FOI release

Freedom of Information request about adverse drug reactions in Guernsey (FOI-21-449)

Published 28 June 2021

Thank you for your email dated 27th April 2021, where you asked for information on the following:

1. I would particularly be interested in knowing the vaccine adverse reactions reported from Guernsey residents. Would you have that further analysis available?

2. Is there any reason why our Guernsey health authorities would not be able to record the Guernsey-based vaccine adverse reactions reported directly by the local population, which our authorities could then report to you in total?

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. The best way to report to us is via our reporting website: https://coronavirus-yellowcard.mhra.gov.uk/ the reporting forms contain all the necessary questions needed in order for us to carry out assessment of the information we receive.

As per your request, I can confirm up to and including 13th May 2021 the MHRA have received 145 Adverse Drug Reaction (ADR) reports associated with all COVID-19 vaccinations from Guernsey. The accuracy of the data provided relies on the postcode being provided by the reporter on the original Yellow Card. Furthermore, if the postcode is incorrectly provided, the Yellow Card will not be included in this analysis. Also, if the reporter has only provided their email address, that report will not be included. Please see Table 1 below for a breakdown of the number of reports received from Guernsey for each COVID-19 vaccine. Please note, no reports were received regarding the COVID-19 Moderna vaccine.

Table 1: UK Spontaneous suspected ADR reports received up to and including 13th May 2021, from Guernsey in association with COVID-19 vaccines.

Reported vaccine	Number of suspected ADR report
Pfizer/ BioNTech	47
Oxford University/ AstraZeneca	97
Brand unspecified	1

Please find enclosed Drug Analysis Prints (DAPs) listing all the ADRs associated with the COVID-19 vaccinations from Guernsey. A DAP guidance sheet is also enclosed which provides you with further information on how to interpret the print. The one ADR report where the brand was not provided relates to a case of a tremor reaction ‘shaking’.

It is important to bear in mind the following points when interpreting Yellow Card data:

• Reports are also received by the MHRA from pharmaceutical companies who have a legal obligation to report serious suspected ADRs relating to their products. This information should only be used for education and promotion and not be used for audit purposes.

• Please be aware, the reporting of a particular reaction does not necessarily mean that it has been caused by a drug or vaccine. Many factors must be considered in assessing the relationship between a drug or vaccine and suspected reaction including the possible contribution of other drugs being taken, and the underlying disease.

• Furthermore, the number of reports received should not be used as a basis for determining incidence of a reaction as neither the total number of reactions occurring, nor the number of patients using a drug or vaccine is included in this data.

I hope the information provided is helpful, however 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