Received Nov 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y010374 | — |
No additional adverse event; HCP called to report a TE occurring on 8/18/2025 for PROQUAD and VARIVAX.; This spontaneous report was received from a Physician and refers to an approximately 1-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 18-AUG-2025, a temperature excursion (TE) occurred for Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) at 6.9 degree Fahrenheit (F) for 1 hour, with no prior TE. On unknown date in 2025, after the TE, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection, 0.5 mL, administered as prophylaxis (lot number Y010374 has been verified to be valid for Varicella Virus Vaccine Live [Oka-Merck] [VARIVAX], expiration date 05-JUN-2026; route of administration, dose number and anatomical site of injection were not provided); which was reconstituted with sterile diluent (HOLLISTER-STIER STERILE DILUENT), Injection (expiration date, and lot number were not reported) (Product storage error). No additional adverse event was reported for the patient. This is one of several reports received from the same reporter.
DILUENT MRK INJ