Received Sep 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z008197 | — |
calling to report administering PROQUAD and VARIVAX after experiencing a temperature excursion; No additional AE; This spontaneous report has been received from an Other health professional, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot number Z008197, expiration date 30-APR-2027) with sterile diluent, both as prophylaxis (dose, route of administration, anatomical site of injection). The administered dose wase stored at a temperature of -13.4 degrees Celsius (C) during a time frame of 9 hours and 32 minutes (product storage error). There was a previous temperature excursion reported as -12.9 C for 2 hours and 22 minutes. No additional side effects were reported in the patients.
Sterile diluent