Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y017915 | — |
No additional AE; Office Manager called regarding temperature excursions for VARIVAX, PROQUAD, and MMR-II; reference TE case # 02873629. Per Office Manager, VARIVAX and MMR-II products were administered. Office Manager provided verbal consent for the Merck National Se; This spontaneous report was received from a Consumer or other non-health professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 02-Sep-2025, the patient was vaccinated with improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), lot #Y017915, expiration date: 28-Oct-2026, 0.5 mL (0.5mL/once) (route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (lot # and expiration date were unknown). On an unknown date, administered dose of vaccine was exposed to the temperature excursion of 27.3 degrees Fahrenheit for 2 hours (product storage error). No additional adverse event reported (no adverse event).
Sterile diluent