Received Mar 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | Y010292 | — |
No adverse event; A HCP called to report a TE for PROQUAD that occurred on 02/23/2025 and was also inadvertently administered on 02/25/2025. The HCP stated the patient did not experience any adverse issues or side effects related to the administered dose. Please also; This spontaneous report has been received from a registered nurse (R.N), regarding a 12-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported. On 23-FEB-2025, it was stated that a temperature excursion occurred for measles, mumps, rubella and varicella (oka-merck) virus vaccine live lyophilisate and solvent for solution for injection (PROQUAD), after a temperature excursion of 54 degree Fahrenheit (F) during a time frame of 13 hours with 10 minutes; thus on 25-FEB-2025 the patient was inadvertently vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live lyophilisate and solvent for solution for injection (rHA [recombinant Human albumin]) (PROQUAD) 0.5 mL, administered as prophylaxis (Lot No. Y010292 has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live lyophilisate and solvent for solution for injection], expiration date reported and upon internal validation established as 01-DEC-2025) (strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided) that was reconstituted with sterile diluent solution for injection (BAXTER STERILE DILUENT) (Lot No., expiration date and route of administration were not provided) (product storage error). Previous temperature excursions were not provided. No additional adverse event was reported (no adverse event).
MERCK STERILE DILUENT