Received Nov 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | j757k | — |
accidentally give 3 doses of Rotarix; Respiratory side effects; This non-serious case was reported by a nurse via call center representative and described the occurrence of respiratory disorder in a 4-month-old male patient who received Rota (Rotarix liquid formulation) (batch number j757k) for prophylaxis. Concomitant products included Rotavirus vaccine live oral 1v (Rotarix) and Rotavirus vaccine live oral 1v (Rotarix). On 13-NOV-2025, the patient received the 3rd dose of Rotarix liquid formulation. On 13-NOV-2025, an unknown time after receiving Rotarix liquid formulation, the patient experienced extra dose administered (Verbatim: accidentally give 3 doses of Rotarix). In NOV-2025, the patient experienced respiratory disorder (Verbatim: Respiratory side effects). The outcome of the respiratory disorder was not reported and the outcome of the extra dose administered was not applicable. It was unknown if the reporter considered the respiratory disorder to be related to Rotarix liquid formulation and Rotarix Pre-Filled Oral Applicator Device. It was unknown if the company considered the respiratory disorder 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: 18-NOV-2025 The Vaccine Administration Facility was the same as the Primary Reporter. A Licensed Vocational Nurse reported that a patient had accidentally been given 3 doses of Rotarix instead of 2 doses. The caller stated that the parents had claimed respiratory side effects, but they did not know if these were related to the vaccine or not.
ROTARIX