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Journal of Clinical and
            Basic Psychosomatics                                         Concerns about COVID-19 vaccination and AE rate



            Writing – original draft: Isabel Hach                 Disease-specific adverse events following nonlive vaccines:
            Writing – review & editing: All authors               A paradoxical placebo effect or a nocebo phenomenon?
                                                                  Vaccine. 2011;29(37):6321-6326.
            Ethics approval and consent to participate            doi: 10.1016/j.vaccine.2011.05.045

            The institutional review board of the PMU Nuremberg has   9.   Colloca L, Barsky AJ. Placebo and nocebo effects. N Engl J
            evaluated the study approvingly (IRB 2022_003). The data   Med. 2020;382(6):554-561.
            protection officer of Klinikum Nuremberg confirmed that      doi: 10.1056/NEJMra1907805
            the study is general data protection regulation (GDPR)-
            compliant.                                         10.  Colloca L. The nocebo effect. Annu Rev Pharmacol Toxicol.
                                                                  2024;64:171-190.
            Consent for publication                               doi: 10.1146/annurev-pharmtox-022723-112425

            Not applicable.                                    11.  Haas JW, Bender FL, Ballou S, et al. Frequency of adverse
                                                                  events in the placebo arms of COVID-19 vaccine trials:
            Availability of data                                  A systematic review and meta-analysis. JAMA Netw Open.
                                                                  2022;5(1):e2143955.
            After completion of the study and 6  months after
            publication, we will make the raw data (excel file) available      doi: 10.1001/jamanetworkopen.2021.43955.  Erratum in:
            in completely anonymized form after request (ca. 05/25).  JAMA Netw Open. 2022;5(2):e221277.
                                                                  doi: 10.1001/jamanetworkopen.2022.1277
            References
                                                               12.  Amanzio M, Mitsikostas DD, Giovannelli F, Bartoli M,
            1.   Holzmann-Littig C, Frank T, Schmaderer  C,  et al.   Cipriani GE, Brown WA. Adverse events of active and
               COVID-19 vaccines: Fear of side effects among German   placebo groups in SARS-CoV-2 vaccine randomized trials:
               health care workers. Vaccines (Basel). 2022;10(5):689.  A systematic review. Lancet Reg Health Eur. 2022;12:100253.
               doi: 10.3390/vaccines10050689                      doi: 10.1016/j.lanepe.2021.100253
            2.   Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy   13.  Lee YH, Song GG. Nocebo responses in randomized
               of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med.   controlled trials of COVID-19 vaccines. Int J Clin Pharmacol
               2020;383(27):2603-2615.                            Ther. 2022;60(1):5-12.
               doi: 10.1056/NEJMoa2034577                         doi: 10.5414/CP204028
            3.   Yan Z, Yang M, Lai CL. COVID-19 vaccinations: A   14.  Wartolowska K, Colloca L, Amanzio M. Editorial: The
               comprehensive review of their safety and efficacy in special   nocebo effect and its consequences for clinical trials and
               populations. Vaccines (Basel). 2021;9(10):1097.    clinical practice. Front Psychol. 2023;13:1111324.
               doi: 10.3390/vaccines9101097                       doi: 10.3389/fpsyg.2022.1111324
            4.   Mallah SI, Alawadhi A, Jawad J, et al. Safety and efficacy of   15.  Bashar MA, Kamble B, Kumar S, Nandekar SV, Mathur SK.
               COVID-19 prime-boost vaccinations: Homologous BBIBP-  Assessment of safety and adverse events following
               CorV versus heterologous BNT162b2 boosters in BBIBP-  COVID-19 vaccination and their predictors in first 30 days
               CorV-primed individuals. Vaccine. 2023;41(12):1925-1933.  among healthcare workers of a tertiary care teaching hospital
                                                                  in North India. Vaccine X. 2024;19:100522.
               doi: 10.1016/j.vaccine.2023.01.032
                                                                  doi: 10.1016/j.jvacx.2024.100522
            5.   Cai C, Peng Y, Shen E, et al. A comprehensive analysis of
               the efficacy and safety of COVID-19 vaccines.  Mol Ther.   16.  Mitsikostas DD, Aravantinou-Fatorou K, Deligianni C,
               2021;29(9):2794-2805.                              et al. Nocebo-prone behavior associated with SARS-CoV-2
                                                                  vaccine hesitancy in healthcare workers.  Vaccines  (Basel).
               doi: 10.1016/j.ymthe.2021.08.001
                                                                  2021;9(10):1179.
            6.   Webster RK, Weinman J, Rubin GJ. A systematic review of
               factors  that  contribute  to  nocebo  effects.  Health  Psychol.      doi: 10.3390/vaccines9101179
               2016;35(12):1334-1355.                          17.  Mitsikostas DD, Deligianni CI. Q-No: A  questionnaire
                                                                  to predict nocebo in outpatients seeking neurological
               doi: 10.1037/hea0000416
                                                                  consultation. Neurol Sci. 2015;36(3):379-381.
            7.   Hutchinson P, Moerman DE. The meaning response, “placebo,”      doi: 10.1007/s10072-014-1959-2
               and methods. Perspect Biol Med. 2018;61(3):361-378.
                                                               18.  Du Prel JB, Röhrig B, Hommel G, Blettner M. Choosing
               doi: 10.1353/pbm.2018.0049
                                                                  statistical tests: part 12 of a series on evaluation of scientific
            8.   Okaïs C, Gay C, Seon F, Buchaille L, Chary E, Soubeyrand B.   publications. Dtsch Arztebl Int. 2010;107(19):343-348.


            Volume 3 Issue 1 (2025)                        107                              doi: 10.36922/jcbp.4727
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