Abstract: Various embodiments include methods, computer program products and systems for analyzing reported adverse event (AE) data about a pharmaceutical, vaccine or medical device. In some cases, that reported AE data is unstructured. In these cases, a method can include: applying a natural language processing (NLP) filter to the unstructured reported AE data to generate an initial set of reporting codes for the unstructured reported AE data; providing the initial set of reporting codes for review by a healthcare professional, to either verify each of the reporting codes or modify at least one of the reporting codes, and generating a refined set of reporting codes based upon the review; and creating a safety case report linking the pharmaceutical, vaccine or medical device with the refined set of reporting codes. In additional embodiments, the safety report is provided to relevant authorities according to prescribed reporting criteria.

Abstract: Various embodiments include methods, computer program products and systems for analyzing reported adverse event (AE) data about a pharmaceutical, vaccine or medical device. In some cases, that reported AE data is unstructured. In these cases, a method can include: applying a natural language processing (NLP) filter to the unstructured reported AE data to generate an initial set of reporting codes for the unstructured reported AE data; providing the initial set of reporting codes for review by a healthcare professional, to either verify each of the reporting codes or modify at least one of the reporting codes, and generating a refined set of reporting codes based upon the review; and creating a safety case report linking the pharmaceutical, vaccine or medical device with the refined set of reporting codes. In additional embodiments, the safety report is provided to relevant authorities according to prescribed reporting criteria.