Received Aug 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | Y013582 | OT / LL |
no adverse event; Improper storage of product in use; This spontaneous report was received from a nurse and refers to a 5-year-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 10-Apr-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 mL, lot #Y013582, which was confirmed to be a valid lot#; expiration date: 03-Feb-2026, administered by Intramuscular route in Left Thigh, which was reconstituted with sterile diluent (dose, units, lot# and expiration date were not reported) for prophylaxis. It was reported that there was a temperature excursion of freezer and the vaccine was administered to the patient after (reported as prior, conflicting information) to known temperature excursion (Product storage error). As determined by the manufacturer, vaccine was not supported for use. There was no adverse event. Lot# (regarding sterile diluent) is being requested and will be submitted if received.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user :, Index date : 2025-08-04 , number : , number : , number : , number : AA , Central date : 2025-07-31 , Classification :, Attachment description : Minimal Data Entry , Safety case number :
sterile diluent