Received Sep 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | Y013347 | OT / RL |
No additional AE; Inadvertent administrations of VARIVAX after a temperature excursion/frozen tem out of range given; This spontaneous report was received from a Physician Assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. Patients between 21-Jul-2025 and 22-Jul-2025,unsure if system will allow to determine which patients inadvertent were vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Solution for injection , (lot #Z004455, expiration date: 13-Feb-2027), 1 dosage form(lot #Y017062, expiration date: 11-Oct-2026), and (lot #Y013347, expiration date: 02-Aug-2026) administered by Unknown route, for prophylaxis, after temperature excursion. No additional adverse event reported (Product storage error). The vaccines were reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT), Solution for injection 1 dosage form administered by Unknown route (lot # and expiration date were not reported) for prophylaxis. The vaccines experienced a temperature time frame: 6 grade Fahrenheit for 45 minutes with previous temperature excursion 6.7 to 14 grade Fahrenheit for 45 minutes; 14 to 46 grade Fahrenheit for 15 minutes. There was no adverse effect reported. No product quality complaint was involved. This report is considered to be invalid due to lack of numbers of patients and patients' identifiers. Upon receipt of follow-up information on 05-SEP-2025 and it was determined that this case is now valid because patient identifier was received. Follow up information has been received from a Physician Assistant on 05-Sep-2025 regarding a 1-year-old female patient with no illness a t the time of vaccination or current conditions. The patient's medical history was not reported. No concomitant therapies administered. On 21-Jul-2025, the patient was inadvertently vaccinated with a first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Solution for injection (lot #Y013347, expiration date: 02-Aug-2026), 1 dosage form administered by Subcutaneous route in Right thigh for prophylaxis, after temperature excursion(freezer temperature out range) (Product storage error) with public funds at private doctor's office. The freezer went out of range for 45 minutes. The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT), Solution for injection 1 dosage form administered by Subcutaneous route in Right thigh (dose number, lot # and expiration date were not reported) for prophylaxis, on the same date. Lot # will be requested and will be submitted if received. This is one of several reports received from the same reporter.
sterile diluent