Global burden of vaccine‐associated hepatobiliary and gastrointestinal adverse drug reactions, 1967–2023: A comprehensive analysis of the international pharmacovigilance database
Journal of Medical Virology,
Journal Year:
2024,
Volume and Issue:
96(7)
Published: July 1, 2024
Abstract
Although
previous
studies
have
focused
on
hepatobiliary
and
gastrointestinal
adverse
drug
reactions
(ADRs)
associated
with
COVID‐19
vaccines,
literature
such
ADRs
other
vaccines
is
limited,
particularly
a
global
scale.
Therefore,
we
aimed
to
investigate
the
burden
of
vaccine‐associated
identify
implicated
in
these
occurrences.
This
study
utilized
data
from
World
Health
Organization
(WHO)
international
pharmacovigilance
database
extract
reports
1967
2023
(total
=
131
255
418).
Through
reporting
counts,
reported
odds
ratios
(ROR)
95%
confidence
interval
(CI),
information
components
(IC)
IC
0.25
,
examined
association
between
16
incidence
across
156
countries.
Of
6
842
303
ADRs,
10
786
liver
injury,
927
870
symptoms,
2978
pancreas
bile
duct
96
intra‐abdominal
hemorrhage
were
identified.
Most
surged
after
2020,
majority
attributed
messenger
RNA
(mRNA)
vaccines.
Hepatitis
A
exhibited
highest
injury
(ROR
[95%
CI]:
10.30
[9.65–10.99];
[IC
]:
3.33
[3.22]),
followed
by
hepatitis
B,
typhoid,
rotavirus.
Specifically,
ischemic
had
significant
both
Ad5‐vectored
mRNA
Gastrointestinal
symptoms
all
except
for
tuberculosis
rotavirus
(11.62
[11.45–11.80];
3.05
[3.03])
typhoid
(11.02
[10.66–11.39];
3.00
[2.96]).
Pancreas
(1.99
[1.89–2.09];
0.90
[0.83]),
MMR
(measles,
mumps,
rubella),
papillomavirus
For
hemorrhage,
inactivated
whole‐virus
(3.93
[1.86–8.27];
1.71
[0.41])
association,
(1.81
[1.42–2.29];
0.77
[0.39]).
short
time
onset,
within
1
day,
low
mortality
rate.
scale
database,
occurred
emphasizing
importance
healthcare
workers'
vigilant
monitoring
timely
management.
Language: Английский
Analytical review of facial nerve palsy following SARS-CoV-2 vaccination: comprehensive assessment
European Archives of Oto-Rhino-Laryngology,
Journal Year:
2025,
Volume and Issue:
unknown
Published: Jan. 10, 2025
Language: Английский
Global Burden of Drug‐Induced Severe Cutaneous Adverse Reactions Associated With 33 Classes of Antibiotics (1968–2024): An Analysis of International Pharmacovigilance Reports
Clinical & Experimental Allergy,
Journal Year:
2025,
Volume and Issue:
unknown
Published: April 10, 2025
Language: Английский
Post COVID-19 and Long COVID Symptoms in Otorhinolaryngology—A Narrative Review
Journal of Clinical Medicine,
Journal Year:
2025,
Volume and Issue:
14(2), P. 506 - 506
Published: Jan. 14, 2025
Post/Long
COVID
(syndrome)
is
defined
as
a
condition
with
symptoms
persisting
for
more
than
12
weeks
after
the
onset
of
SARS-CoV-2
infection
that
cannot
be
explained
otherwise.
The
prevalence
self-reported
otorhinolaryngological
high.
aim
this
review
was
to
analyze
current
literature
regarding
actual
prevalence,
knowledge
etiopathology,
and
evidence-based
treatment
recommendations
otorhinolaryngology-related
symptoms.
A
systematic
search
articles
published
since
2019
in
PubMed
ScienceDirect
performed
resulted
108
articles.
These
were
basis
formed
comprehensive
series
consented
therapy
statements
on
most
important
Otorhinolaryngological
did
not
appear
isolated
but
part
multi-organ
syndrome.
Self-reported
often
confirmed
by
objective
testing.
estimated
anosmia,
dysgeusia,
cough,
facial
palsy,
hoarseness/dysphonia,
acute
hearing
loss,
tinnitus,
vertigo/dizziness
about
4%,
2%,
4-19%,
0%,
17-20%,
8%,
20%,
5-26%,
respectively.
