Reporting of Acute Inflammatory Neuropathies with COVID-19 Vaccines: Subgroup Disproportionality Analyses in VigiBase

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...

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Vydáno v:Vaccines (Basel) Ročník 9; číslo 9; s. 1022
Hlavní autoři: Noseda, Roberta, Ripellino, Paolo, Ghidossi, Sara, Bertoli, Raffaela, Ceschi, Alessandro
Médium: Journal Article
Jazyk:angličtina
Vydáno: Basel MDPI AG 14.09.2021
MDPI
Témata:
acute inflammatory neuropathy
Age
Bell's palsy
Brief Report
Confidence intervals
Coronaviruses
COVID-19
COVID-19 vaccines
Decision making
disproportionality
Guillain-Barre syndrome
Inflammation
Influenza
Males
Neuropathy
Paralysis
Patients
Risk factors
Risk groups
safety
Sex
Subgroups
Vaccines
VigiBase
United States > US
ISSN:2076-393X, 2076-393X
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Popis
Shrnutí: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.
Bibliografie:ObjectType-Article-1
SourceType-Scholarly Journals-1
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ISSN:2076-393X
2076-393X
DOI:10.3390/vaccines9091022