Received Sep 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
Specks of blood in stool 5 days after vaccination; This serious case was reported by a physician via sales rep and described the occurrence of blood in stool in a patient who received Rotavirus vaccine for prophylaxis. On an unknown date, the patient received the 1st dose of Rotavirus vaccine. On an unknown date, 5 days after receiving Rotavirus vaccine, the patient experienced blood in stool (Verbatim: Specks of blood in stool 5 days after vaccination) (serious criteria GSK medically significant). The outcome of the blood in stool was resolved. The reporter considered the blood in stool to be related to Rotavirus vaccine. It was unknown if the reporter considered the blood in stool to be related to Rotarix Unspecified Oral Administration Device. The company considered the blood in stool to be unrelated to Rotavirus vaccine and Rotarix Unspecified Oral Administration 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: 27-SEP-2025 Physician reported that patient experienced specks of blood in stool 5 days after vaccination.; Sender's Comments: A case of Haematochezia, 5 days after receiving Rotavirus vaccine and Rotarix UNSPECIFIED ORAL ADMINISTATION DEVICE in a patient. Based on the available information a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.