Received Apr 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | Z011683 | OT |
No additional adverse events; Products were administered after being improperly stored. Products were administered on Date of administration: 2/3/2026, 2/10/2026, 2/13/2026 and 3/3/2026. -10°C to 8°C (5.5C) for 580 hours 45 minutes 0 seconds; This Spontaneous report was received from a medical assistant and referred to 4 unspecified patients'. The patients' concurrent conditions, medical history and concomitant therapies were not provided. On 03-FEB-2026, 10-FEB-2026, 13-FEB-2026 and 03-MAR-2026, the patients were vaccinated with a dose of improperly stored measles (+) mumps (+) rubella (+) varicella vaccine (PROQUAD) lot # Z011683, expiration date 10-JAN-2027 (dose, route of administration, anatomical location were not provided) for prophylaxis (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # 2031279, expiration date: 26-DEC-2026). The suspect vaccine was improperly stored at a temperature between -10 and 8 degrees Celsius for 580 h 45 minutes. No adverse events were reported. This is an invalid case due to multiple patients without identifiers. Follow-up information has been received from a medical assistant on 24-MAR-2026. The reporter provided detailed information on particular patients. This spontaneous report refers to a 4-year-old male patient. His concurrent conditions, medical history and concomitant therapies were not provided. On 03-FEB-2026, the patient was vaccinated with a dose of improperly stored measles (+) mumps (+) rubella (+) varicella vaccine (PROQUAD) lot # Z011683, expiration date 10-JAN-2027 (dose, route of administration, anatomical location were not provided) for prophylaxis (Product storage error). No adverse events were reported. The case is no longer considered as invalid. This is one of 4 reports received from the same reporter (linked GSD # 2418808, 2418809 and 2418810).; Sender's Comments: Priority : 5 , Is case serious : No , Index user : @merck.com , Index date : 2026-03-27 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : US-009507513-2394586 , Central date : 2026-03-27 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
MERCK STERILE DILUENT