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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.
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  • Naina Kumar,
  • Neha Gagane,
  • Ipsita Mahopatra,
  • Charushila Rukadikar,
  • Vijayan Sharmila,
  • K. Pushpalatha,
  • Madhavi Eerike,
  • G. Santhoshi,
  • Subha Samantaray,
  • Shikha Seth,
  • Pragati Trigunait,
  • Nanditha Reddy,
  • Shweta Patel,
  • Sandhya Rani,
  • Roopanshi Mishra,
  • Kamlesh Negi
Naina Kumar
All India Institute of Medical Sciences - Bibinagar

Corresponding Author:[email protected]

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Neha Gagane
All India Institute of Medical Science - Bhopal
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Ipsita Mahopatra
All India Institute of Medical Sciences - Kalyani
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Charushila Rukadikar
All India Institute of Medical Sciences - Gorakhpur
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Vijayan Sharmila
All India Institute of Medical Sciences - Mangalagiri
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K. Pushpalatha
All India Institute of Medical Science - Bhopal
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Madhavi Eerike
All India Institute of Medical Sciences - Bibinagar
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G. Santhoshi
All India Institute of Medical Sciences - Bibinagar
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Subha Samantaray
All India Institute of Medical Sciences - Kalyani
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Shikha Seth
All India Institute of Medical Sciences - Gorakhpur
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Pragati Trigunait
All India Institute of Medical Sciences - Mangalagiri
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Nanditha Reddy
All India Institute of Medical Sciences - Mangalagiri
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Shweta Patel
All India Institute of Medical Science - Bhopal
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Sandhya Rani
All India Institute of Medical Sciences - Bibinagar
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Roopanshi Mishra
All India Institute of Medical Sciences - Gorakhpur
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Kamlesh Negi
All India Institute of Medical Sciences - Gorakhpur
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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.