Received Mar 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 2096661 | OT |
Medical assistant reported ROTATEQ was administered after a temperature excursion; This spontaneous report was received from a physician assistant (reported as medical assistant) (C.M.A) 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 24-Feb-2026, the patient was vaccinated with improperly stored (48.1 F for 28 hours, no previous temperature excursion) rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral solution, administered orally as prophylaxis (Lot No. 2096661 has been verified to be a valid lot number for [rotavirus vaccine, live, oral, pentavalent], expiration date reported and upon internal validation established as 07-Mar-2026) (exact dose was not reported) (product storage error). No further information was provided. This is one of 6 reports received from the same reporter.