Freedom of Information onthe Yellow Card reporting system and how many of these deaths do you have histopathological analyses of organs, particularly heart, lung and lymph nodes (FOI 22/025)
Published 31 May 2022
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FOI 22/025
24th January 2022
Dear,
Auto-immune like pathology following vaccination for COVID-19
Thank you of your email dated 31st December 2021, where you requested the following:
• To date, according to the Yellow Card reporting system, there have been 1889 deaths following COVID-19 vaccinations. For how many of these deaths do you have histopathological analyses of organs, particularly heart, lung and lymph nodes?
• What conclusion have you drawn from your histopathological analyses regarding cause of death and vaccine safety?
When considering the number of Yellow Card reports with a fatal outcome, it should be noted that over 130 million doses of vaccines against COVID-19 have been administered in the UK, with over 80% of the population having received 2 doses. In addition to this, it is not unexpected that some people may naturally fall ill due to their age or underlying conditions shortly after being vaccinated, without the vaccine playing any role in that. The MHRA takes all reports of fatal events in patients who have received a COVID-19 vaccine very seriously. Where these events are reported to us, we follow up to request details of the events and the cause of death and, where applicable, further information of any post-mortem findings. The information is thoroughly analysed for patterns or evidence which might suggest a causal link between the vaccination and the death. All reports from the UK vaccination campaign undergo robust scientific evaluation by the MHRA alongside data from our public health partners and that available from international sources. If a safety concern arises this is further considered by the Commission on Human Medicine and its Expert Advisory Groups. Review of specific fatal reports is provided in the Coronavirus Vaccines - summary of Yellow Card reporting.
The expected benefits of the vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known side effects. As with all vaccines and medicines, the safety of COVID-19 vaccines is continuously monitored, and benefits and possible risks remain under review.
We have determined that the information you have requested is exempt under Section 12 of the Freedom of Information Act and we cannot process your request any further. Section 12 of the Act allows public authorities to 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. It is not mandatory to provide the results of tests/clinical investigations when submitting a Yellow Card report. In order to process your request, we would need to conduct a manual review all the fatal reports and we consider that this would take longer than 24 working hours to complete.
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 22/025
24th January 2022
Dear,
Auto-immune like pathology following vaccination for COVID-19
Thank you of your email dated 31st December 2021, where you requested the following:
• To date, according to the Yellow Card reporting system, there have been 1889 deaths following COVID-19 vaccinations. For how many of these deaths do you have histopathological analyses of organs, particularly heart, lung and lymph nodes?
• What conclusion have you drawn from your histopathological analyses regarding cause of death and vaccine safety?
When considering the number of Yellow Card reports with a fatal outcome, it should be noted that over 130 million doses of vaccines against COVID-19 have been administered in the UK, with over 80% of the population having received 2 doses. In addition to this, it is not unexpected that some people may naturally fall ill due to their age or underlying conditions shortly after being vaccinated, without the vaccine playing any role in that. The MHRA takes all reports of fatal events in patients who have received a COVID-19 vaccine very seriously. Where these events are reported to us, we follow up to request details of the events and the cause of death and, where applicable, further information of any post-mortem findings. The information is thoroughly analysed for patterns or evidence which might suggest a causal link between the vaccination and the death. All reports from the UK vaccination campaign undergo robust scientific evaluation by the MHRA alongside data from our public health partners and that available from international sources. If a safety concern arises this is further considered by the Commission on Human Medicine and its Expert Advisory Groups. Review of specific fatal reports is provided in the Coronavirus Vaccines - summary of Yellow Card reporting.
The expected benefits of the vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known side effects. As with all vaccines and medicines, the safety of COVID-19 vaccines is continuously monitored, and benefits and possible risks remain under review.
We have determined that the information you have requested is exempt under Section 12 of the Freedom of Information Act and we cannot process your request any further. Section 12 of the Act allows public authorities to 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. It is not mandatory to provide the results of tests/clinical investigations when submitting a Yellow Card report. In order to process your request, we would need to conduct a manual review all the fatal reports and we consider that this would take longer than 24 working hours to complete.
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