Table 1.

Examples of Data Sources and Methods Used in Data Mining for Pharmacovigilance²–⁴,¹⁴,¹⁷

Type of Data	Stage	Method	Tool	Purpose
Observational
SRS reports	Routine	MGPS	Empirica Signal	Identify drug–ADE signals
	Developmental	Text mining	Vaccine Adverse Event Text Mining system	Identify vaccine–ADE signals; plot temporal association
	Developmental	MGPS	MASE	Molecular analysis of drug–ADE association
	Developmental	GIS	Various investigational	Manage drug safety data temporally and geographically
Electronic health records	Developmental	Text mining	Various investigational	Identify drug–ADE signals
Medical Literature
MEDLINE	Developmental	Text mining	MeSH	Identify drug–ADE signals
Medical literature	Developmental	NLP	Linguamatics I2E	Predict drug–ADE associations based on chemical structure
	Developmental	Text mining	G-VISR	Identify vaccine–ADE signals; examine molecular information
Internet
Social media	Developmental	Text mining	MedWatcher Social	Identify drug–ADE signals
Other Internet sources (websites, search logs, etc.)	Developmental	Text mining	Various investigational	Identify drug–ADE signals

ADE = adverse drug event; GIS = geographical information systems; G-VISR = Georgetown Vaccine Information and Safety Resources; MeSH = medical subject headings; MGPS = multi-item gamma-Poisson shrinker; NLP = natural language processing; SRS = spontaneous reporting system.