Received Mar 2, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
administered Rotarix and immediately vomited the vaccine; the baby immediately vomited the vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of vomiting in a 10-week-old female patient who received Rota (Rotarix liquid formulation) for prophylaxis. Concurrent medical conditions included esophageal acid reflux (the patient has severe acid reflux and immediately vomits any medication unless it is mixed into breastmilk). On 24-FEB-2026, the patient received Rotarix liquid formulation. On 24-FEB-2026, immediately after receiving Rotarix liquid formulation, the patient experienced vomiting (Verbatim: administered Rotarix and immediately vomited the vaccine) and underdose (Verbatim: the baby immediately vomited the vaccine). The outcome of the vomiting was not reported and the outcome of the underdose was not applicable. It was unknown if the reporter considered the vomiting to be related to Rotarix liquid formulation and Rotarix Pre-Filled Oral Applicator Device. It was unknown if the company considered the vomiting 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: 24-FEB-2026 The medical assistant also mentioned that the patient's mother stated that the baby was currently receiving antibiotics mixed into breastmilk. The batch number was not provided upon follow- up with the reporter.
Esophageal acid reflux (the patient has severe acid reflux and immediately vomits any medication unless it is mixed into breastmilk)