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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.
Moro, Pedro L; Olson, Christine K; Clark, Elizabeth; Marquez, Paige; Strid, Penelope; Ellington, Sascha; Zhang, Bicheng; Mba-Jonas, Adamma; Alimchandani, Meghna; Cragan, Janet; Moore, Cynthia.
  • Moro PL; 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.
  • Olson CK; Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Zoonotic and Emerging Infectious Diseases, Centers for Disease Control and Prevention (CDC).
  • Clark E; Fertility Epidemiology Studies Team, Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, CDC.
  • Marquez P; Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Zoonotic and Emerging Infectious Diseases, Centers for Disease Control and Prevention (CDC).
  • Strid P; Emergency Preparedness and Response Team, Field Support Branch, Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, CDC.
  • Ellington S; Emergency Preparedness and Response Team, Field Support Branch, Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, CDC.
  • Zhang B; Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Zoonotic and Emerging Infectious Diseases, Centers for Disease Control and Prevention (CDC).
  • Mba-Jonas A; Center for Biologics Evaluation and Research, Food and Drug Administration.
  • Alimchandani M; Center for Biologics Evaluation and Research, Food and Drug Administration.
  • Cragan J; Division of Birth Defects and Infant Disorders, National Center on Birth Defects and Developmental Disabilities, CDC.
  • Moore C; Division of Birth Defects and Infant Disorders, National Center on Birth Defects and Developmental Disabilities, CDC.
Vaccine ; 40(24): 3389-3394, 2022 05 26.
Article in English | MEDLINE | ID: covidwho-1783826
ABSTRACT

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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Vaccines / COVID-19 Type of study: Reviews / Screening study Topics: Vaccines Limits: Female / Humans / Infant / Infant, Newborn / Pregnancy Country/Region as subject: North America Language: English Journal: Vaccine Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Vaccines / COVID-19 Type of study: Reviews / Screening study Topics: Vaccines Limits: Female / Humans / Infant / Infant, Newborn / Pregnancy Country/Region as subject: North America Language: English Journal: Vaccine Year: 2022 Document Type: Article