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Safety of COVID-19 vaccines in pregnancy: a VAERS based analysis

Greta Santi Laurini1, Nicola Montanaro2, Domenico Motola3

  • 1Unit of Pharmacology, Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy.

European Journal of Clinical Pharmacology
|March 24, 2023
PubMed

Insights

COVID-19 vaccination in pregnant individuals is recommended. This study analyzed Vaccine Adverse Event Reporting System (VAERS) data from December 2020 to April 2022, finding most adverse events were non-serious, supporting maternal immunization safety.

Area of Science:

  • Immunology
  • Public Health
  • Obstetrics & Gynecology

Background:

  • COVID-19 vaccination is recommended for pregnant individuals.
  • Evidence on vaccine safety during pregnancy is crucial for informed clinical decisions.

Purpose of the Study:

  • To provide further evidence on the safety profile of COVID-19 vaccines administered during pregnancy.
  • To support clinicians in recommending maternal immunization.

Main Methods:

  • Analysis of COVID-19 vaccine adverse events following immunization (AEFIs) in pregnant individuals.
  • Data retrieved from the Vaccine Adverse Event Reporting System (VAERS) between December 2020 and April 2022.

Main Results:

  • 4,869 reports of COVID-19 vaccination in pregnant women were submitted to VAERS.
  • Most adverse events (80.43%) were non-serious, with headache, fatigue, and pyrexia being most common.
  • mRNA vaccines (mRNA-1273 and BNT162b2) were most frequently reported; spontaneous abortion and vaginal hemorrhage had the highest reporting rates among pregnancy-related outcomes.

Conclusions:

  • Post-marketing surveillance of VAERS data provides updated evidence on COVID-19 vaccine safety in pregnancy.
  • Findings support the recommendation of maternal immunization against COVID-19.
Abstract

Keywords:
Adverse eventsCOVID-19PregnancySafetySurveillanceVaccines

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