Table 1 Severity grading of solicited adverse events
Adverse Event | Intensity grade | Parameter |
|---|---|---|
Pain at injection site | 0 | Absent |
1 | Minor reaction to touch | |
2 | Cries/protests on touch | |
3 | Cries when limb is moved/spontaneously painful | |
Swelling at injection site | Recorded greatest surface diameter in mm | |
0 | None | |
1 | < 5 mm | |
2 | 5 to 20 mm | |
3 | > 20 mm | |
Induration at injection site | Recorded greatest surface diameter in mm and graded as swelling above | |
Erythema at injection site | Recorded greatest surface diameter in mm and graded as swelling above | |
Pruritus at injection site | 0 | Absent |
1 | Easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. | |
2 | Sufficiently discomforting to interfere with normal everyday activities. | |
3 | Prevents normal, everyday activities. | |
Fever | Recorded axillary temperature in °C | |
0 | < 37.5°C | |
1 | 37.5 °C – 38.0°C | |
2 | > 38°C – 39.0°C | |
3 | > 39.0°C | |
Irritability/Fussiness | 0 | Behavior as usual |
1 | Crying more than usual/no effect on normal activity | |
2 | Crying more than usual/interferes with normal activity | |
3 | Crying that cannot be comforted/prevents normal activity | |
Drowsiness | 0 | Behavior as usual |
1 | Drowsiness easily tolerated | |
2 | Drowsiness that interferes with normal activity | |
3 | Drowsiness that prevents normal activity | |
Loss of appetite | 0 | Appetite as usual |
1 | Eating less than usual/no effect on normal activity | |
2 | Eating less than usual/interferes with normal activity | |
3 | Not eating at all |