Received Mar 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y017063 | OT |
No additional AE; VARIVAX administered after temperature excursion; This spontaneous report was received from a medical assistant and refers to a 12-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 26-Feb-2026, temperature of the freezer was out of range and the temperature excursion occurred (at 12:45 PM: -14.61 C; at 13:00 PM: -13.57 C; temperature came back to normal range at 13:15 PM: -15.84 C). The temperature excursion occurred as a result of a reading from a digital data logger. On 26-Feb-2026, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) injection, 0.5 mL, total, lot #Y017063, expiration date: 11-Oct-2026, administered subcutaneously (sub) for prophylaxis after the being improperly stored (product storage error). The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (lot# and expiration date were not reported). On 19-Mar-2026, the excursion was discovered. The excursion was identified while downloading data definition language (DDL). No adverse events were reported (no adverse event). The is one of several cases received from the same reporter.
Sterile Diluent