Received Mar 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | X011441 | — |
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | — | — |
No additional AE reported; Nurse reported MMR II was administered after a temperature excursion to unknown amount of patients. HCP is unable to provide patient information or dates of administration at this time.; This spontaneous report was received from a nurse and refers to a 1-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported. On 13-JAN-2025, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administered as prophylaxis (Lot No. X011441 has been verified to be a valid lot number for [measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live], expiration date reported and upon internal validation established as 19-APR-2025 (strength, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided) (product storage error); that was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (Lot N., expiration date, route and anatomical location of administration were not provided), after a temperature excursion of 10.9 degree Celsius (C) during a time frame of 1 hour with 37 minutes. No previous temperature excursion was reported. No additional adverse event (AE) was reported. (no adverse event).; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-03-24 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : X011441 GF , Central date : 2025-03-21 , Classification : DMC, Attachment description : Minimal Data Entry , Safety case number :