影响高血压人群季节性流感疫苗接种后恢复的不良事件:一项基于人群的药物警戒分析。
Adverse events affecting recovery from seasonal influenza vaccination in the hypertensive population: A population-based pharmacovigilance analysis.
作者信息
Wu Hao, He Xiaona, Cao Yu, Gao Wei
机构信息
Department of Epidemiology and Health Statistics, School of Public Health, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi, China.
Jiangxi Provincial Key Laboratory of Disease Prevention and Public Health, Nanchang University, Nanchang, Jiangxi, China.
出版信息
PLoS One. 2025 May 20;20(5):e0310474. doi: 10.1371/journal.pone.0310474. eCollection 2025.
Seasonal influenza vaccination is crucial for preventing influenza and its complications. Data from the United States 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 identified 4647 individuals aged 18 years or older with a history of hypertension who received seasonal influenza vaccination and 6380 seasonal influenza-vaccine-induced AEs between 1 January 2013 and 23 June 2023 from VAERS. We identified two groups for comparison: recovery and no recovery from seasonal influenza-vaccine-induced AEs. Propensity score matching (PSM) was performed to adjust for potential confounding factors, including demographic characteristics (age, sex, and region) and 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.
季节性流感疫苗接种对于预防流感及其并发症至关重要。来自美国疫苗不良事件报告系统(VAERS)的数据表明,高血压患者接种流感疫苗后出现不良事件(AE)的比例更高。然而,关于高血压患者季节性流感疫苗接种后不良事件的证据有限。我们从VAERS中确定了4647名18岁及以上有高血压病史且接种了季节性流感疫苗的个体,以及2013年1月1日至2023年6月23日期间6380例季节性流感疫苗引起的不良事件。我们确定了两组进行比较:季节性流感疫苗引起的不良事件恢复组和未恢复组。进行倾向得分匹配(PSM)以调整潜在的混杂因素,包括人口统计学特征(年龄、性别和地区)和发病季节。使用Cox回归分析计算季节性流感疫苗接种后影响恢复的报告不良事件(AE)的风险比。大多数不良事件不严重,且发生在48小时内。最常见的不良事件是全身性疾病和接种部位情况(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与不适、滑囊疾病、关节相关体征和症状)。所有三种类型的季节性流感疫苗都与注射部位反应相关(47.07%三价流感疫苗[TIA],风险比,HR 2.04,95%置信区间,CI 1.22 - 3.40;20.00%四价流感疫苗[QIA],HR 2.81,95% CI,1.81 - 4.37;67.48%流感疫苗,生产商未知[FLUX],HR 2.83,95% CI,1.12 - 7.15),并且是影响高血压人群延迟恢复比例最大的不良事件。季节性流感疫苗接种后的潜在不良事件可能会影响高血压人群的恢复。报告的大多数不良事件是全身性疾病,主要是注射部位反应,且不严重。