Received Oct 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z008195 | — |
Medical Assistant calling to report administering PROQUAD and VARIVAX after experiencing a temperature excursion. Products were supported. see TE Case# 02868092 filed. Permission to contact HCP was granted. No additional information provided. No addi; No additional AE; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with a dose of improperly stored varicella virus vaccine (VARIVAX) lot # Z008195, expiration date 30-APR-2027 (dose, route of administration and anatomical location were not provided) for prophylaxis (the vaccine was reconstituted with sterile diluent however lot # could not be established). The suspect vaccine was stored in the temperature of -13.4 degrees Celsius for 9 hours and 32 minutes (product storage error). Previous excursions was also reported (-12.9 degrees Celsius for 2 hours and 22 minutes). No adverse events were reported. This is one of several reports received from the same reporter.; Reporter's Comments: Keywords : MUL
sterile diluent