Reporting of acute inflammatory neuropathies with COVID-19 vaccines

Noseda, Roberta; Ripellino, Paolo; Ghidossi, Sara; Bertoli, Raffaela; Ceschi, Alessandro

doi:10.3390/vaccines9091022

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Journal article

Reporting of acute inflammatory neuropathies with COVID-19 vaccines : subgroup disproportionality analyses in VigiBase

Noseda, Roberta Division of Clinical Pharmacology and Toxicology, Institute of Pharmacological Sciences of Southern Switzerland, Ente Ospedaliero Cantonale, Lugano, Switzerland
Ripellino, Paolo Neurology Department, Neurocenter of Southern Switzerland, Ente Ospedaliero Cantonale, Lugano, Switzerland
Ghidossi, Sara Division of Clinical Pharmacology and Toxicology, Institute of Pharmacological Sciences of Southern Switzerland, Ente Ospedaliero Cantonale, Lugano, Switzerland
Bertoli, Raffaela Division of Clinical Pharmacology and Toxicology, Institute of Pharmacological Sciences of Southern Switzerland, Ente Ospedaliero Cantonale, Lugano, Switzerland
Ceschi, Alessandro Division of Clinical Pharmacology and Toxicology, Institute of Pharmacological Sciences of Southern Switzerland, Ente Ospedaliero Cantonale, Lugano, Switzerland - Clinical Trial Unit, Ente Ospedaliero Cantonale, Lugano, Switzerland - Faculty of Biomedical Sciences, Università della Svizzera italiana, Switzerland - Department of Clinical Pharmacology and Toxicology, University Hospital Zurich, Zurich, Switzerland

14.09.2021

Published in:

Vaccines / Siddappa, N.. - MDPI. - 2021, vol. 9, no. 9, p. 7

English 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.

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