Received Oct 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | Y018157 | — |
PROQUAD was administered after having experienced two TE; No other AE; This spontaneous report was received from a medical assistant and refers to a 5-year-old female patient. The patients' pertinent medical histories, concurrent conditions, previous drugs reactions or allergies and concomitant medications were not reported. On an unspecified day of 2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT), lot #Y018157 has been verified to be a valid lot number, expiration date: 29-Apr-2026, administered at a dose of 0.5 mL for prophylaxis (route of administration and anatomical site of injection were not provided). The vaccine administered experienced two temperature exposures (reported as on 11-Apr-2025 and 12-Apr-2025) at a temperature of 14.85°C for a time frame of 0 hours, 30 minutes and 0 seconds and at a temperature of 14.08°C for 0 hours, 5 minutes and 0 seconds (Product storage error). Additionally, it was stated that on 07-Jul-2025, the patient received the varicella virus vaccine (OkaMerck), lot number Y013348 (expiration date: 02-Aug-2026), administered subcutaneously in the right rectus femoris. No further information was provided, and no additional adverse event was reported (no adverse event).; Sender's Comments: Priority : 5 , Is case serious : No , Index user : [withheld]@merck.com , Index date : 2025-09-17 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : caso_Part5 , Central date : 2025-09-17 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Sterile diluent