Evidence map›Paper›PMID 38679512›Full record

ArticleVaccine2024

Association between Covishield vaccine and menstrual disturbance. Findings from a cross-sectional study among participants of Zero TB cohort in India.

Kunchok Dorjee, Tenzin Namdon, Sonam Topgyal, Ugen Gyatso, Tenzin Tsundue, Tashi Dolma, Vipan Kumar, Dekyi Lhadon, Tenzin Yangkyi, Tenzin Khachoe and 8 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Vaccine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Kunchok DorjeeCenter for TB and AIDS Research, Division of Infectious Diseases, Johns Hopkins University, Baltimore, MD, USA; Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA; Gupta Klinsky India Institute, Johns Hopkins University, Baltimore, MD, USA. Electronic address: kdorjee1@jhmi.edu.
Tenzin NamdonDelek Hospital, Dharamsala, India.
Sonam TopgyalDelek Hospital, Dharamsala, India.
Ugen GyatsoDelek Hospital, Dharamsala, India.
Tenzin TsundueDelek Hospital, Dharamsala, India.
Tashi DolmaDelek Hospital, Dharamsala, India.
Vipan KumarDepartment of Orthopedics, Dr. Rajendra Prasad Govt. Medical College, Tanda, HP, India.
Dekyi LhadonDelek Hospital, Dharamsala, India.
Tenzin YangkyiDelek Hospital, Dharamsala, India.
Tenzin KhachoeDelek Hospital, Dharamsala, India.
Sangyal DorjeeCenter for TB and AIDS Research, Division of Infectious Diseases, Johns Hopkins University, Baltimore, MD, USA; Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.
R C SadoffCenter for TB and AIDS Research, Division of Infectious Diseases, Johns Hopkins University, Baltimore, MD, USA.
David PetersDepartment of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.
Amita GuptaCenter for TB and AIDS Research, Division of Infectious Diseases, Johns Hopkins University, Baltimore, MD, USA; Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA; Gupta Klinsky India Institute, Johns Hopkins University, Baltimore, MD, USA.
Zorba PasterDepartment of Family Medicine, University of Wisconsin, Wisconsin, USA.
Richard E ChaissonCenter for TB and AIDS Research, Division of Infectious Diseases, Johns Hopkins University, Baltimore, MD, USA; Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.
Dawa PhunkyiDelek Hospital, Dharamsala, India.
Tsetan D SadutshangDelek Hospital, Dharamsala, India.

Funding

Vaccine Response and Immunotherapeutics SWGP30AI094189 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Richard E. Chaisson · 2012 to 2026
$67.0M
Tuberculosis Transmission and Preventive Therapy in Tibetan Children and Young Adults in IndiaK01AI148583 · NIAID · JOHNS HOPKINS UNIVERSITY · PI DORJEE, KUNCHOK · 2020 to 2024
$734k
NIAID NIH HHS K01 AI148583NIAID NIH HHS P30 AI094189
6 · The paper itself

Abstract

backgroundThe association between covid-19 vaccine and menstrual disturbance is unclear.

methodsAn in-person cross-sectional survey among female members ≥ 18 years enrolled in an ongoing Zero TB prospective cohort in Northern India who had received one or two doses of covid-19 vaccine was conducted to study the characteristics and association of menstrual disturbance within six months of receiving Covishield.

resultsBetween June 29 and September 5, 2021, 339 females ≥ 18 years of age were administered the survey. Median age was 30 (IQR: 22-39) years; 84 % were between 18 and 49 and 16 % were ≥ 50 years old. There were 152 college students, 27 healthcare workers, and 160 nuns. Forty-two women (12 %) had received one dose and 297 (88 %) had received two doses of Covishield. Overall, 66 (20 %) women reported experiencing menstrual disturbance after receiving Covishield vaccine. The problems included early menstruation: 6 % (n = 19/339); late menstruation: 4 % (n = 14/339); and heavier bleeding: 5 % (n = 17/339). Disturbances lasted for less than seven days and cycles normalized in 1-3 months. There was no post-menopausal bleeding. There was no significant difference in menstrual disturbance based on receiving one vs. two doses of Covishield (OR: 1.58; 95 % CI: 0.55-4.57; p = 0.381). History of SARS-CoV-2 infection was not associated with the development of menstrual disturbance among the vaccinees (OR: 0.63; 95 % CI: 0.24-1.73; p = 0.379). Presence of emotional disturbance at baseline (OR: 31; 95 % CI: 3.52-267; p = 0.002) or previous history of dysmenorrhea (OR: 41; 95 % CI: 8.7-196; p < 0.001) was associated with menstrual disturbance in the vaccinees, indicating their potential to confound or bias study results.

conclusionMenstrual problems were reported by Covishield vaccinees, but they were minor and reversible within three months and do not constitute a ground for vaccine hesitancy. Studies designed to assess causal link taking care to avoid selection bias or confounding are needed.

Indexed as

COVID-19COVID-19 VaccinesMenstruation DisturbancesAdolescentAdultCross-Sectional StudiesFemaleHumansIndiaMiddle AgedProspective StudiesSARS-CoV-2Young AdultCOVID-19 VaccinesCovid-19 vaccineMenstrual disturbanceWomen’s health

Identifiers

PMID38679512
PMCPMC11875020

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.