Received Apr 30, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | 2208058 | — |
No additional AE; stored dose of ROTATEQ was administered to a patient 4/29/2026; This spontaneous report was received from an administrator/supervisor 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 29-Apr-2026, the patient was vaccinated with an improperly store dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, administered as prophylaxis (Lot No. 2208058 has been verified to be a valid lot number for [rotavirus vaccine, live, oral, pentavalent], expiration date reported and upon internal validation established as 04-Jun-2027 (strength and vaccination scheme frequency were not provided) (product storage error), after a temperature excursion of 33.7 degree Fahrenheit (F) during a time frame of 40 minutes. No previous temperature excursion was reported. No symptoms reported. No additional adverse event was reported (No adverse event). This is one of several reports received from the same reporter.