Received Jul 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z003882 | — |
Medical Assistant calling to report inadvertently administering VARIVAX vaccine after experiencing a temperature excursion.; No additional AE; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) . On an unknown date, the patient was inadvertently vaccinated with Varicella Virus Vaccine Live (Oka- Merck) (VARIVAX), (invalid lot # Z003882, expiration date: 02-MAR-2027) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided) after experiencing a temperature excursion of -13.3C in time frame of 144 hours 0 minutes and 0 seconds (product storage error). No previous temperature excursion was noted. No additional adverse event (AE) was reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user :, Index date : 2025-07-10 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : Patient 4 , Central date : 2025-07-10 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
MMR II; Sterile diluent