MHRA - Medicines and Healthcare products Regulatory Agency

03/08/2023 | Press release | Distributed by Public on 03/08/2023 04:29

Coronavirus (COVID-19) vaccines adverse reactions

Research and analysis

Coronavirus (COVID-19) vaccines adverse reactions

A report covering adverse reactions to approved COVID-19 vaccines

From:Medicines and Healthcare products Regulatory AgencyPublished5 February 2021Last updated 8 March 2023 - See all updates
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Documents

Coronavirus vaccine - summary of Yellow Card reporting

PDF, 401 KB, 28 pages

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ARCHIVED - Coronavirus vaccine - summary of Yellow Card reporting

PDF, 680 KB, 49 pages

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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.

Published 5 February 2021
Last updated 8 March 2023 + show all updates
  1. 8 March 2023

    The Coronavirus - Summary of Yellow Card reporting was updated to include data up to and including 22 February 2023.

  2. 3 February 2023

    The Coronavirus - Summary of Yellow Card reporting was updated to include data up to 25 January 2023

  3. 13 January 2023

    The Coronavirus - Summary of Yellow Card reporting was updated to include data up to and including 28 December 2022.

  4. 21 December 2022

    The MHRA has begun implementing a new enhanced format of data visualisations. This enables us to provide improvements in format, accessibility and data protection, while also providing more data than has been published previously. From December 2022, COVID-19 vaccine reports will replace the previous Vaccine Analysis Prints (VAPs). The links below have been updated to link to the new COVID-19 vaccine reports. The VAPs associated with the December 2022 report (data up to and including 23/11/22) remain available in the PDF version.

  5. 1 December 2022

    The Coronavirus - Summary of Yellow Card reporting was updated to include data up to 23 November 2022.

  6. 3 November 2022

    The Coronavirus - Summary of Yellow Card reporting was updated to include data up to 26 October 2022.

  7. 7 October 2022

    The Coronavirus - Summary of Yellow Card reporting was updated to include data up to 28 September 2022.

  8. 1 September 2022

    Updated to include data up to and including 24 August 2022.

  9. 4 August 2022

    ADR report - August 2022 published.

  10. 25 July 2022

    Following publication on 22 July 2022, inconsistencies were noted between the html and pdf versions for tables 1 and 2 of the report. On 25 July 2022, data in table 1 and 2 published on the html webpage were corrected. No changes were made to the PDF report and this data remains correct.

  11. 22 July 2022

    Updated to include data up to and including 13 July 2022.

  12. 7 July 2022

    Updated to include data up to and including 29 June 2022.

  13. 24 June 2022

    The summary has been updated to include data up to 15 June 2022.

  14. 17 June 2022

    The summary has been updated to include data up to 8 June 2022.

  15. 1 June 2022

    The summary has been updated to include data up to 25 May 2022.

  16. 26 May 2022

    The summary has been updated to include data up to 18 May 2022.

  17. 19 May 2022

    The summary has been updated to include data up to 11 May 2022.

  18. 13 May 2022

    The summary has been updated to include data up to 4 May 2022.

  19. 28 April 2022

    Updated figures to 20 April 2022

  20. 14 April 2022

    The weekly summary has been updated to include data up to 6 April 2022.

  21. 7 April 2022

    The weekly summary has been updated to include data up to 30 March.

  22. 31 March 2022

    New edition for 31 March 2022.

  23. 25 March 2022

    New edition for 24 March 2022

  24. 17 March 2022

    Weekly update

  25. 10 March 2022

    Updating the weekly report to include figures up to and including 2 March 2022.

  26. 3 March 2022

    The summary of Yellow Card reporting has been updated to reflect reports up to and including 23 February 2022.

  27. 24 February 2022

    Updated stats up to 16 February 2022

  28. 17 February 2022

    Updated to include data up to 9 February 2022

  29. 10 February 2022

    Weekly update

  30. 3 February 2022

    New edition for 3 February 2022

  31. 27 January 2022

    Weekly reports added for 19 Jan 22

  32. 20 January 2022

    Updated with weekly figures

  33. 13 January 2022

    Weekly figures updated

  34. 6 January 2022

    Updated the report to include data up to and including 22 December 2021.

