Table 6. Definitions of solicited injection-site and systemic reactions.

Reactions	Definitions
Solicited injection-site reactions
Pain	Grade 1: easily tolerated Grade 2: sufficiently discomforting to interfere with normal behavior or activities Grade 3: Incapacitating, unable to carry out usual activities
Erythema and swelling	Grade 1: adults/adolescents: ≥ 2.5 cm to ≤ 5 cm; children: < 2.5 cm Grade 2: adults/adolescents: ≥ 5.1 cm to ≤ 10 cm; children: 2.5–4.9 cm Grade 3: adults/adolescents: > 10 cm; children: ≥ 5 cm
Solicited systemic reactions
Fever	Grade 1 ≥ 38°C to ≤ 38.4°C Grade 2: ≥ 38°5C to ≤ 38. 9°C Grade 3: ≥ 39.0°C
Headache, malaise, myalgia, and asthenia	Grade 1: No interference with activity Grade 2: Some interference with activity Grade 3: Significant; daily activity prevented