ABSTRACT
Introduction: During the current pandemic, Covid-19 vaccination has become an indispensable solution for what used to be a normal life. Several side effects commonly reported with Covid-19 vaccination are injection site reactions, fatigue, and fever. Although not common, there have been some reports of hormonal disturbances such as menstrual irregularities and hair loss. A reasonable explanation of menstrual changes includes the effect of immune response activation on menstrual cycle driving hormones. Similarly, hair loss could be explained by the interrelation of the immune response with vaccination (1,2). Objective(s): To determine the rate and seriousness of menstrual disturbance and hair loss events following COVID-19 vaccine administration in Saudi Arabia using the Saudi Food and Drug Authority's (SFDA) spontaneous reporting system. Method(s): a cross-sectional retrospective study measured the rate of spontaneous reports of hormonal change, including menstrual disorder and hormonal hair loss events, after the COVID-19 vaccine was received on SFDA electronic system from January 2021 to December 2021. All reports associated with hormonal change other than menstrual disturbance and hair loss were excluded. The SFDA manages the Vigilance reporting System, which receives spontaneous reports from healthcare providers and the public. The study examines the rate and seriousness of the hormonal changes post-vaccination, specifically menstrual irregularities & hair loss (AEFI), for all covid-19 reports received from any stakeholders during 2021 and for all types of COVID-19 registered vaccines in Saudi Arabia including Pfizer (BNT162 vaccine), AstraZeneca (ChAdOx1-S) and Moderna (mRNA embedded in SM-102 lipid nanoparticles) vaccines. Result(s): During the study period, a total of 280,000 Adverse events Following Immunization (AEFI) reports with COVID-19 vaccines were received. Of all reports, 58 reports concerning menstrual disturbance and 20 reports concerning hair loss were identified. The majority of reported hair loss cases were female (95%). By vaccines, BioNTech BNT162 (14), AstraZeneca (5), Moderna (1). On the other hand, (76%) of menstrual disturbance cases occurred after administering BioNTech BNT162, followed by (17%) AstraZeneca, and a minor percentage was with Moderna at (7%). Regarding seriousness, from the total number of cases reported, 97% were non-serious. Conclusion(s): The association between hormonal disturbances and COVID-19 vaccines remains uncertain. Hence, further studies are warranted to investigate our observation. In conclusion, the key recommendation generated from the study is the implementation of awareness campaigns to promote an ADR reporting culture to correlate rare events occurrences with the use of COVID-19 vaccines.
ABSTRACT
Introduction: During the current pandemic, Covid-19 vaccination has become an indispensable solution for what used to be a normal life. Several side effects commonly reported with Covid-19 vaccination are injection site reactions, fatigue, and fever. Although not common, there have been some reports of hormonal disturbances such as menstrual irregularities and hair loss. A reasonable explanation of menstrual changes includes the effect of immune response activation on menstrual cycle driving hormones. Similarly, hair loss could be explained by the interrelation of the immune response with vaccination (1,2). Objective: To determine the rate and seriousness of menstrual disturbance turbance and hair loss events following COVID-19 vaccine administration in Saudi Arabia using the Saudi Food and Drug Authoritys (SFDA) spontaneous reporting system. Methods: a cross-sectional retrospective study measured the rate of spontaneous reports of hormonal change, including menstrual disorder and hormonal hair loss events, after the COVID-19 vaccine was received on SFDA electronic system from January 2021 to December 2021. All reports associated with hormonal change other than menstrual disturbance and hair loss were excluded. The SFDA manages the Vigilance reporting System, which receives spontaneous reports from healthcare providers and the public. The study examines the rate and seriousness of the hormonal changes post-vaccination, specifically menstrual irregularities & hair loss (AEFI), for all covid-19 reports received from any stakeholders during 2021 and for all types of COVID-19 registered vaccines in Saudi Arabia including Pfizer (BNT162 vaccine), AstraZeneca (ChAdOx1-S) and Moderna (mRNA embedded in SM-102 lipid nanoparticles) vaccines. Results: During the study period, a total of 280,000 Adverse events Following Immunization (AEFI) reports with COVID-19 vaccines were received. Of all reports, 58 reports concerning menstrual disturbance and 20 reports concerning hair loss were identified. The majority of reported hair loss cases were female (95%). By vaccines, BioNTech BNT162 (14), AstraZeneca (5), Moderna (1). On the other hand, (76%) of menstrual disturbance cases occurred after administering BioNTech BNT162, followed by (17%) AstraZeneca, and a minor percentage was with Moderna at (7%). Regarding seriousness, from the total number of cases reported, 97% were non-serious. Conclusion: The association between hormonal disturbances and COVID-19 vaccines remains uncertain. Hence, further studies are warranted to investigate our observation. In conclusion, the key recommendation generated from the study is the implementation of awareness campaigns to promote an ADR reporting culture to correlate rare events occurrences with the use of COVID-19 vaccines.