Received Jul 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | 1 | Z002990 | RA |
No other AE; product which underwent a TE was administered to a patient; This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 11-JUN-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 as prophylaxis (lot number reported as Z002990, which has been verified as valid, expiration date reported and validated as 14-JUL-2026) (strength, vaccination scheme, route of administration, and anatomical site of injection were not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date were not reported). The administered dose was exposed to a temperature excursion of 46 Fahrenheit degree (F) for 51 hours and 5 minutes (Product storage error). No other adverse events were reported. Follow up information has been received on 11-JUL-2025. This report was regarding a 4-year-old female patient. The patient's demographic information has been updated. On 11-JUN-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), administered on the right arm as the first dose.
DILUENT MRK