  35. 24 December 2021

    Updated to include data up to 15 December

  36. 16 December 2021

    Updated to include figures up to 8 December 2021

  37. 9 December 2021

    Updated to include data up to 1 December 2021

  38. 2 December 2021

    New edition for 2 December 2021

  39. 26 November 2021

    Summary of Yellow Card reporting updated to include figures up to and including 17 nov

  40. 19 November 2021

    Updated with figures up to and including 10 November 2021

  41. 11 November 2021

    Updated with figures up to and including 3 November 2021

  42. 4 November 2021

    Weekly update to adverse reactions to COVID-19 vaccines.

  43. 28 October 2021

    Weekly report updated to include data up to and including 20 October 2021

  44. 21 October 2021

    Updated to include reports up to and including 13 October

  45. 14 October 2021

    Updated with figures up to 6 October 2021

  46. 7 October 2021

    A weekly update covering adverse reactions to approved COVID-19 vaccines.

  47. 30 September 2021

    Updates to the weekly summary of adverse reactions.

  48. 23 September 2021

    Updated figures up to and including 15 September

  49. 16 September 2021

    Updated the report to include data up to and including 8 September 2021.

  50. 9 September 2021

    Updated the ADR report to include data up to 1 September 2021

  51. 2 September 2021

    Updated the weekly ADR report to cover the period from 9 December 2020 to 25 August 2021.

  52. 26 August 2021

    Updated the ADR report with figures up to and including 18 August.

  53. 19 August 2021

    Updated the report to include information up to and including 11 August

  54. 13 August 2021

    Updated with figures to 4 August 2021

  55. 6 August 2021

    Updated with figures for up to 28 July 2021

  56. 30 July 2021

    Updated report with figures up to and including 21 July

  57. 22 July 2021

    Updated weekly report published with figures up to and including 14 July

  58. 16 July 2021

    Updated with figures up to 7 July 2021

  59. 9 July 2021

    Updates for ADR's summary up to 30 June 2021.

  60. 1 July 2021

    Updated to include new data up to 23 June 2021.

  61. 24 June 2021

    Updated to include new data up to 16 June 2021.

  62. 17 June 2021

    New weekly summary of Yellow Card reporting for Coronavirus Vaccines with data until 9 June 2021

  63. 10 June 2021

    Updated to include new data up to 2 June 2021.

  64. 3 June 2021

    Updated to include new data up to 26 May 2021.

  65. 27 May 2021

    Updated to include new data up to 19 May 2021.

  66. 20 May 2021

    Updated to include new data up to 12 May 2021.

  67. 13 May 2021

    Updated to include new data up to 5 May 2021.

  68. 6 May 2021

    Updated to include new data up to 28 April 2021.

  69. 29 April 2021

    Updated to include new data up to 21 April 2021.

  70. 22 April 2021

    We have uploaded the updated weekly summary of Yellow Card reporting on Coronavirus vaccines' ADRs

  71. 15 April 2021

    Updated to include new data up to 5 April 2021.

  72. 8 April 2021

    Updated to include new data up to 28 March 2021.

  73. 1 April 2021

    Updated to include new data up to 21 March.

  74. 25 March 2021

    Updated to include new data up to 14 March.

  75. 18 March 2021

    Published latest ADR (adverse drug reaction) weekly report and iDAPs, covering the period up to 7 March 2021.

  76. 11 March 2021

    Updated pages and PDF attachments to include data from 9 December 2020 to 28 February 2021.

  77. 4 March 2021

    Published updated report with data to 21 February 2021

  78. 25 February 2021

    Published latest ADR (adverse drug reaction) data, covering the period up to 14 February 2021.

  79. 18 February 2021

    Published latest ADR (adverse drug reaction) data, covering the period up to 7 February 2021.

  80. 11 February 2021

    Published latest ADR (adverse drug reaction) data, covering the period up to 31 January 2021.

  81. 5 February 2021

    First published.

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