Table 2.
Injection-site reactions and systemic AE s related to ZOSTAVAX at minimum-release specification approaching expiry potency in the 28 d following vaccination (safety set; N = 96)
| n (%)* | |
| Any injection-site reactions or systemic AEs related to the vaccine | 52 (54.2%) |
| Injection-site reactions (day 0–28) | 50 (52.1) |
| Solicited (day 0–4) | 50 (52.1) |
| Erythema 36 | (37.5) |
| Swelling 21 | (21.9) |
| Pain | 39 (40.6) |
| Spontaneously reported (day 0–28) | 4 (4.2) |
| Pruritus | 4 (4.2) |
| Systemic AEs related to the vaccine (day 0–28) | 8 (8.3) |
| Asthenia | 2 (2.1) |
| Headache | 2 (2.1) |
| Keratitis | 1 (1.0) |
| Pyrexia (body temperature ≥38.3°C) | 1 (1.0) |
| Rash of interest† | 2 (2.1) |
| Herpes zoster | 1 (1.0) |
| Vesicular rash | 1 (1.0) |
| Paresthesia | 1 (1.0) |
*
Number and percentage of participants reporting at least one adverse event (AE )
†
specific descriptions were required for rashes, including number and type of lesion, location (injection-site or non-injection-site) and confirmation of diagnosis.