Received Mar 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | X011441 | — |
No additional AE reported; MMR II was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to a 13-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 27-Aug-2024 at 09:56 AM, the patient was vaccinated with an improperly storage dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #X0114411, expiration date expiration date was not reported, however upon internal validation determined as 19-Apr-2024 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided). Administered dose of vaccine was exposed to the temperature excursion of 12.3 degrees Celsius for 6 hours and 23 minutes (product storage error). No previous temperature excursion occurred. There were no additional adverse events reported (no adverse event). This is one of several reports received from the same reporter. Follow-up information has been received from the reporting Nurse on 21-MAR-2025. The Nurse stated the following: "The Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was currently and had previously always been stored in a FREEZER (unknown temperature) throughout the out-of-range temperature times (previously reported) and not in a refrigerator." Additionally, the patient had no adverse effects. No more medical information has been reported.; Reporter's Comments:
Sterile diluent