Adverse events following COVID-19 virus vaccination in Japanese young population: The first cross-sectional study conducted by a questionnaire survey after the first-time-injection
Adverse events following COVID-19 virus vaccination in Japanese young population: The first cross-sectional study conducted by a questionnaire survey after the first-time-injection
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日本年轻人接种 COVID-19 病毒疫苗后的不良事件：首次注射后通过问卷调查进行的首次横断面研究
DOI：
10.1101/2021.07.23.21261029
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发表时间：
2021
期刊：
影响因子：
--
通讯作者：
T. Muro
中科院分区：
文献类型：
--
作者：
M. Suehiro;S. Okubo;K. Nakajima;K. Kanda;M. Hayakawa;S. Oiso;T. Kabashima;H. Fujita;Y. Ando;T. Muro
进行了一项横断面研究，以澄清日本年轻人群中COVID-19疫苗的不良事件。在接种现场（接种后立即或30分钟内）发生不良事件的受试者比例为0.5%，1名女学生发生过敏反应（0.03%）。我们分析了从对1,993名接种疫苗的人进行的问卷调查中获得的1,877份数据。82%的参与者抱怨局部不良事件。注射部位疼痛是最常见的局部不良事件（71%）。48%的参与者发生了全身不良事件。最常见的不良事件是肌痛（34%）。采用多变量logistic回归模型确定危险因素。局部不良事件与性别（女性）和过敏史相关，比值比（OR）（95%置信区间[CI]）分别为2.15（1.69-2.73）和1.73（1.10-2.74）。全身不良事件与性别（女性）、年龄（<20岁）、过敏史和既往药物不良事件史相关，OR（95%CI）分别为2.49（2.03-3.06）、1.80（1.44-2.24）、1.39（1.03-1.89）和1.53（1.02-2.29）。这项研究的结果首次澄清了年龄小于20岁是COVID-19疫苗Moderna肌内注射全身不良事件的风险因素。这些信息将对考虑mRNA疫苗接种的不良事件及其机制产生影响。
A cross-sectional study was conducted to clarify the adverse events of COVID-19 vaccines in Japanese young population. The proportion of participants with adverse events at the vaccination site (immediately or within 30 minutes after vaccination) was 0.5%, and anaphylaxis occurred in one female student (0.03%). We analyzed 1,877 data obtained from a questionnaire survey of 1,993 vaccinated individuals. Eighty-two percent of participants complained of local adverse events. Injection site pain was the most common local adverse event (71%). Systemic adverse events occurred in 48% of participants. The most common adverse event was myalgia (34%). A multivariable logistic regression model was used to determine risk factors. Local adverse events were associated with sex (female) and allergy history, with odds ratios (ORs) (95% confidence interval [CI]) of 2.15 (1.69-2.73) and 1.73 (1.10-2.74), respectively. Systemic adverse events were associated with sex (female), age (<20 years old), allergy history, and history of adverse events with previous medications, with ORs (95% CI) of 2.49 (2.03-3.06), 1.80 (1.44-2.24), 1.39 (1.03-1.89), and 1.53 (1.02-2.29). The results of this study clarified for the first time that age less than 20 years is a risk factor for systemic adverse events from the COVID-19 Vaccine Moderna Intramuscular Injection. This information will give impacts on considering adverse events and its mechanisms in mRNA vaccination.
DOI：
10.1056/nejmoa2035389
发表时间：
2021-02-04
期刊：
The New England journal of medicine
影响因子：
--
作者：
Baden LR;El Sahly HM;Essink B;Kotloff K;Frey S;Novak R;Diemert D;Spector SA;Rouphael N;Creech CB;McGettigan J;Khetan S;Segall N;Solis J;Brosz A;Fierro C;Schwartz H;Neuzil K;Corey L;Gilbert P;Janes H;Follmann D;Marovich M;Mascola J;Polakowski L;Ledgerwood J;Graham BS;Bennett H;Pajon R;Knightly C;Leav B;Deng W;Zhou H;Han S;Ivarsson M;Miller J;Zaks T;COVE Study Group
通讯作者：
COVE Study Group