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The objective of this study was to determine whether the Food and Drug Administration's Adverse Event Reporting System (FAERS) data set could serve as the basis of automated electronic health record (EHR) monitoring for the adverse drug reaction (ADR) subset of adverse drug events. We retrospectively collected EHR entries for 71 909 pediatric inpatient visits at Cincinnati Children's Hospital Medical Center. Natural language processing (NLP) techniques were used to identify positive diseases/disorders and signs/symptoms (DDSSs) from the patients' clinical narratives. We downloaded all FAERS reports submitted by medical providers and extracted the reported drug-DDSS pairs. For each patient, we aligned the drug-DDSS pairs extracted from their clinical notes with the corresponding drug-DDSS pairs from the FAERS data set to identify Drug-Reaction Pair Sentences (DRPSs). The DRPSs were processed by NLP techniques to identify ADR-related DRPSs. We used clinician annotated, real-world EHR data as reference standard to evaluate the proposed algorithm. During evaluation, the algorithm achieved promising performance and showed great potential in identifying ADRs accurately for pediatric patients.

Leveraging Food and Drug Administration Adverse Event Reports for the Automated Monitoring of Electronic Health Records in a Pediatric Hospital