Received Jan 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | Z008197 | OT / RL |
No side effects or symptoms reported; patient received product after it was improperly stored; This spontaneous report was received from a medical assistant and refers to a 5-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported. On 20-Nov-2025, the patient received an improperly stored dose of varicella virus vaccine live (oka-merck) (VARIVAX) powder and solvent for solution for injection, 0.5 mL (valid lot number: Z008197; expiry date reported and confirmed as 30-Apr-2027) as prophylaxis (product storage error). The suspect vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (lot # and expiry date not provided). The temperature excursion was reported as 10.5 degree Celsius for 1 hour. No side effects or symptoms reported (no adverse event). This is one of several reports received from the same reporter. Follow-up information has been received from a consumer on 14-Jan-2026. The report refers to a female patient. Previously reported vaccination with varicella virus vaccine live (oka-merck) (VARIVAX) reconstituted with sterile diluent referred to a first dose, administered subcutaneously in the right thigh, by a trained healthcare professional, according to the instruction leaflet. On 30-Oct-2025, the vaccine underwent a temperature excursion for 1 hour and 5 minutes, during routine freezer cleaning. As of 14-Jan-2025, no adverse reaction was reported therefore no medical evaluation or treatment was needed.
Sterile diluent