Received Apr 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | Z009834 | OT |
No symptoms reported/No additional AE or PQC reported; Customer calling to report the inadvertent administration of a ROTATEQ dose following a temperature excursion.; This spontaneous report was received from a consumer or other non health professional and referred to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 08-Apr-2026, the patient was inadvertently vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot #Z009834, expiration date: 04-Mar-2027, 1 dosage form, frequency: total, strength unknown) administered by oral route for prophylaxis following a temperature excursion (Product storage error). No symptoms were reported. No additional adverse event was reported. The stored temperature was 11.2 degrees Celsius (C). The time frame was 1 hour and 24 minutes. There was no previous temperature excursion.