Received Nov 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | Y011015 | OT |
No adverse events; Nurse called to report T/E. Nurse stated 1 VARIVAX was administered to 1 patient on 10/14/2025. T/E date was on 10/14/2025. No additional AE reported . No PQC reported. ? Names of vaccines involved (including lot/exp) 00006482700 Y0110; 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. On 14-Oct-2025, the patient was vaccinated with an improper storage dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y011015, expiration date: 18-Jun-2026), 1st dose/ 0.5ml, subcutaneously (SQ); diluted with a sterile diluent (Hollister-Stier STERILE DILUENT), (lot # and expiration date were not reported) administered as of Prophylaxis. The patient started therapy with sterile diluent (Hollister-Stier STERILE DILUENT), for the treatment of prophylaxis. It was confirmed that the temperature excursion was of -5.6 Celsius degrees (C), during a time frame of 1 hour 5 minutes; without previous temperature excursion.
Sterile diluent