Journal of Clinical Medicine,
Год журнала:
2024,
Номер
13(23), С. 7291 - 7291
Опубликована: Ноя. 30, 2024
Clarifying
and
differentiating
the
causes
of
diseases
is
an
essential
step
in
any
clinical
activity,
but
it
takes
on
particular
relevance
complexity
case
that
arise
following
vaccinations.
The
WHO
has
proposed
a
protocol
uses
list
specific
questions
about
vaccine-related
adverse
events
algorithm
for
making
judgement.
Here,
we
analyze
discuss
important
limitations
this
when
applied
to
new
genetic-based
anti-COVID-19
vaccines,
particularly
once
dealing
with
rare
unexpected
pathological
events.
main
controversial
aspects
concern:
(a)
prevailing
consideration
other
possible
causes;
(b)
biological
plausibility
choice
appropriate
time
window
consider
effects
possibly
caused
by
vaccines;
(c)
reference
scientific
literature,
which
may
be
very
limited
often
early
stages
introducing
vaccines
because
short
period
observation;
(d)
final
classification
into
only
three
classes,
leaves
ample
space
"indeterminate"
category.
Failure
address
these
issues
lead
distorted
pharmacovigilance
reports
significant
consequences
benefit/harm
assessment.
In
anticipation
future
pandemics
managed
needs
revised
protocols
monitoring
evaluation
take
account
novel
mechanism
action
real-world
epidemiological
data.
BMJ Sexual & Reproductive Health,
Год журнала:
2024,
Номер
50(3), С. 212 - 225
Опубликована: Июнь 10, 2024
Menstrual
health
is
a
key
patient-reported
outcome
beyond
its
importance
as
general
indicator
of
and
fertility.
However,
menstrual
function
was
not
measured
in
the
clinical
trials
COVID-19
vaccines.
The
purpose
this
review
to
synthesise
existing
literature
on
relationship
between
vaccination
outcomes.
Frontiers in Drug Safety and Regulation,
Год журнала:
2024,
Номер
4
Опубликована: Янв. 31, 2024
Introduction:
Menstrual
disorders
are
commonly
reported
after
COVID-19
vaccination
and
heavy
menstrual
bleeding
was
added
to
the
product
information
of
vaccines
Moderna
Pfizer.
The
aim
this
review,
using
a
systematic
search,
is
provide
an
overview
available
literature
on
risk
vaccination.
Methods:
review
conducted
according
Preferred
Reporting
Items
for
Systematic
reviews
Meta-Analysis
(PRISMA)
guidelines.
A
PubMed
search
performed
15
August
2023,
including
solely
quantitative
studies
in
English
Dutch.
Results:
total
61
were
included,
which
40
cross-sectional
studies,
18
cohort
three
self-controlled
case
series.
Outcomes
included
wide
variety
disorders,
changes
cycle
length
(
n
=
54),
amount
44),
menses
30),
experience
(pre)menstrual
pain
21),
breakthrough
18).
All
found
higher
percentage
at
least
one
disorder
first
different
types
doses.
Discussion:
In
conclusion,
evidence
suggests
that
may
cause
women
reproductive
age.
However,
there
need
more
longitudinal
because
important
limitations
study
designs
many
studies.
Although
short-lived
predominantly
mild,
it
healthcare
professionals
be
informed
about
these
potential
adverse
reactions
assess
events
clinical
trials
vaccines.
Women & Health,
Год журнала:
2025,
Номер
unknown, С. 1 - 15
Опубликована: Янв. 17, 2025
A
growing
body
of
evidence
suggests
a
potential
link
between
the
SARS-CoV-2
vaccine
and
menstrual
changes
in
women
who
were
menstruating
at
time
vaccination.
Nevertheless,
prevalence
this
event
those
with
secondary
amenorrhea
for
different
causes,
i.e.
formerly
women,
remains
unclear.
It
is
plausible
that,
analogous
to
observed
currently
they
experienced
some
degree
alteration
their
reproductive
health,
defined
here
as
menstrual-related
disturbances.
The
aim
was
analyze
phenomenon
identify
factors
associated
occurrence
disturbances
subpopulation.
Study
design:
retrospective
observational
cross-sectional
study
conducted
among
adult
Spanish
December
2021
using
an
online
survey
(N
=
17,512).
present
analysis
includes
subpopulation
vaccinated
548).
