Received Jul 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | 3Z34X | — |
patient older than 15 weeks of age; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received Rotavirus vaccine (batch number 3Z34X, expiry date 09-NOV-2026) for prophylaxis. On 15-JUL-2025, the patient received the 1st dose of Rotavirus vaccine. On 15-JUL-2025, an unknown time after receiving Rotavirus vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: patient older than 15 weeks of age). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 15-JUL-2025 A health care provider reported that a patient older than 15 weeks of age received Rotarix vaccine which led to inappropriate age at vaccine administration.