Adverse event grading criteria for solicited and unsolicited events after vaccination
| Adverse event | Severity grade | Definition | |
|---|---|---|---|
| Systemic adverse events | Oral temperature | 0 | <37.6°C |
| 1 | 37.6–38.0°C | ||
| 2 | 38.1–39.0°C | ||
| 3 | >39.0°C | ||
| Headache, nausea and/or vomiting, malaise, myalgia and arthralgia and any other systemic symptom | 0 | Absence or resolution of symptom | |
| 1 | Awareness of symptom but tolerated; transient or mild discomfort, little/no medical intervention required | ||
| 2 | Discomfort enough to cause limitation of usual activity; some medical intervention or therapy required | ||
| 3 | Incapacitating, absent from work or bed rest required; hospitalisation possible | ||
| Local adverse events after IM injection | Tenderness/pain at the site of injection | 0 | None |
| 1 | Painful to touch; easily tolerated | ||
| 2 | Painful when the limb is moved; interferes with daily activity | ||
| 3 | Severe pain at rest; prevents daily activity | ||
| Redness and induration at the site of injection | 0 | 0–2 mm maximal diameter reaction | |
| 1 | 3–50 mm maximal diameter reaction | ||
| 2 | 51–100 mm maximal diameter reaction | ||
| 3 | >100 mm maximal diameter reaction | ||
| Swelling at the site of injection | 0 | No visible reaction | |
| 1 | 1–20 mm maximal diameter reaction | ||
| 2 | 21–50 mm maximal diameter reaction | ||
| 3 | >50 mm maximal diameter reaction | ||
| Local adverse events after IN spray | Nasal tenderness/pain | 0 | None |
| 1 | Painful on touch only and minimal | ||
| 2 | Painful without touch, moderate severity | ||
| 3 | Painful without touch, severe and interferes with smell | ||
| Nasal irritation | 0 | None | |
| 1 | Mild irritation only | ||
| 2 | Moderate irritation, distracting | ||
| 3 | Severe irritation, disturbs rest or interferes with normal activity | ||
| Nasal discharge | 0 | None | |
| 1 | Mild discharge | ||
| 2 | Moderate discharge, readily controlled | ||
| 3 | Severe discharge, interferes with normal activity |
Adverse events are graded as 0 (normal), 1 (mild), 2 (moderate) or 3 (severe) from the recorded outcome measures in this table.
IM, intramuscular; IN, intranasal.