Freedom of Information request on a weekly summary of Yellow Card reporting which summarises information received via the Yellow Card scheme and includes events with a fatal outcome (FOI 22/399)
Published 31 May 2022
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FOI 22/399
2nd February 2022
Dear,
Thank you for your FOI request dated 20th January 2022.
The MHRA is responsible for monitoring the COVID-19 vaccines on an ongoing basis to ensure their benefits continue to outweigh any risks. This is a requirement for all authorised medicines and vaccines in the UK. This monitoring strategy is continuous, proactive and based on a wide range of information sources, with a dedicated team of scientists reviewing information daily to look for safety issues or unexpected rare events. All reports with a fatal outcome are fully and continuously evaluated by the MHRA. We publish a weekly summary of Yellow Card reporting which summarises information received via the Yellow Card scheme and includes events with a fatal outcome. This summary specifies the number of reports in which the patient died shortly after vaccination for each COVID-19 vaccine and is updated on a weekly basis.
When reviewing all of the data received via the Yellow Card Scheme, it is important to note that just because a Yellow Card has been submitted reporting a suspected adverse reaction to the vaccine, it does not necessarily mean that the vaccine caused the reaction. Vaccination and surveillance of large populations means that, by chance, some people will experience and report a new illness or events (including events with a fatal outcome) in the days and weeks after vaccination. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.
Reports received via the Yellow Card Scheme are spontaneous suspected adverse reactions, therefore the reporter only requires a suspicion that the vaccine caused the adverse event. Whilst we evaluate every report, we do not assign each fatal report a category to determine if the death was caused by the vaccine.
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 DivisionFOI 22/399
2nd February 2022
Dear,
Thank you for your FOI request dated 20th January 2022.
The MHRA is responsible for monitoring the COVID-19 vaccines on an ongoing basis to ensure their benefits continue to outweigh any risks. This is a requirement for all authorised medicines and vaccines in the UK. This monitoring strategy is continuous, proactive and based on a wide range of information sources, with a dedicated team of scientists reviewing information daily to look for safety issues or unexpected rare events. All reports with a fatal outcome are fully and continuously evaluated by the MHRA. We publish a weekly summary of Yellow Card reporting which summarises information received via the Yellow Card scheme and includes events with a fatal outcome. This summary specifies the number of reports in which the patient died shortly after vaccination for each COVID-19 vaccine and is updated on a weekly basis.
When reviewing all of the data received via the Yellow Card Scheme, it is important to note that just because a Yellow Card has been submitted reporting a suspected adverse reaction to the vaccine, it does not necessarily mean that the vaccine caused the reaction. Vaccination and surveillance of large populations means that, by chance, some people will experience and report a new illness or events (including events with a fatal outcome) in the days and weeks after vaccination. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.
Reports received via the Yellow Card Scheme are spontaneous suspected adverse reactions, therefore the reporter only requires a suspicion that the vaccine caused the adverse event. Whilst we evaluate every report, we do not assign each fatal report a category to determine if the death was caused by the vaccine.
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