Received Sep 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | Y017062 | OT / RL |
No additional AE; Freezer temperature out of range; This spontaneous report was received from a Physician Assistant and refers to a 4-year-old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (Hollister-Stier STERILE DILUENT). On 21-Jul-2025, the patient was vaccinated with dose 2 of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) lot #Y017062, expiration date: 11-Oct-2026, administered by Subcutaneous route in the right thigh as prophylaxis. The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (lot # and expiration date were not reported). The freezer temperature where the vaccine was stored was out of range for 45 minutes on the same day (product storage error).
Sterile diluent