Active Surveillance of Adverse Events in Healthcare Workers Recipients After Vaccination with COVID-19 BNT162b2 Vaccine (Pfizer-BioNTech, Comirnaty): A Cross-Sectional Study

In this cross-sectional study, adverse events after the first and second dose of BNT162b2 mRNA (Pfizer-BioNTech, Comirnaty) vaccine against coronavirus disease 2019 were investigated among employees of clinics in central Italy. A 42-items questionnaire was administrated to vaccine recipients. Advers...

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Bibliographic Details
Published in:	Journal of community health Vol. 47; no. 2; pp. 211 - 225
Main Authors:	Ripabelli, Giancarlo, Tamburro, Manuela, Buccieri, Nicandro, Adesso, Carmen, Caggiano, Valeria, Cannizzaro, Fabio, Di Palma, Michela Anna, Mantuano, Gloria, Montemitro, Valeria Giovanna, Natale, Anna, Rodio, Leonardo, Sammarco, Michela Lucia
Format:	Journal Article
Language:	English
Published:	New York Springer US 01-04-2022 Springer Nature B.V
Subjects:	Adverse events Age BNT162 Vaccine Chi-square test Community and Environmental Psychology Confidence intervals Coronaviruses COVID-19 COVID-19 - epidemiology COVID-19 - prevention & control COVID-19 vaccines COVID-19 Vaccines - adverse effects Cross-Sectional Studies Ethics Female Females Health care Health Personnel Health Promotion and Disease Prevention Health surveillance Humans Male Medical personnel Medicine Medicine & Public Health Middle Aged mRNA Original Paper Risk analysis Risk assessment Risk factors SARS-CoV-2 Sex Side effects Vaccination Vaccination - adverse effects Vaccines Viral diseases Watchful Waiting BNT162b2 mRNA vaccine First dose Sex differences Safety Second dose Younger adults
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Summary:	In this cross-sectional study, adverse events after the first and second dose of BNT162b2 mRNA (Pfizer-BioNTech, Comirnaty) vaccine against coronavirus disease 2019 were investigated among employees of clinics in central Italy. A 42-items questionnaire was administrated to vaccine recipients. Adverse events were classified based on severity and occurrence as reported in the literature. A descriptive/univariate analysis using Chi-square or Fisher’s Exact tests was performed. Odds ratio (OR) and 95% confidence intervals were calculated to assess risk factors. 340 individuals (61.5% females; median age 49 years) participated. Adverse events were reported by 279 (82%) and 281 (82.6%) individuals as induced by the first and second dose, respectively. Mild reactions were mainly reported (80.9% and 80.3%), followed by moderate (11.8% and 37.1%) and severe (3.8% and 4.7%). Adverse events were identical to those already described as very common (81.8% and 80.6%), although vaccine-coincidental events not cited in the literature were reported by 6% and 15.6% following each dose. Age ≤ 55 years was a risk factor for any adverse event after each injection (ORs: 2.942 and 2.818), as well as female sex for those mild (ORs: 1.856 and 2.818) and common (ORs: 3.452 and 2.145). Findings were consistent with national reports as most of the adverse events were mild and associated with female sex and young age, while investigations are needed for reactions not described elsewhere. Data are useful to support the vaccine safety profile, also because largely targeted healthcare personnel more skilled than general population in self-diagnosis of health-related issues.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0094-5145 1573-3610
DOI:	10.1007/s10900-021-01039-3