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.
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.