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Adverse events after first and second doses of COVID-19 vaccination in England: a national vaccine surveillance platform self-controlled case series study

Ruby SM Tsang, Utkarsh Agrawal Orcid Logo, Mark Joy, Rachel Byford, Chris Robertson, Sneha N Anand, William Hinton, Nikhil Mayor Orcid Logo, Debasish Kar, John Williams, William Victor, Ashley Akbari Orcid Logo, Declan T Bradley, Siobhan Murphy, Dermot O’Reilly, Rhiannon Owen Orcid Logo, Antony Chuter, Jillian Beggs, Gary Howsam Orcid Logo, Aziz Sheikh, FD Richard Hobbs, Simon de Lusignan

Journal of the Royal Society of Medicine

Swansea University Authors: Ashley Akbari Orcid Logo, Rhiannon Owen Orcid Logo

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DOI (Published version): 10.1177/01410768231205430

Abstract

Objectives: To estimate the incidence of adverse events of interest (AEIs) after receiving their first and second doses of coronavirus disease 2019 (COVID-19) vaccinations, and to report the safety profile differences between the different COVID-19 vaccines. Design: We used a self-controlled case se...

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Published in: Journal of the Royal Society of Medicine
ISSN: 0141-0768 1758-1095
Published: SAGE Publications 2023
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URI: https://cronfa.swan.ac.uk/Record/cronfa65099
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Design: We used a self-controlled case series design to estimate the relative incidence (RI) of AEIs reported to the Oxford-Royal College of General Practitioners national sentinel network. We compared the AEIs that occurred seven days before and after receiving the COVID-19 vaccinations to background levels between 1 October 2020 and 12 September 2021. Setting: England, UK. Participants: Individuals experiencing AEIs after receiving first and second doses of COVID-19 vaccines. Main outcome measures: AEIs determined based on events reported in clinical trials and in primary care during post-license surveillance. Results: A total of 7,952,861 individuals were vaccinated with COVID-19 vaccines within the study period. Among them, 781,200 individuals (9.82%) presented to general practice with 1,482,273 AEIs. Within the first seven days post-vaccination, 4.85% of all the AEIs were reported. There was a 3–7% decrease in the overall RI of AEIs in the seven days after receiving both doses of Pfizer-BioNTech BNT162b2 (RI = 0.93; 95% CI: 0.91–0.94) and 0.96; 95% CI: 0.94–0.98), respectively) and Oxford-AstraZeneca ChAdOx1 (RI = 0.97; 95% CI: 0.95–0.98) for both doses), but a 20% increase after receiving the first dose of Moderna mRNA-1273 (RI = 1.20; 95% CI: 1.00–1.44)). Conclusions: COVID-19 vaccines are associated with a small decrease in the incidence of medically attended AEIs. Sentinel networks could routinely report common AEI rates, which could contribute to reporting vaccine safety.</abstract><type>Journal Article</type><journal>Journal of the Royal Society of Medicine</journal><volume/><journalNumber/><paginationStart/><paginationEnd/><publisher>SAGE Publications</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint>0141-0768</issnPrint><issnElectronic>1758-1095</issnElectronic><keywords>Epidemiology, public health, vaccination programmes</keywords><publishedDay>3</publishedDay><publishedMonth>11</publishedMonth><publishedYear>2023</publishedYear><publishedDate>2023-11-03</publishedDate><doi>10.1177/01410768231205430</doi><url>http://dx.doi.org/10.1177/01410768231205430</url><notes/><college>COLLEGE NANME</college><department>Health Data Science</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>HDAT</DepartmentCode><institution>Swansea University</institution><apcterm/><funders>This study was part of the Data and Connectivity National Core Study (DaCVaP, led by Prof Sir Aziz Sheikh at Edinburgh. 