Factors Associated with Adverse Reactions to BNT162b2 COVID-19 Vaccine in a Cohort of 3969 Hospital Workers

Abstract

Factors associated with adverse reactions to BNT162b2 COVID-19 vaccine reported by hospital workers are unclear. Our aim was to collect all reported adverse events in a cohort of hospital workers and to analyze the factors associated with their presence. We conducted an observational longitudinal study on all hospital workers of our center who received COVID-19 vaccination from 27 December 2020 to 1 September 2021. Information on adverse events was reported telephonically and confirmed through clinical records. Chi-square and t tests as well as multivariate logistic regression models were used. Cluster analysis was designed to explore associations between reactions. A total of 3969 hospital workers were included in the sample. Of the total sample, 182 workers (4.6%) reported adverse events. The most frequent symptoms were general malaise (n = 95), fever (n = 92), arthromyalgia (n = 80), and headache (n = 47). The factors associated with adverse events in adjusted analyses were an antecedent of COVID-19 infection (OR = 2.09, 95% CI: 1.47–2.98), female sex (OR = 1.51, 95% CI: 1.03–2.20), and professional category (OR for physicians = 0.41, 95% CI: 0.21–0.80). We report a low frequency of adverse events in hospital workers after COVID-19 vaccination and no severe reaction. Men and physicians underreported their symptoms. These data should guide future strategies for recording adverse events and future research on COVID-19 vaccination safety.

Sex-disaggregated outcomes of adverse events after COVID-19 vaccination: A Dutch cohort study and review of the literature

“…After exclusion of 340 irrelevant articles based on title or abstract, 96 articles were subjected to full-text screening of which 84 were eligible to be included in the review ( Supplementary Figure S3 and Table S8). Forty-three of these articles concerned cross-sectional studies (51.2%) ( 12 , 13 , 17 – 57 ), 26 were prospective cohort studies (31.0%) ( 2 , 5 , 14 , 58 – 80 ), eight retrospective cohort studies (9.5%) ( 81 – 88 ) and seven were other types of studies ( 6 , 89 – 94 ) (8.3%). The majority of the studies were performed in Europe (n=26, 31.0%), in Asia (n=24, 28.6%) and in the Middle East (n=21, 25.0%).…”

“…Several studies report a significant higher incidence of reported AEFIs after COVID-19 vaccination in females than males (12)(13)(14). Yet, only a limited number of studies focus specifically on the association between the occurrence of AEFIs and sex.…”

Adverse Events Associated with BNT162b2 and AZD1222 Vaccines in the Real World: Surveillance Report in a Single Italian Vaccine Center

“…A complete vaccination cycle represents the only effective strategy to avoid worsened outcomes related to the COVID-19 syndrome, including hospitalization and admission to intensive care units also in vulnerable patients [ 30 , 31 , 32 ]. Furthermore, it has been repeatedly underlined the importance to expand, as soon as possible, the audience of the vaccinated subjects [ 33 ].…”

Dermatological adverse reactions after vaccination with BNT162b2 in a cohort of healthcare workers

“…The associations found between DAR and other adverse reactions in previous studies (mainly fever, general malaise, and asthenia) 7 suggest that DAR after the BNT162b2 vaccine are part of a complex systemic response after vaccination, probably associated with a transitory decrease in immunity during the generation of new antibodies against COVID‐19. This may justify the relatively high presence of herpes simplex reactivations (0.13% of the total vaccinated workers) and the herpes zoster reactivation of one worker (0.03%).…”