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Adverse events following first and second dose COVID-19 vaccination in England, October 2020 to September 2021: a national vaccine surveillance platform self-controlled case series study

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

Eurosurveillance, Volume: 28, Issue: 3

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

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DOI (Published version): 10.2807/1560-7917.es.2023.28.3.2200195

Abstract

BackgroundPost-authorisation vaccine safety surveillance is well established for reporting common adverse events of interest (AEIs) following influenza vaccines, but not for COVID-19 vaccines.AimTo estimate the incidence of AEIs presenting to primary care following COVID-19 vaccination in England, a...

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Published in: Eurosurveillance
ISSN: 1560-7917
Published: European Centre for Disease Control and Prevention (ECDC) 2023
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URI: https://cronfa.swan.ac.uk/Record/cronfa62389
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fullrecord <?xml version="1.0"?><rfc1807><datestamp>2023-02-16T10:12:34.7142969</datestamp><bib-version>v2</bib-version><id>62389</id><entry>2023-01-21</entry><title>Adverse events following first and second dose COVID-19 vaccination in England, October 2020 to September 2021: a national vaccine surveillance platform self-controlled case series study</title><swanseaauthors><author><sid>aa1b025ec0243f708bb5eb0a93d6fb52</sid><ORCID>0000-0003-0814-0801</ORCID><firstname>Ashley</firstname><surname>Akbari</surname><name>Ashley Akbari</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>0d30aa00eef6528f763a1e1589f703ec</sid><ORCID>0000-0001-5977-376X</ORCID><firstname>Rhiannon</firstname><surname>Owen</surname><name>Rhiannon Owen</name><active>true</active><ethesisStudent>false</ethesisStudent></author></swanseaauthors><date>2023-01-21</date><deptcode>HDAT</deptcode><abstract>BackgroundPost-authorisation vaccine safety surveillance is well established for reporting common adverse events of interest (AEIs) following influenza vaccines, but not for COVID-19 vaccines.AimTo estimate the incidence of AEIs presenting to primary care following COVID-19 vaccination in England, and report safety profile differences between vaccine brands.MethodsWe used a self-controlled case series design to estimate relative incidence (RI) of AEIs reported to the national sentinel network, the Oxford-Royal College of General Practitioners Clinical Informatics Digital Hub. We compared AEIs (overall and by clinical category) 7 days pre- and post-vaccination to background levels between 1 October 2020 and 12 September 2021.ResultsWithin 7,952,861 records, 781,200 individuals (9.82%) presented to general practice with 1,482,273 AEIs, 4.85% within 7 days post-vaccination. Overall, medically attended AEIs decreased post-vaccination against background levels. There was a 3&#x2013;7% decrease in incidence within 7 days after both doses of Comirnaty (RI: 0.93; 95% CI: 0.91&#x2013;0.94 and RI: 0.96; 95% CI: 0.94&#x2013;0.98, respectively) and Vaxzevria (RI: 0.97; 95% CI: 0.95&#x2013;0.98). A 20% increase was observed after one dose of Spikevax (RI:&#x2009;1.20; 95% CI: 1.00&#x2013;1.44). Fewer AEIs were reported as age increased. Types of AEIs, e.g. increased neurological and psychiatric conditions, varied between brands following two doses of Comirnaty (RI: 1.41; 95% CI: 1.28&#x2013;1.56) and Vaxzevria (RI: 1.07; 95% CI: 0.97&#x2013;1.78).ConclusionCOVID-19 vaccines are associated with a small decrease in medically attended AEI incidence. Sentinel networks could routinely report common AEI rates, contributing to reporting vaccine safety.