Page 110 - JCBP-3-1

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

the AE rates in the placebo groups were high after the the susceptibility to nocebo effects, we did not include the
first dose. In retrospect, the AEs that occurred during the Q-No questionnaire. For example, the questionnaire asks
2
registration trials were interpreted as being associated with whether patients read the summary of drug characteristics
nocebo effects. 11-13 before consuming it. 16,17 This behavior may favor the
Nocebo effects are verifiable (neurophysiologically and development of nocebo effects or be considered normal by
clinically) and can lead to life-threatening situations. medical personnel and for new vaccines. Questionnaires
6,10
Thus, downplaying nocebo effects as imaginary and not completed by the same person were linked using a
concerning is wrong and contrary to scientific knowledge. pseudonymization code. Once entered into a database,
In non-interventional studies, the placebo arm is missing. the data were completely anonymized and analyzed. The
Therefore, nocebo effects cannot be directly distinguished study has been registered with the Deutsches Register
from side effects. Nocebo effects could change a vaccine’s Klinischer Studien (German Register Clinical Studies, No:
safety classification in clinical trials, which is highly DRKS00027976) and was approved by the review board of
relevant. Placebo and nocebo effects are more likely PMU Nuremberg (No: IRB 2022_003; February 2, 2022).
8,14
to develop during treatment initiation. The frequency 2.1. Statistical analysis
6-9
of adverse events after COVID-19 vaccinations varied in
studies, predictors for vaccination side effects could not Data were checked for incorrect entries. Fisher’s exact
be determined. 15,16 However, no study has investigated and Pearson’s Chi-square tests were used to analyze cross-
concerns regarding a nocebo effect before the first dose. tabulations. These tests were best suited to compare the
Herein, we investigated the association between concerns frequency of side effects in different groups (our sample
18
regarding the course of an mRNA COVID-19 vaccine and vs. registration study sample; subgroups of our sample).
the prevalence rate of AEs in healthcare workers (HCWs). The significance level was 5%. No correction was made
for multiple testing. All analyses were performed using
2. Methods STATISTICA (version 13; Hill, T. & Lewicki, P. Statistics:
All employees of the Nuremberg Hospital – one of the Methods and Applications. StatSoft, Tulsa, OK, USA) and
largest municipal hospitals in Europe providing the NCSS (version 2022; NCSS, LLC. Kaysville, UT, USA).
highest care – who were vaccinated as of December 27, 3. Results
2020 (start of COVID-19 vaccinations in prioritized
individuals in Germany) were invited to volunteer in this Our cohort comprised 78% women (18 – 35 years: 25%;
pharmacovigilance study. There were no special inclusion 36 – 50 years: 35%; and >51 years: 40%) and 22% men (18
or exclusion criteria. Questionnaires were available at – 35 years: 29%; 36 – 50 years: 29%; and > 51 years: 41%).
the two vaccination centers of the hospital, as well as Allergies were the most common pre-existing condition
online, and included all previously identified AEs. We in both sexes (women: 53%; men: 50%), followed by
2
analyzed the prevalence of AEs after the first dose of an cardiovascular (women: 11.5%; men: 12%) and thyroid
mRNA vaccine (total n = 982; Comirnaty BNT162b2: (women: 11.5%; men: 2.8%) diseases. Mental illnesses
n = 596). The participants were asked to report any were rarely reported (women: 1.5%; men: 1.7%). In total,
AEs that developed within 1 week of the first dose. The 25% of the women and 20% of the men were smokers. The
participants selected the symptoms in the questionnaire prevalence of obesity (body mass index >30 kg/m²) was
that applied to them and classified them according to 14% among women and 10% among men.
their intensity – mild, moderate, or severe. Completed Fatigue, headache, and myalgia were the most common
questionnaires could either be physically submitted in systemic AEs after the first vaccine dose. Fatigue, headache,
prepared boxes or returned via internal mail. There were chills, and vomiting developed significantly less frequently
no special requests to fill out the questionnaires from in patients aged <55 years in our study than in those in the
memory, for example, 2 – 3 weeks after vaccination, to registration study for Comirnaty (Table 1).
avoid recall bias. The questionnaire included an empty field
for personal comments and perceived AEs not listed in the HCWs who reported concerns regarding the
questionnaire. The questionnaire did not include questions vaccination course (n = 180) were significantly more likely
regarding professional affiliation. Patients vaccinated with to exhibit systemic AEs (80% vs. 68%) after the first mRNA
mRNA vaccines were predominantly medical professions vaccine dose than those who reported no concerns (n = 605;
(mostly nurses) directly involved in the care of patients Figure 1). Women were significantly more worried than
with COVID-19. The participant’s anamnestic data were men (27.5% vs. 10%, P < 0.05). After the second dose, the
collected, and they were asked if they were worried about AE rates were not significantly different between the two
the vaccination course (Answers: Yes or No). To assess groups.

Volume 3 Issue 1 (2025) 104 doi: 10.36922/jcbp.4727