Received Oct 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | Y013348 | — |
No other AE/No PQC.; Improper storage of product in use; This spontaneous report has been received from an other health professional, regarding to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 21-JUL-2025, the patient was vaccinated with improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) lyophilisate and solvent for solution for injection (VARIVAX) plus sterile diluent (lot number Y013348, expiration date 02-AUG-2026), plus sterile diluent as prophylaxis (dose, route of administration, anatomical site of injection was not provided). The administered doses were stored at a temperature of 14.85 degrees Celsius (C) during a time frame of 30 minutes (product storage error). There was a previous temperature excursion reported of 14.08 C. No additional side effects were reported in the patients.; Sender's Comments: :
Sterile diluent