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, 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 K Owen, Antony Chuter, Jillian Beggs, Gary Howsam, Aziz Sheikh, FD Richard HobbsSimon de Lusignan

Research output: Contribution to journalArticlepeer-review

Abstract / Description of output

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.

Original languageEnglish
JournalEurosurveillance
Volume28
Issue number3
DOIs
Publication statusPublished - 19 Jan 2023

Keywords / Materials (for Non-textual outputs)

  • Humans
  • BNT162 Vaccine
  • ChAdOx1 nCoV-19
  • COVID-19/epidemiology
  • COVID-19 Vaccines/adverse effects
  • England/epidemiology
  • Influenza Vaccines/adverse effects
  • Vaccination/adverse effects

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