There
are
manifold
theoretical
concepts
etiopathology
different
symptoms,
there
no
clear
proof.
This
certainly
contributes
fact
effective
specific
option
any
mentioned.
Healthcare
pathways
must
established
so
can
recognized
evaluated
otorhinolaryngologists
provide
counseling.
would
also
help
establish
selectively
include
patients
clinical
trials
investigating
therapeutic
concepts.
Language: Английский
Global burden of anticancer drug-induced acute kidney injury and tubulointerstitial nephritis from 1967 to 2023
Scientific Reports,
Journal Year:
2024,
Volume and Issue:
14(1)
Published: July 12, 2024
Abstract
This
study
aims
to
figure
out
the
worldwide
prevalence
of
anticancer
therapy-associated
acute
kidney
injury
(AKI)
and
tubulointerstitial
nephritis
(TIN)
relative
risk
each
cancer
drug.
We
conducted
an
analysis
VigiBase,
World
Health
Organization
pharmacovigilance
database,
1967–2023
via
disproportionate
Bayesian
reporting
method.
further
categorized
drugs
into
four
groups:
cytotoxic
therapy,
hormone
immunotherapy,
targeted
therapy.
Reporting
odds
ratio
(ROR)
information
component
(IC)
compares
observed
expected
values
investigate
associations
category
with
AKI
TIN.
identified
32,722
2056
reports
(male,
n
=
17,829
1,293)
TIN,
respectively,
among
4,592,036
all-drug
caused
There
has
been
a
significant
increase
in
since
2010,
primarily
due
increased
therapy
immunotherapy.
Immunotherapy
exhibited
association
both
(ROR:
8.92;
IC
0.25
:
3.06)
TIN
(21.74;
4.24),
followed
by
(7.14;
2.68),
(5.83;
2.40),
(2.59;
1.24)
for
AKI,
(2.60;
1.21)
(1.54;
0.61)
were
more
prevalent
individuals
under
45
years
age,
female
preponderance
males
These
events
reported
close
temporal
relationship
after
initiation
respective
drug
(16.53
days
27.97
TIN),
high
fatality
rate,
23.6%
16.3%
findings
underscore
that
kidney-related
adverse
reactions
are
prognostic
significance
strategies
mitigate
such
side
effects
required
optimize
Language: Английский
Global burden of vaccine-associated Guillain-Barré syndrome over 170 countries from 1967 to 2023
Yi Deun Jeong,
No information about this author
Seoyoung Park,
No information about this author
Sooji Lee
No information about this author
et al.
Scientific Reports,
Journal Year:
2024,
Volume and Issue:
14(1)
Published: Oct. 19, 2024
Research
on
Guillain-Barré
syndrome
(GBS)
as
a
neurological
adverse
effect
of
vaccines
global
scale
is
scarce,
highlighting
the
need
for
further
investigation
to
evaluate
its
long-term
impact
and
associated
risk
factors
comprehensively.
Hence,
this
study
aims
assess
burden
vaccine-associated
GBS
vaccines.
This
utilized
data
from
VigiBase,
World
Health
Organization
database
event
reports
medicines
vaccines,
encompassing
period
1967
2023
(total
reports,
n
=
131,255,418)
investigate
GBS.
Reported
odds
ratios
(ROR)
information
components
(IC)
were
analyzed
association
between
19
occurrence
over
170
countries.
We
identified
15,377
(8072
males
[52.49%])
among
22,616
all
drugs-cause
1978
2023.
Cumulative
have
been
increasing
steadily
time,
with
notable
surge
observed
since
commencement
COVID-19
administration
in
2020.
Most
showed
significant
associations
such
Ad5-vectored
(ROR,
14.88;
IC,
3.66),
mRNA
9.66;
2.84),
inactivated
whole-virus
3,29;
IC
1.69).
Influenza
highest
77.91;
5.98).
Regarding
age-and
sex-specific
risks,
remained
similar
regardless
sex,
an
increased
advancing
age.
The
mean
time
onset
was
5.5
days.
Amid
pandemic,
surged
response
widespread
vaccination.
