FOI release

Freedom of Information request on deaths following vaccination (FOI 21/770)

Published 29 December 2021

7th July 2021

FOI 21/770

Dear

Thank you for your email, please also accept our apologies for the delay in responding to your request for information regarding the following:

• Total number of fatalities reported as potential reactions to all vaccines to the Yellow Card scheme each year
• Total number of over 18’s suffering fatal reactions to vaccines reported to the Yellow Card scheme each year

Further to your request, please see table 1 below which provides a breakdown of the total number of UK spontaneous suspected Adverse Drug Reaction (ADR) reports received for any vaccine received over the last 10 years between 01/01/2011 – 31/05/2021 and the number of those which were fatal in patients aged 18 years or over or where the age group selected by the reporter was adult or elderly. To note we have provided the data for the last 10 years to keep within cost and time exemptions.

It’s important to note whilst we encourage as much detail as possible for each Yellow Card report submitted to us, unfortunately the age of the patient may not always be provided by reporters.

Please note the table below excludes reports received for the COVID-19 vaccines as the information available on these vaccines is provided in the weekly summary of Yellow Card reporting which can be found here:

COVID-19 vaccines summary of Yellow Card reporting

As you will be aware, the COVID-19 vaccines have been given to millions of people in the UK and we have worked to ensure that people know to report suspected side effects to the Yellow Card scheme. In addition to social media campaigns, we have issued a Drug Safety Update, a press release, and run social media campaigns informing healthcare professionals and members of the public that reporting to the Coronavirus Yellow Card reporting site will help will enable the MHRA to rapidly identify new and emerging side effects. Vaccination materials have also signposted individuals to the Coronavirus Yellow Card reporting site.

Table 1: Total number of UK spontaneous suspected ADR reports received for all vaccines (excluding COVID-19 vaccines) per year.

Year	Total reports	Fatal reports	Fatal reports in patients 18+ years old
2011	2507	24	13
2012	1875	15	7
2013	2899	24	11
2014	2733	20	6
2015	3079	26	6
2016	3394	22	5
2017	3880	19	6
2018	3926	25	7
2019	3360	23	15
2020	2739	14	7
Up to and including 31/05/2021	2052	5	2

The MHRA takes all reports of fatal events in patients who have received any vaccine very seriously. Where these events are reported to us, we follow up to find out full 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. No new safety concerns related to the vaccine received have arisen from these fatal reports.

Vaccination and surveillance of large populations means that, by chance, some people will experience and report a new illness or events in the days and weeks after vaccination. It is therefore important that we carefully review these reports to distinguish possible side effects from illness that would have occurred irrespective of vaccination.

Please be aware underlying or previously undiagnosed illness unrelated to vaccination can also be factors in such reports. The relative number and nature of reports should therefore not be used to compare the safety of the different vaccines.

When considering spontaneous data, it is important to be aware of the following points:

• A reported reaction does not necessarily mean it has been caused by the vaccine, only that the reporter had a suspicion it may have. Each year, millions of doses of routine vaccinations are given in the UK alone, and when any vaccine is administered to large numbers of people, some recipients will inevitably experience illness following vaccination. The fact that symptoms occur after use of a vaccine or medicine, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by it. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.

• It is also important to note that the number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions and therefore cannot be used to determine the incidence of a reaction or compare the safety profile of different vaccines. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular medicine or vaccine, and may be stimulated by promotion and publicity. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time.

The MHRA continuously monitors the safety of vaccines through a variety of pharmacovigilance processes including the Yellow Card scheme. As part of our signal detection processes all adverse reaction reports received by the Yellow Card scheme are individually assessed and cumulative information reviewed at regular intervals. If appropriate, regulatory action would be taken if any serious risks were confirmed.

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