Factors Associated with Non-Severe Adverse Reactions after Vaccination against SARS-CoV-2: A Cohort Study of 908,869 Outpatient Vaccinations in Germany.
Factors Associated with Non-Severe Adverse Reactions after Vaccination against SARS-CoV-2: A Cohort Study of 908,869 Outpatient Vaccinations in Germany.
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DOI：
10.3390/vaccines10040566
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发表时间：
2022-04-06
期刊：
影响因子：
7.8
通讯作者：
Kostev, Karel
中科院分区：
文献类型：
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作者：
Loosen, Sven H.;Bohlken, Jens;Weber, Kerstin;Konrad, Marcel;Luedde, Tom;Roderburg, Christoph;Kostev, Karel
背景：针对SARS-CoV-2的疫苗接种可显著降低病毒的传播性和COVID-19严重病程的可能性，因此是克服当前大流行的关键组成部分。与SARS-CoV-2疫苗接种后不良反应相关的因素尚未得到充分评估。方法：我们使用疾病分析器数据库（IQVIA）确定了2021年4月至9月期间在德国827个普通诊所共接种了908,869次SARS-CoV-2疫苗的531,468名个体。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28,287例（占所有疫苗接种的3.1%）。肢体疼痛（24.3%）、疲劳（21.0%）、头晕（17.9%）、关节痛（15.7%）、发热（9.5%）、恶心（7.5%）和肌痛（6.4%）是12575例有明确副作用的疫苗接种中最常见的副作用。在多变量回归分析中，年轻的年龄与报告的副作用的几率要高得多（OR18-30岁：4.45，OR31-40岁：3.50，OR41-50岁：2.89）。此外，先前存在的合并症，如痴呆（OR: 1.54）、躯体形式障碍（OR: 1.53）、焦虑症（OR: 1.43）、抑郁症（OR: 1.37）、慢性呼吸道疾病（OR: 1.27）、高血压（OR: 1.20）和肥胖（1.14），显著增加了副作用的发生几率。最后，男性与报告的副作用的几率增加有关（OR: 1.17）。结论：我们的研究基于来自德国的一个大型门诊数据库，确定了年轻、男性和先前存在的合并症，如痴呆、身体形式障碍、焦虑症和抑郁症，是全科医生诊断出的疫苗相关不良事件的相关因素。这些数据可以帮助确定在SARS-CoV-2疫苗接种背景下需要特别建议和护理的亚群体。
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 (OR18–30 years: 4.45, OR31–40 years: 3.50, OR41–50 years: 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.
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DOI：
10.1056/nejmoa2034577
发表时间：
2020-12-31
期刊：
The New England journal of medicine
影响因子：
--
作者：
Polack FP;Thomas SJ;Kitchin N;Absalon J;Gurtman A;Lockhart S;Perez JL;Pérez Marc G;Moreira ED;Zerbini C;Bailey R;Swanson KA;Roychoudhury S;Koury K;Li P;Kalina WV;Cooper D;Frenck RW Jr;Hammitt LL;Türeci Ö;Nell H;Schaefer A;Ünal S;Tresnan DB;Mather S;Dormitzer PR;Şahin U;Jansen KU;Gruber WC;C4591001 Clinical Trial Group
通讯作者：
C4591001 Clinical Trial Group
影响因子：
13.8
作者：
Vilches TN;Moghadas SM;Sah P;Fitzpatrick MC;Shoukat A;Pandey A;Galvani AP
通讯作者：
Galvani AP
DOI：
10.1056/nejmoa2105290
发表时间：
2021-12-16
期刊：
The New England journal of medicine
影响因子：
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作者：
Falsey AR;Sobieszczyk ME;Hirsch I;Sproule S;Robb ML;Corey L;Neuzil KM;Hahn W;Hunt J;Mulligan MJ;McEvoy C;DeJesus E;Hassman M;Little SJ;Pahud BA;Durbin A;Pickrell P;Daar ES;Bush L;Solis J;Carr QO;Oyedele T;Buchbinder S;Cowden J;Vargas SL;Guerreros Benavides A;Call R;Keefer MC;Kirkpatrick BD;Pullman J;Tong T;Brewinski Isaacs M;Benkeser D;Janes HE;Nason MC;Green JA;Kelly EJ;Maaske J;Mueller N;Shoemaker K;Takas T;Marshall RP;Pangalos MN;Villafana T;Gonzalez-Lopez A;AstraZeneca AZD1222 Clinical Study Group
通讯作者：
AstraZeneca AZD1222 Clinical Study Group
影响因子：
12.7
作者：
Tanislav, Christian;Kostev, Karel
通讯作者：
Kostev, Karel
影响因子：
4.8
作者：
Jacob L;Koyanagi A;Smith L;Bohlken J;Haro JM;Kostev K
通讯作者：
Kostev K