Heavy menstrual bleeding in product information Pfizer and Moderna vaccines

The EMA recommended to add heavy menstrual bleeding to the product information of the COVID-19 vaccines of Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax). The Netherlands Pharmacovigilance Centre Lareb received over 9000 cases of heavy menstrual bleeding until now.

The EMA advised to adapt the product information of Pfizer/BioNTech and Moderna vaccines based on the assessment of available data, such as cases in clinical trails and cases reported via the spontaneous reporting system in Europe. Read more about the recommendation of the EMA on their website.

The Netherlands Pharmacovigilance Centre Lareb received 9.379 cases of menstrual bleeding after COVID-19 vaccination till the end of October. Of theses cases, 7.376 regarded the Pfizer/BioNTech vaccine, 1.115 the Moderna vaccine and 888 the other COVID-19 vaccines. In total Lareb received over 27.000 cases of various menstrual disorders after the vaccination. The full analysis of all the cases of menstrual disorders reported to Lareb until March 29 2022 can be found here.

Lareb is conducting further research on the number of women experiencing menstrual disorders before and after the COVID-19 vaccination based on data from the general practitioner.

There is no evidence to suggest that the COVID-19 vaccines have a negative effect on the reproduction, fertility or pregnancy.