Received Dec 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
Necrotizing enterocolitis in a term infant following rotavirus vaccine / NEC, in context of recent rotavirus vaccination; Necrotizing enterocolitis in a term infant following rotavirus vaccine / NEC, in context of recent rotavirus vaccination; This literature marketed report has been received from the authors of a published literature article, titled as stated below, and refers to a 2-month-old term male patient. The patient's medical history and concomitant therapies were not reported. His concurrent conditions included milk protein allergy. On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) oral solution, administered by oral route for prophylaxis (dose, lot # and expiration date were not reported). On an unknown date, 5 days after vaccination, the patient experienced an episode of bloody stool at home, after which he presented to hospital and was admitted to the Neonatal Intensive Care Unit (NICU). The patient was well-appearing, abdominal radiograph was normal, but abdominal ultrasound showed pneumatosis intestinalis and portal venous gas. Viral gastroenteritis polymerase chain reaction (PCR) panel was positive for rotavirus A. The patient was treated for Bell's stage IIA necrotizing enterocolitis (NEC) in context of recent rotavirus vaccination, with nil per os status, parenteral nutrition, sepsis evaluation and intravenous metronidazole, ampicillin, and amikacin. The patient remained well throughout the NICU stay. On an unknown date, after 7 days of antibiotics, feeds were restarted without recurrence of bloody stools. Repeated abdominal ultrasound upon reaching full feeds showed resolution of pneumatosis. On an unknown date, the patient was discharged home with gastroenterology follow up for milk protein allergy. At the reporting time, the patient recovered from the events of necrotizing enterocolitis and viral enterocolitis. The authors considered the events of necrotizing enterocolitis and viral enterocolitis to be related to suspect vaccine. A copy of the published article is attached as further documentation of the patient's experience. Lot # is being requested and will be submitted if received.
Milk protein allergy; Term baby
Test Name: Abdominal radiograph; Result Unstructured Data: normal; Test Name: abdominal ultrasound; Result Unstructured Data: pneumatosis intestinalis and portal venous gas; Test Name: Viral gastroenteritis PCR panel; Result Unstructured Data: positive for rotavirus A; Test Name: Repeated abdominal ultrasound; Result Unstructured Data: resolution of pneumatosis