Adverse events report of inactivated COVID-19 vaccine from 4040 healthcare workers

ABSTRACT

Objectives

Numerous vaccination studies are conducted to protect against COVID-19 infection, and preclinical and clinical studies are still ongoing worldwide. During this extraordinary period, the necessity to perform COVID-19 vaccine studies and immunization programs together has emerged. Vaccine Adverse Effects (VAEs) need to be documented quickly. We aimed to determine the VAEs and to compare the frequency of VAEs between groups according to sociodemographic characteristics after the inactivated vaccine (CoronaVac) was administered to healthcare workers (HCWs) in Turkey.

Methods

An online questionnaire was delivered to 4040 volunteer HCWs across the whole country who were vaccinated with CoronaVac. Sociodemographic characteristics, medical history, history of COVID-19 infection, and VAEs occurring after the first and second doses of the inactivated vaccine were evaluated.

Results

The most common local and systemic VAEs after first and second doses of the COVID-19 vaccine were reported as, pain at the injection site (37.9%; 37.6%), headache (21.5%; 16.8%), fatigue (18%; 15%), drowsiness (9.6%; 8.2%), back pain (8.8%; 8.2%), nausea (6.3%; 4.8%), and joint pain (4.7%; 4.7%). Individuals with a history of allergies (generalized or vaccine-related) and females had a higher rate of VAE. Participants aged 60 and over reported less frequent VAEs.

Conclusion

It is extremely important to identify and document the VAEs occurring in the early postvaccination period in different groups of the community. These initial findings may provide reassurance to healthcare providers and vaccine recipients and promote confidence in the safety of this inactive COVID-19 vaccine, however longitudinal follow-up studies are recommended.

KEYWORDS:

• COVID-19
• vaccine
• vaccination
• adverse effect

Declaration of interest

The authors have no relevant conflicts of interest to disclose. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Ethics approval

The study was approved by the University of Health Sciences Bozyaka Training and Research Hospital Ethics Committee (approval number: No: 2021/29).

Additional information

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.