Vestibular disorders following BNT162b2 mRNA COVID-19 vaccination: A retrospective case series

被引:0
|
作者
Ammar, Helmi [1 ,8 ]
Le Beller, Christine [1 ]
Bouccara, Didier [2 ,3 ]
Malinvaud, David [2 ,3 ]
Jouffroy, Romain [4 ,5 ,6 ,7 ]
Lillo-Le Louet, Agnes [1 ]
机构
[1] Univ Paris Cite, Hop Europeen Georges Pompidou, AP HP, Pharmacovigilance Reg Ctr, Paris, France
[2] Univ Paris Cite, Hop Europeen Georges Pompidou, AP HP, Serv Otorhinolaryngol & Chirurg Cervicofaciale, Paris, France
[3] Univ Paris Cite, Unite CNRS, INCC Integrat Neurosci & Cognit Grp, UMR 8002, Paris, France
[4] Ambroise Pare Hosp, AP HP, Intens Care Unit, Paris, France
[5] Paris Univ, Inst Rech BioMed & Epidemiol Sport, EA7329, INSEP, Paris, France
[6] Paris Saclay Univ, Ctr Rech Epidemiol & St Populat, INSERM, U1018, Paris, France
[7] Univ Antilles, EA 7525, Fort De France, France
[8] Univ Paris Cite, Hop Europeen Georges Pompidou, Pharmacovigilance Reg Ctr, AP HP Ctr, Paris, France
关键词
BNT162b2; vaccine; COVID-19; reporting rate; side effects; vestibular disorders; EPIDEMIOLOGY; SYMPTOMS;
D O I
10.1111/fcp.12942
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
BackgroundThere are few publications regarding manifestations of vestibular disorders (VDs) following BNT162b2 mRNA COVID-19 vaccination. PurposeWe describe cases of VD potentially related to BNT162b2 vaccination and calculate its reporting rate, in order to enlarge knowledge about this adverse effect. MethodsA retrospective analysis of cases of VD following BNT162b2 vaccination reported to the pharmacovigilance centre of Georges-Pompidou European Hospital (France), in 2021 was performed. In order to identify these cases from the pharmacovigilance database containing all our registered cases, we used the Standardised MedDRA Query (SMQ) 'vestibular disorders'. Then we analysed cases with vestibular symptoms, based on the association of typical manifestations. The reporting rate was calculated based on the number of VD cases and the number of vaccinated patients. ResultsAmong 6608 cases reported to our centre related to COVID-19 vaccines during 2021, 34 VDs associated with BNT162b2 administration were included. They were mainly reported in females (79%), 62% occurred after the first dose and 32% were serious. Symptoms had completely resolved in 13 cases (38%). Vertigo was the most common symptom followed by balance disorders. Three patients received second dose without reappearance of VD. The final diagnosis was reported in 10 patients (six cases of vestibular neuritis, two cases of central VD, two cases of benign paroxysmal positional vertigo). The regional reporting rate was 26 [95% CI: 17-34] cases of VD per 1 million persons vaccinated. ConclusionAlthough the relationship between vaccination and VD cannot be established, clinicians should be aware of this rare adverse effect.
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收藏
页码:192 / 204
页数:13
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