Parálisis de Bell tras vacuna de la Influenza en un niño de 8 años : Caso clínico y revisión de la base de datos europea EudraVigilance

A Case Report and Review of the EudraVigilance Database

Abstract

Introduction and objective: During pandemic influenza A (H1N1) vaccination campaign in 2009, relative risk for Bell’s palsy (BP) following vaccine increased significantly. Now, during SARS-CoV-2 pandemic, data from both SARS-CoV-2 Pfizer-BioNTech and Moderna vaccine trials suggest an imbalance in the incidence of BP following vaccination (seven cases) compared with the placebo group (one case). The national agencies of pharmacovigilance pointed out that a causal relationship between vaccines and BP cannot be excluded and consequently, recommended strict pharmacovigilance for BP after vaccination in large populations.Method: Case report and review of EudraVigilance database for children between 3-11 years-old with facial palsy or Bell´s palsy.Results: CASE REPORT: In December 2021, we had the opportunity to treat an 8-year-old boy who developed a right facial palsy following Influenze vaccine. On 30th November, 2021, our patient received his first dose of Vaxigrip Tetra vaccine. On 28 December , 2021 , our patient received his second dose of VaxigripTetra Vaccine. On 29 December, 2021 (24 hours), he developed right facial pain with a House-Brackmann grade III facial palsy. The SARS-CoV-2 PCR test was negative in nasal swab, and IgG SARS-CoV-2 was also negative. Deflazacort (1,5 ml/Kg/day ) and eye support were prescribed. Facial palsy began to improve four days after, and full recovery was achieved.EUDRAVIGILANCE DATABASE REPORT: We reviewed the European database report of facial palsy or Bell´s palsy for 3-11 years-old patients, looking for similar patients between 2021-2022. We collected 53 patients with facial palsy after drugs or vaccines between 2021-2022. Out of them, 41 facial palsy patients were developed after vaccines: 17 cases after COVID-19 vaccine, 8 after influenza vaccine (5 H1Vi pandemic vaccine ) and 5 after Papilloma Virus vaccine.Discussion and Conclusions: Data from Eudravigilance suggests that vaccines play a role in etiopathogenetic of the Bell´s palsy. Out of 53 children who developed a facial palsy after drug or vaccine in the last ten years, 77% were developed after vaccination. In this pandemic COVID-19 vaccination campaign, otolaryngologist must be alert on these nerve pathology in the paediatric population.