Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | 2 | — | — |
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | 1 | Y013571 | LL |
No other AE/PQC; HCP reporting that PROQUAD was administered to two patients on the 13th of August. The product had undergone a temperature excursion / temperature was out of range. No alarms went off; Proquad given again; This spontaneous report was received from other health professional and refers to a 1-year-old male patient. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On 13-AUG-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) dose number 1, 1 dosage form, administered by subcutaneous route in the left thigh as prophylaxis (lot number Y013571 has been verified to be valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live [PROQUAD], expiration date 03-FEB-2026), which was reconstituted with sterile diluent (HOLLISTER-STIER STERILE DILUENT) (lot number and expiration date were not reported). The vaccine had undergone a temperature exposure (TE) at 33.6 degree Fahrenheit for 144 hours, with no previous TE. The temperature was out of range and no alarms went off (Product storage error). The reporter stated that the patient´s parents were very understanding, and on an unknown date in 2025, Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was given again at 1 dosage form, administered as prophylaxis (formulation, route of administration, anatomical site of injection, lot number and expiration date were not provided) (Extra dose administered), which was also reconstituted with sterile diluent (HOLLISTER-STIER STERILE DILUENT) (expiration date, and lot number were not reported). No harm or other adverse event was reported for the patient. This is one of three reports from the same reporter.
DILUENT MRK