Does side effects of COVID-19 vaccination include changes in menstrual cycle or its associated pre- and post-menstrual symptoms in reproductive-age women: A Multi-centric Observational study in India.

Abstract

Objective: The study was conducted to know the impact of COVID-19 vaccination on menstrual cycle patterns, pre- and post-menstrual symptoms in women aged 18-45 years. Design & Setting: Multicentric observational study conducted in six institutes of national importance in different states of India over one year. Population: A total of 5709 female participants fulfilling inclusion criteria were enrolled. Methods: Data about impact of vaccines (COVISHIELD and COVAXIN) and prior COVID-19 infection on menstrual cycle and its associated symptoms were obtained using an online and offline survey. Main Outcome: COVID-19 vaccination with COVISHILED/COVAXIN resulted in menstrual cycle disturbances. Results: Of 5709 participants, 78.2% received COVISHIELD, 21.8% COVAXIN. Of all, 333(5.8%) developed post-vaccination menstrual disturbances with 32.7% frequent cycles, 63.7% prolonged cycles, and 3.6% inter-menstrual bleed. 301 participants, noticed changes in the amount of bleeding, with 50.2% excessive, 48.8% scanty, and 0.99% amenorrhea followed by heavy bleeding. Furthermore, the irregularities of menstrual cycle (p=0.011) and length (0.001) were significantly higher in the COVAXIN group (7.2%) as compared to COVISHIELD (5.3%). A total of 721 participants complained of newly developed/worsening pre- and post-menstrual symptoms. These symptoms were significantly higher in COVISHIELD group (p=0.031) with generalized weakness and body pains as main complaints (p=0.001). No significant difference was observed in COVID-19 infection incidence with these vaccines. When comparing menstrual abnormalities among those with COVID-19 infection, no significant associations were observed (p >0.05). Conclusions: COVISHILED and COVAXIN resulted in menstrual cycle disturbances and pre-and post-menstrual symptoms. The menstrual irregularities were significantly higher with COVAXIN vaccine.

COVID-19 Vaccination and Women's Menstrual Cycle: A Cross-sectional Study Performed

“…This observation can be due to differences in the studied society and race. In addition, in a study performed on 721 participants in India with the aim of investigating menstrual disorders after COVID-19 vaccine administration (Covaxin and Covishield), it was revealed that these disorders were considerably increased after Covaxin administration (15).…”

Evaluation of prenatal administration of valproic acid on the cerebellum of albino rat offspring

“…Since the launch of the coronavirus disease 2019 (COVID- 19) in December 2019, it has disturbed almost every aspect of lives worldwide with not only remarkable morbidity and mortality, but also crucial social, educational as well as economic challenges [1].…”