Lessons learned from annotation of VAERS reports on adverse events following influenza vaccination and related to Guillain-Barré syndrome

Table 3 Annotation examples of events from VAERS text

Description of events	Mapped to MedDRA term (SOC / LLT or SOC)	Annotated event (in bold text) examples
Medical problems: Phrases / words that specify a disease, syndrome, symptom or sign	Nervous system disorders (SOC) / Guillain-Barré Syndrome (LLT)	“suffering from *Guillain–Barre Syndrome*”
	Nervous system disorders (SOC term) / Ataxia (LLT)	“pt was admitted into hospital for *loss of mobility*”
	Gastrointestinal disorders (SOC term)	“developed *vomiting* and *diarrhea*”
	Gastrointestinal disorders (SOC term)	“symptoms of *heart burn* suspected of *gastroesophageal reflux disease*”
Non-medical problems that impact social life	Social circumstances	“Pt's current condition is *confinement to a wheel chair*”
Non-medical problems that impact social life	Social circumstances	“truncal weakness with *inability to support himself*”
Clinical investigations	Investigations	“*MRI,CT scan* was suggestive of spinal tumor and fracture”
Clinical investigations	Investigations	“Had repeat *EMG/NCS* done as outpatient”
Treatments / procedures	Surgical and medical procedures	“the pt received 6 courses of plasmaphoresis”
		“Patient was hospitalised for evaluation, and received *tracheotomy* as result of difficulties”
		“10/15/14 referral to *physical therapy* due to weakness and short endurance”

ISSN: 1472-6947