</abstract><type>Journal Article</type><journal>Eurosurveillance</journal><volume>28</volume><journalNumber>3</journalNumber><paginationStart/><paginationEnd/><publisher>European Centre for Disease Control and Prevention (ECDC)</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint>1560-7917</issnPrint><issnElectronic/><keywords/><publishedDay>19</publishedDay><publishedMonth>1</publishedMonth><publishedYear>2023</publishedYear><publishedDate>2023-01-19</publishedDate><doi>10.2807/1560-7917.es.2023.28.3.2200195</doi><url/><notes>Data sharing statement:The statistical analysis plan, R scripts used for the analysis, and meta-data are available upon request. The data that support the findings of this study are not publicly available because they are based on pseudonymised sentinel network clinical records. These data are, however, available by application via ORCHID. The terminology lists for the variables are available in Supplementary Table S1.</notes><college>COLLEGE NANME</college><department>Health Data Science</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>HDAT</DepartmentCode><institution>Swansea University</institution><apcterm/><funders>UK Research and Innovation (grant ref MC_PC_20029, MC_PC_20058).</funders><projectreference/><lastEdited>2023-02-16T10:12:34.7142969</lastEdited><Created>2023-01-21T13:55:26.3202321</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">Swansea University Medical School - Health Data Science</level></path><authors><author><firstname>Ruby SM</firstname><surname>Tsang</surname><orcid>0000-0002-2520-526x</orcid><order>1</order></author><author><firstname>Mark</firstname><surname>Joy</surname><orcid>0000-0002-4974-3724</orcid><order>2</order></author><author><firstname>Rachel</firstname><surname>Byford</surname><orcid>0000-0002-4792-8995</orcid><order>3</order></author><author><firstname>Chris</firstname><surname>Robertson</surname><orcid>0000-0001-6848-5241</orcid><order>4</order></author><author><firstname>Sneha N</firstname><surname>Anand</surname><orcid>0000-0002-0538-3974</orcid><order>5</order></author><author><firstname>William</firstname><surname>Hinton</surname><orcid>0000-0003-4927-0901</orcid><order>6</order></author><author><firstname>Nikhil</firstname><surname>Mayor</surname><orcid>0000-0003-2681-2501</orcid><order>7</order></author><author><firstname>Debasish</firstname><surname>Kar</surname><orcid>0000-0002-1524-1312</orcid><order>8</order></author><author><firstname>John</firstname><surname>Williams</surname><orcid>0000-0002-6118-0434</orcid><order>9</order></author><author><firstname>William</firstname><surname>Victor</surname><orcid>0000-0003-3660-6517</orcid><order>10</order></author><author><firstname>Ashley</firstname><surname>Akbari</surname><orcid>0000-0003-0814-0801</orcid><order>11</order></author><author><firstname>Declan T</firstname><surname>Bradley</surname><orcid>0000-0003-1468-1823</orcid><order>12</order></author><author><firstname>Siobhan</firstname><surname>Murphy</surname><orcid>0000-0001-9765-3873</orcid><order>13</order></author><author><firstname>Dermot</firstname><surname>O&#x2019;Reilly</surname><order>14</order></author><author><firstname>Rhiannon</firstname><surname>Owen</surname><orcid>0000-0001-5977-376X</orcid><order>15</order></author><author><firstname>Antony</firstname><surname>Chuter</surname><orcid>0000-0002-0646-5939</orcid><order>16</order></author><author><firstname>Jillian</firstname><surname>Beggs</surname><order>17</order></author><author><firstname>Gary</firstname><surname>Howsam</surname><orcid>0000-0001-6699-5504</orcid><order>18</order></author><author><firstname>Aziz</firstname><surname>Sheikh</surname><orcid>0000-0001-7022-3056</orcid><order>19</order></author><author><firstname>FD Richard</firstname><surname>Hobbs</surname><orcid>0000-0001-7976-7172</orcid><order>20</order></author><author><firstname>Simon de</firstname><surname>Lusignan</surname><orcid>0000-0002-8553-2641</orcid><order>21</order></author></authors><documents><document><filename>62389__26594__3d2bae363d144215a42938dd00596af4.pdf</filename><originalFilename>62389_VoR.pdf</originalFilename><uploaded>2023-02-16T10:09:56.9140004</uploaded><type>Output</type><contentLength>2708933</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><documentNotes>This work is licensed under a Creative Commons Attribution 4.0 International License</documentNotes><copyrightCorrect>true</copyrightCorrect><language>eng</language><licence>http://creativecommons.org/licenses/by/4.0/</licence></document></documents><OutputDurs/></rfc1807>
