Received Aug 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | X028882 | — |
No symptoms reported; "ROTATEQ VIAL 2" dose frequency ".5 ml"; an expired dose of ROTATEQ was administered to a patient on 7/7/2025. HCP reported that ROTATEQ expired 7/4//2025 (X028882 7/4/2025); This spontaneous report was received from a nurse and refers to a 4 month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 07-JUL-2025, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) solution, lot #X028882, expiration date: 04-Jul-2025, at a dose of ".5 ml" (suspect vaccine provided also as "ROTATEQ VIAL 2 frequency .5") administered for prophylaxis (inappropriate dose of vaccine administered, expired product administered). Potency of the dose was supported by the Post Expiry Memo. No symptoms reported at the time of the call (no adverse event).; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-07-18 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : US-009507513-2308432 , Central date : 2025-07-18 , Classification : DMC, Attachment description : Minimal Data Entry , Safety case number :