| アブストラクト | Since marketing authorization, cases of neuralgic amyotrophy (NA), facial paralysis/Bell's palsy (FP/BP), and Guillain-Barre 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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| ジャーナル名 | Vaccines |
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| 投稿日 | 2021/9/29 |
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| 投稿者 | Noseda, Roberta; Ripellino, Paolo; Ghidossi, Sara; Bertoli, Raffaela; Ceschi, Alessandro |
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| 組織名 | Division of Clinical Pharmacology and Toxicology, Institute of Pharmacological;Sciences of Southern Switzerland, Ente Ospedaliero Cantonale, 6900 Lugano,;Switzerland.;Neurology Department, Neurocenter of Southern Switzerland, Ente Ospedaliero;Cantonale, 6900 Lugano, Switzerland.;Clinical Trial Unit, Ente Ospedaliero Cantonale, 6900 Lugano, Switzerland.;Faculty of Biomedical Sciences, Universita della Svizzera Italiana, 6900 Lugano,;Department of Clinical Pharmacology and Toxicology, University Hospital Zurich,;8091 Zurich, Switzerland. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/34579259/ |
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