Received Jun 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | — |
stools green in appearance; stool consistency has briefly changed to liquid and frothy; This non-serious case was reported by a physician via sales rep and described the occurrence of greenish stool in a 4-month-old male patient who received Rotavirus vaccine oral drops for prophylaxis. On an unknown date, the patient received the 1st dose of Rotavirus vaccine. On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced greenish stool (Verbatim: stools green in appearance) and stools watery (Verbatim: stool consistency has briefly changed to liquid and frothy). The outcome of the greenish stool and stools watery were not reported. It was unknown if the reporter considered the greenish stool and stools watery 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. Linked case(s) involving the same patient: US2026AMR076673 Additional Information: GSK Receipt Date: 05-JUN-2026 According to the reporting Healthcare professional, he had not vaccinated the 4.5-month-old patient but had received a call from the concerned parent, who reported that after the first dose the stool consistency had briefly changed to liquid and frothy, green in appearance. For tolerance of 2nd dose of Rotavirus vaccine, refer case US2026AMR076673.