• Ruby Sm Tsang, Utkarsh Agrawal, 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, Richard HobbsF DFDNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK.6396, and LusignanSimon deSNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK.6396Department of Mathematics and Statistics, University of Strathclyde, Glasgow, G1 1XH, UK.3527.
• Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK.
• J R Soc Med. 2024 Apr 1; 117 (4): 134148134-148.

ObjectivesTo 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.DesignWe 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.SettingEngland, UK.ParticipantsIndividuals experiencing AEIs after receiving first and second doses of COVID-19 vaccines.Main Outcome MeasuresAEIs determined based on events reported in clinical trials and in primary care during post-license surveillance.ResultsA 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)).ConclusionsCOVID-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.

26 keywords...

hide…