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

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

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

アブストラクト	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.
ジャーナル名	Vaccines
Pubmed追加日	2020/7/9
投稿者	Noda, Aoi; Sakai, Takamasa; Tsuchiya, Masami; Oyanagi, Gen; Obara, Taku; Mano, Nariyasu
組織名	Division of Preventive Medicine and Epidemiology, Tohoku University Tohoku;Medical Megabank Organization, Sendai, Miyagi 980-8573, Japan.;Division of Molecular Epidemiology, Environment and Genome Research Center,;Graduate School of Medicine, Tohoku University, Sendai, Miyagi 980-8573, Japan.;Department of Pharmaceutical Sciences, Tohoku University Hospital, Sendai, Miyagi;980-8574, Japan.;Drug Informatics, Faculty of Pharmacy, Meijo University, Nagoya, Aichi 468-8503,;Japan.;Laboratory of Clinical Pharmacy, Tohoku University Graduate School of;Pharmaceutical Sciences, Sendai, Miyagi 980-8574, Japan.;Department of Pharmacy, Miyagi Cancer Center, Natori, Miyagi 981-1293, Japan.
Pubmed リンク	https://www.ncbi.nlm.nih.gov/pubmed/32635349/