Received Mar 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y015108 | — |
Caller reported VARIVAX administered after temperature excursion. No other information provided.; This spontaneous report has been received from a nurse, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported. On 07-FEB-2025, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka-merck) lyophilisate and solvent for solution for injection (VARIVAX) 0.5 milliliter (mL) administered as prophylaxis Lot No. Y015108 has been verified to be a valid lot number for [varicella virus vaccine live (oka-merck) lyophilisate and solvent for solution for injection], expiration date reported and upon internal validation established as 06-SEP-2026 (strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided) that was reconstituted with an sterile diluent solution for injection (BAXTER STERILE DILUENT) (Lot number, expiration date and route of administration was not provided (product storage error), after a temperature excursion of -2.1 degree Celsius (C) (-2.1C) during a time frame of 6 hours 45 minutes and 0 seconds. No previous temperature excursion was reported. This is one of several reports received from the same reporter.
Sterile Diluent