Received Apr 10, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | Z009834 | OT |
Customer calling to report the inadvertent administration of a ROTATEQ dose following a temperature excursion; No adverse event; This spontaneous report was received from a Consumer and refers to a patient of unknown age and gender. The patient's medical history, current conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improper storage dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), Oral solution (lot #Z009834 who had been verified to be a valid lot number, expiration date: 04-MAR-2027) administered by Oral route as prophylaxis. The vaccine was storage at temperature of 11.2 C, with a time frame of 1 hour 24 minutes and 0 seconds. There was no information about previous temperature excursion (Product storage error). No adverse event.