Association of clinical and epidemiological characteristics with COVID-19 BNT162b2 mRNA vaccine short-term adverse reactions in healthcare workers

ABSTRACT

Introduction

The aim of the study was to investigate the prevalence and severity of adverse reactions (ARs) after immunization of healthcare workers (HCWs) with BNT162b2 vaccine and to associate them with clinical and epidemiological characteristics.

Methods

A form containing demographic and clinical data as well as ARs after both doses of the vaccine was completed, and statistical association analysis was performed.

Results

A total of 502 HCWs (females 78.3%) with mean age (±SD) 48.17 years (±12.97) participated. After the first dose, 404 (80.5%) HCWs reported at least one local AR (LAR) and 366 (72.9%) after the second dose (p-value=0.004). After the first dose, 121 (24.1%) HCWs reported at least one systemic AR (SAR) and 275 (54.8%) after the second dose (p-value<0.0001).

In the logistic regression analysis, there was no association of gender or medical history of underlying disease with LARs. There was a negative association of age with the cumulative score (CS) of LARs (OR: 0.82, 95% CI: 0.69–0.96) after the first dose. Females had a positive association with CS of SARs following both doses (OR, 95% CI: 2.57, 1.39–4.73 and 2.71, 1.76–4.19, respectively). Age was negatively associated with CS of SARs (OR: 0.66, 95% CI: 0.57–0.76) after the second dose. Severe ARs included Bell’s palsy (1) and tinnitus with temporary hearing loss (1).

Conclusion

The administration of the BNT162b2 vaccine in our HCWs cohort had a good safety profile with the most common ARs being self-limited. An increasing rate of SARs following the second vaccine dose was noticed. Rare but severe possible ARs should be further investigated.

KEYWORDS:

• Healthcare worker
• biontech
• mRNA
• vaccine
• adverse reactions

Author contributions

FF, EBT and CD performed the collection of data. ND performed the statistical analysis. AM and VS designed and overviewed the study. FF, EBT and AM wrote the initial manuscript. All authors reviewed and approved the final manuscript.

Availability of data and material

Not applicable.

Code availability

Not applicable.

Consent to participate

Written informed consent was obtained from the participants.

Disclosure statement

All authors declare no competing interests regarding the present study.

Ethics approval

The study protocol was approved by the scientific and bioethics committee of “Aghia Sophia” Children’s Hospital (No: 2794) and was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki.

Supplementry material

Supplemental data for this article can be accessed on the publisher’s website at https://doi.org/10.1080/21645515.2021.1985356

Additional information

Funding

The author(s) reported there is no funding associated with the work featured in this article.