Reporting on Adverse Clinical Events

J. Dill, T. Mcevoy
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Abstract

In a prospective observational study, the incidence of adverse events was examined in 438 hemodialysis (HD) patients who received 3 doses of COVID-19 vaccines. Most patients included in the analysis received Oxford/AstraZeneca ChAdOx1 as the first 2 doses and Moderna mRNA1273 as the third dose. Overall, 79%, 50%, and 84% of the patients experienced at least 1 adverse event after the first, second, and third doses, respectively. Most reactions were minor and temporary. Compared with the first dose, the second dose was associated with a lower rate of adverse events and the third dose was associated with a higher rate of local injection site reactions but a lower rate of systemic effects. Further analysis indicated that characteristics associated with increased risk of adverse events included female sex (odds ratio [OR]: 2.82; 95% confidence interval [CI]: 1.90-4.18) and arteriovenous fistula access (OR: 1.73; 95% CI: 1.05-2.84). Based on the results of this prospective observational study in HD patients, the authors concluded that COVID-19 vaccination was generally well tolerated. Factors associated with increased risk of adverse events included female sex and arteriovenous fistula access. COVID Vaccine [ChAdOx1, mRNA-1273] Pai MF et al (Wan-Chuan Tsai: Division of Nephrology, Department of Internal Medicine; Center for General Education, Lee-Ming Institute of Technology, Far Eastern Memorial Hospital, No. 21, Section 2, Nanya South Road, Banciao District, New Taipei City 220, New Taipei City, Taiwan; e-mail: mkks618@gmail.com) Adverse events following the first, second and third doses of a COVID-19 vaccine in hemodialysis patients. Ren Fail 45:2172432 (Dec) 2023
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不良临床事件报告
在一项前瞻性观察研究中,对438名接受3剂COVID-19疫苗的血液透析(HD)患者的不良事件发生率进行了研究。纳入分析的大多数患者接受Oxford/AstraZeneca ChAdOx1作为前2剂,Moderna mRNA1273作为第三剂。总体而言,79%、50%和84%的患者分别在第一次、第二次和第三次给药后经历了至少一次不良事件。大多数反应都是轻微和暂时的。与第一次剂量相比,第二次剂量的不良事件发生率较低,第三次剂量的局部注射部位反应发生率较高,但全身反应发生率较低。进一步分析表明,与不良事件风险增加相关的特征包括女性(优势比[OR]: 2.82;95%可信区间[CI]: 1.90-4.18)和动静脉瘘通路(OR: 1.73;95% ci: 1.05-2.84)。基于这项针对HD患者的前瞻性观察性研究的结果,作者得出结论,COVID-19疫苗接种通常耐受性良好。与不良事件风险增加相关的因素包括女性和动静脉瘘通路。新冠肺炎疫苗[ChAdOx1, mRNA-1273] Pai MF等;台湾新北市220号新北市板桥区南亚南路二段21号远东纪念医院明理工学院通识教育中心;电子邮件:mkks618@gmail.com)血液透析患者接种第一、第二和第三剂COVID-19疫苗后的不良事件。任失败45:2172432 (Dec) 2023
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