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Serious Adverse Drug Reactions to COVID-19 Vaccines in the Pediatric Population: A Retrospective, Cross-Sectional

Grzegorz Nazar1, Julia Olszlegier1, Aleksandra Kamińska1

  • 1Faculty of Medicine, Medical University of Gdańsk, Marii Skłodowskiej-Curie 3a, 80-210 Gdańsk, Poland.

Journal of Clinical Medicine
|September 27, 2025
PubMed

Insights

Serious adverse drug reactions (SADRs) in children following COVID-19 vaccination are rare. This study found Comirnaty and Spikevax have similar safety profiles in the pediatric population.

Area of Science:

  • Pediatric pharmacology
  • Vaccine safety surveillance
  • Public health

Background:

  • COVID-19 pandemic necessitated widespread vaccination.
  • Concerns exist regarding serious adverse drug reactions (SADRs) in children post-vaccination.
  • Understanding pediatric vaccine safety is crucial.

Purpose of the Study:

  • To analyze the risk of SADRs associated with COVID-19 vaccines in the pediatric population.
  • To compare the safety profiles of Pfizer-BioNTech (Comirnaty) and Moderna (Spikevax) in children.
  • To determine the real-world reporting rates of SADRs in vaccinated children.

Main Methods:

  • Retrospective, cross-sectional study design.
  • Analysis of 5422 SADR cases following 37,344,343 COVID-19 vaccine doses in the European Economic Area (December 2020 - October 2023).
  • Reporting rates adjusted using real-world trial-based scaling (APMR) for 207 types of SADRs.

Main Results:

  • Estimated real-world reporting rates of SADRs were 5792 APMR for Comirnaty and 5671 APMR for Spikevax.
  • Most common SADR categories included neuropsychiatric, cardiovascular, and gastroenterological disorders.
  • Frequently reported SADRs were headaches, myocarditis, syncope, dizziness, and dyspnea.

Conclusions:

  • SADRs were reported in children post-COVID-19 vaccination, but appear to be rare.
  • The risk profiles of Comirnaty and Spikevax in children seem comparable.
  • Continued monitoring of pediatric vaccine safety is warranted.

Keywords:
COVID-19ComirnatyEudraVigilanceSpikevaxadverse drug reactionsreal-worldvaccination

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