{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T07:57:19Z","timestamp":1781596639943,"version":"3.54.5"},"reference-count":40,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2022,10,3]],"date-time":"2022-10-03T00:00:00Z","timestamp":1664755200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Immunol."],"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Although the European Medicines Agency (EMA) encourage coronavirus disease 2019 (COVID-19) vaccination in pregnant women, the scientific evidence supporting the use of COVID-19 vaccines during pregnancy is still limited.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>We aimed to investigate adverse events following immunization (AEFI) with COVID-19 vaccines during pregnancy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We retrieved Individual Case Safety Reports (ICSRs) related to the use of COVID-19 vaccines during pregnancy from the EudraVigilance database for the year 2021. We analyzed AEFI related to the mother and fetus\/newborn. The reporting odds ratio (ROR) was computed to compare the reporting probability of spontaneous abortion between COVID-19 vaccines.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>During the study period, among 1,315,315 ICSRs related to COVID-19 vaccines, we retrieved 3,252 (0.25%) reports related to the use in pregnancy. More than half (58.24%) of ICSRs were submitted by non-healthcare professionals. Although the majority (87.82%) of ICSRs concerned serious AEFI, their outcomes were mostly favorable. In this study, 85.0% of total ICSRs referred to pregnant women (n = 2,764), while 7.9% referred to fetuses\/newborns (n = 258). We identified 16,569 AEFI. Moreover, 55.16% were AEFI not related to pregnancy (mostly headache, pyrexia, and fatigue), while 17.92% were pregnancy-, newborn-, or fetus-related AEFI. Among pregnancy-related AEFI, the most reported was spontaneous abortion. Messenger RNA (mRNA) vaccines had a lower reporting probability of spontaneous abortion than viral vector-based vaccines (ROR 0.80, 95% CI 0.69\u20130.93). Moderna and Oxford-AstraZeneca vaccines had a higher reporting probability of spontaneous abortion (ROR 1.2, 95% CI 1.05\u20131.38 and ROR 1.26, 95% CI 1.08\u20131.47, respectively), while a lower reporting probability was found for Pfizer-BioNTech vaccine compared with all other COVID-19 vaccines (ROR 0.73, 95% CI 0.64\u20130.84). In addition, 5.8% of ICSRs reported a fatal outcome.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>No strong insight of unknown AEFI associated with COVID-19 vaccination in pregnant women was observed. Considering the high risk associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, our analysis suggests that the benefits of COVID-19 vaccines during pregnancy outweigh the possible risks. However, it is important to continue monitoring the safety profile of COVID-19 vaccines in this subpopulation.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fimmu.2022.965171","type":"journal-article","created":{"date-parts":[[2022,10,3]],"date-time":"2022-10-03T05:35:20Z","timestamp":1664775320000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":22,"title":["Maternal, fetal and neonatal outcomes among pregnant women receiving COVID-19 vaccination: The preg-co-vax study"],"prefix":"10.3389","volume":"13","author":[{"given":"Annamaria","family":"Mascolo","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriella","family":"di Mauro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federica","family":"Fraenza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mario","family":"Gaio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessia","family":"Zinzi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ciro","family":"Pentella","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Rossi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annalisa","family":"Capuano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liberata","family":"Sportiello","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2022,10,3]]},"reference":[{"key":"B1","unstructured":"COVID-19 vaccines2022"},{"key":"B2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2021.06.007","article-title":"Adverse effects of COVID-19 messenger RNA vaccines among pregnant women: a cross-sectional study on healthcare workers with detailed self-reported symptoms","volume":"225","author":"Kadali","year":"2021","journal-title":"Am J Obstet Gynecol"},{"key":"B3","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2104983","article-title":"Preliminary findings of mRNA covid-19 vaccine safety in pregnant persons","volume":"384","author":"Shimabukuro","year":"2021","journal-title":"N Engl J Med"},{"key":"B4","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2022.4255","article-title":"Association of COVID-19 vaccination in pregnancy with adverse peripartum outcomes","volume":"327","author":"Fell","year":"2022","journal-title":"JAMA"},{"key":"B5","doi-asserted-by":"publisher","DOI":"10.1111\/1471-0528.16941","article-title":"Covid-19 vaccination during the third trimester of pregnancy: Rate of vaccination and maternal and neonatal outcomes, a multicentre retrospective cohort study","volume":"129","author":"Rottenstreich","year":"2022","journal-title":"BJOG"},{"key":"B6","doi-asserted-by":"publisher","first-page":"591","DOI":"10.1016\/j.chom.2019.10.001","article-title":"Adenovirus vector-based vaccines confer maternal-fetal protection against zika virus challenge in pregnant IFN-\u03b1\u03b2R-\/- mice","volume":"26","author":"Larocca","year":"2019","journal-title":"Cell Host Microbe"},{"key":"B7","doi-asserted-by":"publisher","first-page":"e22","DOI":"10.1016\/S0140-6736(20)31822-5","article-title":"COVID-19 vaccines and neglected pregnancy","volume":"396","author":"Dashraath","year":"2020","journal-title":"Lancet"},{"key":"B8","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2017.01.047","article-title":"Spontaneous abortion and ectopic pregnancy: Case definition & guidelines for data collection, analysis, and presentation of maternal immunization safety data","volume":"35","author":"Rouse","year":"2017","journal-title":"Vaccine"},{"key":"B9","unstructured":"Introductory guide MedDRA version 24.12021"},{"key":"B10","unstructured":"Important medical event terms list - MedDRA version 25.02022"},{"key":"B11","doi-asserted-by":"publisher","DOI":"10.3390\/vaccines10020275","article-title":"Determinants of COVID-19 vaccination hesitancy among Romanian pregnant women","volume":"10","author":"Citu","year":"2022","journal-title":"Vaccines"},{"key":"B12","doi-asserted-by":"publisher","DOI":"10.1080\/14740338.2018.1458837","article-title":"Preventable statin adverse reactions and therapy discontinuation. 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