Table 2. Summary of Treatment-Related Adverse Events.
| Adverse Event | All Grades | Grade 3 or 4 | ||
|---|---|---|---|---|
| # Patients | % | # Patients | % | |
| Local vaccine site reactions | ||||
| Erythema/induration | 20 | 100 | 0 | 0 |
| Pruritus | 20 | 100 | 0 | 0 |
| Pain/soreness/tenderness | 17 | 85 | 0 | 0 |
| Local rash at/near vaccine site | 7 | 35 | 1 | 5 |
| Blister formation | 5 | 25 | 0 | 0 |
| Hyperpigmentation | 4 | 20 | 0 | 0 |
| Ecchymosis (bruising) | 3 | 15 | 0 | 0 |
| Local edema | 2 | 10 | 0 | 0 |
| Vaccine site flare | 2 | 10 | 0 | 0 |
| Groin tightness | 1 | 5 | 0 | 0 |
| Systemic toxicities | ||||
| Fatigue | 8 | 40 | ||
| Urticaria | 7 | 35 | 2 | 10 |
| Pruritus (distant from vaccine site) | 6 | 30 | 1 | 5 |
| Fever | 5 | 25 | ||
| Flu-like symptoms/myalgia | 4 | 20 | ||
| Lymphadenopathy | 4 | 20 | ||
| Abdominal pain | 3 | 15 | 1 | 5 |
| Rash (distant from vaccine site) | 3 | 15 | 1 | 5 |
| Achiness/malaise | 3 | 15 | ||
| Chills | 3 | 15 | ||
| Dizziness | 2 | 10 | ||
| Anorexia | 1 | 5 | ||
| Erythema (distant from vaccine site) | 1 | 5 | ||
| Headache | 1 | 5 | ||
| Nausea | 1 | 5 | ||
| Arm pain | 1 | 5 | ||
| Cancer site pain | 1 | 5 | ||
| Leg tenderness | 1 | 5 | ||
NOTE: Data are given as any incident per patient, for a maximum of 20 counts per event.