Evaluation of menstrual symptoms after Coronavirus disease 2019 vaccination in women with endometriosis

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Abstract

Background:

Vaccination can have an impact on menstruation, and this impact may be more notable in women with inflammatory gynecological pathologies such as endometriosis.

Objectives:

We aimed to investigate the impact of mRNA-based SARS-CoV-2 vaccines on menstrual cycle–related symptoms in women with endometriosis and assess the effect of hormonal therapy on potential SARS-CoV-2 vaccination-induced menstrual changes.

Design:

A total of 848 women who received at least two doses of mRNA-based COVID-19 vaccines were prospectively recruited: 407 with endometriosis (endometriosis group) and 441 healthy controls (non-endometriosis group).

Methods:

Data regarding demographics, clinical characteristics, hormonal treatment, and menstrual-associated symptoms in the first and second cycle after vaccination were collected through an online survey.

Results:

A similar percentage of patients in both the endometriosis and the non-endometriosis group self-reported menstrual-associated changes the first (52.6% versus 48.8%, respectively) and second cycle after vaccination (29.0% versus 28.1%, respectively). Although the total symptoms recorded were not different between the two groups, several specific symptoms were statistically more frequent in the endometriosis group. These were pain disorders and fatigue in the first cycle after vaccination and pain disorders, menstrual headache and fatigue in the second cycle after vaccination. Bleeding frequency/regularity disorders were found to be more frequent in the non-endometriosis group in the first cycle after vaccination. Patients under hormonal treatment reported fewer changes in menstrual symptoms in the first and second cycle after vaccination compared with those not receiving this treatment. Similarly, patients in the endometriosis group receiving hormonal treatment reported fewer changes in menstrual-associated symptoms compared with those not following any hormonal treatment in the first and second menstrual cycle after the last vaccination.

Conclusion:

Women with endometriosis immunized with mRNA-based SARS-CoV-2 vaccines did not perceive greater worsening or new menstrual-associated symptoms after complete COVID-19 vaccination compared with healthy controls. Hormonal treatment may have a protective effect against worsened or new menstrual symptoms induced by COVID-19 vaccination.

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Most cited references 38

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Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

Fernando P Polack, Stephen J. Thomas, Nicholas R.E. Kitchin … (2023)

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. Methods In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. Results A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. Conclusions A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)

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World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.

(2013)

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Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

Lindsey Baden, Hana El Sahly, Brandon Essink … (2020)

Abstract Background Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle–encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19. Methods This phase 3 randomized, observer-blinded, placebo-controlled trial was conducted at 99 centers across the United States. Persons at high risk for SARS-CoV-2 infection or its complications were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo 28 days apart. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with SARS-CoV-2. Results The trial enrolled 30,420 volunteers who were randomly assigned in a 1:1 ratio to receive either vaccine or placebo (15,210 participants in each group). More than 96% of participants received both injections, and 2.2% had evidence (serologic, virologic, or both) of SARS-CoV-2 infection at baseline. Symptomatic Covid-19 illness was confirmed in 185 participants in the placebo group (56.5 per 1000 person-years; 95% confidence interval [CI], 48.7 to 65.3) and in 11 participants in the mRNA-1273 group (3.3 per 1000 person-years; 95% CI, 1.7 to 6.0); vaccine efficacy was 94.1% (95% CI, 89.3 to 96.8%; P<0.001). Efficacy was similar across key secondary analyses, including assessment 14 days after the first dose, analyses that included participants who had evidence of SARS-CoV-2 infection at baseline, and analyses in participants 65 years of age or older. Severe Covid-19 occurred in 30 participants, with one fatality; all 30 were in the placebo group. Moderate, transient reactogenicity after vaccination occurred more frequently in the mRNA-1273 group. Serious adverse events were rare, and the incidence was similar in the two groups. Conclusions The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.)

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Author and article information

Contributors

María Ángeles Martínez-Zamora: Role: ConceptualizationRole: Formal analysisRole: InvestigationRole: MethodologyRole: SoftwareRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing

Georgina Feixas: Role: ConceptualizationRole: Formal analysisRole: InvestigationRole: MethodologyRole: ResourcesRole: SoftwareRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing

Meritxell Gracia: Role: InvestigationRole: MethodologyRole: Writing – review & editing

Mariona Rius: Role: ConceptualizationRole: Formal analysisRole: ValidationRole: Writing – review & editing

Lara Quintas: Role: MethodologyRole: VisualizationRole: Writing – review & editing

Cristian de Guirior: Role: ConceptualizationRole: InvestigationRole: SupervisionRole: Writing – review & editing

Francisco Carmona:

ORCID: https://orcid.org/0000-0002-0172-1761

Role: ConceptualizationRole: Data curationRole: Formal analysisRole: MethodologyRole: SupervisionRole: Writing – original draftRole: Writing – review & editing

Journal

Journal ID (nlm-ta): Womens Health (Lond)

Journal ID (iso-abbrev): Womens Health (Lond)

Journal ID (publisher-id): WHE

Journal ID (hwp): spwhe

Title: Women's Health

Publisher: SAGE Publications (Sage UK: London, England )

ISSN (Print): 1745-5057

ISSN (Electronic): 1745-5065

Publication date (Electronic): 7 June 2023

Publication date Collection: 2023

Publication date PMC-release: 7 June 2023

Volume: 19

Electronic Location Identifier: 17455057231176751

Affiliations

[1 ]Department of Gynecology, Clinical Institute of Gynecology, Obstetrics and Neonatology, Hospital Clinic of Barcelona, University of Barcelona, Barcelona, Spain

[2 ]Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain

Author notes

[*]Francisco Carmona, Department of Gynecology, Clinical Institute of Gynecology, Obstetrics and Neonatology, Hospital Clinic of Barcelona, University of Barcelona, Villarroel 170, Barcelona 08036, Spain. Email: fcarmona@ 123456clinic.cat

[*]

These authors contributed equally to this work.

Author information

Francisco Carmona https://orcid.org/0000-0002-0172-1761

Article

Publisher ID: 10.1177_17455057231176751

DOI: 10.1177/17455057231176751

PMC ID: 10251079

PubMed ID: 37282979

SO-VID: 56ddfd1b-caa7-4e09-8910-0caad4e2eee1

License:

This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page( https://us.sagepub.com/en-us/nam/open-access-at-sage).

History

Date received : 3 November 2022

Date revision received : 26 April 2023

Date accepted : 27 April 2023

Custom metadata

cover-date January-December 2023

typesetter ts1

Keywords: covid-19 vaccination,endometriosis,hormonal therapy,immunization,menstrual abnormalities,sars-cov-2 vaccine

Data availability:

Keywords: covid-19 vaccination, endometriosis, hormonal therapy, immunization, menstrual abnormalities, sars-cov-2 vaccine

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Evaluation of menstrual symptoms after Coronavirus disease 2019 vaccination in women with endometriosis

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Abstract

Background:

Objectives:

Design:

Methods:

Results:

Conclusion:

Related collections

Novel Coronavirus Disease COVID-19

Most cited references 38

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.

Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

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Cited by 2

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