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

Autor: Gen Oyanagi, Nariyasu Mano, Takamasa Sakai, Aoi Noda, Taku Obara, Masami Tsuchiya
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: Vaccines, Vol 8, Iss 357, p 357 (2020)
Vaccines
Volume 8
Issue 3
Popis: 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 &ldquo
death&rdquo
and &ldquo
did not recover&rdquo
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&ndash
19 years, respectively. The most frequently reported vaccine&ndash
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.
Databáze: OpenAIRE