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