Received Sep 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | Y013347 | OT / LL |
No additional AE; Freezer temperature out of range; This spontaneous report was received from a Physician Assistant on 05-SEP-2025 and refers to a 4-year-old male patient with no illness at the time of vaccination or current conditions. The patient's medical history was not reported. No concomitant therapies administered. On 22-Jul-2025, the patient was vaccinated with second dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y013347, expiration date: 02-Aug-2026), 1 dosage form administered by Subcutaneous route in Left 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), 1 dosage form administered by Subcutaneous route in Left Thigh for prophylaxis, on the same date. The vaccine 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 is one of several reports from the same source. Lot # is being requested and will be submitted if received.
Sterile diluent