Received Aug 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 3C34X | — |
a patient received a dose of rotarix and vomited after that; This non-serious case was reported by a other health professional via call center representative and described the occurrence of vomiting in a patient who received Rota (Rotarix liquid formulation) (batch number 3C34X, expiry date 09-NOV-2026) for prophylaxis. On an unknown date, the patient received Rotarix liquid formulation. On an unknown date, an unknown time after receiving Rotarix liquid formulation, the patient experienced vomiting (Verbatim: a patient received a dose of rotarix and vomited after that). The outcome of the vomiting was unknown. It was unknown if the reporter considered the vomiting to be related to Rotarix liquid formulation and Rotarix Pre-Filled Oral Applicator Device. It was unknown if the company considered the vomiting to be related to Rotarix liquid formulation and Rotarix Pre-Filled Oral Applicator Device. 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: 12-AUG-2025 A vaccine coordinator called to know how to proceed after a patient received a dose of Rotarix and vomited after that. She wanted to know if the dose should be repeated. No demographics (age, gender, date of birth) or date of administration were provided because she refused to share the information.