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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.
Tsang, Ruby Sm; 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, Siobhan; O'Reilly, Dermot; Owen, Rhiannon K; Chuter, Antony; Beggs, Jillian; Howsam, Gary; Sheikh, Aziz; Hobbs, Fd Richard; de Lusignan, Simon.
  • Tsang RS; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.
  • Joy M; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.
  • Byford R; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.
  • Robertson C; Public Health Scotland, Glasgow, United Kingdom.
  • Anand SN; Department of Mathematics and Statistics, University of Strathclyde, Glasgow, United Kingdom.
  • Hinton W; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.
  • Mayor N; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.
  • Kar D; Chelsea and Westminster Hospital NHS Foundation Trust, London, United Kingdom.
  • Williams J; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.
  • Victor W; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.
  • Akbari A; Royal College of General Practitioners, London, United Kingdom.
  • Bradley DT; Population Data Science, Swansea University Medical School, Swansea University, United Kingdom.
  • Murphy S; Public Health Agency, Belfast, United Kingdom.
  • O'Reilly D; Centre for Public Health, Queen's University Belfast, Belfast, United Kingdom.
  • Owen RK; Centre for Public Health, Queen's University Belfast, Belfast, United Kingdom.
  • Chuter A; Centre for Public Health, Queen's University Belfast, Belfast, United Kingdom.
  • Beggs J; Population Data Science, Swansea University Medical School, Swansea University, United Kingdom.
  • Howsam G; BREATHE - The Health Data Research Hub for Respiratory Health, Edinburgh, United Kingdom.
  • Sheikh A; BREATHE - The Health Data Research Hub for Respiratory Health, Edinburgh, United Kingdom.
  • Hobbs FR; Royal College of General Practitioners, London, United Kingdom.
  • de Lusignan S; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.
Euro Surveill ; 28(3)2023 01.
Article in English | MEDLINE | ID: covidwho-2215127
ABSTRACT
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Influenza Vaccines / COVID-19 Vaccines / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study Topics: Vaccines Limits: Humans Country/Region as subject: Europa Language: English Journal subject: Communicable Diseases Year: 2023 Document Type: Article Affiliation country: 1560-7917.ES.2023.28.3.2200195

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Influenza Vaccines / COVID-19 Vaccines / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study Topics: Vaccines Limits: Humans Country/Region as subject: Europa Language: English Journal subject: Communicable Diseases Year: 2023 Document Type: Article Affiliation country: 1560-7917.ES.2023.28.3.2200195