Received Mar 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | OT |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | — | OT |
FBE calling to report AE for a pediatric patient. FBE reports the patient received their first dose of ROTATEQ on 08/25/2026 with no reported reactions. The second dose of ROTATEQ was administered on 10/21/2026. Following the second dose on an unspec; This spontaneous report was received from an employee and refers to an infant patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 25-Aug-2025 (also reported as 25-Aug-2026, conflicting information), the patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), administered by oral route (dose, lot # and expiration date were not reported) as prevention of rotavirus with no reported reactions. On 21-Oct-2025 (also reported as 21-Oct-2026, conflicting information), the patient was vaccinated with the second dose of Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), administered by oral route (dose, lot # and expiration date were not reported) as prevention of rotavirus. Following the second dose on an unspecified/unknown date the patient experienced vomiting, severe abdominal pain, could not hold down formula and lethargy. On an unknown date, the patient was seen by their health care professional (HCP) who sent them for an ultrasound and was diagnosed with intussusception. On an unknown date, the patient experienced intussusception. On an unknown date, the patient was admitted to the hospital and was there for 1 day. The patient received air enema procedure that resolved the issues within a few hours. The patient was able to go home with no additional problems. On an unknown date, the patient recovered from the event and was discharged from the hospital. The patient had no history of gastrointestinal (GI) issues prior to this experience. No further details were provided. No additional adverse event (AE) was reported. The action taken with the suspect vaccine and the event was not applicable. The casual relationship between the event of intussusception and Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq) was not reported. Lot # is being requested and will be submitted if received.
Test Name: ultrasound; Result Unstructured Data: intussusception