Table 2. Number of AEs (number of patients, pts) by grade, where relationship to vaccine is definite, probable, or possible.
| Body system | Adverse event | Severity scale grade | All AEs | |||||
|---|---|---|---|---|---|---|---|---|
| 1: Mild | 2: Moderate | 3: Severe | ||||||
| AEs | (pts) | AEs | (pts) | AEs | (pts) | |||
| Gastrointestinal disorders | Abdominal distension | – | – | 1 | (1) | 1 | (1) | 2 |
| General disorders and
administrative site conditions |
Fatigue | 1 | (1) | 2 | (2) | 1 | (1) | 4 |
| Injection site reaction | 23 | (23) | 4 | (3) | – | – | 27 | |
| intermittent fatigue | 1 | (1) | 2 | (2) | – | – | 3 | |
| Musculoskeletal and
connective tissue disorders |
Musculoskeletal and connective
tissue disorders - other, sharp pains in random spots |
– | – | 1 | (1) | – | – | 1 |
| Nervous system disorders | Headache | – | – | 1 | (1) | – | – | 1 |
| Intermittent headaches | – | – | 1 | (1) | – | – | 1 | |
| Reproductive system and
breast disorders |
Intermittent left breast pain | 1 | (1) | – | – | – | – | 1 |
| Reproductive system and breast
disorders - other, burning sensation left breast |
1 | (1) | – | – | – | – | 1 | |
| Vascular disorders | Vascular disorders – other, night sweats | 1 | (1) | – | – | – | – | 1 |
| All AEs | 28 | (28) | 12 | (11) | 2 | (2) | 42 | |