spelling 2023-02-16T10:12:34.7142969 v2 62389 2023-01-21 Adverse events following first and second dose COVID-19 vaccination in England, October 2020 to September 2021: 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 2023-01-21 HDAT BackgroundPost-authorisation vaccine safety surveillance is well established for reporting common adverse events of interest (AEIs) following influenza vaccines, but not for COVID-19 vaccines.AimTo estimate the incidence of AEIs presenting to primary care following COVID-19 vaccination in England, and report safety profile differences between vaccine brands.MethodsWe used a self-controlled case series design to estimate relative incidence (RI) of AEIs reported to the national sentinel network, the Oxford-Royal College of General Practitioners Clinical Informatics Digital Hub. We compared AEIs (overall and by clinical category) 7 days pre- and post-vaccination to background levels between 1 October 2020 and 12 September 2021.ResultsWithin 7,952,861 records, 781,200 individuals (9.82%) presented to general practice with 1,482,273 AEIs, 4.85% within 7 days post-vaccination. Overall, medically attended AEIs decreased post-vaccination against background levels. There was a 3–7% decrease in incidence within 7 days after both doses of Comirnaty (RI: 0.93; 95% CI: 0.91–0.94 and RI: 0.96; 95% CI: 0.94–0.98, respectively) and Vaxzevria (RI: 0.97; 95% CI: 0.95–0.98). A 20% increase was observed after one dose of Spikevax (RI: 1.20; 95% CI: 1.00–1.44). Fewer AEIs were reported as age increased. Types of AEIs, e.g. increased neurological and psychiatric conditions, varied between brands following two doses of Comirnaty (RI: 1.41; 95% CI: 1.28–1.56) and Vaxzevria (RI: 1.07; 95% CI: 0.97–1.78).ConclusionCOVID-19 vaccines are associated with a small decrease in medically attended AEI incidence. Sentinel networks could routinely report common AEI rates, contributing to reporting vaccine safety. Journal Article Eurosurveillance 28 3 European Centre for Disease Control and Prevention (ECDC) 1560-7917 19 1 2023 2023-01-19 10.2807/1560-7917.es.2023.28.3.2200195 Data sharing statement:The statistical analysis plan, R scripts used for the analysis, and meta-data are available upon request. The data that support the findings of this study are not publicly available because they are based on pseudonymised sentinel network clinical records. These data are, however, available by application via ORCHID. The terminology lists for the variables are available in Supplementary Table S1. COLLEGE NANME Health Data Science COLLEGE CODE HDAT Swansea University UK Research and Innovation (grant ref MC_PC_20029, MC_PC_20058). 2023-02-16T10:12:34.7142969 2023-01-21T13:55:26.3202321 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Health Data Science Ruby SM Tsang 0000-0002-2520-526x 1 Mark Joy 0000-0002-4974-3724 2 Rachel Byford 0000-0002-4792-8995 3 Chris Robertson 0000-0001-6848-5241 4 Sneha N Anand 0000-0002-0538-3974 5 William Hinton 0000-0003-4927-0901 6 Nikhil Mayor 0000-0003-2681-2501 7 Debasish Kar 0000-0002-1524-1312 8 John Williams 0000-0002-6118-0434 9 William Victor 0000-0003-3660-6517 10 Ashley Akbari 0000-0003-0814-0801 11 Declan T Bradley 0000-0003-1468-1823 12 Siobhan Murphy 0000-0001-9765-3873 13 Dermot O’Reilly 14 Rhiannon Owen 0000-0001-5977-376X 15 Antony Chuter 0000-0002-0646-5939 16 Jillian Beggs 17 Gary Howsam 0000-0001-6699-5504 18 Aziz Sheikh 0000-0001-7022-3056 19 FD Richard Hobbs 0000-0001-7976-7172 20 Simon de Lusignan 0000-0002-8553-2641 21 62389__26594__3d2bae363d144215a42938dd00596af4.pdf 62389_VoR.pdf 2023-02-16T10:09:56.9140004 Output 2708933 application/pdf Version of Record true This work is licensed under a Creative Commons Attribution 4.0 International License true eng http://creativecommons.org/licenses/by/4.0/
