Received Nov 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | Y009341 | OT |
No additional AEs were reported; patient received improperly stored vaccine; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported. On 15-May-2025, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), oral solution, administered orally as prophylaxis (Lot No. Y009341 has been verified to be a valid lot number for [rotavirus vaccine, live, oral, pentavalent], expiration date reported and upon internal validation established as 24-Nov-2025) (strength, dose number, exact dose quantity volume and vaccination scheme frequency were not provided) (product storage error); after a temperature excursion of 31. 3 degree Fahrenheit (F) during a time frame of 15 minutes. No previous temperature excursion was reported. No additional adverse event was reported (No adverse event)