Freedom of Information request (FOI 22/868)
Published 17 January 2024
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FOI 22/868
31st August 2022
Dear
Thank you for your email dated 3rd August 2022, where you requested the following:
1. Can you specify the total amount of adverse reactions including deaths submitted to the Yellow Card scheme for all COVID-19 vaccines administered in Scotland from 8th December 2020 - August 2022?
2. What is the estimated rate of under-reporting to the Yellow Card scheme?
Between 08/12/2020 and 15/08/2022 inclusive, the MHRA has received 33,952 UK spontaneous suspected Adverse Drug Reaction (ADR) reports (Yellow Cards) associated with COVID-19 vaccines directly from reporters in Scotland. Of the 33,952 reports, 179 are associated with a fatal outcome.
Please be aware that the above figures have been extracted based on the reporters’ postal codes. Hence, the accuracy of this data relies on the postcode being correctly provided in the original Yellow Card. Please also note that it is not mandatory to provide a postal address when submitting a Yellow Card to the MHRA. Therefore, if the postcode is not provided or if the reporter has only provided their email address, the report will not be included in these data. With this in mind, the data provided may not reflect the true incidence of reporting to the MHRA following COVID-19 vaccination from Scotland.
It is important to be aware that a report of a suspected ADR to the Yellow Card scheme does not necessarily mean that it was caused by the vaccine, only that the reporter has a suspicion it may have been. 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.
Further to your question on under-reporting, the MHRA does not hold the estimated rate of underreporting to the Yellow Card scheme as it is variable and unknown.
The total number and the nature of the majority of Yellow Cards received so far is not unusual for a new vaccine. Some historical studies have estimated only 10% of adverse drug reactions (ADRs) are reported; however, the reporting rate for spontaneous ADRs is variable and can depend on a multitude of factors, as it is influenced by public awareness and seriousness of events as well as publicity around usage. For COVID-19 vaccines, there is a higher than normal public awareness of the Yellow Card scheme and the reporting of suspected reactions; therefore, these estimates should not be used as indicators as we consider the reporting rate to be higher for these products. Please be assured we evaluate all aspects of the data, including the variability in levels of reporting, as part of our ongoing monitoring procedures.
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 embedded information about Yellow Card reporting into healthcare professionals’ training materials to enable us to rapidly identify new and emerging side effects. The general public has also been encouraged to report any suspected side effects to the vaccine to the MHRA via a Yellow Card on the recent televised press briefings and vaccination materials signpost individuals to the Coronavirus Yellow Card reporting site.
We publish our monthly summary of Yellow Card reporting to ensure the public is aware of what has been reported to the MHRA in association with the COVID-19 vaccines. The publication summarises information received via the Yellow Card scheme as well as other safety investigations we have carried out under the COVID-19 Vaccine Surveillance Strategy.
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