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

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Tsang, Ruby SM and Agrawal, Utkarsh and Joy, Mark and Byford, Rachel and Robertson, Chris and Anand, Sneha N and Hinton, William and Mayor, Nikhil and Kar, Debasish and Williams, John and Victor, William and Akbari, Ashley and Bradley, Declan T and Murphy, Siobhan and O’Reilly, Dermot and Owen, Rhiannon K and Chuter, Antony and Beggs, Jillian and Howsam, Gary and Sheikh, Aziz and Richard Hobbs, FD and Lusignan, Simon de (2023) Adverse events after first and second doses of COVID-19 vaccination in England: a national vaccine surveillance platform self-controlled case series study. Journal of the Royal Society of Medicine, 117 (4). pp. 134-148. ISSN 0141-0768 (https://doi.org/10.1177/01410768231205430)

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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 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.

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