Received Aug 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z008195 | — |
Caller stated no patient symptoms have been reported; Nurse called and reported VARIVAX was administered to a patient after being involved in a temperature excursion. Caller stated PROQUAD and VARIVAX were also administered to multiple other patients. See AE cases 02856250, 02856303, 02856304, 02856305,; This spontaneous report was received from a Nurse (LVN) 14-Aug-2025 and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improper storage dose of with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Z008195, expiration date: 30-Apr-2027) 1 dosage form reported as 1 dose (dose and dose number was unspecified) for Prophylaxis (Product storage error). The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) 1 dosage form reported as 1 dose (dose and dose number, lot # and expiration date were not reported was unspecified) for Prophylaxis. No patient symptoms have been reported. The administered doses of the vaccine experienced a temperature excursion -8 degree centigrade for 15 minutes. It was unspecified if the data was recorded by a data logger and no previous temperature excursion reported. There was no adverse effect reported. No product quality complaint was involved. Lot # will be requested and will be submitted if received. This is one of several reports from the same source.
Sterile diluent