Received Jul 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | Z003309 | — |
No symptoms or side effects were reported by HCP. No additional AE; HCP reporting that a patient received a dose of improperly stored PROQUAD. HCP reported that she did not know the date the excursion occurred, but knows the PROQUAD was administered following the excursion.; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 14-JUL-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 mL, administered for prophylaxis (lot number Z003309 has been verified to be valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live [PROQUAD], expiration date not provided but upon internal validation established as 21-JUL-2026; formulation, route of administration, vaccination scheme frequency and anatomical site of injection were not reported), which was reconstituted with sterile diluent (MERCK STERILE DILUENT) (expiration date, and lot number were not reported). The vaccine was administered following a temperature excursion (TE) that occurred at 52.2 degree Fahrenheit (F) (Product storage error). The time frame of the TE was unknown by the reporter. No symptoms, side effects or additional adverse events were reported for the patient. No additional information was provided. This is one of several reports from the same reporter.
Sterile diluent