Table 3.

Grading of solicited reactions according to the China Food and Drug Administration scale.

Solicited reaction	Age group	Grade 1	Grade 2	Grade 3
Injection-site
Tenderness	6–23 mo	Minor reaction when injection site is touched	Cries or protests when injection site is touched	Cries when injected limb is moved or movement of the injected limb is reduced
Pain	2–11 y	Easily tolerated	Sufficiently discomforting to interfere with normal behavior or activities	Incapacitating, unable to perform usual activities
	≥ 12 y	No interference with activity	Some interference with activity	Significant, prevents daily activity
Erythema, swelling, induration, ecchymosis	All	>0 to <15 mm	≥ 15 to ≤ 30 mm	>30 mm
Systemic
Fever	All	≥ 37.1°C to ≤ 37.5°C	>37.5°C to ≤ 39°C	>39°C
Vomiting	6–23 mo	1 episode/24 h	2–5 episodes/24 h	≥ 6 episodes/24 h
Abnormal crying	6–23 mo	<1 h	1–3 h	>3 h
Drowsiness	6–23 mo	Sleepier than usual or less interested in surroundings	Not interested in surroundings or did not wake up for a feed/meal	Sleeping most of the time or difficult to wake
Loss of appetite	6–23 mo	Eating less than normal	Missed 1 or 2 feeds/meals completely	Refuses ≥ 3 feeds/meals or refuses most feeds/meals
Irritability	6–23 mo	Easily consolable	Requiring increased attention	Inconsolable
Headache, malaise, myalgia, shivering	≥ 2 y	No interference with activity	Some interference with activity	Significant, prevents daily activity