Received Jun 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 2088619 | OT |
No side effects reported; ROTATEQ experienced excursion 5/29/2025 and was administered today 6/5/2025 to one patient; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-MAY-2025, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot# 2088619 underwent temperature excursion (3 hours, 7 minutes and 0 seconds in 11.7 degrees Celsius). There were no previous temperature excursions. On 05-JUN-2025, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral solution, administered orally, lot #2088619, expiration date was reported as 30-SEP-2026, however upon internal validation determined as 09-MAR-2026, for prophylaxis (dose was not reported); the administered vaccine underwent temperature excursion mentioned above (Product storage error). No side effects reported.