Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 7Y953 | PO / MO |
after ingestion of Rotarix liquid, the patient vomited it; after ingestion of Rotarix liquid, the patient vomited it; This non-serious case was reported by a other health professional via call center representative and described the occurrence of regurgitation of medication in a 4-month-old female patient who received Rota (Rotarix liquid formulation) (batch number 7Y953, expiry date 09-NOV-2026) for prophylaxis. On 23-SEP-2025, the patient received Rotarix liquid formulation (oral). On 23-SEP-2025, less than a day after receiving Rotarix liquid formulation, the patient experienced regurgitation of medication (Verbatim: after ingestion of Rotarix liquid, the patient vomited it) and accidental underdose (Verbatim: after ingestion of Rotarix liquid, the patient vomited it). The outcome of the regurgitation of medication was unknown and the outcome of the accidental underdose was not applicable. It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix liquid formulation and Rotarix Unspecified Oral Administation Device. It was unknown if the company considered the regurgitation of medication to be related to Rotarix liquid formulation and Rotarix Unspecified Oral Administation Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.