Side effects | Possible treatment related*, Patients (%) | Probable treatment related** Patients (%) | All treatment-related events Patients (%) |
Fatigue | 2 (9.1) grade 1 | 1 (4.5) grade 1 | 3 (13.6) |
Injection site reaction | 2 (9.1) grade 1 | 18 (81.8) grade 1 | 22 (100) |
4 (18.2) grade 2 | |||
Viral upper respiratory tract infection | 1 (4.5) grade 1 | 1 (4.5) | |
Headache | 1 (4.5) grade 1 | 1 (4.5) | |
Paraesthesia | 1 (4.5) grade 1 | 1 (4.5) | |
Hot flush | 1 (4.5) grade 1 | 1 (4.5) grade 1 | 2 (9.1) |
Total no of patients†| 6 (27.3) | 22 (100) | 22 (100) |
Clinical events, including laboratory test abnormality, with a reasonable time sequence to administration of the vaccine, (*) which can also be explained by concurrent disease or other drugs or chemicals, or (**) which can unlikely be attributed to concurrent disease or other drugs or chemicals.
†Indicates the total number of patients reporting at least one event.