Received May 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z002625 | — |
no adverse event; HCP called to report TE where one patient received a dose of VARIVAX after stored improperly; This spontaneous report was received from 09-MAY-2025 and refers to a 13-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-MAY-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Z002625, expiration date: 09-JAN-2027), dose: 0.5 mL (route and dose number were not reported) and with sterile diluent (MERCK STERILE DILUENT), 0.5 mL (route, dose number, lot # and expiration date were not reported) for prophylaxis (Product storage error). The administered dose of the vaccine experienced a temperature excursion 7.1 Fahrenheit for 1-hour hour with no previous excursions. There was no adverse effect reported.
sterile diluent