Received Oct 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | 7E9Y2 | — |
an 8-month patient had received a dose of Rotarix; 3rd dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-month-old female patient who received Rotavirus vaccine (batch number 7E9Y2, expiry date 30-MAY-2026) for prophylaxis. Previously administered products included Rotarix (received 2 doses on an unknown date). On 15-SEP-2025, the patient received the 3rd dose of Rotavirus vaccine. On 15-SEP-2025, an unknown time after receiving Rotavirus vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: an 8-month patient had received a dose of Rotarix) and extra dose administered (Verbatim: 3rd dose administered). The outcome of the inappropriate age at vaccine administration and extra dose administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.