Adverse events affecting recovery from seasonal influenza vaccination in the hypertensive population: A population-based pharmacovigilance analysis

Hao Wu, Xiaona He, Yu Cao, Wei Gao
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Abstract

Seasonal influenza vaccination is crucial for preventing influenza and its complications. Data from the U.S. Vaccine Adverse Event Reporting System (VAERS) indicate a higher proportion of adverse events (AEs) after influenza vaccination in hypertensive people. However, there is limited evidence on AEs in hypertensive people following seasonal influenza vaccination. We collected a total of 4647 individuals on seasonal influenza vaccination and 6380 AEs from VAERS for hypertensive people aged 18 years or older from 1 January 2013 to 23 June 2023. We conducted propensity score matching (PSM) by adjusting for the demographic characteristics of the seasonal influenza-vaccinated hypertensive population and the season of onset. Cox regression analysis was used to calculate the risk ratio of reported adverse events (AEs) that affected recovery after seasonal influenza vaccination. Most AEs were nonserious and occurred within 48 hours. The most common AEs were general disorders and administration site conditions (therapeutic and non-therapeutic responses, inflammation) and musculoskeletal and connective tissue disorders (musculoskeletal and connective tissue pain and discomfort, bursal disorders, joint-related signs, and symptoms). All three types of seasonal influenza vaccines were associated with injection site reactions (47.07% trivalent influenza vaccine [TIA], hazard ratio, HR 2.04, 95% confidence interval, CI 1.22–3.40; 20.00% quadrivalent influenza vaccine [QIA], HR 2.81, 95% CI, 1.81–4.37; 67.48% influenza vaccine, unknown manufacturer [FLUX], HR 2.83, 95% CI, 1.12–7.15) and were the AEs affecting the largest proportion of delayed recoveries in the hypertensive population. Potential AEs following seasonal influenza vaccination may affect the recovery of the hypertensive population. The majority of AEs reported were general disorders, predominantly injection site reactions, and nonserious.
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影响高血压人群接种季节性流感疫苗后康复的不良事件:基于人群的药物警戒分析
接种季节性流感疫苗对于预防流感及其并发症至关重要。美国疫苗不良事件报告系统 (VAERS) 的数据显示,高血压患者接种流感疫苗后发生不良事件 (AE) 的比例较高。然而,有关高血压患者接种季节性流感疫苗后发生不良反应的证据却很有限。我们从 VAERS 收集了从 2013 年 1 月 1 日至 2023 年 6 月 23 日期间接种季节性流感疫苗的 4647 人和 6380 例 AE,接种对象为 18 岁或以上的高血压患者。通过调整季节性流感疫苗接种高血压人群的人口统计学特征和发病季节,我们进行了倾向得分匹配(PSM)。我们使用 Cox 回归分析法计算了接种季节性流感疫苗后影响康复的不良事件(AEs)的风险比。大多数不良事件并不严重,且发生在 48 小时之内。最常见的不良事件是一般疾病和接种部位状况(治疗性和非治疗性反应、炎症)以及肌肉骨骼和结缔组织疾病(肌肉骨骼和结缔组织疼痛和不适、滑囊疾病、关节相关体征和症状)。所有三种季节性流感疫苗都与注射部位反应有关(47.07%的三价流感疫苗[TIA],危险比,HR 2.04,95%置信区间,CI 1.22-3.40;20.00%的四价流感疫苗[QIA],HR 2.81,95% 置信区间,1.81-4.37;67.48% 流感疫苗,未知生产商[FLUX],HR 2.83,95% 置信区间,1.12-7.15),是影响高血压人群延迟康复比例最大的 AE。接种季节性流感疫苗后的潜在AE可能会影响高血压人群的康复。报告的大多数不良反应为一般失调,主要是注射部位反应,且为非严重不良反应。
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