Received Jun 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | — |
no reports of the patient experiencing any medical concerns or symptoms after being administered the dose of ROTATEQ earlier than recommended schedule; a patient was administered their first dose of ROTATEQ today, 5/8/2025, at the age of 5 weeks and 3 days old; This spontaneous report was received from a medical assistant and refers to a 5-week-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 08-May-2025, the patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, 2 mL (2 mL / three dose series) (lot # and expiration date were not reported) for prophylaxis, which was earlier than the recommended age of 6 weeks old as stated on the patient information (PI) leaflet (product administered to patient of inappropriate age). The Medical Assistant confirmed there have been no reports of the patient experiencing any medical concerns or symptoms after being administered the dose of the suspect vaccine earlier than recommended schedule (no adverse event). Consent granted for correspondence. No additional information provided. Lot # is being requested and will be submitted if received.