FOI release

Freedom of Information request on yellow card reports for COVID-19 vaccines (FOI 21/984)

Published 17 January 2022

17th September 2021

FOI 21/984

Dear

Thank you for your recent correspondence on the 23rd August whereby you requested:

• All Yellow Card reports from COVID-19 vaccinations for Guernsey in the Channel Islands.
• The number of suspected fatalities, in addition to the type of adverse reaction. Any other data you may have (i.e. age demographic, date reported etc.) would be much appreciated.

To provide some background, the MHRA works closely with the UK devolved administrations as well as the governments of the Channel Islands. All individuals receiving a vaccine are encouraged to report side effects to COVID-19 vaccines to the Yellow Card Scheme by the governments in these territories.

Following a search of our database up to and including 8th September 2021, I can confirm that the MHRA have received 287 spontaneous suspected Adverse Drug Reaction (ADR) reports associated with all COVID-19 vaccinations reported from Guernsey. Further to your request, of these 287 reports, 3 reports concern a fatal outcome suspected to be associated with COVID-19 vaccine administration.

The data included within this FOI response has been extracted based on reporter postal code. It is therefore important to note that the accuracy of this data relies on the postcode correctly being provided by the reporter in the original Yellow Card. The provision of postal addresses are not required to submit a valid report; reporters are required only to provide a contactable address which can be either an email address or postal address. If reporters only provided an email address, these will not have been included in this analysis. As the data has been extracted using available postal addresses only, it may not reflect the true incidence of reporting following COVID-19 vaccination reported from Guernsey. Please see Table 1 below for a breakdown of the number of reports received from Guernsey for each COVID-19 vaccine.

Table 1: UK Spontaneous suspected ADR reports received up to and including 8th September 2021, from Guernsey in association with COVID-19 vaccines.

Reported vaccine	Number of suspected ADR reports	Number of suspected fatal ADR reports
Pfizer/ BioNTech	121	1
Oxford University/ AstraZeneca	161	2
Moderna	4	0
Brand unspecified	1	0
Total	287	3

As detailed within Table 1, 2 of the 3 suspected fatal reports pertain to use of the COVID-19 vaccine AstraZeneca, and 1 report has been received where the suspected vaccine is COVID-19 Vaccine Pfizer/BioNTech. 2 of the reports with a fatal outcome occurred in male patients, with 1 report concerning a female patient. Where provided, age of the patient in these 3 cases ranged between 42 to 70 years old.

To note, the MHRA has not received any reports suspecting the use of the COVID-19 vaccine Moderna, or a report where vaccine brand has not been specified with a fatal outcome where the reporter has also provided a Guernsey postal address. The four ADR reports for Moderna noted above relate to cases of vaccination site reactions, muscle pain, joint pain, dizziness, fatigue, headache, fever and lip swelling and are mostly in line with those reactions seen within clinical trial data or listed within the product information. The one ADR report where the brand was not provided relates to a case of a tremor reaction ‘shaking’.

Further to your request, please find enclosed Vaccine Analysis Prints (VAPs) listing all the ADRs associated with the Pfizer/BioNTech COVID-19 vaccine and the Oxford/AstraZeneca COVID-19 vaccine from Guernsey, including those reported as the fatal reaction. A VAP guidance sheet is also enclosed which provides you with further information on how to interpret the print.

When considering the spontaneous ADR 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 vaccines are given in the UK alone, and when any vaccine is administered to very large numbers of people, some recipients will inevitably experience illness following vaccination. The fact that symptoms or events occur after use of a vaccine, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by the vaccine. 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. Therefore, Yellow Card data cannot be used to determine the incidence of a reaction or to compare the side effect profiles of different medicines or vaccines. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug or vaccine and may be stimulated by promotion and publicity about a drug. 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 takes all reports of fatal events in patients who have received a COVID-19 vaccine very seriously and every report with a fatal outcome is fully evaluated and kept under continual review. We follow up reports with a fatal outcome for further information, including post-mortem details if available. All details within a report are thoroughly assessed by a team of multidisciplinary medical and scientific assessors to consider whether the vaccine may have caused the event, or whether the event and fatal outcome were likely to be purely coincidental and due to underlying illness. We would like to reassure you that the information is thoroughly analysed for patterns or evidence which might suggest a causal link between vaccination and the death alongside data available from international sources, as well as the data being further considered by the Commission on Human Medicine and its Expert Advisory Groups. Any emerging evidence relating to possible risks associated with vaccines and medicines alike, are carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks were confirmed and communicated with the public with the upmost importance.

I would like to take this opportunity to draw your attention to the Coronavirus vaccine – weekly summary of Yellow Card reporting, which is updated weekly and available here. This document may be of use to you as contains details of all ADR reports pertaining to the COVID-19 vaccines received via the Yellow Card Scheme, as well as summaries of our assessment so far on particular safety topics surrounding the COVID-19 vaccinations and break, as well as some detail on patient demographics. Unfortunately, this data is not broken down by location, as per your initial request, but provides an overview of all reports received.

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 this response’s date and can be addressed to this email address.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division