What question did this study set out to answer?

To assess the frequency and nature of adverse drug reactions (ADRs) following COVID-19 vaccination in children.

February 11, 2026Anales de Pediatría (English Edition)0 citationsOpen Access

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

MPM. Ángeles Rivas Paterna CICarla Pérez Ingidua APAna B. Rivas PaternaHospital Clínico San Carlos

Key Points

To assess the frequency and nature of adverse drug reactions (ADRs) following COVID-19 vaccination in children.
Survey of pediatric population in Spain.
Collection of data on reported adverse drug reactions.
Assessment of ADR severity and classification.
35.6% of participants reported at least one ADR, totaling 1437 reactions.
99.5% of reactions were mild and resolved spontaneously.
Injection site pain was the most common ADR at 57.1%.

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.

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Cite This Study

Paterna et al. (Sun,) studied this question.

synapsesocial.com/papers/698c1c53267fb587c655eb17 https://doi.org/https://doi.org/10.1016/j.anpede.2026.504088

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