With the advent of large language models (LLMs), there has been growing interest in exploring their potential for medical applications. This research aims to investigate the ability of LLMs, specifically ChatGPT, in the context of pharmacovigilance event extraction, of which the main goal is to identify and extract adverse events or potential therapeutic events from textual medical sources. We conduct extensive experiments to assess the performance of ChatGPT in the pharmacovigilance event extraction task, employing various prompts and demonstration selection strategies. The findings demonstrate that while ChatGPT demonstrates reasonable performance with appropriate demonstration selection strategies, it still falls short compared to fully fine-tuned small models. Additionally, we explore the potential of leveraging ChatGPT for data augmentation. However, our investigation reveals that the inclusion of synthesized data into fine-tuning may lead to a decrease in performance, possibly attributed to noise in the ChatGPT-generated labels. To mitigate this, we explore different filtering strategies and find that, with the proper approach, more stable performance can be achieved, although constant improvement remains elusive.

The primary goal of drug safety researchers and regulators is to promptly identify adverse drug reactions. Doing so may in turn prevent or reduce the harm to patients and ultimately improve public health. Evaluating and monitoring drug safety (i.e., pharmacovigilance) involves analyzing an ever growing collection of spontaneous reports from health professionals, physicians, and pharmacists, and information voluntarily submitted by patients. In this scenario, facilitating analysis of such reports via automation has the potential to rapidly identify safety signals. Unfortunately, public resources for developing natural language models for this task are scant. We present PHEE, a novel dataset for pharmacovigilance comprising over 5000 annotated events from medical case reports and biomedical literature, making it the largest such public dataset to date. We describe the hierarchical event schema designed to provide coarse and fine-grained information about patients’ demographics, treatments and (side) effects. Along with the discussion of the dataset, we present a thorough experimental evaluation of current state-of-the-art approaches for biomedical event extraction, point out their limitations, and highlight open challenges to foster future research in this area.