Nonetheless,
exhibited
lowest
compared
other
Vigilance
at
least
one-week
post-vaccination
crucial,
particularly
older
adults.
Further
research
warranted
elucidate
underlying
mechanisms
linking
Language: Английский
Biologics Use for Psoriasis during Pregnancy and Its Related Adverse Outcomes in Pregnant Women and Newborns: Findings from WHO Pharmacovigilance Study
Yi Deun Jeong,
No information about this author
Hyesu Jo,
No information about this author
Hanseul Cho
No information about this author
et al.
International Archives of Allergy and Immunology,
Journal Year:
2024,
Volume and Issue:
unknown, P. 1 - 15
Published: Dec. 3, 2024
Introduction:
The
safety
of
biologics,
other
than
TNF-α
inhibitors,
during
pregnancy
has
not
been
sufficiently
established.
To
assess
the
risk
pregnancy-related
adverse
outcomes
biologics
used
for
psoriasis,
compared
to
we
utilized
WHO
global
pharmacovigilance
database
(1968–2024).
Methods:
We
World
Health
Organization’s
from
1968
2024.
From
over
140
million
reports
more
170
countries,
extracted
6,518
associated
with
interest.
These
included
inhibitors
(e.g.,
etanercept,
infliximab,
adalimumab,
certolizumab
pegol),
IL-12/IL-23
inhibitor
ustekinumab),
IL-17
secukinumab,
brodalumab,
ixekizumab,
bimekizumab),
and
IL-23
guselkumab,
tildrakizumab,
risankizumab).
Each
biologic
was
pegol
in
two
separate
disproportionality
analyses.
reporting
odds
ratio
(ROR)
calculated
maternal,
fetal,
neonatal
outcomes,
categorized
into
seven
major
groups.
Multivariable
sensitivity
analyses
were
conducted
validate
primary
results.
Results:
analysis
showed
that,
most
had
a
lower
frequency
exception
brodalumab.
Specifically,
ROR
95%
confidence
intervals
(CIs)
as
follows:
ustekinumab
(ROR,
0.27;
CI:
0.21–0.35),
secukinumab
(0.17;
0.13–0.22),
brodalumab
(0.20;
0.02–2.21),
ixekizumab
(0.05;
0.03–0.08),
bimekizumab
(0.10;
0.01–0.71),
guselkumab
(0.09;
0.05–0.15),
tildrakizumab
(0.02;
0.00–0.14),
risankizumab
(0.38;
0.25–0.58).
However,
reported
higher
abortion
stillbirth
(1.87;
1.32–2.63).
findings
consistent
when
pegol,
well
multivariable
Furthermore,
comparing
infliximab
0.71;
0.55–0.92),
etanercept
comparable
(1.00;
0.77–1.31),
adalimumab
(1.42;
1.11–1.81).
Conclusions:
Biologics
exhibit
suggesting
their
potential
be
safe
options
pregnancy.
further
studies
are
necessary
evaluate
these
pregnancy,
accounting
confounding
factors.
Language: Английский
Lower Motor Neuron Facial Nerve Paralysis Following Recombinant Hepatitis B Vaccine Administration: A Case Report and Literature Review
Raza Gulzar Ghouri,
No information about this author
Hamza Naeem,
No information about this author
Mirza Rehan Yousaf
No information about this author
et al.
Clinical Case Reports,
Journal Year:
2024,
Volume and Issue:
12(12)
Published: Dec. 1, 2024
The
Hepatitis
B
vaccine's
safety
profile
is
considered
safe,
but
sometimes
neurological
complications,
like
Bell's
palsy
(acute
peripheral
facial
neuropathy),
can
occur
after
its
administration.
A
35-year-old
female
doctor
experienced
left-sided
weakness
and
paralysis
six
days
getting
the
vaccine.
On
examination,
she
had
lower
motor
neuron
nerve
palsy.
After
excluding
other
causes,
a
diagnosis
of
was
made
following
She
treated
with
corticosteroids,
antiviral
medication,
physiotherapy,
which
led
to
complete
resolution
over
four
weeks.
still
an
uncommon
potential
side
effect
even
though
advantages
vaccination
exceed
risks.
Further
investigation
necessary
prove
conclusive
link
between
vaccine
effects.
Language: Английский