Characteristics of Adverse Events Following Immunization Reporting in Children: The Japanese Adverse Drug Event Report Database

被引:2
|
作者
Noda, Aoi [1 ,2 ,3 ]
Sakai, Takamasa [4 ]
Tsuchiya, Masami [5 ,6 ]
Oyanagi, Gen [3 ]
Obara, Taku [1 ,2 ,3 ]
Mano, Nariyasu [3 ,5 ]
机构
[1] Tohoku Univ, Div Prevent Med & Epidemiol, Tohoku Med Megabank Org, Sendai, Miyagi 9808573, Japan
[2] Tohoku Univ, Environm & Genome Res Ctr, Grad Sch Med, Div Mol Epidemiol, Sendai, Miyagi 9808573, Japan
[3] Tohoku Univ Hosp, Dept Pharmaceut Sci, Sendai, Miyagi 9808574, Japan
[4] Meijo Univ, Fac Pharm, Drug Informat, Nagoya, Aichi 4688503, Japan
[5] Tohoku Univ, Lab Clin Pharm, Grad Sch Pharmaceut Sci, Sendai, Miyagi 9808574, Japan
[6] Miyagi Canc Ctr, Dept Pharm, Natori, Miyagi 9811293, Japan
关键词
adverse events following immunization; vaccine; children; spontaneous reports; HPV VACCINE;
D O I
10.3390/vaccines8030357
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
The present study aimed to describe the trends and characteristics of adverse events following immunization (AEFI) reporting for children in the Japanese Adverse Drug Event Report database (JADER). We used 6280 AEFI reports for children aged <19 years among 504,407 ADR reports included in the JADER from 2004 to 2017. The number of AEFI reports gradually increased among children aged <10 years and was the highest in 2011 among children aged 10-19 years. The number of suspected vaccines per AEFI report increased after 2011 among children aged <10 years. The percentage of "death" and "did not recover" as AEFI outcomes reported were 4.3% and 3.7% among children aged <10 years and 0.2% and 21.1% among children aged 10-19 years, respectively. The most frequently reported vaccine-reaction pair was Haemophilus influenzae type b conjugate vaccine and pyrexia among children aged <10 years and recombinant adsorbed bivalent human papillomavirus-like particle vaccine and a loss of consciousness among children aged 10-19 years. It is necessary to consider the Weber effects to understand the trend and characteristics of AEFI reporting because pharmacovigilance activity regarding vaccination is not sufficient in Japan.
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页码:1 / 13
页数:13
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