Freedom of Information Yellow Card Reporting System and how many of these deaths do you have histopathological analyzes of organs, specifically heart, lungs and lymph nodes (FOI 22/025)

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FAITH 22/025

January 24, 2022

Expensive,

Autoimmune type pathology following vaccination against COVID-19

Thank you for your email of December 31, 2021, in which you requested the following:

• To date, according to the yellow card reporting system, there have been 1,889 deaths from COVID-19 vaccinations. For how many of these deaths do you have histopathological analyzes of organs, including the heart, lungs and lymph nodes?

• What conclusion did you draw from your histopathology 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 COVID-19 vaccines have been administered in the UK, with over 80% of the population that received 2 doses. Also, it is not surprising that some people become naturally ill due to age or underlying conditions soon after being vaccinated, without the vaccine playing a role in this. The MHRA takes all reports of fatal events in patients who have received a COVID-19 vaccine very seriously. When these events are reported to us, we follow up to request details of the events and cause of death and, if applicable, additional information about any post-mortem findings. The information is thoroughly analyzed to look for patterns or evidence that might suggest a causal link between vaccination and death. All UK vaccination campaign reports undergo rigorous scientific assessment by the MHRA, alongside data from our public health partners and data available from international sources. If a safety issue arises, it is then reviewed by the Human Medicine Commission and its expert advisory groups. Review of specific fatal reports is provided in Coronavirus Vaccines – Summary of Yellow Card Reports.

The expected benefits of vaccines in preventing COVID-19 and serious complications associated with COVID-19 far exceed any currently known side effects. As with all vaccines and drugs, the safety of COVID-19 vaccines is continuously monitored, and the possible benefits and risks remain under review.

We have determined that the information you requested is exempt under Section 12 of the Freedom of Information Act and we can no longer process your request. Article 12 of the law allows public authorities to refuse requests when the cost of processing them would exceed the

appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 hours of work determining if the service has the information, locating, retrieving and extracting the information. It is not mandatory to provide clinical test/investigation results when submitting a yellow card report. In order to process your request, we would need to perform a manual review of all fatal reports and we consider this to take longer than 24 business hours.

I hope you find the information provided helpful, but if you are not satisfied with the handling of your request, you have the right to request an internal review. Requests for internal review must be submitted within two months of the date of this response; and can be sent to this e-mail address.

Cordially,

The FOI team,

Vigilance and Drug Risk Management DivisionFOI 22/025

January 24, 2022

Expensive,

Autoimmune type pathology following vaccination against COVID-19

Thank you for your email of December 31, 2021, in which you requested the following:

• To date, according to the yellow card reporting system, there have been 1,889 deaths from COVID-19 vaccinations. For how many of these deaths do you have histopathological analyzes of organs, including the heart, lungs and lymph nodes?

• What conclusion did you draw from your histopathology 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 COVID-19 vaccines have been administered in the UK, with over 80% of the population that received 2 doses. Also, it is not surprising that some people become naturally ill due to age or underlying conditions soon after being vaccinated, without the vaccine playing a role in this. The MHRA takes all reports of fatal events in patients who have received a COVID-19 vaccine very seriously. When these events are reported to us, we follow up to request details of the events and cause of death and, if applicable, additional information about any post-mortem findings. The information is thoroughly analyzed to look for patterns or evidence that might suggest a causal link between vaccination and death. All UK vaccination campaign reports undergo rigorous scientific assessment by the MHRA, alongside data from our public health partners and data available from international sources. If a safety issue arises, it is then reviewed by the Human Medicine Commission and its expert advisory groups. Review of specific fatal reports is provided in Coronavirus vaccines – summary of yellow card reports.

The expected benefits of vaccines in preventing COVID-19 and serious complications associated with COVID-19 far exceed any currently known side effects. As with all vaccines and drugs, the safety of COVID-19 vaccines is continuously monitored, and the possible benefits and risks remain under review.

We have determined that the information you requested is exempt under Section 12 of the Freedom of Information Act and we can no longer process your request. Article 12 of the law allows public authorities to refuse requests when the cost of processing them would exceed the

appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 hours of work determining if the service has the information, locating, retrieving and extracting the information. It is not mandatory to provide clinical test/investigation results when submitting a yellow card report. In order to process your request, we would need to perform a manual review of all fatal reports and we consider this to take longer than 24 business hours.

I hope you find the information provided helpful, but if you are not satisfied with the handling of your request, you have the right to request an internal review. Requests for internal review must be submitted within two months of the date of this response; and can be sent to this e-mail address.

Cordially,

The FOI team,

Drug Vigilance and Risk Management Division

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