Messenger RNA (mRNA) vaccines had a lower reporting probability of spontaneous abortion than viral vector-based vaccines (ROR 0.80, 95% CI 0.69–0.93). Among pregnancy-related AEFI, the most reported was spontaneous abortion. Moreover, 55.16% were AEFI not related to pregnancy (mostly headache, pyrexia, and fatigue), while 17.92% were pregnancy-, newborn-, or fetus-related AEFI. In this study, 85.0% of total ICSRs referred to pregnant women (n = 2,764), while 7.9% referred to fetuses/newborns (n = 258). Although the majority (87.82%) of ICSRs concerned serious AEFI, their outcomes were mostly favorable. More than half (58.24%) of ICSRs were submitted by non-healthcare professionals. Results: 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. The reporting odds ratio (ROR) was computed to compare the reporting probability of spontaneous abortion between COVID-19 vaccines. We analyzed AEFI related to the mother and fetus/newborn. Methods: 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. Introduction: 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.Īim: We aimed to investigate adverse events following immunization (AEFI) with COVID-19 vaccines during pregnancy. 3UOC Pharmacy, AORN Santobono-Pausilipon Children’s Hospital, Naples, Italy.2Department of Experimental Medicine, University of Campania “Luigi Vanvitelli”, Naples, Italy.1Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, University of Campania “Luigi Vanvitelli”, Naples, Italy.Annamaria Mascolo 1,2† Gabriella di Mauro 1,2,3† Federica Fraenza 1,2* Mario Gaio 1,2 Alessia Zinzi 1,2 Ciro Pentella 1,2 Francesco Rossi 1,2 Annalisa Capuano 1,2‡ Liberata Sportiello 1,2‡
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