Postmarketing Safety Surveillance of a Hexavalent Vaccine in the Vaccine Adverse Event Reporting System

被引：0

作者：

Moro, Pedro L. ^{[1
,3
]}

Zhang, Bicheng ^{[1
]}

Marquez, Paige ^{[1
]}

Reich, Jonathan ^{[2
]}

机构：

[1] Div Healthcare Qual Promot CDC, Immunizat Safety Off, Silver Spring, MD USA

[2] US FDA, Ctr Biol Evaluat & Res, Silver Spring, MD 20993 USA

[3] Ctr Dis Control & Prevent, Div Healthcare Qual Promot, Immunizat Safety Off, 1600 Clifton Rd,MS D26, Atlanta, GA 30333 USA

来源：

JOURNAL OF PEDIATRICS | 2023年 / 262卷

关键词：

CLINICAL-TRIAL; DOUBLE-BLIND; IMMUNOGENICITY; INTUSSUSCEPTION; TOLERABILITY; DIPHTHERIA; PERTUSSIS; TETANUS; RISK;

D O I：

10.1016/j.jpeds.2023.113643

中图分类号：

R72 [儿科学];

学科分类号：

100202 ;

摘要：

We assessed the safety of hexavalent vaccine diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, hepatitis b, and haemophilus influenzae b conjugate vaccine in the Vaccine Adverse Event Reporting System. Five hundred-one reports of adverse events (AEs) were identified; 21 (4.2%) were serious. Most frequently reported AEs were fever (10.2%) and injection site erythema (5.4%). AEs reported were consistent with findings from prelicensure studies. (J Pediatr 2023;262:113643).

引用

页数：4

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