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Journal of Clinical and

                                                                   Basic Psychosomatics




                                        BRIEF REPORT
                                        Association between concerns regarding

                                        COVID-19 mRNA vaccination and the adverse
                                        event rate among healthcare workers



                                                                                             3
                                                  1†
                                                                                                            4
                                        Isabel Hach * , Bunila-Yuwang Francisca 1,2† , Wolfgang Hitzl , Annette Sattler ,
                                        Stephan Kolb , and Cosima Brucker 2
                                                    1
                                        1 Department of Education and Science, Klinikum Nürnberg, Paracelsus Medical University,
                                        Nuremberg, Germany
                                        2 Clinic for Gynecology and Obstetrics, Klinikum Nürnberg, Paracelsus Medical University Nuremberg,
                                        Germany
                                        3 Department of Research and Innovation Management, Biostatistics and Publication of Clinical Trial
                                        Studies, Paracelsus Medical University, Salzburg, Austria
                                        4 Department of Hospital Pharmacy, Klinikum Nürnberg, Paracelsus Medical University, Nuremberg,
                                        Germany



            † These authors contributed equally
            to this work.               Abstract
            *Corresponding author:
            Isabel Hach                 Healthcare workers must be vaccinated regularly. However, vaccination-related side
            (isabel.hach@klinikum-nuernberg.de)  effects can lead to sick leaves and decreased willingness to be vaccinated. Negative
            Citation: Hach I, Francisca B,   expectations can cause nocebo effects, potentially increasing the rates of adverse
            Hitzl W, Sattler A, Kolb S,   events (AEs). Herein, we evaluated the relationship between concerns regarding the
            Brucker C. Association between   vaccination course and the prevalence rate of AEs after the first and second doses
            concerns regarding COVID-19
            mRNA vaccination and the adverse   of mRNA vaccines in 982 healthcare workers from the Nuremberg Hospital. Most of
            event rate among healthcare   our participants were women (78%). Fatigue and headache were the most common
            workers. J Clin Basic Psychosom.   systemic AEs. Healthcare workers who were worried about the vaccination process
            2025;3(1):103-108.
            doi: 10.36922/jcbp.4727     reported significantly more AEs after the first vaccine dose than those who were not
                                        worried (80% vs. 68%, P < 0.05). Thus, strategies to minimize concerns could reduce
            Received: August 31, 2024   vaccination-related side effects and improve willingness to be vaccinated.
            1st revised: October 21, 2024
            2nd revised: October 23, 2024  Keywords: Nocebo effects; Self-fulfilling prophecy; Pharmacovigilance
            3rd revised: October 31, 2024
            Accepted: November 12, 2024
            Published Online: December 12,   1. Introduction
            2024
                                        No vaccination in recent decades has been as eagerly anticipated as the one for COVID-19;
            Copyright: © 2024 Author(s).   however,  this  has  been  accompanied  by  fears  of  (unknown)  side  effects.   Although
                                                                                                    1
            This is an Open-Access article
            distributed under the terms of the   authorized vaccines are safe, precise information regarding their tolerability and safety
            Creative Commons Attribution   can only be determined during the course of use.  The rates of side effects reported
                                                                                2-5
            License, permitting distribution,
            and reproduction in any medium,   in observational studies conducted after vaccine authorization differ based on age, sex,
                                                            2,5
            provided the original work is   vaccine type, and country.  Individuals working in the German healthcare system have
            properly cited.             expressed fears regarding the COVID-19 vaccination.  Negative expectations from
                                                                                     1
                                                                                               6-9
            Publisher’s Note: AccScience   vaccines or drugs can cause a nocebo (Latin for “I will harm”) effect.  Nocebo effects
            Publishing remains neutral with   are specific to the side effects discussed.  In clinical trials, the development of adverse
                                                                       7,10
            regard to jurisdictional claims in
            published maps and institutional   events (AEs) in the placebo group, that is, patients who receive a preparation without the
            affiliations.               active substance, is considered a nocebo effect. In mRNA vaccine registration studies,
            Volume 3 Issue 1 (2025)                        103                              doi: 10.36922/jcbp.4727
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