Received Nov 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
babies spit up Rotarix; babies spit up Rotarix; This non-serious case was reported by a other health professional via sales rep and described the occurrence of regurgitation of medication in a patient who received Rotavirus vaccine for prophylaxis. On an unknown date, the patient received Rotavirus vaccine. On an unknown date, immediately after receiving Rotavirus vaccine, the patient experienced regurgitation of medication (Verbatim: babies spit up Rotarix) and accidental underdose (Verbatim: babies spit up Rotarix). 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 Rotavirus vaccine and Rotarix Unspecified Oral Administation Device. It was unknown if the company considered the regurgitation of medication to be related to Rotavirus vaccine 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. Additional Information: GSK Receipt Date: 07-NOV-2025 The nurse had may babies spit up Rotarix. She wanted to know when she should redose the rotarix and wanted to know if the baby spits up enough that she needs to redose.