Validation of Febrile Seizures Identified in the Sentinel Post-Licensure Rapid Immunization Safety Monitoring Program

Project Title Validation of Febrile Seizures Identified in the Sentinel Post-Licensure Rapid Immunization Safety Monitoring Program
Date
Saturday, June 8, 2019
Location
Description

The Sentinel Initiative was established in 2008 to monitor the safety of FDA-regulated medical products. This article evaluated the positive predictive value (PPV) of ICD-9 codes for post-vaccination febrile seizures to identify optimal algorithms for use in post-market safety surveillance. The authors identified ICD-9 diagnosis codes for fever and seizures in the emergency department or inpatient setting after vaccinations of interest from July 1, 2010 to June 30, 2011. Medical record review was conducted to verify febrile seizure events. Results indicate that ICD-9 diagnosis codes in the inpatient and emergency department settings have high predictive value for identifying febrile seizures within the Sentinel Distributed Database.

Corresponding Author

Alison Tse Kawai, RTI Health Solutions, 307 Waverley Oaks Road, Suite 101, Waltham, MA 02452, United States. Tel.: 781-434-1787.

Affiliation at time of authorship: Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, United States

Authors

Alison Tse Kawai, David Martin, Sarah E. Henrickson, Ashleigh Goff, Megan Reidy, Diana Santiago, Nandini Selvam, Mano Selvan, Cheryl McMahill-Walraven, Grace M. Lee

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