ArticleJournal of Korean medical science2024
Safety of COVID-19 Vaccination During Pregnancy and Lactation: A VigiBase Analysis.
Article in Journal of Korean medical science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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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.
The trial behind it
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Who cites it
5 citing papers in PubMed, 9 citations in OpenAlex.
- Uncovering Pregnancy Exposures in Pharmacovigilance Case Report Databases: A Comprehensive Evaluation of the VigiBase Pregnancy Algorithm.Drug safety · 2025Article
- Article
- The impact of SARS-CoV-2 infection on vaccinated versus unvaccinated pregnant women: a retrospective cohort study.BMC pregnancy and childbirth · 2025Observational
- Identification of Pregnancy Adverse Drug Reactions in Pharmacovigilance Reporting Systems: A Novel Algorithm Developed in EudraVigilance.Drug safety · 2024Article
- Surveillance Systems for Assessing Vaccine Safety: Possibilities and Limitations.Journal of Korean medical science · 2024Article
Corrections and comments
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Authors and funding
5 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundThere is limited evidence on the safety of coronavirus disease 2019 (COVID-19) vaccination during pregnancy and lactation. Thus, we aimed to evaluate the association between COVID-19 vaccination during pregnancy and lactation and reporting risk of adverse pregnancy or lactation outcomes.
methodsUsing VigiBase, we performed a disproportionality analysis with case/non case design. Cases were defined based on the Standardized MedDRA Queries (SMQs) of "pregnancy and neonatal topics" and non-cases were defined as all other adverse events. We included all reports with COVID-19 vaccines as the suspected cause. Using the full database as the comparators, reporting odds ratios (RORs) with 95% confidence intervals (CIs) were estimated by logistic regression while adjusting for maternal age. Infants' age and sex were additionally adjusted in analyzing the risk of COVID-19 vaccination during lactation.
resultsWe identified 10,266 and 6,474 reports with the SMQ of "pregnancy and neonatal topics" associated with COVID-19 vaccines during pregnancy and lactation, respectively. No significant RORs of adverse pregnancy outcomes associated with COVID-19 vaccines during pregnancy were observed; however, "functional lactation disorders" showed significant disproportionality during lactation with adjusted ROR of 1.48 (95% CI, 1.21-1.79). Further analysis that analyzed "functional lactation disorders" at a preferred term level, showed higher ROR in mastitis (2.76 [95% CI, 1.45-5.27]).
conclusionOverall, we did not observe a positive association between COVID-19 vaccination during pregnancy and risk of reporting adverse pregnancy outcomes. However, we found a significant disproportionate reporting association between COVID-19 vaccination during lactation and "functional lactation disorders", specifically mastitis. Continuous surveillance is warranted to confirm the safety of COVID-19 vaccine during pregnancy and lactation.
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Registered trials
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