Received Jul 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | Y018376 | — |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | Y018376 | — |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | Y018376 | — |
ROTATEQ administered to a patient to greater that 32 weeks old. HCP stated that the patient was administered their third dose of ROTATEQ today, 6/25/2025, due to the patient being behind with their vaccination appointments; No additional AE; HCP calling to report adverse event regarding ROTATEQ administered to a patient to greater that 32 weeks old.; This spontaneous report was received from a medical assistant and refers to a specified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date, the patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 mL (2 mL / three dose series) (lot #Y018376, expiration date reported as and upon internal validation confirmed to be: 07-May-2026) (route of administration and vaccination site were not reported) administered for prophylaxis. On an unspecified date, the patient was vaccinated with the second dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 mL (2 mL / three dose series) (lot #Y018376, expiration date reported as and upon internal validation confirmed to be: 07-May-2026) (route of administration and vaccination site were not reported) administered for prophylaxis. On 25-Jun-2025, the patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 mL (2 mL / three dose series) (lot #Y018376, expiration date reported as and upon internal validation confirmed to be: 07-May-2026) (route of administration and vaccination site were not reported) administered for prophylaxis. On that day (today), Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was administered to the patient who was greater than 32 weeks old (Product administered to patient of inappropriate age). Health care professional (HCP) stated that the patient was administered their third dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) today, due to the patient being behind with their vaccination appointments (inappropriate schedule of product administration). HCP confirmed the patient has not experienced any medical concerns at this time after being administered Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) beyond the recommended 32 weeks age. No additional information was provided. No additional adverse event or product quality compliant (AE/PQC) was noted (no adverse event).