Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials.

Anke H Maitland-van der ZeeNicoletta LuxiMonika RaethkeSandor SchmikliFabio RiefoloPutri Widi SaraswatiCamelia BucsaAlhadi OsmanMegan LiddiardFrancisco Batel MaquesGiuliana PetrelliSimona SonderlichováNicolas H ThurinFelipe VillalobosGianluca TrifiròMiriam Sturkenboomnull null

Published in: Drug safety (2023)

The CVM study showed high frequencies of local solicited reactions after vaccination but lower rates than in pivotal clinical trials. Injection-site pain, fatigue, and headache were the most commonly reported ADRs for clinical trials, but higher than spontaneously reported data.

Keyphrases

clinical trial
phase ii
coronavirus disease
sars cov
emergency department
chronic pain
public health
intensive care unit
open label
phase iii
electronic health record
spinal cord
neuropathic pain
physical activity
depressive symptoms
postoperative pain