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Table 1 Severity grading of solicited adverse events

From: Satisfactory safety and immunogenicity of MSP3 malaria vaccine candidate in Tanzanian children aged 12–24 months

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