Waldo: Automated discovery of adverse events from unstructured self reports.

Adverse event (AE) detection is labor-intensive and costly given the task is to find rare events. Automated solutions to enhance efficiency, reduce costs, and capture unnoticed safety signals are needed. To develop and evaluate an automated machine learning tool, "Waldo," for AE detection from unstructured social media text data, specifically targeting consumer health products that lack traditional post-market surveillance channels. We tested three models - (i) N-gram model, (ii) BERT (Bidirectional Encoder Representations from Transformers), and (iii) RoBERTa (Robustly optimized BERT approach) - trained on 10,000 previously published unstructured reports on cannabis-derived products (CDPs) annotated by humans for the presence of adverse events to determine the best-performing AE detection method. This method was then benchmarked against an AI chatbot (ChatGPT: gpt-3.5-turbo-0613) and applied to previously unstudied user narratives about CDPs from 20 subreddits.RoBERTa demonstrated the highest accuracy at 99.7%, hereafter referred to as Waldo, with 22 false positives and 12 false negatives, yielding an F1-score of 95.1% for the positive class. In contrast, the chatbot had an accuracy of 94.4%, with 401 false positives (18.23-fold more than Waldo) and 163 false negatives (13.58-fold more than Waldo), yielding an F1-score of 38% for the positive class. Applying Waldo to 437,132 posts identified 28,832 potential AEs. The subreddit r/Marijuana had the highest AE rate (12.7%), followed by r/weed (10.5%) and r/AskTrees (10.0%). r/weedstocks (0.1%), r/macrogrowery (0.2%), and r/weedbiz (0.2%) had the lowest rates of potential AEs. Waldo addresses critical gaps in safety surveillance for unregulated consumer health products by automatically detecting adverse events from social media-a capability absent in traditional industry systems. Unlike existing approaches limited to structured databases or narrow domains, Waldo processes informal user narratives at scale with high precision. We have open-sourced Waldo for immediate application by the health community [https://waldo-ae-detection.github.io/WALDO/].