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

J R Soc Med. 2024 Apr;117(4):134-148. doi: 10.1177/01410768231205430. Epub 2023 Nov 3.

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.

Keywords: Epidemiology; public health; vaccination programmes.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • BNT162 Vaccine / adverse effects
  • COVID-19 Vaccines* / administration & dosage
  • COVID-19 Vaccines* / adverse effects
  • COVID-19* / epidemiology
  • COVID-19* / prevention & control
  • ChAdOx1 nCoV-19
  • England / epidemiology
  • Female
  • Humans
  • Incidence
  • Male
  • Middle Aged
  • SARS-CoV-2
  • Vaccination / adverse effects
  • Young Adult