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Adverse Events Following One Dose of mRNA COVID-19 Vaccination Among US Nursing Home Residents With and Without a Previous SARS-CoV-2 Infection

机译:既往有或未感染过 SARS-CoV-2 的美国疗养院居民接种一剂 mRNA COVID-19 疫苗后的不良事件

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? 2021 AMDA – The Society for Post-Acute and Long-Term Care MedicineObjectives: To compare rates of adverse events following Coronavirus Disease 2019 (COVID-19) vaccination among nursing home residents with and without previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Design: Prospective cohort. Setting and Participants: A total of 20,918 nursing home residents who received the first dose of messenger RNA COVID-19 vaccine from December 18, 2020, through February 14, 2021, in 284 facilities within Genesis Healthcare, a large nursing home provider spanning 24 US states. Methods: We screened the electronic health record for adverse events, classified by the Brighton Collaboration, occurring within 15 days of a resident's first COVID-19 vaccine dose. All events were confirmed by physician chart review. To obtain risk ratios, multilevel logistic regression model that accounted for clustering (variability) across nursing homes was implemented. To balance the probability of prior SARS-CoV-2 infection (previous positive test or diagnosis by the International Classification of Diseases, 10th Revision, Clinical Modification) more than 20 days before vaccination, we used inverse probability weighting. To adjust for multiplicity of adverse events tested, we used a false discovery rate procedure. Results: Statistically significant differences existed between those without (n = 13,163) and with previous SARS-CoV-2 infection symptomatic (n = 5617) and asymptomatic (n = 2138) for all baseline characteristics assessed. Only 1 adverse event was reported among those with previous SARS-CoV-2 infection (asymptomatic), venous thromboembolism 46.8 per 100,000 residents 95 confidence interval (CI) 8.3–264.5, which was not significantly different from the rate reported for those without previous infection (30.4 per 100,000 95 CI 11.8–78.1). Several other adverse events were observed for those with no previous infection, but were not statistically significantly higher than those reported with previous infection after adjustments for multiple comparisons. Conclusions and Implications: Although reactogenicity increases with preexisting immunity, we did not find that vaccination among those with previous SARS-CoV-2 infection resulted in higher rates of adverse events than those without previous infection. This study stresses the importance of monitoring novel vaccines for adverse events in this vulnerable population.
机译:?2021 AMDA – 急性后和长期护理医学学会目标:比较既往有和没有严重急性呼吸系统综合症冠状病毒 2 (SARS-CoV-2) 感染的疗养院居民接种 2019 年冠状病毒病 (COVID-19) 疫苗后的不良事件发生率。设计:前瞻性队列。环境和参与者:从 2020 年 12 月 18 日至 2021 年 2 月 14 日,共有 20,918 名疗养院居民在美国 24 个州的大型疗养院提供商 Genesis Healthcare 的 284 个设施中接种了第一剂信使 RNA COVID-19 疫苗。方法:我们筛选了由布莱顿合作组织分类的不良事件的电子健康记录,这些不良事件发生在居民首次接种 COVID-19 疫苗后 15 天内。所有事件均通过医师图表审查确认。为了获得风险比,实施了多层次逻辑回归模型,该模型考虑了疗养院的聚类(变异性)。为了平衡接种疫苗前 20 天以上既往 SARS-CoV-2 感染的概率(既往检测呈阳性或被国际疾病分类第 10 次修订版、临床修改版诊断),我们使用了逆概率加权。为了调整所测试不良事件的多样性,我们使用了错误发现率程序。结果:对于评估的所有基线特征,未感染 (n = 13,163) 和既往感染 SARS-CoV-2 [有症状 (n = 5617) 和无症状 (n = 2138)] 的患者之间存在统计学显着差异。在既往感染过SARS-CoV-2(无症状)的患者中,仅报告了1例不良事件,静脉血栓栓塞[46.8/100,000居民,95%置信区间(CI)8.3-264.5],这与既往未感染者报告的发生率(30.4/100,000,95%CI 11.8-78.1)无显著差异。对于既往未感染的患者,观察到其他几种不良事件,但在调整多重比较后,未在统计学上显着高于先前感染的患者。结论和意义:尽管反应原性随着先前存在的免疫力而增加,但我们没有发现既往感染过SARS-CoV-2的人接种疫苗会导致不良事件发生率高于既往未感染的人。这项研究强调了监测这一脆弱人群中不良事件的新型疫苗的重要性。

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