Received Sep 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | Y003753 | OT |
no adverse effects; a patient who is 15 weeks and 5 days old received their first dose of ROTATEQ.; This spontaneous report was received from a physician assistant on 24-Sep-2025, referring to a 15-week-old and 5-day-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 24-Sep-2025, the patient (15-week-old and 5-day-old) was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), (lot #Y003753, expiration date: 18-Oct-2025), administered by Oral route as prophylaxis (Product administered to patient of inappropriate age). No additional information was provided to further clarify the details. The caller said they administered the dose approximately 40 minutes prior to calling the company and no adverse effects were noted (no adverse event).