The impact of regulation changes in the spontaneous reporting system for vaccines on reporting trends and signal detection in Japan.

Makoto MiyazakiTakamasa SakaiTaku ObaraNariyasu Mano

Published in: Pharmacoepidemiology and drug safety (2021)

We concluded that the regulation changes increased the number of vaccine reports, and could have improved signal detection performance for vaccines by accelerating accumulation of reports, while more spontaneous reports are necessary to optimize signal detection.

Keyphrases

adverse drug
loop mediated isothermal amplification
real time pcr
label free
emergency department
electronic health record
drug induced
quantum dots