Table 2.
Summary of Treatment-Related Adverse Events
| Adverse Event | All Grades |
Grade 3 or 4 |
||
|---|---|---|---|---|
| No. of Patients | % | No. of Patients | % | |
| Local vaccine site reactions | ||||
| Erythema/induration | 28 | 100 | 0 | 0 |
| Pruritus | 27 | 96 | 0 | 0 |
| Pain/soreness/tenderness | 27 | 96 | 0 | 0 |
| Blister formation | 7 | 25 | 0 | 0 |
| Hyperpigmentation | 3 | 11 | 0 | 0 |
| Ecchymosis | 2 | 7 | 0 | 0 |
| Local desquamation | 1 | 4 | 0 | 0 |
| Systemic toxicities | ||||
| Fatigue/malaise | 11 | 39 | 0 | 0 |
| Flu-like symptoms/myalgia | 10 | 32 | 0 | 0 |
| Fever | 7 | 25 | 0 | 0 |
| Chills | 6 | 21 | 0 | 0 |
| Headache | 5 | 18 | 0 | 0 |
| Urticaria | 2 | 7 | 0 | 0 |
| Eczema | 2 | 7 | 0 | 0 |
| Lymphadenopathy | 2 | 7 | 0 | 0 |
| Lymph node pain | 2 | 7 | 0 | 0 |
| Pruritus (distant from vaccine site) | 1 | 4 | 0 | 0 |
| Rash (distant from vaccine site) | 1 | 4 | 0 | 0 |
| Anorexia | 1 | 4 | 0 | 0 |
| Nausea | 1 | 4 | 0 | 0 |
| Anxiety | 1 | 4 | 0 | 0 |
NOTE. Data are given as any incident per patient, for a maximum of 28 counts per event.