Received Apr 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y015558 | — |
No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant and refers to unknown patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT). On an unknown date, the patients were vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event). Follow-up information has been received from reporter on 01-APR-2025. On 21-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # Y015558, expiration date 16-Sep-2026). The temperature excursion was 6.8 degree Fahrenheit for 115 hours. This previous invalid report become valid since patient information was reported. This is one of several reports received from the same reporter.
DILUENT MRK