2019冠状病毒病疫苗接种后非严重不良反应的相关因素：德国908,869例门诊疫苗接种队列研究
Factors Associated with Non-Severe Adverse Reactions after Vaccination against SARS-CoV-2: A Cohort Study of 908,869 Outpatient Vaccinations in Germany.
作者信息
Loosen Sven H, Bohlken Jens, Weber Kerstin, Konrad Marcel, Luedde Tom, Roderburg Christoph, Kostev Karel
机构信息
Clinic for Gastroenterology, Hepatology and Infectious Diseases, University Hospital Düsseldorf, Medical Faculty of Heinrich Heine University Düsseldorf, 40225 Düsseldorf, Germany.
Institut für Sozialmedizin, Arbeitsmedizin und Public Health (ISAP), Medical Faculty, University of Leipzig, 04103 Leipzig, Germany.
出版信息
Vaccines (Basel). 2022 Apr 6;10(4):566. doi: 10.3390/vaccines10040566.
BACKGROUND
Vaccination against SARS-CoV-2 significantly reduces the transmissibility of the virus and the likelihood of a severe course of COVID-19, and is thus a critical component in overcoming the current pandemic. The factors associated with adverse reactions after vaccination against SARS-CoV-2 have not yet been sufficiently evaluated.
METHODS
We used the Disease Analyzer database (IQVIA) to identify 531,468 individuals who received a total of 908,869 SARS-CoV-2 vaccinations in 827 general practices in Germany between April and September 2021. Cox regression models were used to analyze the frequency of vaccination-related side effects reported within 14 days after SARS-CoV-2 vaccination, as well as subjects' demographic characteristics and comorbidities.
RESULTS
The total number of side effects documented was 28,287 (3.1% of all vaccinations). Pain in the limb (24.3%), fatigue (21.0%), dizziness (17.9%), joint pain (15.7%), fever (9.5%), nausea (7.5%), and myalgia (6.4%) were the most common side effects documented among the 12,575 vaccinations with definite side effects. In the multivariate regression analysis, young age was associated with much higher odds of reported side effects (OR: 4.45, OR: 3.50, OR: 2.89). In addition, pre-existing comorbidities such as dementia (OR: 1.54), somatoform disorder (OR: 1.53), anxiety disorder (OR: 1.43), depression (OR: 1.37), chronic respiratory tract disease (OR: 1.27), hypertension (OR: 1.20), and obesity (1.14) significantly increased the odds of side effects. Finally, the male sex was associated with increased odds of reported side effects (OR: 1.17).
CONCLUSION
Our study, based on a large outpatient database from Germany, identified young age, male sex, and pre-existing comorbidities such as dementia, somatoform disorders, anxiety disorders, and depression as factors associated with vaccine-related adverse events diagnosed in GP practices. These data could help to identify subgroups needing particular advice and care in the context of SARS-CoV-2 vaccinations.
背景
接种针对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的疫苗可显著降低该病毒的传播性以及感染新型冠状病毒肺炎（COVID-19）后出现重症病程的可能性，因此是战胜当前疫情的关键组成部分。接种SARS-CoV-2疫苗后出现不良反应的相关因素尚未得到充分评估。
方法
我们使用疾病分析器数据库（艾昆纬公司），在德国827家普通诊所中识别出531468名个体，他们在2021年4月至9月期间共接种了908869剂SARS-CoV-2疫苗。采用Cox回归模型分析SARS-CoV-2疫苗接种后14天内报告的疫苗相关副作用的发生频率，以及受试者的人口统计学特征和合并症。
结果
记录的副作用总数为28287例（占所有接种疫苗的3.1%）。在12575例有明确副作用的疫苗接种中，肢体疼痛（24.3%）、疲劳（21.0%）、头晕（17.9%）、关节疼痛（15.7%）、发热（9.5%）、恶心（7.5%）和肌痛（6.4%）是最常见的副作用。在多变量回归分析中，年轻与报告副作用的几率高得多相关（比值比：4.45、比值比：3.50、比值比：2.89）。此外，痴呆（比值比：1.54）、躯体形式障碍（比值比：1.53）、焦虑症（比值比：1.43）、抑郁症（比值比：1.37）、慢性呼吸道疾病（比值比：1.27）、高血压（比值比：1.20）和肥胖症（1.14）等既往合并症显著增加了出现副作用的几率。最后，男性与报告副作用的几率增加相关（比值比：1.17）。
结论
我们基于德国一个大型门诊数据库开展的研究，确定了年轻、男性以及痴呆、躯体形式障碍、焦虑症和抑郁症等既往合并症是普通诊所中诊断出的与疫苗相关不良事件相关的因素。这些数据有助于识别在SARS-CoV-2疫苗接种背景下需要特别建议和护理的亚组人群。
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