Received Aug 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | Y015559 | — |
No additional AE/PQC.; VARIVAX was administered after TE on 8/18/2025; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. Between 01-Aug-2025 and 19-Aug-2025, a temperature excursion (TE) occurred with a cumulative time of 432 hours with a max temperature of (-12.5C) with 2 prior excursions (prior excursion: -10°C up to 8°C (-8.94C) for 0 hours, 11 minutes, 0 seconds; prior excursion: -10°C up to 8°C (-10C) for 1 hour, 54 minutes, 0 seconds; current excursion: -14°C up to -10°C (-12.5C) for 432 hours, 0 minutes, 0 seconds (cumulative for August 2025)). On 18-Aug-2025, after the TE, the patient was vaccinated with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot #Y015559, expiration date reported as and upon internal validation confirmed to be 16-Sep-2026) for prophylaxis (dose, route of administration and vaccination site were not reported) (product storage error). TE evaluation was communicated as "supported". No additional adverse event (AE) and no product quality complaint (PQC) was noted (no adverse event).
DILUENT MRK INJ