Received Sep 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y013349 | OT |
No adverse reactions reported associated to any of the administrations of either VARIVAX or PROQUAD to any of the patients involved./No additional AE; HCP called to report TE occurring on 6/20/2025 for VARIVAX and PROQUAD that were administered on multiple different dates to multiple patients.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 24-Jun-2025, the patient was vaccinated with improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) solution for injection, 0.5 ml, lot # Y013349, expiration date: 02-Aug-2026 (dose number, route of administration and anatomical location were not reported), for prophylaxis (Product storage error). The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) solution for injection (expiration date, and lot # were not reported). On 20-Jun-2025, the vaccine underwent a temperature excursion of 10 up to 8 (-4.76) Celsius (C) degrees for 30 minutes. There were no previous excursions. No additional adverse event was reported. The action taken with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) and sterile diluent (Hollister-Stier STERILE DILUENT) was considered as not applicable. This is one of several reports from the same reporter.
MERCK STERILE DILUENT