General
characteristics,
medical
history,
adverse
events
following
COVID-19
vaccination
recorded.
Chi-square,
Mann-Whitney
U
McNemar
mid-P
tests
performed.
Bivariate
logistic
regression
then
used
key
influencing
unexpected
event.
In
comparison
first
dose,
significantly
higher
percentages
respondents
(dose
1:
38.5
percent
vs.
dose
2:
44.8
percent)
after
receiving
second
one.
Among
them,
related
length
flow
stand
out,
being
long-term
nature
about
17-20
cases.
Interindividual
1
may
include
weight,
perimenopause,
preexisting
diagnoses
non-autoimmune
rheumatic/articular
conditions,
use
hormonal
contraceptives,
suffering
from
other
side
effects
-
such
arm
pain
number
previous
pregnancies;
2,
these
alterations
1,
well
contraceptives
perimenopause.
Formerly
might
experience
Potential
pregnancies.
Pharmacoepidemiology,
Год журнала:
2025,
Номер
4(2), С. 8 - 8
Опубликована: Апрель 7, 2025
Objective:
The
aim
of
this
study
was
to
investigate
a
possible
relationship
between
the
time
onset
(TTO)
adverse
events
following
immunization
(AEFIs)
and
recall
bias
compare
it
AEFIs
COVID-19
vaccines
reported
though
spontaneous
reporting
system
(SRS)
those
from
cohort
event
monitoring
(CEM)
study.
Methods:
A
retrospective
comparing
TTO
patterns
four
SRS
CEM
performed.
Reports
concerning
related
vaccination
were
used
for
stratified
dose
number,
perceived
burden
AEFI,
being
pre-defined.
Additionally,
since
menstrual
disorders
received
much
media
attention,
their
effect
on
pattern
investigated
reports
only.
Results:
total
160,613
19,979
CEM,
containing
755,647
103,703
AEFIs,
respectively,
included.
For
with
short
TTO,
no
differences
in
observed.
However,
median
lower
increasing
duration.
There
both
before
during
episodes
but
correlation
two
could
be
found.
Conclusions:
Based
performed
analyses,
does
not
seem
more
evident
compared
studies
TTO.
longer
may
pronounced.
Vaccine,
Год журнала:
2024,
Номер
42(25), С. 126130 - 126130
Опубликована: Июль 14, 2024
Several
studies
described
that
COVID-19
vaccinations
can
cause
menstrual
disorders.
Our
study
aimed
to
describe
whether
this
also
resulted
in
more
general
practitioner
(GP)
consultations
for
disorders
after
vaccination,
based
on
a
large
cohort
study.
Vaccine,
Год журнала:
2024,
Номер
42(24), С. 126252 - 126252
Опубликована: Сен. 2, 2024
COVID-19
vaccination
has
been
inconsistently
associated
with
an
increased
risk
of
heavy
menstrual
bleeding
in
previous
studies.
This
study
aimed
to
assess
the
requiring
hospital
care
following
according
number
doses
received
and
time
elapsed
since
vaccination.
In
March
2020,
World
Health
Organization
recognized
severe
acute
respiratory
syndrome
coronavirus
2
(SARS-CoV-2)
emergence
as
a
public
health
emergency
of
international
concern.
One
the
major
preventative
measures
developed
against
disease
2019
(COVID-19)
was
vaccines.
To
monitor
their
use
and
safety
vaccines
from
first
utilization
in
humans
during
clinical
development
phases
to
implementation
for
general
population,
an
enhanced
national
pharmacovigilance
system
enabled
by
French
National
Agency
Medicines
Products
Safety
collaboration
with
30
Regional
Pharmacovigilance
Centres.
Here,
we
review
significant
outcomes
2-year
experience
between
Safety,
Centres,
disease-related
experts
risk
assessment
committee
at
European
medicine
agency.
France,
until
January
2023,
over
155
million
doses
COVID-19
were
administrated,
190,000
adverse
events
following
immunizations
(25%
classified
serious)
analysed.
Altogether
53
potential
signals
reported
Risk
Assessment
Committee
Medicine
Safety:
13
confirmed,
24
are
still
under
investigation
16
not
confirmed.
The
PV
contributed
actively
better
define
profile
newly
vaccines,
continues
benefit
risks
