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Adverse events after COVID-19 vaccination in the pediatric population in Spain
M Ángeles Rivas Paterna1, Carla Pérez Ingidua2, Ana B Rivas Paterna3
1Unidad de Cuidados Intensivos Pediátricos y Unidad de Recuperación Postanestésica, Hospital Clínico San Carlos, Madrid, Spain.
Insights
The COVID-19 Comirnaty® vaccine is safe for children aged 5-11 years, showing mostly mild side effects in a real-world Spanish study. Most adverse drug reactions were injection site pain, fever, and headache, with few severe cases.
Area of Science:
- Pediatric Vaccinology
- Public Health
- Immunology
Background:
- Spain initiated COVID-19 vaccination for 5-11 year olds in December 2021.
- Concerns regarding mRNA vaccine technology and parental hesitancy were noted.
- Limited real-world data existed for pediatric COVID-19 vaccine safety.
Purpose of the Study:
- To evaluate the frequency and characteristics of adverse drug reactions (ADRs) post-pediatric COVID-19 vaccination.
- To provide real-world safety data to inform public health policies.
Main Methods:
- Prospective, observational study of 2126 children aged 5-11 years in Spain.
- Data collected via interviews, health records, and registries.
- ADRs assessed for causality and severity by an expert committee.
Main Results:
- 35.6% of children experienced at least one ADR, with 1437 reactions reported.
- Most ADRs were mild (99.5%), including injection site pain (57.1%), fever (11.1%), and headache (5.7%).
- No increase in reactogenicity was observed after the second dose; only one severe ADR occurred.
Conclusions:
- The Comirnaty® vaccine demonstrates a favorable safety profile in children under real-world conditions.
- ADRs are predominantly mild and self-limiting, requiring minimal medical intervention.
- The study supports the safety of COVID-19 vaccination in this pediatric age group.
Introduction:
In December 2021, Spain launched its COVID-19 vaccination campaign for children aged 5-11 years. Although the Comirnaty® vaccine exhibited a favorable safety profile in premarketing trials, its rapid deployment and novel mRNA technology raised concerns among the public, leading to parental hesitancy. Real-world postmarketing data are limited but crucial for guiding clinical and public health policy decisions.
Objective:
To assess the incidence and nature of adverse drug reactions (ADRs) following pediatric COVID-19 vaccination.
Methods:
Prospective, observational and descriptive study cconducted at a tertiary care hospital in Spain. The sample consisted of a total of 2126 children aged 5-11 years. Data on ADRs were collected through telephone interviews, health record reviews and institutional registries. An expert committee evaluated each ADR using predefined criteria for causality and severity.
Results:
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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