PMID- 35489985 OWN - NLM STAT- MEDLINE DCOM- 20220519 LR - 20221221 IS - 1873-2518 (Electronic) IS - 0264-410X (Print) IS - 0264-410X (Linking) VI - 40 IP - 24 DP - 2022 May 26 TI - Post-authorization surveillance of adverse events following COVID-19 vaccines in pregnant persons in the vaccine adverse event reporting system (VAERS), December 2020 - October 2021. PG - 3389-3394 LID - S0264-410X(22)00447-9 [pii] LID - 10.1016/j.vaccine.2022.04.031 [doi] AB - BACKGROUND: Pregnant persons are at increased risk of severe illness from COVID-19 infection, including intensive care unit admission, mechanical ventilation, and death compared with non-pregnant persons of reproductive age. Limited data are available on the safety of COVID-19 vaccines administered during and around the time of pregnancy. OBJECTIVE: To evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system, in pregnant persons who received a COVID-19 vaccine to assess for potential vaccine safety problems. METHODS: We searched VAERS for US reports of adverse events (AEs) in pregnant persons who received a COVID-19 vaccine from 12/14/2020-10/31/2021. Clinicians reviewed reports and available medical records. Crude reporting rates for selected AEs were calculated, and disproportional reporting was assessed using data mining methods. RESULTS: VAERS received 3,462 reports of AEs in pregnant persons who received a COVID-19 vaccine; 1,831 (52.9%) after BNT162b2, 1,350 (38.9%) after mRNA-1273, and 275 (7.9%) after Ad26.COV2.S. Eight maternal deaths and 12 neonatal deaths were reported. Six-hundred twenty-one (17.9%) reports were serious. Pregnancy-specific outcomes included: 878 spontaneous abortions (<20 weeks), 101 episodes of vaginal bleeding, 76 preterm deliveries (<37 weeks), 62 stillbirths (>/=20 weeks), and 33 outcomes with birth defects. Crude reporting rates for preterm deliveries and stillbirths, as well as maternal and neonatal mortality rates were below background rates from published sources. No disproportional reporting for any AE was observed. CONCLUSIONS: Review of reports to VAERS following COVID-19 vaccines in pregnant persons did not identify any concerning patterns of maternal or infant-fetal outcomes. CI - Published by Elsevier Ltd. FAU - Moro, Pedro L AU - Moro PL AD - Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Zoonotic and Emerging Infectious Diseases, Centers for Disease Control and Prevention (CDC). Electronic address: pmoro@cdc.gov. FAU - Olson, Christine K AU - Olson CK AD - Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Zoonotic and Emerging Infectious Diseases, Centers for Disease Control and Prevention (CDC). FAU - Clark, Elizabeth AU - Clark E AD - Fertility Epidemiology Studies Team, Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, CDC. FAU - Marquez, Paige AU - Marquez P AD - Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Zoonotic and Emerging Infectious Diseases, Centers for Disease Control and Prevention (CDC). FAU - Strid, Penelope AU - Strid P AD - Emergency Preparedness and Response Team, Field Support Branch, Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, CDC. FAU - Ellington, Sascha AU - Ellington S AD - Emergency Preparedness and Response Team, Field Support Branch, Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, CDC. FAU - Zhang, Bicheng AU - Zhang B AD - Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Zoonotic and Emerging Infectious Diseases, Centers for Disease Control and Prevention (CDC). FAU - Mba-Jonas, Adamma AU - Mba-Jonas A AD - Center for Biologics Evaluation and Research, Food and Drug Administration. FAU - Alimchandani, Meghna AU - Alimchandani M AD - Center for Biologics Evaluation and Research, Food and Drug Administration. FAU - Cragan, Janet AU - Cragan J AD - Division of Birth Defects and Infant Disorders, National Center on Birth Defects and Developmental Disabilities, CDC. FAU - Moore, Cynthia AU - Moore C AD - Division of Birth Defects and Infant Disorders, National Center on Birth Defects and Developmental Disabilities, CDC. LA - eng PT - Journal Article DEP - 20220412 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - JT2NS6183B (Ad26COVS1) RN - 0 (COVID-19 Vaccines) RN - 0 (Vaccines) RN - N38TVC63NU (BNT162 Vaccine) SB - IM MH - Ad26COVS1 MH - Adverse Drug Reaction Reporting Systems MH - BNT162 Vaccine MH - *COVID-19/epidemiology/prevention & control MH - COVID-19 Vaccines/adverse effects MH - Female MH - Humans MH - Infant MH - Infant, Newborn MH - Pregnancy MH - Stillbirth/epidemiology MH - United States/epidemiology MH - *Vaccines PMC - PMC9001176 OTO - NOTNLM OT - Adenovirus type 26 OT - Adverse events OT - COVID-19 OT - Coronavirus OT - Epidemiology OT - Pregnancy OT - SARS-CoV-2 OT - Surveillance OT - Vaccine safety OT - mRNA vaccines COIS- Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. EDAT- 2022/05/01 06:00 MHDA- 2022/05/20 06:00 PMCR- 2022/04/12 CRDT- 2022/04/30 22:05 PHST- 2022/01/25 00:00 [received] PHST- 2022/03/13 00:00 [revised] PHST- 2022/04/06 00:00 [accepted] PHST- 2022/05/01 06:00 [pubmed] PHST- 2022/05/20 06:00 [medline] PHST- 2022/04/30 22:05 [entrez] PHST- 2022/04/12 00:00 [pmc-release] AID - S0264-410X(22)00447-9 [pii] AID - 10.1016/j.vaccine.2022.04.031 [doi] PST - ppublish SO - Vaccine. 2022 May 26;40(24):3389-3394. doi: 10.1016/j.vaccine.2022.04.031. Epub 2022 Apr 12.