Received Dec 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z008197 | — |
No side effects or symptoms reported. No Additional AE/ No PQC.; HCP called to report TE where patient received product VARIVAX: Z008197 exp: 04/30/2027 after it was improperly stored.; This spontaneous report was received from a physician assistant (reported as medical assistant) and refers to a 15-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported. On 07-Nov-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 as prophylaxis (Lot No. Z008197 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 30-Apr-2027) (strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided); that was reconstituted with sterile diluent, solution for injection (Lot No., expiration date and indication were not provided) (product storage error), after a temperature excursion of -10.5 degree Celsius (C) during a time frame of 1 hour. No previous temperature excursion was reported. No side effects or symptoms reported. No additional information or adverse events or PQC were provided (no adverse event).
sterile diluent