Received Apr 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y011712 | — |
no adverse event; improper storage of product in use; This spontaneous report was received from a/an Consumer or other non-health professional and refers to a(n) 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 21-Mar-2025, the patient was vaccinated with improper stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), formulation: injection, lot #Y011712, expiration date: 02-Jul-2026, 0.5 mL (route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). On 29-Jan-2025, administered dose of vaccine was exposed to the temperature excursion of 14.65 degrees Fahrenheit for 13 hours and 15 minutes (product storage error). No previous temperature excursion has occurred. No additional adverse event reported (no adverse event).
Sterile diluent