Adverse events after COVID-19 vaccination in the pediatric population in Spain

Overall, 35.6% of participants reported at least one ADR, totaling 1437 reactions. Most were mild (99.5%) and resolved spontaneously. Only one case was classified as severe. The most common ADRs were injection site pain (57.1%), fever (11.1%) and headache (5.7%). There was no evidence of increased reactogenicity after the second dose. Of all ADRs, 65.1% were considered «definite» or «probable.» CONCLUSIONS: The Comirnaty® vaccine maintains a favorable safety profile in children under real-world conditions, with predominantly mild, self-limiting reactions and minimal need for medical care.

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Publication Details

Journal
Anales de Pediatría (English Edition)
Published
2026-02-01
DOI
https://doi.org/10.1016/j.anpede.2026.504088
Primary Topic
Intramuscular injections and effects
Type
article
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article

Adverse events after COVID-19 vaccination in the pediatric population in Spain

David Ortega Martínez, Emilio Vargas Castrillón, Esther Aleo Luján, M. Ángeles Rivas Paterna et al.
Anales de Pediatría (English Edition)
Intramuscular injections and effects
article

Adverse events after COVID-19 vaccination in the pediatric population in Spain

David Ortega Martínez, Emilio Vargas Castrillón, Esther Aleo Luján, M. Ángeles Rivas Paterna, Carla Pérez Ingidua, Ana B. Rivas Paterna
article en

Abstract

Overall, 35.6% of participants reported at least one ADR, totaling 1437 reactions. Most were mild (99.5%) and resolved spontaneously. Only one case was classified as severe. The most common ADRs were injection site pain (57.1%), fever (11.1%) and headache (5.7%). There was no evidence of increased reactogenicity after the second dose. Of all ADRs, 65.1% were considered «definite» or «probable.» CONCLUSIONS: The Comirnaty® vaccine maintains a favorable safety profile in children under real-world conditions, with predominantly mild, self-limiting reactions and minimal need for medical care.

Anales de Pediatría (English Edition)Vol. 104(2)
Hospital Clínico San Carlos (ES), Hospital Infantil Universitario Niño Jesús (ES)
Good health and well-being
Openalex Percentile: Top 63%
Intramuscular injections and effects
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