Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z008430 | OT |
No additional AE; Customer called to report TE. VARIVAX was administered to 3 patients.; This spontaneous report was received from a Nurse and refers to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) 0.5 mL (lot #Z008430, expiration date: 06-May-2027) as prophylaxis, which was reconstituted with sterile diluent 0.7 mL (lot # Z002901, expiration date: 25-Nov-2027) (dose number, route of administration, anatomical location not provided) as prophylaxis; which underwent a temperature excursion (TE) at 14 degree Fahrenheit (F) up to 46 F (17.44 F) for 17 hours and 30 minutes on 05-Jan-2026. No previous TE were reported, no additional adverse events reported. This is one of three cases reported by the same reporter.
MERCK STERILE DILUENT