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Research and analysis

Coronavirus (COVID-19) vaccines adverse reactions

A report covering adverse reactions to approved COVID-19 vaccines

Documents

Coronavirus vaccine - summary of Yellow Card reporting

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ARCHIVED - Coronavirus vaccine - summary of Yellow Card reporting

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If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Details

This report covers the period up to and including 22 February for COVID-19 vaccines used from the beginning of Autumn 2022.

The Commission on Human Medicine (CHM) has advised that given the end of the Autumn 2022 booster campaign and the stable safety profile of the COVID-19 vaccines, the MHRA should transition to routine data publication and communication of safety concerns for COVID-19 vaccines. The report published 8 March 2023 is therefore the last regular publication of the Summary of Yellow Card reporting for COVID-19 vaccines.

Robust safety monitoring and surveillance of any COVID-19 vaccines used in the UK will continue along with timely communication on any updated safety advice when needed. Additionally, monthly updates of Adverse Drug Reaction (ADR) data will continue with the new interactive COVID-19 vaccine reports.

We would ask anyone who suspects they have experienced a side effect linked with their COVID-19 vaccine to report via the Yellow Card website.

The MHRA has played an active role in responding to the coronavirus pandemic. In relation to COVID-19 vaccines, the MHRA has authorised their supply following a rigorous review of their safety, quality and efficacy. The clinical trials of COVID-19 vaccines have shown them to be effective and acceptably safe; however, as part of its statutory functions, the MHRA is responsible for monitoring these vaccines on an ongoing basis to ensure their benefits continue to outweigh any risks.

This is a requirement for all authorised medicines and vaccines in the UK. This monitoring strategy is continuous, proactive and based on a wide range of information sources, with a dedicated team of scientists reviewing information to look for safety issues or unexpected rare events.

This report summarises information received via the Yellow Card scheme and includes other safety investigations carried out by the MHRA under the COVID-19 Vaccine Surveillance Strategy.

In January 2023, the MHRA revised the format of the Summary of Yellow Card reporting to focus on the COVID-19 vaccines administered from the beginning of the Autumn 2022 booster campaign. This page provides an archived version of the report published in December 2022 as a record of the reporting for the monovalent vaccines used in the previous primary and initial booster campaign.

Since December 2022, COVID-19 vaccine reports replaced the previous Vaccine Analysis Prints (VAPs). The VAPs associated with the December 2022 report (data up to and including 23 November 2022) remain available in the PDF version.

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