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spelling v2 65099 2023-11-25 Adverse events after first and second doses of COVID-19 vaccination in England: a national vaccine surveillance platform self-controlled case series study aa1b025ec0243f708bb5eb0a93d6fb52 0000-0003-0814-0801 Ashley Akbari Ashley Akbari true false 0d30aa00eef6528f763a1e1589f703ec 0000-0001-5977-376X Rhiannon Owen Rhiannon Owen true false 2023-11-25 HDAT Objectives: To estimate the incidence of adverse events of interest (AEIs) after receiving their first and second doses of coronavirus disease 2019 (COVID-19) vaccinations, and to report the safety profile differences between the different COVID-19 vaccines. Design: We used a self-controlled case series design to estimate the relative incidence (RI) of AEIs reported to the Oxford-Royal College of General Practitioners national sentinel network. We compared the AEIs that occurred seven days before and after receiving the COVID-19 vaccinations to background levels between 1 October 2020 and 12 September 2021. Setting: England, UK. Participants: Individuals experiencing AEIs after receiving first and second doses of COVID-19 vaccines. Main outcome measures: AEIs determined based on events reported in clinical trials and in primary care during post-license surveillance. Results: A total of 7,952,861 individuals were vaccinated with COVID-19 vaccines within the study period. Among them, 781,200 individuals (9.82%) presented to general practice with 1,482,273 AEIs. Within the first seven days post-vaccination, 4.85% of all the AEIs were reported. There was a 3–7% decrease in the overall RI of AEIs in the seven days after receiving both doses of Pfizer-BioNTech BNT162b2 (RI = 0.93; 95% CI: 0.91–0.94) and 0.96; 95% CI: 0.94–0.98), respectively) and Oxford-AstraZeneca ChAdOx1 (RI = 0.97; 95% CI: 0.95–0.98) for both doses), but a 20% increase after receiving the first dose of Moderna mRNA-1273 (RI = 1.20; 95% CI: 1.00–1.44)). Conclusions: COVID-19 vaccines are associated with a small decrease in the incidence of medically attended AEIs. Sentinel networks could routinely report common AEI rates, which could contribute to reporting vaccine safety. Journal Article Journal of the Royal Society of Medicine SAGE Publications 0141-0768 1758-1095 Epidemiology, public health, vaccination programmes 3 11 2023 2023-11-03 10.1177/01410768231205430 http://dx.doi.org/10.1177/01410768231205430 COLLEGE NANME Health Data Science COLLEGE CODE HDAT Swansea University This study was part of the Data and Connectivity National Core Study (DaCVaP, led by Prof Sir Aziz Sheikh at Edinburgh. This was funding created for studies as part of the UK response to the COVID-19 pandemic and funded by Health Data Research UK in partnership with the Office for National Statistics and funded by UK Research and Innovation (grant ref MC_PC_20029, MC_PC_20058). 2023-12-21T16:10:55.1178474 2023-11-25T15:42:42.5655902 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Health Data Science Ruby SM Tsang 1 Utkarsh Agrawal 0000-0001-5181-6120 2 Mark Joy 3 Rachel Byford 4 Chris Robertson 5 Sneha N Anand 6 William Hinton 7 Nikhil Mayor 0000-0003-2681-2501 8 Debasish Kar 9 John Williams 10 William Victor 11 Ashley Akbari 0000-0003-0814-0801 12 Declan T Bradley 13 Siobhan Murphy 14 Dermot O’Reilly 15 Rhiannon Owen 0000-0001-5977-376X 16 Antony Chuter 17 Jillian Beggs 18 Gary Howsam 0000-0001-6699-5504 19 Aziz Sheikh 20 FD Richard Hobbs 21 Simon de Lusignan 22 65099__29293__bb8c362f799347be9de2baaa734a615d.pdf 65099.VOR.pdf 2023-12-19T15:39:19.4463255 Output 783241 application/pdf Version of Record true Distributed under the terms of a Creative Commons Attribution 4.0 International License (CC BY 4.0). true eng https://creativecommons.org/licenses/by/4.0/
title Adverse events after first and second doses of COVID-19 vaccination in England: a national vaccine surveillance platform self-controlled case series study
