Page 111 - JCBP-3-1

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

Table 1. Comparison of prevalence of selected AEs after administration of the first dose of BNT162b2 (Comirnaty) (registration
study cohort vs. our cohort)
AE AE prevalence among AE prevalence among P-value (Fisher’s AE prevalence among AE prevalence among
<55-year-olds in registration <55-year-olds in our exact test, two-sided) >55-year-olds in registration >55-year-olds in our
study (n=10,889) (%) study (n=453) (%) study (n=7,971) (%) study (n=143) (%)
a
a
Fatigue 47 175 (41) 0.008* 0.48** 34 45 (31)
Headache 42 123 (29) 0.000* 0.70** 25 33 (23)
Arthralgia 11 63 (15) 0.034* 0.053** 9 20 (14)
Chills 14 28 (7) 0.000* 0.48** 6 6 (4)
Vomiting 4 10 (2) 0.044* 0.004** 8 6 (4)
a
Notes: : Data are presented as n (%); *: Comparison of AE prevalence among 16 – 55-year-olds (1) in the registration study versus 18 – 55-year-old
HCWs in our study; **: Comparison of AE prevalence among >55-year-olds (1) in the registration study versus >55-year-old; HCWs in our study; The
significance level was set at 5% (P<0.05).
Abbreviations: AE: Adverse event; HCW: Health care workers.

the pivotal study ; this was unexpected due to the high
2,5
proportion of women in our sample and previous reports
of greater prevalence of side effects in (younger) women
than men. The proportion of women and men was half
16
in registration studies, and the results for both sexes are
always published together. Therefore, in samples such as
2
ours, with a significantly higher proportion of women,
the side effects should have been more than in samples
with a 50/50 sex distribution. In a survey of German
hospital staff, approximately 4.4% – 13.1% (vaccinated
with Comirnaty and Moderna) of participants were sick
for at least 1 day due to side effects after the first mRNA
21
vaccine dose. Thus, considering the high workload of
hospital staff, measures should be taken to reduce the rate
of side effects. 21,22 Our sample may have had high positive
Figure 1. Prevalence of systemic AEs (after 1 mRNA vaccine dose, expectations of the vaccination because they were burdened
st
Comirnaty or Moderna) in relation to expressed concerns regarding 22,23
the vaccination process. Image created by the author by the pandemic. Such positive expectations may have
Abbreviation: AE: adverse event. manifested as better tolerability to the vaccine (similar
to a placebo effect). Furthermore, our sample may have
9
4. Discussion demonstrated a positive attitude toward the vaccinations
and preventive measures or were used to them (e.g., annual
The sex distribution in our sample (78% women) is relatively flu vaccinations). At the beginning of the vaccination
typical for German hospital staff. A health report prepared drive, only information regarding vaccine tolerability was
by a large German health insurance company (Techniker available from registration studies. However, information
2
Krankenkasse) stated that 75% of nursing staff are women regarding side effects can significantly contribute to
19
and compared the incapacity to work diagnosis of nursing nocebo effects. The lack of knowledge regarding the
6-9
staff with those of other occupational groups. Compared side effects could have protected against nocebo effects.
with the normal German population, our participants were Finally, the high proportion of women in our sample could
less obese (women: 24% vs. 14%; men: 23% vs. 10%). Our influence the development of nocebo effects. However,
20
study and the GEDA 2019/2020-EHIS used self-reported previous studies have not yet established a clear influence
data from participants, often leading to an underestimation of sex on the respective placebo or nocebo response in
of body weight compared with standard values. The male RCTs. 24,25 Approximately one-fifth of our patient sample
HCWs in our study smoked less frequently than those in expressed worries regarding the vaccination course; this
the German general population (20.1% vs. 33.9%); similar is consistent with Holzmann-Littig et al.’s results, in which
data was obtained for women (25% vs. 24%). 20 approximately 15% of the surveyed staff expressed fears
Similar to previous studies, our study partially of short-term side effects of the vaccination. Herein,
1
demonstrated significantly lower AE rates than those in there was a clear association between existing concerns

Volume 3 Issue 1 (2025) 105 doi: 10.36922/jcbp.4727