Department of Pharmacology, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India.
Department of Pharmacology, M.S. Ramaiah Medical College, Bengaluru, Karnataka, India.
Clin Drug Investig. 2020 Sep;40(9):883-889. doi: 10.1007/s40261-020-00952-0.
Several cases of facial paralysis have been reported following influenza vaccination; however, recent surveillance studies have not shown an increased risk. In this study, we analyzed the vaccine adverse event reporting system (VAERS) data to determine whether the facial paralysis reporting rate is higher in those who received influenza vaccination compared with those who received other vaccines.
We evaluated reports of facial paralysis in people who received influenza vaccination during January 2015 to October 2019 using Medical Dictionary for Regulatory Activities Preferred Terms. A disproportionality analysis was performed to determine the proportional reporting ratio (PRR), Chi-square statistic, and reporting odds ratio (ROR) with 95% confidence interval (CI). The demographic and clinical characteristics of the cases were also analyzed.
Two hundred fifty cases of facial paralysis following influenza vaccination were reported during the study period. The median age of the patients was 45 (interquartile range, 30-57) years; 132 (52.8%) patients were females. The majority of the patients received the injected trivalent or quadrivalent seasonal influenza vaccine by intramuscular route. The PRR, Chi-square statistic, and ROR (95% CI) was 2.44, 122.32, and 2.44 (2.08-2.88), respectively; on excluding cases involving concomitant paresis/paralysis of limbs or Guillain-Barre syndrome, the disproportionality statistics were 2.30, 89.37, and 2.30 (1.93-2.75), respectively.
Our study shows increased reporting of facial paralysis following influenza vaccination as compared with other vaccines. Considering the inherent limitations of the VAERS database analysis, and the fact that disproportionality measures only indicate the presence of a signal, our study findings need to be explored in well-designed prospective pharmacoepidemiologic studies.
有几例面瘫病例在流感疫苗接种后报告；然而，最近的监测研究并未显示风险增加。在这项研究中，我们分析了疫苗不良事件报告系统（VAERS）的数据，以确定与接种其他疫苗相比，接种流感疫苗的人群中面瘫报告率是否更高。
我们使用监管活动医学词典首选术语评估了 2015 年 1 月至 2019 年 10 月期间接种流感疫苗的人群中面瘫的报告。进行了不均衡分析，以确定比例报告比（PRR）、卡方统计量和报告比值比（ROR）及其 95%置信区间（CI）。还分析了病例的人口统计学和临床特征。
在研究期间，报告了 250 例接种流感疫苗后发生的面瘫病例。患者的中位年龄为 45 岁（四分位距 30-57）；132 例（52.8%）患者为女性。大多数患者通过肌内途径接种了注射用三价或四价季节性流感疫苗。PRR、卡方统计量和 ROR（95%CI）分别为 2.44、122.32 和 2.44（2.08-2.88）；排除同时伴有四肢麻痹/瘫痪或格林-巴利综合征的病例后，不均衡统计量分别为 2.30、89.37 和 2.30（1.93-2.75）。
与其他疫苗相比，我们的研究显示接种流感疫苗后面瘫报告增加。考虑到 VAERS 数据库分析的固有局限性，以及不均衡衡量标准仅表明存在信号，我们的研究结果需要在精心设计的前瞻性药物流行病学研究中进一步探索。