spellingShingle Adverse events after first and second doses of COVID-19 vaccination in England: a national vaccine surveillance platform self-controlled case series study
Ashley Akbari
Rhiannon Owen
title_short Adverse events after first and second doses of COVID-19 vaccination in England: a national vaccine surveillance platform self-controlled case series study
title_full Adverse events after first and second doses of COVID-19 vaccination in England: a national vaccine surveillance platform self-controlled case series study
title_fullStr Adverse events after first and second doses of COVID-19 vaccination in England: a national vaccine surveillance platform self-controlled case series study
title_full_unstemmed Adverse events after first and second doses of COVID-19 vaccination in England: a national vaccine surveillance platform self-controlled case series study
title_sort Adverse events after first and second doses of COVID-19 vaccination in England: a national vaccine surveillance platform self-controlled case series study
author_id_str_mv aa1b025ec0243f708bb5eb0a93d6fb52
0d30aa00eef6528f763a1e1589f703ec
author_id_fullname_str_mv aa1b025ec0243f708bb5eb0a93d6fb52_***_Ashley Akbari
0d30aa00eef6528f763a1e1589f703ec_***_Rhiannon Owen
author Ashley Akbari
Rhiannon Owen
author2 Ruby SM Tsang
Utkarsh Agrawal
Mark Joy
Rachel Byford
Chris Robertson
Sneha N Anand
William Hinton
Nikhil Mayor
Debasish Kar
John Williams
William Victor
Ashley Akbari
Declan T Bradley
Siobhan Murphy
Dermot O’Reilly
Rhiannon Owen
Antony Chuter
Jillian Beggs
Gary Howsam
Aziz Sheikh
FD Richard Hobbs
Simon de Lusignan
format Journal article
container_title Journal of the Royal Society of Medicine
publishDate 2023
institution Swansea University
issn 0141-0768
1758-1095
doi_str_mv 10.1177/01410768231205430
publisher SAGE Publications
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Health Data Science{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Health Data Science
url http://dx.doi.org/10.1177/01410768231205430
document_store_str 1
active_str 0
description Objectives: To estimate the incidence of adverse events of interest (AEIs) after receiving their first and second doses of coronavirus disease 2019 (COVID-19) vaccinations, and to report the safety profile differences between the different COVID-19 vaccines. Design: We used a self-controlled case series design to estimate the relative incidence (RI) of AEIs reported to the Oxford-Royal College of General Practitioners national sentinel network. We compared the AEIs that occurred seven days before and after receiving the COVID-19 vaccinations to background levels between 1 October 2020 and 12 September 2021. Setting: England, UK. Participants: Individuals experiencing AEIs after receiving first and second doses of COVID-19 vaccines. Main outcome measures: AEIs determined based on events reported in clinical trials and in primary care during post-license surveillance. Results: A total of 7,952,861 individuals were vaccinated with COVID-19 vaccines within the study period. Among them, 781,200 individuals (9.82%) presented to general practice with 1,482,273 AEIs. Within the first seven days post-vaccination, 4.85% of all the AEIs were reported. There was a 3–7% decrease in the overall RI of AEIs in the seven days after receiving both doses of Pfizer-BioNTech BNT162b2 (RI = 0.93; 95% CI: 0.91–0.94) and 0.96; 95% CI: 0.94–0.98), respectively) and Oxford-AstraZeneca ChAdOx1 (RI = 0.97; 95% CI: 0.95–0.98) for both doses), but a 20% increase after receiving the first dose of Moderna mRNA-1273 (RI = 1.20; 95% CI: 1.00–1.44)). Conclusions: COVID-19 vaccines are associated with a small decrease in the incidence of medically attended AEIs. Sentinel networks could routinely report common AEI rates, which could contribute to reporting vaccine safety.
published_date 2023-11-03T16:10:55Z
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