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      Menstrual Symptoms After COVID-19 Vaccine: A Cross-Sectional Investigation in the MENA Region

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          Abstract

          Background

          Since the emergence of COVID-19 vaccinations, many women around the world are reporting abnormalities in their menstrual periods post-vaccination. The aim of this study is to investigate the prevalence and impact of menstrual abnormalities after the COVID-19 vaccine among females residing within the Middle East and North Africa (MENA).

          Methods

          The study utilized a cross-sectional online self-administered survey from July 2021 to August 2021 targeting females living in the MENA region above the age of menarche who had received vaccine and were not pregnant or lactating, and do not have a history of primary ovarian insufficiency, hypothalamic menopause, or have undergone a hysterectomy. The survey was distributed regionally via social media.

          Results

          A total of 2269 females were included in our study, with a mean age of 34.3 ± 8.5 years. About 66.3% of participants reported menstrual symptoms post-vaccination, of which 46.7% experienced them after their first dose. However, in 93.6% of participants, the symptoms resolved within 2 months. Vaccine type did not significantly influence the incidence of abnormalities (p > 0.05). Participants who had confirmed previous COVID-19 infection had a very similar percentage of menstrual abnormalities compared to people who did not have COVID-19 infection or symptoms suspected of COVID-19 infection and did not test (67.5%, 66.8%, respectively); nevertheless, those who had experienced the COVID-19 vaccine general side effects had significantly more abnormalities (p < 0.001). Compared to their pandemic status, females reported significantly more abnormalities post-vaccination.

          Conclusion

          The study showed a possible link between the COVID-19 vaccine and menstrual abnormalities that have impacted their quality of life.

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          Most cited references35

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          Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting

          Background Preapproval trials showed that messenger RNA (mRNA)–based vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had a good safety profile, yet these trials were subject to size and patient-mix limitations. An evaluation of the safety of the BNT162b2 mRNA vaccine with respect to a broad range of potential adverse events is needed. Methods We used data from the largest health care organization in Israel to evaluate the safety of the BNT162b2 mRNA vaccine. For each potential adverse event, in a population of persons with no previous diagnosis of that event, we individually matched vaccinated persons to unvaccinated persons according to sociodemographic and clinical variables. Risk ratios and risk differences at 42 days after vaccination were derived with the use of the Kaplan–Meier estimator. To place these results in context, we performed a similar analysis involving SARS-CoV-2–infected persons matched to uninfected persons. The same adverse events were studied in the vaccination and SARS-CoV-2 infection analyses. Results In the vaccination analysis, the vaccinated and control groups each included a mean of 884,828 persons. Vaccination was most strongly associated with an elevated risk of myocarditis (risk ratio, 3.24; 95% confidence interval [CI], 1.55 to 12.44; risk difference, 2.7 events per 100,000 persons; 95% CI, 1.0 to 4.6), lymphadenopathy (risk ratio, 2.43; 95% CI, 2.05 to 2.78; risk difference, 78.4 events per 100,000 persons; 95% CI, 64.1 to 89.3), appendicitis (risk ratio, 1.40; 95% CI, 1.02 to 2.01; risk difference, 5.0 events per 100,000 persons; 95% CI, 0.3 to 9.9), and herpes zoster infection (risk ratio, 1.43; 95% CI, 1.20 to 1.73; risk difference, 15.8 events per 100,000 persons; 95% CI, 8.2 to 24.2). SARS-CoV-2 infection was associated with a substantially increased risk of myocarditis (risk ratio, 18.28; 95% CI, 3.95 to 25.12; risk difference, 11.0 events per 100,000 persons; 95% CI, 5.6 to 15.8) and of additional serious adverse events, including pericarditis, arrhythmia, deep-vein thrombosis, pulmonary embolism, myocardial infarction, intracranial hemorrhage, and thrombocytopenia. Conclusions In this study in a nationwide mass vaccination setting, the BNT162b2 vaccine was not associated with an elevated risk of most of the adverse events examined. The vaccine was associated with an excess risk of myocarditis (1 to 5 events per 100,000 persons). The risk of this potentially serious adverse event and of many other serious adverse events was substantially increased after SARS-CoV-2 infection. (Funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.)
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            Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine

