Received Dec 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 7YS93 | — |
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | 2 | 215 563 8 | — |
patient received the first Rotarix and the second dose in the series being Rotateq; This non-serious case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 7YS93, expiry date 15-NOV-2026) for prophylaxis. Co-suspect products included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) (batch number 215 563 8) for prophylaxis. On 23-OCT-2025, the patient received the 1st dose of Rotarix lyophilized formulation. On 29-DEC-2025, the patient received the 2nd dose of ROTATEQ. On 29-DEC-2025, 67 days after receiving Rotarix lyophilized formulation, the patient experienced interchange of vaccine products (Verbatim: patient received the first Rotarix and the second dose in the series being Rotateq). The outcome of the interchange of vaccine products 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: 29-DEC-2025 A nurse wanted to know about the interchangeability of Rotarix and Rotateq, after the patient received the first Rotarix when they were 2 months old and the second dose in the series being Rotateq being administered at 4 months of age. The batch number was not provided and a request for this information has been made.