Received Sep 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 2 | Y013347 | OT / LL |
No additional AE; Freezer Temperature out of range; This spontaneous report was received from a medical Assistant and refers to a 4-year-old male patient who weighted 6lbs, 6.3oz at birth. He had no siblings. The patient had not pre-existed physician diagnosed with allergies, birth defects nor medical conditions. He had no illness at the time of vaccination and had not previous vaccines. Concomitant therapies were not reported. On 21-Jul-2025, the freezer where de vaccine was storage, went out of range to 6.3F for 45 minutes. There was a previous temperature excursion of 6°F to 14°F for 0 Hours 45 Minutes 0 Seconds; 14°F to 46°F (14.5F) for 0 Hours 15 Minutes 0 Seconds. The temperature excursion was reading from a digital data logger. On 22-Jul-2025, the patient was vaccinated with the inappropriate storage vaccine, it was his second dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y013347, expiration date: 02-Aug-2026), administered by Subcutaneous route in Left Thigh as prophylaxis. The vaccine was reconstituted with a sterile diluent (Hollister-Stier STERILE DILUENT) (lot # and expiration date were not reported). The vaccine was administered by a trained healthcare professional at private doctor's office/hospital with public funds. No additional adverse events (AE). This is one of several cases form the same source.
Sterile diluent