Received May 26, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | Z013990 | — |
No additional AE; black specks in diluent; black specks were noticed; Product reconstitution quality issue; black specks were noticed; Product preparation issue/ 0.7 ml of diluent; This spontaneous report was received from a nurse and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On 11-MAY-2026, the patient was vaccinated with measles (+) mumps (+) rubella (+) varicella vaccine (PROQUAD) 0.5 ml, lot # Z013990, expiration date 02-MAR-2027 (route of administration, anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) 0.7 ml (lot # 2173884, expiration date: 13-DEC-2027) (Product preparation issue). The nurse reported that after injecting diluent into a measles (+) mumps (+) rubella (+) varicella vaccine (PROQUAD) vial, black specks were notice. Black specks were attached to the inside glass body of the syringe of the diluent along the label and window of the label (circular dark grey or black in color, smaller than the tip of a pen, between 1-5 black specks in the syringe (Liquid product physical issue, Product contamination, Product preparation issue, Product with quality issue administered, Product reconstitution quality issue). The diluent was properly stored. There was no damage to carton or package. There was no damage to shipping container. No adverse events were reported. This is one of 3 reports received from the same reporter (linked GSD # 2429063 and 2428938).; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02999757-02999751 , CLIC number : , ESTAR number : , IRMS number : 500TP00000jK9RsYAK|20052026230032|5600 , Central date : 2026-05-21 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2428976 , MNSC case number : 02999757 , MNSC interaction number : 02999751 , Integration log UniqueID : 500TP00000jK9RsYAK|20052026230032|5600 , Service cloud CaseID : 500TP00000jK9RsYAK
sterile diluent