Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y011712 | — |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | — | — |
No additional adverse event; Precautionary AE being filed due to HCP being unable to determine if products were administered to any patients during a temperature excursion; Information has been received from Business Partner/CRO on 31-Mar-2025. This spontaneous report was received from a Other health professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 07-Feb-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), (lot #Y011712) 0.5 mL (expiration date was not reported) for prophylaxis. On 07-Feb-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported)for prophylaxis. The vaccine underwent temperature excursion (Product storage error). No additional adverse event was reported.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02762511-02762488 , CLIC number : , ESTAR number : , IRMS number : 500UW00000V5avRYAR|19032025170024|9692 , Central date : 2025-03-19 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2260591 , MNSC case number : 02762511 , MNSC interaction number : 02762488 , Integration log UniqueID : 500UW00000V5avRYAR|19032025170024|9692 , Service cloud CaseID : 500UW00000V5avRYAR