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

Autor: Almohaya AM; Department of Internal Medicine, Ad-Diriyah Hospital, Ministry of Health, Riyadh, Saudi Arabia. Electronic address: amalmohaya@moh.gov.sa., Alsubie H; Department of Pediatrics, Ad-Diriyah Hospital, Ministry of Health, Riyadh, Saudi Arabia., Alqarni B; Department of Pediatrics, Ad-Diriyah Hospital, Ministry of Health, Riyadh, Saudi Arabia., Alzayad B; Department of Internal Medicine, Ad-Diriyah Hospital, Ministry of Health, Riyadh, Saudi Arabia., Alghar A; Department of Internal Medicine, Ad-Diriyah Hospital, Ministry of Health, Riyadh, Saudi Arabia., Alshahrani K; Department of Internal Medicine, Ad-Diriyah Hospital, Ministry of Health, Riyadh, Saudi Arabia., Barry M; Division of Infectious Diseases, Department of Internal Medicine, College of Medicine, King Saud University, Riyadh, Saudi Arabia.
Jazyk: angličtina
Zdroj: Vaccine [Vaccine] 2022 Jan 24; Vol. 40 (3), pp. 477-482. Date of Electronic Publication: 2021 Dec 13.
DOI: 10.1016/j.vaccine.2021.12.001
Abstrakt: Background: 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.
Method: 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 (<15 min) or extended (<3 h). Statistical analysis was performed to study AAEs association with the study variables and outcomes.
Results: Out of 71,221 vaccine recipients, 144 (0.002%) had developed 345 AAEs, at a rate of 48.4 events per 10,000 dose administered. The majority of cases in AAE group were first dose recipients (93.8%) and previously healthy (59%), while the minority had a previous history of allergy (6.3%) or a laboratory-confirmed COVID-19 (4.2%). We found a significant association between female gender and the occurrence of any AAE (p-value = 0.002). Per every 10,000 doses administered, non-anaphylactic AAEs were dizziness (17.8), headache (9.7), nausea (7.1), or syncope (3.2). Only one in every ten AAEs was considered serious and resulted in an extended observation (4.8 per 10,000 doses), but only 1/144 required hospitalization for non-anaphylaxis reasons (0.1 per 10,000 doses). According to the Brighton collaboration definition of anaphylaxis, no single case of high certainty anaphylaxis was recorded. No death was documented in this cohort.
Conclusion: Acute adverse events due toBNT162b2 vaccinewere rare andmostlynon-seriouswith a tendency to occur more in women. Further prospectivestudieson largervaccine recipientsto evaluatethe incidenceof anaphylaxis in the Saudi population are warranted.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2021 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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