Received Dec 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z004454 | OT |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | — | OT |
No additional information provided. No additional AEs or PQC reported.; Caller reported VARIVAX administered after temperature excursion.; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported. On 03-Dec-2025, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka-merck) lyophilisate and solvent for solution for injection (VARIVAX) injection, at a dose of 0.5 milliliters (mL), administered intramuscular as prophylaxis (Lot No. Z004454 has been verified to be a valid lot number for [varicella virus vaccine live (oka-merck) lyophilisate and solvent for solution for injection], expiration date reported and upon internal validation established as 13-Feb-2027) (strength, dose number, anatomical location of administration and vaccination scheme frequency were not provided); that was reconstituted with sterile diluent, solution for injection, administered intramuscular (Lot No., expiration date and indication were not provided) (product storage error), after a temperature excursion of 8.1 degree Fahrenheit (F) during a time frame of 30 minutes. No previous temperature excursion was reported. No additional information or adverse events or PQC were provided (no adverse event).