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Abstract

Background

Post-authorisation vaccine safety surveillance is well established for reporting common adverse events of interest (AEIs) following influenza vaccines, but not for COVID-19 vaccines.

Aim

To estimate the incidence of AEIs presenting to primary care following COVID-19 vaccination in England, and report safety profile differences between vaccine brands.

Methods

We 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.

Results

Within 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).

Conclusion

COVID-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.

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This work is licensed under a Creative Commons Attribution 4.0 International License.
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2023-01-19
2024-04-23
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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
<p class="citation"> <span>Citation style for this article:</span> <span class="meta-value authors"> <a href="/search?value1=Ruby+SM+Tsang&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Tsang Ruby SM</a>, <a href="/search?value1=Mark+Joy&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Joy Mark</a>, <a href="/search?value1=Rachel+Byford&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Byford Rachel</a>, <a href="/search?value1=Chris+Robertson&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Robertson Chris</a>, <a href="/search?value1=Sneha+N+Anand&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Anand Sneha N</a>, <a href="/search?value1=William+Hinton&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Hinton William</a>, <a href="/search?value1=Nikhil+Mayor&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Mayor Nikhil</a>, <a href="/search?value1=Debasish+Kar&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Kar Debasish</a>, <a href="/search?value1=John+Williams&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Williams John</a>, <a href="/search?value1=William+Victor&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Victor William</a>, <a href="/search?value1=Ashley+Akbari&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Akbari Ashley</a>, <a href="/search?value1=Declan+T+Bradley&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Bradley Declan T</a>, <a href="/search?value1=Siobhan+Murphy&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Murphy Siobhan</a>, <a href="/search?value1=Dermot+O%E2%80%99Reilly&option1=author&noRedirect=true" class="nonDisambigAuthorLink">O’Reilly Dermot</a>, <a href="/search?value1=Rhiannon+K+Owen&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Owen Rhiannon K</a>, <a href="/search?value1=Antony+Chuter&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Chuter Antony</a>, <a href="/search?value1=Jillian+Beggs&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Beggs Jillian</a>, <a href="/search?value1=Gary+Howsam&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Howsam Gary</a>, <a href="/search?value1=Aziz+Sheikh&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Sheikh Aziz</a>, <a href="/search?value1=FD+Richard+Hobbs&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Hobbs FD Richard</a>, <a href="/search?value1=Simon+de+Lusignan&option1=author&noRedirect=true" class="nonDisambigAuthorLink">de Lusignan Simon</a></span>. 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. <a href="/content/ecdc">Euro Surveill.</a> 2023;28(3):pii=2200195. <a href="https://doi.org/10.2807/1560-7917.ES.2023.28.3.2200195" title="doi link" target="_blank">https://doi.org/10.2807/1560-7917.ES.2023.28.3.2200195</a> <span class="ES_Article_citation"> <span class="generated">Received</span>: 23 Feb 2022;&nbsp;&nbsp; <span class="generated">Accepted</span>: 01 Nov 2022 </span> </p>
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