Received Sep 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 2142136 | OT |
No additional AEs were reported; patient received improperly stored vaccine; This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-Aug-2025, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (Product storage error) (lot #2142136, expiration date: 28-May-2026) 1 dose form administered by Oral route as prophylaxis. It was reported that the vaccine was exposed to a Temperature of 8.8C for 30 minutes; and 8.5C for 15 minutes. There was not previous temperature excursion. No additional adverse events were reported, no further information provided.