Table 1.

Grading of solicited adverse events

	Grading
	0	1	2	3
Injection site events
Pain	None	Mild: Any pain neither interfering with nor preventing normal every day activities	Moderate: Painful when limb was moved and interfered with every day activities.	Severe: Significant pain at rest. Prevented normal every day activities.
Redness (diameter)
	<20 mm	20–50 mm	>50–100 mm	>100 mm
Swelling (diameter)
Fatigue
General events
GI symptoms
Headache	None	Mild: Event that was easily tolerated	Moderate: Event that interfered with normal activity	Severe: Event that prevented normal activity
Myalgia
Shivering
Fever (body temperature)	<37.5°C	37.5–38.0°C	38.1–39.0°C	>39.0°C

GI, gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain)