Received Mar 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
patient developed rotavirus, became dehydrated and required hospitalization.; This spontaneous report was received from a Physician via company representative and refers to a child patient of unknown gender and age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent, (lot # and expiration date were not reported), for prophylaxis. On an unknown date, the patient developed rotavirus, became dehydrated and required hospitalization. At the reporting time, the outcome of the event was unknown. The causal relationship between the event and Rotavirus Vaccine, Live, Oral, Pentavalent was not provided. Lot # is being requested and will be submitted if received.