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.

中文翻译：

---

调查季节性流感疫苗的接收与麻醉/感觉异常和严重头痛的发生之间的关联，加拿大2012 / 13–2016 / 17，加拿大疫苗安全网

背景

接受或拒绝疫苗的人都经常提到对免疫后不良事件的担忧。神经系统不良事件尤其令人担忧。

目标

我们的目标是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的发生之间的关联。

方法

数据来自加拿大国家疫苗安全网络。在第0-7天发生的事件是自我报告的，阻止了日常活动，导致上学或工作缺勤，或需要医疗照顾。对照是前一年的疫苗。在每年（2012/13到2016/17）的流感疫苗接种计划开始之前，收集对照中的事件。多变量logistic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的发生之间的关联。

结果

用于调查麻醉/感觉异常的样本总数为107,565，用于调查严重头痛的样本总数为97,420。104 / 107,565（0.10％）位参与者报告了麻醉/感觉异常；63 / 69,129（0.09％）疫苗和41 / 38,436（0.11％）对照（校正比值比（aOR）= 0.89; 95％CI = 0.60，1.32）。1361 / 97,420（1.40％）位参与者报告了严重头痛。907 / 61,463（1.48％）疫苗和454 / 35,957（1.26％）对照（aOR = 1.21; 95％CI = 1.08，1.36）。没有特定的疫苗产品与严重的头痛有关。

结论

我们的研究发现严重麻醉/感觉异常与季节性流感疫苗接种之间没有关联。尽管流感疫苗接种后与严重头痛相关的不良事件有关，但这些事件的发生率与临床试验报告的发生率相似，因此无需担心。