Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
at least 2 pediatric patients with blood in the stool; This spontaneous report was received from a physician and refers to a child (infant) patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq) (formulation, lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced haematochezia (blood in the stool). On an unspecified date, the patient recovered/resolved from the event. The causal relationship between the event and Rotavirus Vaccine, Live, Oral, Pentavalent was unknown/not reported/not provided. Upon internal review, the event of haematochezia (blood in the stool) was determined to be medically significant. This is one of three reports received from the same reporter.