Received Oct 7, 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 a physician assistant (certified medical assistant) referring to 2 unknown patients of unspecified age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On 13-AUG-2025, the patients was vaccinated with improperly stored doses of therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) administered 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) (dose, formulation, anatomical site of injection, dose number and vaccination scheme frequency were not provided), 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 (Product storage error). No other adverse event was reported for the patients. No patient information was provided. This report was considered as non-valid due to the lack of patient´s identifiers and as it concerned to 2 patients. This is one of two reports from the same reporter. Follow up information has been received from Other health professional on 26-SEP-2025 Patient´s identifiers were provided; therefore, this report is no longer considered as non-valid. This case refers to a 1-year-old female patient (the other patient´s information was captured in PV Smart case #2335589). The patient's medical history, concurrent conditions and concomitant therapies were not reported. The previously reported dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was dose number 1, 1 dosage form, administered by subcutaneous route in the left thigh for prophylaxis, which was reconstituted with sterile diluent (HOLLISTER-STIER STERILE DILUENT) (expiration date, and lot number were not reported). It was reported that the temperature was out of range and no alarms went off, so the vaccine was administered after a TE (as previously reported) (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 (Extra dose administered) at 1 dosage form, administered as prophylaxis, which was also reconstituted with sterile diluent (HOLLISTER-STIER STERILE DILUENT) (expiration date, and lot number were not reported). No other adverse event or harm was reported for the patient. This is one of several reports from the same reporter.
DILUENT MRK