Received May 26, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
accidental overdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 2-month-old patient who received Rota (Rotarix liquid formulation) for prophylaxis. Co-suspect products included Rota (Rotarix liquid formulation) for prophylaxis. On 20-MAY-2026, the patient received Rotarix liquid formulation and Rotarix liquid formulation. On 20-MAY-2026, an unknown time after receiving Rotarix liquid formulation and Rotarix liquid formulation, the patient experienced accidental overdose (Verbatim: accidental overdose). The outcome of the accidental overdose 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: 20-MAY-2026 The medical associate accidentally administered two doses of Rotarix to a 2 month old infant today. They counseled on rare side effects (vomiting, diarrhea, severe abdominal pain, bloody stools). And asked should the infant still receive another dose at 4 months old? The batch number was not provided upon follow- up with the reporter.