Freedom of Information request on weekly summary of Yellow Card reports for COVID-19 vaccines (FOI 21/932)
Published 25 February 2022
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-6-september-2021/freedom-of-information-request-on-weekly-summary-of-yellow-card-reports-for-covid-19-vaccines-foi-21932
10th September 2021
FOI 21/932
Dear
Thank you for your email dated 13 August where you requested tables 4, 5 and 6 of the previous weekly summary of Yellow Card reporting associated with the COVID-19 vaccinations.
During the pandemic, information is continually changing and the data on our website is updated on a weekly basis to reflect this. This is to ensure the most current and accurate data is readily available to the public. The latest summary of Yellow Card reporting on Coronavirus vaccine ADRs can be found here: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions. I recommend you check this weekly for the latest analysis and figures.
Please find attached Annex One which contains the following tables.
- Table 4: Number of suspected thrombo-embolic events with concurrent thrombocytopenia ADR reports received for the Oxford University/AstraZeneca vaccine in the UK
- Table 5: number of UK suspected thrombo-embolic events with concurrent thrombocytopenia ADR reports received for the COVID-19 Vaccine AstraZeneca by patient age
- Table 6: Number of UK suspected thrombo-embolic events with concurrent thrombocytopenia ADR reports received for the Oxford University/AstraZeneca vaccineCOVID-19 Vaccine AstraZeneca by patient sex.
Please note that dates provided in Annex One refer to the data lock point of the data rather than the publication date. Table 4 was introduced into the weekly summary on the 5th April 2021, tables 5 and 6 were introduced into the weekly summary on the 21st April 2021.
Additionally, week on week in the tables there is slight fluctuation in the report numbers, this is due to several reasons. Firstly, reports are routinely followed up by the MHRA where additional information is required to aid in the assessment of a case or signal detection activities. The MHRA takes all reports very seriously and every report is fully evaluated by the MHRA and kept under continual review. We follow-up all fatalities, where permission has been provided to do so, for further information, including post-mortem details if available. Follow-up information to a case can also be received spontaneously. In some cases, the information and updated data provided in these follow-ups can change the nature of the case and require it to be reclassified. Secondly, due to high reporting volumes the MHRA sometimes receives multiple reports of the same case from different reporters (for example a family member and a healthcare professional both separately reporting the same fatality). When these cases are picked up by us through our regular monitoring processes, we have a responsibility to merge these cases into one.
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