Received Apr 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | EX434 | — |
Patient recieved 3rd dose of Rotarix; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 18-month-old male patient who received Rotavirus vaccine (batch number EX434, expiry date 01-JUN-2026) for prophylaxis. Previously administered products included Rotarix (1st dose received on 15th November 2023 with lot number YL9Y9) and Rotarix (2nd dose received on 29th January 2024 with lot number 737J5 and expiry date 5th October 2025). On 08-APR-2025, the patient received the 3rd dose of Rotavirus vaccine. On 08-APR-2025, an unknown time after receiving Rotavirus vaccine, the patient experienced extra dose administered (Verbatim: Patient recieved 3rd dose of Rotarix). The outcome of the extra dose administered 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: 08-APR-2025 The patient received 3rd dose of Rotarix at 18 months of age on 08th April 2025 which led to an extra dose administration.