No additional AE; an infant received their first dose of ROTATEQ at 19 weeks of age instead of the recommended 6-12 weeks; This spontaneous report was received from a nurse and refers to a 19-week-old (also reported as 5-month-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 19-DEC-2024, at 19 weeks of age instead of the recommended 6-12 weeks as outlined in the prescribing information, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2ml / series, administered orally for prophylaxis (lot #2032353, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 21-OCT-2025; strength was not provided) (Inappropriate schedule of product administration). No symptomatic events were reported. No additional information was provided. There was no additional adverse event (AE) or product quality complaint (PQC) reported.