Freedom of Information request for information on Yellow Card reports for COVID-19 vaccines (FOI 21-353)
Published 28 June 2021
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5th May 2021 FOI 21/353
Thank you for your email dated 4th April 2021, where you requested the following information for the COVID-19 vaccines: “details of where the information can be found to show how many days after vaccination is the reporting on Covid-19 side effects being provided to the public. I believe it is only those effects that are within seven days of vaccination that are being provided but this is not clear in either the information being provided or indeed within the reports or narrative around these reports.”
All Yellow Card reports received for COVID-19 vaccinations are published in the weekly ADR summary, regardless of the time between when the vaccine is administered and when the suspected side effects occur. Reports received via the Yellow Card scheme can be reported at any time after a suspected side effect has occurred. Please note that the time frame from when the patient received the vaccine to experiencing a suspected side effect is not always provided by the reporter. We review all reports regardless of the time to onset from receiving a medicine or vaccine. All reports are fully evaluated by the MHRA to consider whether the vaccine (or medicine) may have caused the event, or whether the event is likely to be purely coincidental and due to underlying illness.
Further information about the MHRA’s pharmacovigilance strategy can be found here: https://www.gov.uk/government/publications/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance
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