Received Jun 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | 1 | Y018156 | — |
No additional AE reported; Customer called and reported that PROQUAD was administered to 1 patient following a temperature excursion; This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-May-2025, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Y018156, expiration date reported as: 29-Apr-2026) (dose, route of administration and vaccination site were not reported) administered for prophylaxis. The vaccine was reconstituted with sterile diluent, solution for injection. On 29-May-2025, the vaccine was administered to one patient following a temperature excursion (temperature: -13.49C; time frame: 1 hour and 15 minutes) (product storage error). There were no previous temperature excursions. No additional adverse event (AE) reported (no adverse event). No product quality complaint (PQC) was reported. No additional information was provided. This case was considered to be invalid due to lack of patient's identifiers.
Sterile diluent