Received Jun 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
stool what looks like dark red jellylike blood; had bit of rash; This serious case was reported by a physician via call center representative and described the occurrence of blood in stool in a infant patient who received Rota (Rotarix liquid formulation) oral drops for prophylaxis. Previously administered products included Rotarix (receive first dose on an unknown date). On 22-MAY-2026, the patient received the 2nd dose of Rotarix liquid formulation. On an unknown date, an unknown time after receiving Rotarix liquid formulation, the patient experienced blood in stool (Verbatim: stool what looks like dark red jellylike blood) (serious criteria GSK medically significant) and rash (Verbatim: had bit of rash). The outcome of the blood in stool was not resolved and the outcome of the rash was not reported. It was unknown if the reporter considered the blood in stool to be related to Rotarix liquid formulation and Rotarix Oral Applicator Device. The reporter considered the rash to be unrelated to Rotarix liquid formulation. It was unknown if the reporter considered the rash to be related to Rotarix Oral Applicator Device. The company considered the blood in stool and rash to be unrelated to Rotarix liquid formulation. The company considered the blood in stool to be unrelated to Rotarix 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: 04-JUN-2026 The reporter stated that one of their patients had received the Rotarix vaccine from another office, not from them. The reporter mentioned that the patient may have experienced symptoms that may or may not have been attributed to the vaccine. The patient was about 4.5 months old and had received two doses of Rotarix, with the second dose administered on May 22, approximately two weeks ago. The patient's mother had contacted the reporter for two reasons. First, the patient had developed a rash, which the reporter believed was unrelated to the vaccine and was there before the vaccination. Now the patient has one stool what looks like dark red jellylike blood. The patient was not vomiting, was not febrile, and did not have diarrhea. However, there was concern regarding the possibility of intussusception, as noted in the package insert. The reporter explained that there is a small but increased risk of intussusception associated with the vaccine, as observed in some post-marketing studies. The reporter stated that the purpose of the call was to consider the possibility of intussusception, but the patient was not vomiting and to obtain more information about hematochezia and to understand whether hematochezia occurred more frequently than intussusception following Rotarix vaccination. The batch number was not provided upon follow up with the reporter.; Sender's Comments: A case of Haematochezia, unknown time after receiving 2nd dose of Rotarix and Rotavirus vaccine ORAL APPLICATOR DEVICE in an infant patient. Case lacks further information on time to onset, medical history, concurrent conditions and laboratory confirmation. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.