SARS-CoV-2 Vaccines and Adverse Effects in Gynecology and Obstetrics: The First Italian Retrospective Study

Abstract

The most common effects reported by the Italian Medicine Agency following administration of SARS-CoV-2 vaccine are myalgia, soreness to the arm of inoculation, fever, and asthenia. To date, there are no specific and official reports registered by the Italian Medicine Agency on possible alterations of the menstrual cycle, or of the female reproductive system, following the vaccine. Actually, clinical experience showed a spread of transient adverse drug reactions of the menstrual cycle, following the administration of all COVID-19 vaccine types, both mRNA and Adenovirus vectored ones. In this work, we conducted the first retrospective study on Italian patients vaccinated for SARS-CoV-2 in the period between April 2021 and April 2022, to report the onset of menstrual changes after the vaccine in order to understand: etiology, duration of possible adverse effects, and the extent of the phenomenon. We recruited 100 women aged 18-45, vaccinated for SARS-CoV-2, who were asked to complete a questionnaire consisting of 12 multiple choice questions about the effects of the vaccine on the reproductive system. Thirty-seven of them received three doses of the vaccine, while the remaining 63 received two doses. Symptoms such as delayed menstruation and abnormal uterine bleeding (metrorrhagia, menometrorrhagia, and menorrhagia) were generally reported within the first three weeks of vaccination, especially after the second dose, with a percentage of 23% and 77%, respectively. These preliminary data suggest that this problem may be broader and deserving of further investigation in the future.

Keywords: SARS-CoV-2; anomalous uterine bleeding; gynecological and obstetric effects; vaccine.

Figure 1

Histogram of COVID-19 vaccine types and corresponding adverse effects. Legend and abbreviations: y = vaccinated women with menstrual irregularities due to other causes, NoADV/vaccinated women whose menstrual irregularities could be adverse effects to vaccine, VAX-ADV/which adverse effect, late period, LP, or abnormal uterine bleeding, AUB; x = number of all vaccinated women with menstrual irregularities.

Figure 2

Histogram of COVID-19 vaccines doses and corresponding adverse effects. Legend and abbreviations: y = vaccinated women with menstrual irregularities due to other causes, NoADV/vaccinated women whose menstrual irregularities could be adverse effects to vaccine, VAX-ADV/which adverse effect, late period, LP, or abnormal uterine bleeding, AUB; x = number of all vaccinated women with menstrual irregularities.

Figure 3

Obstetric outcome in COVID-19 vaccinated women whose menstrual irregularities could be adverse effects to vaccine. Legend and abbreviations: y = women not seeking pregnancy, NO-SP/women unsuccessfully seeking pregnancy, UNs-SP/women undergone voluntary interruption of pregnancy, VIoP/cases of miscarriages, MSC/cases of threat of preterm labor, ToPreTL/women got pregnant, PGN; x = number of vaccinated women.