            Background Early clinical data from studies of the NVX-CoV2373 vaccine (Novavax), a recombinant nanoparticle vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that contains the full-length spike glycoprotein of the prototype strain plus Matrix-M adjuvant, showed that the vaccine was safe and associated with a robust immune response in healthy adult participants. Additional data were needed regarding the efficacy, immunogenicity, and safety of this vaccine in a larger population. Methods In this phase 3, randomized, observer-blinded, placebo-controlled trial conducted at 33 sites in the United Kingdom, we assigned adults between the ages of 18 and 84 years in a 1:1 ratio to receive two intramuscular 5-μg doses of NVX-CoV2373 or placebo administered 21 days apart. The primary efficacy end point was virologically confirmed mild, moderate, or severe SARS-CoV-2 infection with an onset at least 7 days after the second injection in participants who were serologically negative at baseline. Results A total of 15,187 participants underwent randomization, and 14,039 were included in the per-protocol efficacy population. Of the participants, 27.9% were 65 years of age or older, and 44.6% had coexisting illnesses. Infections were reported in 10 participants in the vaccine group and in 96 in the placebo group, with a symptom onset of at least 7 days after the second injection, for a vaccine efficacy of 89.7% (95% confidence interval [CI], 80.2 to 94.6). No hospitalizations or deaths were reported among the 10 cases in the vaccine group. Five cases of severe infection were reported, all of which were in the placebo group. A post hoc analysis showed an efficacy of 86.3% (95% CI, 71.3 to 93.5) against the B.1.1.7 (or alpha) variant and 96.4% (95% CI, 73.8 to 99.5) against non-B.1.1.7 variants. Reactogenicity was generally mild and transient. The incidence of serious adverse events was low and similar in the two groups. Conclusions A two-dose regimen of the NVX-CoV2373 vaccine administered to adult participants conferred 89.7% protection against SARS-CoV-2 infection and showed high efficacy against the B.1.1.7 variant. (Funded by Novavax; EudraCT number, 2020-004123-16 .)
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              Reports of Anaphylaxis After Receipt of mRNA COVID-19 Vaccines in the US—December 14, 2020-January 18, 2021

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                Author and article information

                Journal
                Int J Womens Health
                Int J Womens Health
                ijwh
                International Journal of Women's Health
                Dove
                1179-1411
                28 March 2022
                2022
                : 14
                : 395-404
                Affiliations
                [1 ]Department of Obstetrics & Gynaecology, Jordan University Hospital , Amman, Jordan
                [2 ]The School of Medicine, The University of Jordan , Amman, Jordan
                [3 ]King Hussein Cancer Center , Amman, Jordan
                Author notes
                Correspondence: Nadia Muhaidat, Department of Obstetrics & Gynaecology, Jordan University Hospital , Queen Rania Street, Amman, 11942, Jordan, Tel +962 798385775, Email Nadiadat@hotmail.com
                Author information
                http://orcid.org/0000-0002-3495-799X
                http://orcid.org/0000-0003-3806-2859
                http://orcid.org/0000-0002-2046-8343
                http://orcid.org/0000-0001-9182-2111
                http://orcid.org/0000-0002-6794-0860
                http://orcid.org/0000-0002-3517-3601
                Article
                352167
                10.2147/IJWH.S352167
                8976114
                35378876
                85bea6a4-846c-44d1-aacf-1ff298482e06
                © 2022 Muhaidat et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                History
                : 02 December 2021
                : 17 February 2022
                Page count
                Figures: 2, Tables: 4, References: 40, Pages: 10
                Funding
                Funded by: No funding was provided for this study;
                No funding was provided for this study.
                Categories
                Original Research

                Obstetrics & Gynecology
                covid-19,mena,menstrual abnormalities,menstrual cycle,vaccine
                Obstetrics & Gynecology
                covid-19, mena, menstrual abnormalities, menstrual cycle, vaccine

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