scheme. Section 12 of the FOI Act specifies that a public authority may refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information. We consider that extracting the adverse reactions data that you have requested will take longer than 24 working hours to complete.

We would be able to provide you with Drug Analysis Prints (DAPs) which include the number of reports of all suspected adverse reactions to a particular medicine or vaccine if you were to narrow your request by, for example, limiting your request to specific vaccines.

Additionally, adverse reaction data for COVID 19 vaccines has been published by the MHRA and is available to view at the following link to our webpage:

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions

Please note this information will be updated weekly.

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 you receive this response and addressed to: info@mhra.gov.uk

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

Please remember to quote the reference number above in any future communications.

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

Kind regards,

FOI Team