Received Jul 25, 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 AE; VARIVAX involved in temperature excursion has been administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-Jul-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), solution for injection (lot #Z004454, expiration date: 13-Feb-2027), 1 dosage form (1 dose) (route of administration, anatomical site and dose number in series were not reported), which was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided), administered as prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 36.5 Fahrenheit for 2 hours, 21 minutes and 0 seconds (Product storage error). No previous excursion was not reported. No adverse event. This is one of several reports from the same source.