Freedom of Information request about adverse drug reactions to COVID-19 vaccines in Northern Ireland (FOI-21-454)
Published 28 June 2021
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Thank you for your email dated 27th April 2021, where you requested:
“the statistics relating to adverse reactions to each of the vaccinations to protect against Covid-19 in Northern Ireland.”
I can confirm that as of the 31st March 2021, the MHRA have received 1465 Yellow Card reports associated with COVID-19 vaccinations from Northern Ireland, between the 8th December 2020 and 16th March 2021. A breakdown of these 1465 reports by brand where specified is given in Table 1.
1. Table 1: Suspected Adverse Drug Reaction (ADR) reports from Northern Ireland concerning COVID-19 vaccines received between the 8th December 2020-16th March 2021.
| Brand | Number of reports |
|---|---|
| Pfizer-BioNTech | 754 |
| Oxford AstraZeneca | 708 |
| Unspecified | 3 |
Please note totals may differ slightly compared to those included in the published data due to the date in which data was extracted and reports of suspected ADRs are held on a purpose designed pharmacovigilance database. The database upon which Yellow Card reports are stored is a dynamic and therefore these numbers are subject to fluctuations through processes such as the merging of duplicate ADR reports received.
It is important to bear in mind the following points when interpreting Yellow Card data:
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The attached data only includes ADR reports received directly from healthcare professionals or from patients, parents and carers. Reports are also received by the MHRA from pharmaceutical companies who have a legal obligation to report serious suspected ADRs relating to their products.
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Please be aware, the reporting of a particular reaction does not necessarily mean that it has been caused by a vaccine. Many factors must be considered in assessing the relationship between a vaccine and suspected reaction including the possible contribution of other drugs being taken, and the underlying disease.
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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 the drug is known.
I would like to reassure you that the MHRA keeps the safety of all medicines and vaccines, under close and continual review. Any emerging evidence relating to possible risks associated with medicines or vaccines would be carefully reviewed and, if appropriate, regulatory action would be taken, and communicated to healthcare professionals and patients alike.
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