Received May 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | y011017 | — |
No adverse event; PFS leaked between the Luer Lock/Hub and the needle while administering VARIVAX; resulting in the patient not receiving the full dose of VARIVAX; This spontaneous report was received from a Nurse and refers to a 1-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-Apr-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) at 0.5 mL (lot #y011017 was verified to be a valid number, expiration date: 18-Jun-2026) diluted with sterile diluent prefilled syringe (PFS) at 0.5 mL (lot #1973320 was verified to be a valid number, expiration date: 20-Nov-2026) (strength, scheme, vaccination site and route of administration were not reported); during the administration sterile diluent PFS leaked between the luer lock/hub and the needle (syringe issue), resulting in the patient not receiving the full dose of VARIVAX (incorrect dose administered). VARIVAX was wasted as a result of the leakage. The nurse confirmed there was no damage to the PFS or to the luer lock/hub when the needle was attached, and no breakage was observed. No photos were available and the product is not available for retrieval, as it has already been discarded into the sharps container. No additional adverse event was reported.
Sterile diluent solution for injection