Pharmacovigilance of special populations using KNIME

Using VAERS for pharmacovigilance of special populations

U.S. Food and Drug Administration (FDA) and drug manufacturers regularly monitor a drug's adverse events during clinical trials and post FDA approval. Post-marketing surveillance is important because there is a greater diversity in patients taking the medication compared to the clinical trial population. An increase in frequency of adverse events reported can result in a drug label change or even removal from the market.
The Vaccine Adverse Event Reporting System (VAERS) is a database of reported adverse events following immunization from U.S. licensed vaccines. VAERS serves the purpose of an early warning system for the U.S. to ensure vaccines are a safe tool for immunization. With KNIME's data mining tools, we wanted to use KNIME to monitor adverse events from special populations.
Special populations are often excluded from clinical trials due to the complexity they may present when interpreting clinical trial results. With rigorous pharmacovigilance tools, we can identify trends and prevent potential harm to patients with unique underlying health conditions. In our proof of concept, we wanted to monitor what adverse events have been reported to VAERS from patients who have been diagnosed with multiple sclerosis and received the COVID-19 vaccine.

P.S.: The data can be downloaded from: https://vaers.hhs.gov/data/datasets.html (2022 Zip File)

External resources

• Video demonstration of the workflow