Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | Y014321 | OT |
patient had no reaction, no symptoms; ROTATEQ was given to a patient who is 23 months old, which is older than the age in which ROTATEQ is indicated; This spontaneous report was received from a Nurse and referred to a 23-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-Feb-2026, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral solution at 2 mL orally as prophylaxis (lot number Y014321 was verified to be valid, expiration date: 01-May-2026). The patient was 23 months old, which is older than the age in which the vaccine is indicated (product administered to patient of inappropriate age); the patient had no reaction, no symptoms (no adverse event). The action taken with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was not applicable.