Neurological Adverse Events from COVID-19 Vaccination and It's Associated Factors in Burkina Faso: Analysis of Spontaneous Reports from the National Database of Pharmacovigilance from 2021 to 2023.

IF 3.5
Alfred Anselme Dabilgou, Emile Wendni Ouedraogo, Julie Marie Adeline Wendlamita Kyelem, Alassane Dravé, Ousmane Wanré, Christain Napon, Athanase Millogo
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Abstract

Introduction: Neurological adverse effects are frequent, primarily non-serious, due to the tropism of COVID 19 adverse effects for neuronal structures and tissues. To our knowledge, there are no studies on neurological adverse effects of COVID-19 vaccines in Burkina Faso. The purpose of this study was to determine the prevalence of neurological side effects of COVID-19 vaccines, to catalogue neurological adverse effects, to describe these manifestations, and to identify factors associated.

Materials and methods: This was a cross-sectional study of people who had experienced adverse events of COVID-19 vaccines during the period from 1 December 2021 to 31 December 2023. Individuals who had experienced at least one adverse event after immunisation (AEFI) of the COVID-19 vaccine registered in the Vigibase Burkina database were included. The data was gathered through a questionnaire.

Results: The study included 1,060 people who experienced adverse events. Of them, 614 (57.9%) had neurological adverse effects. Their mean age was 44.08 ± 18 years. Most of the participants were men (56.8%) and healthcare workers (61.2%). Most of the participants (65.8%) had their side effects occur within 24 h. The AstraZeneca vaccine was reported in 51.8% of participants. The prevalence of side effects after the first dose was 83%.The most common symptoms were headaches (49.7%), myalgia (21.7%) and radiculopathies (9%). There was a significant association between the AstraZeneca vaccine and adverse neurological events (p = 0.000000). Factors associated with the appearance of serious neurological symptoms were age ≥ 60 years (p = 0.02744) and comorbidities (p = 0.000002).

Conclusion: Neurological adverse events after COVID-19 immunisation were frequent and benign among spontaneous notifications. Headache was the most common neurological adverse effect of COVID-19 vaccines. Serious side effects were more frequent in the elderly and people with comorbidities.

布基纳法索COVID-19疫苗接种引起的神经系统不良事件及其相关因素:对2021年至2023年国家药物警戒数据库中自发报告的分析
导言:由于COVID - 19对神经元结构和组织的不良反应倾向,神经系统的不良反应是频繁的,主要不严重。据我们所知,布基纳法索没有关于COVID-19疫苗对神经系统不良反应的研究。本研究的目的是确定COVID-19疫苗的神经系统副作用的发生率,对神经系统不良反应进行分类,描述这些表现,并确定相关因素。材料和方法:这是一项横断面研究,研究对象是在2021年12月1日至2023年12月31日期间经历过COVID-19疫苗不良事件的人群。纳入了在Vigibase布基纳法索数据库中登记的COVID-19疫苗接种后至少经历过一次不良事件(AEFI)的个人。数据是通过问卷调查收集的。结果:该研究包括1060名经历过不良事件的人。其中614例(57.9%)出现神经系统不良反应。平均年龄44.08±18岁。大多数参与者是男性(56.8%)和卫生保健工作者(61.2%)。大多数参与者(65.8%)的副作用发生在24小时内。阿斯利康疫苗的副作用发生在51.8%的参与者中。第一次给药后副作用发生率为83%。最常见的症状是头痛(49.7%)、肌痛(21.7%)和神经根病(9%)。阿斯利康疫苗与不良神经事件之间存在显著关联(p = 0.000000)。与出现严重神经系统症状相关的因素是年龄≥60岁(p = 0.02744)和合并症(p = 0.000002)。结论:自发通报的COVID-19免疫后神经系统不良事件多发且良性。头痛是COVID-19疫苗最常见的神经系统不良反应。严重的副作用在老年人和有合并症的人群中更为常见。
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