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

Authors: Tsang, Ruby S.M.;

Agrawal, Utkarsh ;

Joy, Mark;

Byford, Rachel;

Robertson, Chris;

Anand, Sneha N.;

Hinton, William;

Mayor, Nikhil;

Kar, Debasish;

Williams, John;

Victor, William;

Akbari, Ashley;

Bradley, Declan T. ;

Murphy, Siobhán ;

O'Reilly, Dermot;

Owen, Rhiannon K. ;

Chuter, Antony;

Beggs, Jillian;

Howsam, Gary;

Sheikh, Aziz ;

Hobbs, F.D. Richard;

de Lusignan, Simon

Source: Journal of the Royal Society of Medicine

Full text

: https://doi.org/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 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.

Rights

This article is distributed under the terms of the Creative Commons Attribution 4.0 License (https://creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).

Cite as

Tsang, R., Agrawal, U., Joy, M., Byford, R., Robertson, C., Anand, S., Hinton, W., Mayor, N., Kar, D., Williams, J., Victor, W., Akbari, A., Bradley, D., Murphy, S., O'Reilly, D., Owen, R., Chuter, A., Beggs, J., Howsam, G., Sheikh, A., Hobbs, F. & de Lusignan, S. 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. https://doi.org/10.1177/01410768231205430

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Identifiers

DOI: https://doi.org/10.1177/01410768231205430