Received Aug 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | X019102 | OT / LL |
No additional adverse event; Vaccine involved in temperature excursion; This spontaneous report was received from a nurse and refers to a 10-months-old female patient. The patient's medical history, concomitant therapies and current conditions was not reported. On 17-MAR-2025, the patient was vaccinated with an improper storage dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #X019102, who had been verified to be a valid lot number, expiration date reported and validated as 16-JUL-2025) 0.5 mL administered by Subcutaneous route in Left Thigh as prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported). It was reported that the vaccine experienced temperature excursion of freezer. As determined by manufacturer- vaccine not supported for use-vaccine was given prior to known excursion (product storage error). Also, was storage in clinical practice. The vaccine was no available for return since was discarded after use. In addition, the vaccine was used according to instruction leaflet by health care professional. This event was already reported to doctor, heath department and manufacturer. The patient was vaccinated at private doctor's office with private funds. No additional adverse event reported. This is one of several reports received from the same reporter.
Sterile diluent