Received Mar 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y015100 | OT |
No adverse side effects were reported.; HCP called to report a patient was being administered VARIVAX and the needle came off during administration, received about half of the dose. Requested information on revaccination see request case 02768484. STERILE DILUENT Lot and Expiration were un; Patient received about half of the dose; anyone was injured; This spontaneous report was received from Other health professional and refers to an 11-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 11-Mar-2025, the patient was vaccinated with of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (strength, frequency, route of administration, site of administration, and vaccination scheme were not provided; lot # Y015100 which has been verified as a valid number, and expiration date reported and validated as 06-Sep-2026), and was used with a sterile diluent (strength, frequency, route of administration, site of administration, vaccination scheme, lot #, and expiration date were not provided) as a prophylaxis. however, the needle came off during administration since it came detached at the luer lock. Luer lock remained on the syringe, and product leaked out from between the space between luer lock and where neeedle was attached (syringe connection issue), received about half of the dose (accidental underdose), and an injury (unspecified) was performed. Nevertheless, no adverse side effects were reported. At the reporting time, the outcome of the event of injury NOS was not provided. The causal relationship between the event of injury NOS and the suspect vaccine was not provided.
Sterile diluent