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Acute unsolicited adverse events following BNT162b2 vaccine in Saudi Arabia, a real-world data

•Acute adverse events after BNT162b2 vaccination in Saudi Arabia were extremely rare.•For each 10,000-dose administered, 48.4 events are estimated to occur.•Most common adverse events were dizziness, headache, nausea, and/or fatigue.•Female were significantly more likely to develop non-anaphylactic...

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Bibliographic Details
Published in:Vaccine 2022-01, Vol.40 (3), p.477-482
Main Authors: Almohaya, Abdulellah M., Alsubie, Haya, Alqarni, Bader, Alzayad, Bashayer, Alghar, Ali, Alshahrani, Khalid, Barry, Mazin
Format: Article
Language:English
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Summary:•Acute adverse events after BNT162b2 vaccination in Saudi Arabia were extremely rare.•For each 10,000-dose administered, 48.4 events are estimated to occur.•Most common adverse events were dizziness, headache, nausea, and/or fatigue.•Female were significantly more likely to develop non-anaphylactic adverse events.•The vast majority of the adverse events were managed with short observation. Acute adverse events and anaphylaxis were reported after the administration of coronavirus disease (COVID-19) mRNA vaccines. We aim to explore the nature and outcome of adverse events following BNT162B2 vaccine in a community vaccination center, Riyadh, Saudi Arabia. Within 30 min post vaccination, all acute adverse events (AAEs) that occurred before March 31st, 2021, and in people older than 16 years were reviewed (AAE group). We used the case definition of Brighton collaboration on vaccine safety to define anaphylaxis. Patients’ demographics, comorbidities, allergy history, and outcome at disposition were collected. Observation duration after vaccination was short (
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2021.12.001