Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | Y016876 | — |
No additional adverse event; HCP called to report a TE occurring on 8/18/2025 for PROQUAD and VARIVAX.; This spontaneous report was received from a Physician and refers to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 18-AUG-2025, a temperature excursion (TE) occurred for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) at 6.9 degree Fahrenheit (F) for 1 hour, with no prior TE. On unknown date in 2025, after the TE, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) Injection, 0.5 mL, administered as prophylaxis Lot number [Y016876] is a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD)], expiration date not provided but upon internal validation was established as 07-Apr-2026 (strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided); which was reconstituted with sterile diluent (HOLLISTER-STIER STERILE DILUENT)(expiration date, lot number and route of administration were not reported) (product storage error). No additional adverse event was reported for the patient (no adverse event). This is one of several reports received from the same reporter. This is one of several reports received from the same reporter. This is an amendment reported. The suspect vaccines was updated to measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD). The product lot number issue was deleted.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : [withheld]@merck.com , Index date : 2025-11-03 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : US-009507513-2328641 , Central date : 2025-11-01 , Classification : DMC, Attachment description : Minimal Data Entry , Safety case number :
DILUENT MRK INJ