COVID-19 vaccine short-term adverse events in the real-life family practice in Krakow, Poland

Abstract

Background

In manufacturers’ trials, vaccination against COVID-19 proved to be safe and effective. The officially reported frequency of vaccine adverse events (VAEs) in Poland is lower than that declared by the manufacturers. The anti-vaccination activists questioned the trustworthiness of official data.

Objectives

The aim was to explore the real-life prevalence of VAEs in general practice settings and the factors that may influence it.

Methods

In this pragmatic, mixed prospective and retrospective study, patients vaccinated against COVID-19 between May and October 2021 in three GP practices in Krakow, Poland, were enrolled. Their demographic (age, sex, level of education) and clinical data (weight and height, smoking status, history of allergies, COVID-19 and chronic diseases) were collected. Then, they were interviewed about VAEs they experienced.

Results

Out of 1530 patients invited to participate, 1051 (69%) agreed and were eligible for analyses. Only 8.8% did not report any VAE. Pain at the injection site was the most frequently reported reaction (800, 76.2%). The most prevalent systemic ones were excessive fatigue/lethargy (527, 50.6%), sleep/circadian rhythm disturbances (433, 41.6%) and headache (399, 38.3%). Fifty required medical assistance − 39 experienced presyncope (3.7%) and 11 loss of consciousness (1.1%). Only two others were hospitalised. Females, younger adults, those with higher education and with a history of COVID-19 reported systemic VAEs more frequently, while those who were older and obese were less likely to report local reactions.

Conclusion

Although more than 90% of patients vaccinated against COVID-19 in general practice settings may experience VAEs, in short-term observation, the vast majority are localised and mild.

Keywords:

• COVID-19 vaccine
• vaccine adverse event
• primary care
• family medicine
• pragmatic study

Acknowledgements

The authors would like to thank Magdalena Wilanowska, the President of ZiZ Educational Center Ltd; all the volunteers involved in the fieldwork, especially the students of the Family Medicine Student Interest Group: Katarzyna Dąbek, Nicole Garwecki, Marie Lipski, Michał Ochwat, Filip Sadurski and Jan Surma; the staff of the participating GP practices; and the participants themselves.

Author contributions

Study concept and design: AW, EKR, KN, ZM. Drafting of the manuscript: MO, AW. Data acquisition: KG, KN, SP, MB, MP, NS, ZM. Data analysis and interpretation: AW, EW, MO, ZM. Critical manuscript revision for important intellectual content: AW, EW, KN, MO, ZM. Study supervision: AW. Approval of the final version of the manuscript to be published: all authors.

Disclosure statement

The authors alone are responsible for the content and writing of the paper. Adam Windak is the Associate Editor of the European Journal of General Practice and the Guest Editor-in-Chief of the special issue on COVID-19. The other authors declare no conflict of interest.

Additional information

Funding

The study was entirely financed from the budget of the Department of Family Medicine, Jagiellonian University Medical College.