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

Table 2 List of MedDRA terms used for annotation

System Organ Class (SOC)	Lowest Level Terms (LLT)	Number of occurrences
Investigations	Other investigations	205
	Computerised tomogram	8
	Electromyogram	8
	Physical examination	6
	Anti-ganglioside antibody	0
	Albumin CSF abnormal	0
	Oxygen saturation	0
Nervous system disorders	Other Nervous system disorders	180
	Muscular weakness	146
	Guillain-Barré Syndrome	119
	Hypoaesthesia	93
	Paraesthesia	58
	Difficulty in walking	43
	Areflexia	18
	Headache	14
	Ataxia	10
	Dizziness	4
	Muscle spasm	3
Surgical and medical procedures	Immunization	134
	Other surgical and medical procedures	111
	Hospitalisation	89
	Rehabilitation therapy	41
	Emergency care	39
	Physiotherapy	32
	Plasmapheresis	24
	Intensive care	20
	Catheter placement	7
	Intubation	7
	Tracheostomy	4
	Mechanical ventilation	2
	Occupational therapy	1
	Cardiac pacemaker insertion	0
Social circumstances	Other social circumstances	26
	Impaired work abilities	11
	Foreign travel	0
General disorders and administration site conditions		157
Musculoskeletal and connective tissue disorders		104
Respiratory, thoracic and mediastinal disorders		92
Gastrointestinal disorders		59
Infections and infestations		35
Renal and urinary disorders		33
Other organ system disorders		32
Cardiac disorders		18
Eye disorders		12
Blood and lymphatic system disorders		9
Psychiatric disorders		9
Endocrine disorders		5

ISSN: 1472-6947