Received Aug 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y006523 | OT |
Pharmacist calling to report inadvertently administering VARIVAX to patients after a temperature excursion. Caller stated VARIVAX vaccine was "issued" to the facility on 8/9/2024 and was inadvertently stored in the refrigerated throughout administrat; No adverse event; Improper transportation of vaccine from pharmacy to clinic; This spontaneous report was received from a pharmacist and refers to a 20-year-old male patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On an unspecified date from 02-Oct-2024 to 07-Oct-2024, the patient was inadvertently vaccinated with with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE) after a temperature excursion (Temperature 2 to 8 C) (lot number Y006523 and expiration date of 25-Mar-2026) administered by subcutaneous route. The Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE) vaccine was "issued" to the facility on 09-Aug-2024 and was inadvertently stored in the refrigerated throughout administrations. The reporter refused to perform a temperature excursion assessment stating assessment has already been performed. No additional adverse events reported. The reporter informed improper transportation of vaccine from pharmacy to clinic with use of refrigeration vaccine transport equipment used. Additionally, improper storage of vaccine in clinic. Placed in refrigeration when storage. Requirements were kept frozen and only stable for 72 hours in refrigerator.; Reporter's Comments: Keywords: ; Sender's Comments: Priority : 5 , Is case serious : No , number : 02842181-02842148 , number : , number : , number : 500UW00000gVDaKYAW|13082025230037|2645 , Central date : 2025-08-14 , Classification : DMC, Attachment description : Call , Safety case number : 2311714 , case number : 02842181 , Interaction number : 02842148 , Integration log UniqueID : 500UW00000gVDaKYAW|13082025230037|2645 , Service cloud CaseID : 500UW00000gVDaKYAW
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