Received Sep 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y006523 | OT |
no additional adverse event was reported; Product storage error; This spontaneous report was received from an 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 26-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) Powder and solvent for solution for injection, (lot #Y006523, expiration date: 25-Mar-2026) as prophylaxis. The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (lot # and expiration date were not reported). The vaccine was inadvertently stored in the refrigerated before administration (Improper storage of product in use). No additional adverse event was reported. Follow-up information has been received from a nurse regarding a 34-year-old male patient on 11-Aug-2025. On 26-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y006523, expiration date: 25-Mar-2026), 1 dosage from, total, administered subcutaneously, as prophylaxis. It was reported that an improper transportation of vaccine from pharmacy to clinic with use of refrigerated vaccine transport was used. Additionally improper storage of vaccine in clinic. Placed in refrigerator when storage requirements were kept frozen and only stable for 72 hours in refrigerator. The action that was taken with the suspect vaccine was removed from clinic immediately. The patient did not have adverse reaction. The vaccine was not resumed. The vaccine was not available for returned. The operator of the vaccine was a healthcare professional.
sterile diluent