Prospective influenza vaccine safety surveillance using fresh data in the Sentinel System.

ABSTRACT:

Purpose

To develop the infrastructure to conduct timely active surveillance for safety of influenza vaccines and other medical countermeasures in the Sentinel System (formerly the Mini-Sentinel Pilot), a Food and Drug Administration-sponsored national surveillance system that typically relies on data that are mature, settled, and updated quarterly.

Methods

Three Data Partners provided their earliest available ("fresh") cumulative claims data on influenza vaccination and health outcomes 3-4 times on a staggered basis during the 2013-2014 influenza season, collectively producing 10 data updates. We monitored anaphylaxis in the entire population using a cohort design and seizures in children ≤4 years of age using both a self-controlled risk interval design (primary) and a cohor

SUBMITTER: Yih WK 

PROVIDER: S-EPMC5019152 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature