Citation

Noda A, Sakai T, Tsuchiya M, Oyanagi G, Obara T, Mano N. Vaccines 2020; 8(3): 1-13.

Copyright

(Copyright © 2020)

DOI

10.3390/vaccines8030357

PMID

unavailable

Abstract

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. © 2020 by the authors. Licensee MDPI, Basel, Switzerland.

Language: en

Keywords

adolescent; adult; human; Children; child; female; male; suicide attempt; pain; death; major clinical study; vomiting; data base; school child; tachycardia; health care facility; headache; drug industry; seizure; health care personnel; vaccine; heart arrest; fever; amyotrophic lateral sclerosis; muscle weakness; dyspnea; respiratory arrest; immunization; malaise; dizziness; hepatitis B vaccine; myocarditis; Article; sudden infant death syndrome; consciousness disorder; heart ventricle arrhythmia; musculoskeletal stiffness; anaphylaxis; hypesthesia; bacteremia; meningitis; heart bundle branch block; rectum hemorrhage; young adult; osteosarcoma; thrombocytopenic purpura; febrile convulsion; influenza vaccine; Wart virus vaccine; diphtheria pertussis poliomyelitis tetanus vaccine; faintness; Pneumococcus vaccine; Rotavirus vaccine; clinical outcome; intussusception; adverse event; sinus arrhythmia; pharmacovigilance; Adverse events following immunization; BCG vaccine; bulbar paralysis; Haemophilus influenzae type b vaccine; hemagglutinin; Japanese encephalitis vaccine; measles rubella vaccine; mumps vaccine; presyncope; Spontaneous reports; Vaccine