FOI release

Freedom of Information request (FOI 22/921)

Published 17 January 2024

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FOI 22/921

9th September 2022

Dear

Thank you for your emails where you requested access to Yellow Card data for reports of COVID-19 vaccines and inflammatory eye disease. You particularly asked for the following details:

  • Age and gender of reported patients
  • Which vaccine was involved
  • The time between vaccine administration and eye disorder
  • The type of inflammatory eye disease (Iritis, Uveitis, Panuveitis, Choroiditis, Chorioretinitis, Retinitis, Optic neuritis, Scleritis, Orbital, Myositis, Retinal Vasculitis)
  • Detailed information about the clinical presentations of the reported inflammatory eye disease

Please note that under the FOI act, we can only release FOI Category 1b data for Yellow Card data, which excludes any identifiable patient and reporter information and includes the following details:

  • Aggregated patient age
  • Aggregated patient sex (number of males and females)
  • Suspect drug(s)
  • Dose of the suspect drug
  • Route of administration
  • Duration of treatment
  • Suspected adverse drug reaction(s)
  • Outcome of reaction
  • Reaction onset times
  • Patient medical history
  • Year of receipt

Unfortunately, additional information regarding the clinical presentations within these cases falls outside Category 1b data. In instances like this, where enquirers would like more information on reported cases, a request to the Pharmacovigilance Expert Advisory Group (PEAG) would need to be made. Further information on how to request additional Yellow Card data can be found at https://www.gov.uk/government/organisations/commission-on-human-medicines/about/membership#pharmacovigilance-eag. Please note that there may be a cost associated with providing this information should your application be successful.

With the information provided above, please can you confirm if you would like us to complete a category 1b data extraction or if you will make an official request to PEAG for all the desired data.

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,

Safety and Surveillance

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