Neonatal Drug ADR Association Dataset
Description
The Neonatal Drug ADR Association Dataset, curated from the FDA Adverse Event Reporting System (FAERS), focuses on over 140 neonatal health conditions. It comprises approximately 145130 reported cases, from which 32441 unique instances were extracted after deduplication (Version 1). Each instance documents a suspect drug, its associated adverse drug reaction (ADR), and related metadata including drug outcome, patient gender, age, and weight. While demographic details are included, some instances have missing values due to unreported information by patients or healthcare professionals. This comprehensive and refined dataset offers valuable insights for neonatal pharmacovigilance, supporting research in drug safety, ADR pattern analysis, and treatment outcomes in this vulnerable population. This dataset presents a comprehensive analysis of adverse drug reactions (ADRs) associated with neonatal drug use, curated from the FDA Adverse Event Reporting System (FAERS). It is based on over 140 clinically relevant neonatal reaction terms, and includes (i)Total Cases, (ii) # of Serious Cases (including deaths), and (iii) # of Death Cases, for each of the 141 neonatal conditions. The dataset is designed to support research in neonatal pharmacovigilance, drug safety assessment, and ADR risk modeling. Metadata Included in the Dataset: (i) Neonatal Reaction Summary (Neonatal Reaction Terms_Summary.xlsx) that contains over 140 neonatal reaction terms with corresponding Total Cases, Serious Cases (including deaths), and Death Cases. (ii) Year-wise Reported Cases for Neonatal Conditions (xxx. Neonatal Reaction Term.xlsx) provides yearly distribution of ADR reports for each neonatal reaction term to understand longitudinal trends in ADR frequency. (iii) Total Case Statistics (xxx. Neonatal Reaction Term_Total cases.xlsx) that tabulates Total, Serious, and Death cases to support risk quantification across neonatal conditions. (iv) Detailed Case Listings (xxx. Neonatal Reaction Term_List of cases.xlsx) that includes individual reported case details with 24 attributes per record, notably Suspect Drug(s), Reported Reaction(s), Severity Classification, Patient Demographics (Patient Age, Sex, and Weight), and Outcome Information, and Reason for Use
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Steps to reproduce
The dataset was manually curated using publicly available data from the FDA Adverse Event Reporting System (FAERS), focusing on neonatal cases involving adverse drug reactions (ADRs) reporting data. Duplicates were identified and removed to ensure the dataset contained unique instances. Data with incomplete or unreported fields (e.g., missing gender, age, or weight) was retained to reflect real-world reporting challenges. This dataset may require pre-processing depending on the task.