Received Oct 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | 2 | Y015022 | OT |
No additional AE; MMR-2 administration after the temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 26-Aug-2025, the patient was vaccinated with the second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot #Y015022 with expiration date reported as and upon internal validation confirmed to be 05-Sep-2026) 0.5 mL administered subcutaneously route for prophylaxis. The vaccine was reconstituted with sterile diluent, solution for injection (lot # and expiration date not provided). A temperature excursion evaluation with multiple prior excursions was noted. Therefore, the vaccine was administered after the temperature excursion (temperature: 47.7 F for 12 minutes; previous temperature excursion: yes; 46.8 F for 5 minutes ;47.1 F for 9 minutes; 46.6 F for 4 minutes) (product storage error). No symptoms were reported. No further information was provided. No additional adverse event (AE) and no product quality complaint (PQC) was noted (no adverse event). This was one of several cases received from the same reporter.
sterile diluent