title Adverse events following first and second dose COVID-19 vaccination in England, October 2020 to September 2021: a national vaccine surveillance platform self-controlled case series study
spellingShingle Adverse events following first and second dose COVID-19 vaccination in England, October 2020 to September 2021: a national vaccine surveillance platform self-controlled case series study
Ashley Akbari
Rhiannon Owen
title_short Adverse events following first and second dose COVID-19 vaccination in England, October 2020 to September 2021: a national vaccine surveillance platform self-controlled case series study
title_full Adverse events following first and second dose COVID-19 vaccination in England, October 2020 to September 2021: a national vaccine surveillance platform self-controlled case series study
title_fullStr Adverse events following first and second dose COVID-19 vaccination in England, October 2020 to September 2021: a national vaccine surveillance platform self-controlled case series study
title_full_unstemmed Adverse events following first and second dose COVID-19 vaccination in England, October 2020 to September 2021: a national vaccine surveillance platform self-controlled case series study
title_sort Adverse events following first and second dose COVID-19 vaccination in England, October 2020 to September 2021: 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
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 Eurosurveillance
container_volume 28
container_issue 3
publishDate 2023
institution Swansea University
issn 1560-7917
doi_str_mv 10.2807/1560-7917.es.2023.28.3.2200195
publisher European Centre for Disease Control and Prevention (ECDC)
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
document_store_str 1
active_str 0
description BackgroundPost-authorisation vaccine safety surveillance is well established for reporting common adverse events of interest (AEIs) following influenza vaccines, but not for COVID-19 vaccines.AimTo estimate the incidence of AEIs presenting to primary care following COVID-19 vaccination in England, and report safety profile differences between vaccine brands.MethodsWe used a self-controlled case series design to estimate relative incidence (RI) of AEIs reported to the national sentinel network, the Oxford-Royal College of General Practitioners Clinical Informatics Digital Hub. We compared AEIs (overall and by clinical category) 7 days pre- and post-vaccination to background levels between 1 October 2020 and 12 September 2021.ResultsWithin 7,952,861 records, 781,200 individuals (9.82%) presented to general practice with 1,482,273 AEIs, 4.85% within 7 days post-vaccination. Overall, medically attended AEIs decreased post-vaccination against background levels. There was a 3–7% decrease in incidence within 7 days after both doses of Comirnaty (RI: 0.93; 95% CI: 0.91–0.94 and RI: 0.96; 95% CI: 0.94–0.98, respectively) and Vaxzevria (RI: 0.97; 95% CI: 0.95–0.98). A 20% increase was observed after one dose of Spikevax (RI: 1.20; 95% CI: 1.00–1.44). Fewer AEIs were reported as age increased. Types of AEIs, e.g. increased neurological and psychiatric conditions, varied between brands following two doses of Comirnaty (RI: 1.41; 95% CI: 1.28–1.56) and Vaxzevria (RI: 1.07; 95% CI: 0.97–1.78).ConclusionCOVID-19 vaccines are associated with a small decrease in medically attended AEI incidence. Sentinel networks could routinely report common AEI rates, contributing to reporting vaccine safety.
published_date 2023-01-19T04:21:58Z
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