Review of reports involving menstrual disorders and unexpected vaginal bleeding
The MHRA is reviewing, with expert advice, reports of suspected side effects of menstrual disorders and unexpected vaginal bleeding following vaccination against COVID-19 in the UK.
The rigorous evaluation completed to date does not support a link between changes to menstrual periods and related symptoms and COVID-19 vaccines. The number of reports of menstrual disorders and vaginal bleeding is low in relation to both the number of people who have received COVID-19 vaccines to date and how common menstrual disorders are generally. Details are included in the summary of Yellow Card reporting for the COVID-19 vaccines.
The menstrual changes reported are mostly transient in nature. There is no evidence to suggest that COVID-19 vaccines will affect fertility and the ability to have children.
It is important that anyone experiencing changes to their periods that are unusual for them, persist over time, or has any new vaginal bleeding after the menopause, following COVID-19 vaccination, should contact their doctor. Anyone presenting with menstrual disorders and/or unexpected vaginal bleeding following COVID-19 vaccination should be treated according to clinical guidelines for these conditions, as usual.
The MHRA continues to closely review reports of suspected side effects of menstrual disorders and unexpected vaginal bleeding. As with any suspected side effects from the COVID-19 vaccines, please continue to report via the Yellow Card scheme. You can also encourage your patients to do the same.
Safety of COVID-19 vaccines in pregnancy
Further information has also been included in the summary of Yellow Card reporting for the COVID-19 vaccines as the MHRA continues to closely monitor the safety of COVID-19 vaccine exposures in pregnancy, including Yellow Card reports for COVID-19 vaccines used in pregnancy.
The numbers of reports of miscarriage and stillbirth are low in relation to the number of pregnant women who have received COVID-19 vaccines to date and how commonly these events occur in the UK outside of the pandemic. There is no pattern from the reports to suggest that any of the COVID-19 vaccines used in the UK, or any reactions to these vaccines, increase the risk of miscarriage or stillbirth. There is no pattern from the reports to suggest that any of the COVID-19 vaccines used in the UK increase the risk of congenital anomalies or birth complications. Pregnant women have reported similar suspected reactions to the vaccines as people who are not pregnant.
The MHRA will continue to closely monitor safety data for use of the COVID-19 vaccines in pregnancy, including through evaluation of electronic healthcare record data.
Summaries of Yellow Card reporting and other recent MHRA publications
We continue to publish the summaries of the Yellow Card reporting for the COVID-19 vaccines being used in the UK. The report summarises information received via the Yellow Card scheme and will be published regularly to include other safety investigations carried out by the MHRA under the COVID-19 Vaccine Surveillance Strategy.
We have also recently:
We previously included summaries of latest COVID-19 information, including in the May 2021, June 2021, and July 2021 issues of Drug Safety Update.
See guidance on COVID-19 for all our latest information, including after publication of this article.
Reporting Yellow Cards
Suspected adverse reactions associated with COVID-19 vaccines should be reported to the MHRA through the MHRA’s Coronavirus Yellow Card reporting site or via the Yellow Card app.
As these products are under additional monitoring, this includes all suspected adverse reactions associated with these vaccines. This will allow quick identification of new safety information.
When reporting please provide as much information as possible, including information about medical history, any concomitant medications, onset, treatment dates, and vaccine product brand name and batch number.
You may be contacted following submission of a Yellow Card report so that we can gather additional relevant information for the assessment of the report. These contributions form an important part of our understanding of suspected adverse events.
Article citation: Drug Safety Update volume 15 issue 1: August 2021: 1.