Reporting of acute inflammatory neuropathies with COVID-19 vaccines
subgroup disproportionality analyses in VigiBase
Informazioni aggiuntive
Autori
Noseda R.,
Ripellino P.,
Ghidossi S.,
Bertoli R.,
Ceschi A. E.
Tipo
Articolo pubblicato in rivista scientifica
Lingua
Inglese
Sommario
Since marketing authorization, cases of neuralgic amyotrophy (NA), facial paralysis/Bell’s palsy (FP/BP), and Guillain-Barré syndrome (GBS) were reported with COVID-19 vaccines of different technologies. This study aimed to assess whether NA, FP/BP, and GBS were more frequently reported in VigiBase with COVID-19 vaccines (of any technologies) than with other viral vaccines, over the full database and across potential risk groups by sex and age. The reporting odds ratio (ROR) with 95% confidence interval (95% CI) was used as the measure of disproportionality and subgroup disproportionality analyses were performed by sex and age. Out of 808,906 safety reports with COVID-19 vaccines, 57 (0.01%) reported NA, 3320 (0.4%) FP/BP, and 632 (0.1%) GBS. There were not signals of disproportionate reporting for NA and GBS with COVID-19 vaccines against other viral vaccines. FP/BP was disproportionately more frequently reported with COVID-19 vaccines than with other viral vaccines over the full database (ROR 1.12, 95%CI 1.07–1.17), in males (ROR 1.65, 95%CI 1.54–1.78) and in age subgroups 65–74 years (ROR 1.21, 95%CI 1.05–1.39) and ≥75 years (ROR 1.84, 95%CI 1.52–2.22). Albeit not proving causation, these findings might support clinicians in decision-making for patients potentially at risk for developing an acute inflammatory neuropathy with COVID-19 vaccines.
Parole chiave
Acute inflammatory neuropathy, COVID-19 vaccines, VigiBase, Safety, Disproportionality
Periodico
Vaccines
Volume
9
Numero ( Mese )
9
Pagine (o numero dell’articolo)
7
Diffusione
Licenza
CC BY
Visibilità
Pubblico
Status open access
Gold
