Received Feb 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | 4 | — | OT |
No adverse effects were reported.; HCP called to report that a healthy 15 month old female was given a 4th (extra) dose of ROTATEQ today (2/3/2025), above the maximum age limit for administration of ROTATEQ, even though it wasn't ordered for this specific patient. (It was stated that; HCP called to report that a healthy 15 month old female was given a 4th (extra) dose of ROTATEQ today (2/3/2025), above the maximum age limit for administration of ROTATEQ, even though it wasn't ordered for this specific patient. (It was stated that; HCP called to report that a healthy 15 month old female was given a 4th (extra) dose of ROTATEQ today (2/3/2025), above the maximum age limit for administration of ROTATEQ, even though it wasn't ordered for this specific patient. (It was stated that; This spontaneous report was received from a physician regarding a 15-month-old female. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On 03-FEB-2025, the patient received a fourth (4th) an extra dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (formulation also reported as vial 2), 2 mL, administered orally for prophylaxis (strength, lot #, and expiry date were not provided), above the maximum age limit for administration of this vaccine, even though it had not been ordered her specifically (It was stated that it was not product confusion, but possibly given to the wrong patient) (Extra dose administered) (Product administered to patient of inappropriate age) (Wrong patient received product). However, No adverse effects were reported. No other information was provided at the time of the call. Additional information was not expected.