Freedom of Information request about number and type of ADRs reported on COVID-19 vaccines via the yellow card scheme for the crown dependency of the Isle of Man (FOI-21-404)
Published 28 June 2021
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Thank you for your email dated 23 rd April 2021, where you asked for information on the following:
Number and type of ADRs reported on COVID-19 vaccines via the yellow card scheme for the crown dependency of the Isle of Man.
The MHRA works closely with the UK devolved administrations as well as the governments of the Crown Dependencies. 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.
As per your request, I can confirm up to and including 5th May 2021 that we have received 644 Adverse Drug Reaction (ADR) reports associated with all COVID-19 vaccinations from The Isle of Man. The total number of reports received from The Isle of Man are contained within the Coronavirus weekly summaries under England, however, are not currently routinely separated.
The accuracy of the data provided relies on the postcode being provided by the reporter on the original Yellow Card which is associated to the Isle of Man Health Authority. 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 find enclosed Drug Analysis Prints (DAPs) listing all the ADRs associated with the COVID-19 vaccinations from the Isle of Man. Please note, no reports were received regarding the COVID-19 Moderna vaccine therefore the two DAPs correspond to the COVID-19 Pfizer and AstraZeneca vaccines, respectively. A DAP guidance sheet is also enclosed which provides you with further information on how to interpret the print.
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