Received Mar 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | — | OT |
HBP called and placed Medical Assistant on the line who reported an infant who vomited a dose of ROTATEQ about 5 minutes after administration. No patient demographics were known at the time of call. No additional information was known by reporter. No; infant who vomited a dose of ROTATEQ about 5 minutes after administration; This spontaneous report was received from a Consumer or other non-health professional and refers to a(n) Infant patient of unknown exact age and gender. 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 (Rotateq), administered by oral route (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis. On an unknown date (about 5 minutes after administration), the patient experienced infantile vomiting. The patient vomited a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq) (accidental underdose). At the reporting time, the outcome of infantile vomiting was unknown. The causal relationship between the event of i infantile vomiting n and Rotavirus Vaccine, Live, Oral, Pentavalent was unknown/not reported/not provided.