Received Nov 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Rotarix was administered to an infant which produced instant vomiting; Rotarix was administered to an infant which produced instant vomiting; This non-serious case was reported by a nurse via call center representative and described the occurrence of vomiting in a patient who received Rota (Rotarix liquid formulation) for prophylaxis. On 14-NOV-2025, the patient received Rotarix liquid formulation. On 14-NOV-2025, immediately after receiving Rotarix liquid formulation, the patient experienced vomiting (Verbatim: Rotarix was administered to an infant which produced instant vomiting) and accidental underdose (Verbatim: Rotarix was administered to an infant which produced instant vomiting). The outcome of the vomiting was unknown and the outcome of the accidental underdose was not applicable. It was unknown if the reporter considered the vomiting to be related to Rotarix liquid formulation and Rotarix Oral Applicator Device. It was unknown if the company considered the vomiting to be related to Rotarix liquid formulation and Rotarix 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: 14-NOV-2025 Nurse called to report that a dose of Rotarix was administered to an infant which produced instant vomiting. Registered nurse wanted to know next steps to proceed. If they should administer a second dose as the patient was still in the office. The batch number was not provided and a request for this information has been made.