Swissmedic Vigilance News

SARS-CoV-2 test positive
Headache 88
Herpes zoster
Pyrexia
Vaccination failure
Fatigue
COVID-19
Myalgia
Dizziness
Chills
37
39
42
49
49
0 20 40 60 80 100
61
71
86
86
Figure 3: Top 10 reactions from HCPs without an IME match
Injection site pain
Injection site reaction
Musculoskeletal pain
Pyrexia 358
Headache
Fatigue
Chills
Nausea
Myalgia
Dizziness
73
88
102
118
112
149
0 50 100 150 200 250 300 350 400
223
246
331
Figure 4: Top 10 reactions from patients/relatives without an IME match
Discussion
In Switzerland, more than one third of all reported
ADRs related to COVID-19 vaccination during
the period analysed were classified as “serious” by
the primary reporters. Of these reports, 2,260 cases
were classified as “serious” on the basis of the
criterion “medically important” alone. In comparison,
an analysis of the US VAERS database revealed
6.6% serious reports (7.9% serious reports including
deaths) (6). In that analysis, reports were classified
as “serious” only by the more unequivocal
criteria (i.e. inpatient hospitalisation, prolongation
of hospitalisation, permanent disability, life-threat-
ening illness, congenital anomaly or birth defect,
or death) (6). The criterion “medically important”
was not applied in the VAERS analysis to classify a
case as serious, which explains the lower rate of
serious reports.
Other analyses also show a significantly lower proportion
of serious reports compared to Switzerland.
However, seriousness was not defined in the
same way in all studies, and the criterion “medically
important” was not included (10, 11). Analyses using
relatively short data periods at the beginning
of vaccination campaigns tend to show a higher
Swissmedic Vigilance News | Edition 31 – November 2023
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