https://www.ema.europa.eu/en/documents/covid-19-vaccine-safety-update/covid-19-vaccine-safety-update-comirnaty-11-august-2021_en.pdf
Comirnaty is a vaccine that was authorised in the EU on 21 December
2020
Updates on safety assessments for
Comirnaty
PRAC assessed new safety data, including the latest Monthly Summary
Safety Report (MSSR)2
from the marketing authorisation holder and data
reported by patients and healthcare professionals to EudraVigilance (see
section 2), during its meetings on 22 July and 5 August 2021. No further
updates to the product information are currently recommended.
Erythema multiforme
PRAC started an assessment of erythema multiforme (EM; a
hypersensitivity (allergic) reaction with characteristic round skin lesions,
which may also affect mucous membranes in internal body cavities) to
establish whether it is a side effect of Comirnaty. The assessment follows
a small number of cases reported after vaccination with Comirnaty to
EudraVigilance (see section 2). Reported cases concern suspected side
effects, i.e. medical events that have been observed after vaccination, but
which are not necessarily related to or caused by the vaccine.
Further data and analyses have been requested from the marketing
authorisation holder to support the ongoing assessment by PRAC.
Glomerulonephritis and nephrotic syndrome
PRAC started an assessment of glomerulonephritis (inflammation of tiny
filters in the kidneys) and nephrotic syndrome (kidney disorder causing
the kidneys to leak too much protein in the urine) to establish whether
they may be side effects of Comirnaty. Affected patients may present with
bloody or foamy urine, oedema (swelling of the eyelids, feet or abdomen), or fatigue. The assessment follows a small number of cases reported after
vaccination with Comirnaty in the medical literature, including cases
where patients experienced relapse of pre-existing kidney conditions.
Further data and analyses have been requested from the marketing
authorisation holder to support the ongoing assessment by PRAC.
Menstrual disorders
PRAC discussed reported cases of menstrual disorders occurring after
vaccination against COVID-19. No causal association between COVID-19
vaccines and menstrual disorders has been established so far.
Menstrual disorders are very common in the general population and can
occur without an underlying medical condition. Causes can range from
stress and tiredness to conditions such as fibroids and endometriosis.
Women experiencing unexpected vaginal bleeding (e.g. in
postmenopausal women) or who are concerned about prolonged or severe
menstrual disturbances may want to seek medical advice.
The marketing authorisation holders for all COVID-19 vaccines authorised
in the EU have been requested to provide further data as part of the
MSSRs. PRAC will review all available evidence, including reports of
suspected side effects and scientific literature, and will continue
monitoring the issue