FOI release

Freedom of Information request on how many reports of fatigue lasting longer than 4 weeks following COVID-19 vaccines were associated with patients who reported chronic fatigue or ME in their medical background (FOI 21-521)

Published 13 August 2021

7th June 2021 FOI 21/521

Dear

Thank you for your Freedom of Information (FOI) request dated 7th May 2021 where you requested the following:

  • What proportion (and number) of reports of fatigue lasting longer than 4 weeks following the Astra Zeneca vaccine were associated with patients who reported chronic fatigue or ME in their medical background?

  • What proportion (and number) of reports of fatigue lasting longer than 4 weeks following the Pfizer vaccine were associated with patients who reported chronic fatigue or ME in their medical background.

I would also be interested to know how this varies by 1st or 2nd dose, and how it might be impacted by mixing and matching vaccines (eg having Pfizer following initial AZ vaccine).

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 case. Therefore, this information is exempt from release under Section 12 of the FOI Act. 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. 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.

Additionally, reports to the Yellow Card scheme do not always include details on how long a suspected ADR has been ongoing. The outcome of reactions is not a mandatory field on a Yellow Card report and therefore is not always provided. The outcome of reactions is recorded at the time of reporting and therefore may not reflect if the patient subsequently recovered from the event.

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