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调查 2012/13-2016/17 年加拿大季节性流感疫苗接种与麻醉/感觉异常和严重头痛发生之间的关联,加拿大疫苗安全网络。

Investigating the association of receipt of seasonal influenza vaccine with occurrence of anesthesia/paresthesia and severe headaches, Canada 2012/13-2016/17, the Canadian Vaccine Safety Network.

机构信息

Vaccine Evaluation Center, BC Children's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.

School of Public and Population Health, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.

出版信息

Vaccine. 2020 Apr 23;38(19):3582-3590. doi: 10.1016/j.vaccine.2020.03.018. Epub 2020 Mar 27.

Abstract

BACKGROUND

Concern about adverse events following immunization is frequently cited by both those who receive or decline vaccines. Neurological adverse events are especially concerning.

OBJECTIVES

Our aim was to detect associations between seasonal influenza vaccination and the occurrence of severe anesthesia/paresthesia or severe headaches.

METHODS

Data were analyzed from the Canadian National Vaccine Safety network. Events occuring on days 0-7 were self-reported and prevented daily activity, led to school or work absenteeism, or required medical attention. Controls were the previous year's vaccinees; events in controls were collected prior to the start of the influenza vaccination program of each year (2012/13 through 2016/17). Multivariable logistic regression was used to determine the association between seasonal influenza vaccination and the occurrence of anesthesia/paresthesia or severe headaches.

RESULTS

The total sample was 107,565 for investigating anesthesia/paresthesia and 97,420 for investigating severe headaches. Anesthesia/paresthesia was reported by 104/107,565 (0.10%) participants; 63/69,129 (0.09%) vaccinees and 41/38,436 (0.11%) controls (adjusted odds ratio (aOR) = 0.89; 95% CI = 0.60, 1.32). Severe headaches were reported by 1361/97,420 (1.40%) participants; 907/61,463 (1.48%) vaccinees and 454/35,957 (1.26%) controls (aOR = 1.21; 95% CI = 1.08, 1.36). No specific vaccine product was associated with severe headaches.

CONCLUSIONS

Our study found no association between severe anesthesia/paresthesia and seasonal influenza vaccination. While there was an association with severe headaches as an adverse event following influenza vaccination, the rates of these events are similar to rates reported from clinical trials and are not a cause for additional concern.

摘要

背景

无论是接受疫苗还是拒绝疫苗的人,都经常提到对疫苗接种后不良反应的担忧。神经不良反应尤其令人担忧。

目的

我们旨在检测季节性流感疫苗接种与严重麻醉/感觉异常或严重头痛发生之间的关联。

方法

数据分析来自加拿大国家疫苗安全网络。0-7 天内发生的事件为自我报告,且这些事件会阻止日常活动,导致缺课或旷工,或需要就医。对照组为前一年的疫苗接种者;对照组的事件发生在每年流感疫苗接种计划开始之前(2012/13 年至 2016/17 年)。多变量逻辑回归用于确定季节性流感疫苗接种与麻醉/感觉异常或严重头痛发生之间的关联。

结果

总共 107565 人调查麻醉/感觉异常,97420 人调查严重头痛。107565 名参与者中报告有麻醉/感觉异常 104 例(0.10%);69129 名疫苗接种者中有 63 例(0.09%),38436 名对照组中有 41 例(0.11%)(调整后的优势比(aOR)=0.89;95%CI=0.60,1.32)。97420 名参与者中报告有严重头痛 1361 例(1.40%);61463 名疫苗接种者中有 907 例(1.48%),35957 名对照组中有 454 例(1.26%)(aOR=1.21;95%CI=1.08,1.36)。没有特定的疫苗产品与严重头痛有关。

结论

我们的研究未发现严重麻醉/感觉异常与季节性流感疫苗接种之间存在关联。虽然流感疫苗接种后严重头痛作为不良反应存在关联,但这些事件的发生率与临床试验报告的发生率相似,没有引起额外的担忧。

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