Received Jan 2, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z003766 | OT |
No other AE; Yes, the patient was injured; While injecting the product into the patient the needle fell off of the prefilled syringe. This caused half the product to leak out and only half the injection to enter the patient; While injecting the product into the patient the needle fell off of the prefilled syringe. This caused half the product to leak out and only half the injection to enter the patient; This spontaneous report was received from a nurse and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 08-Dec-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) solution for injection (lot #Z003766, expiration date: 30-Jan-2027) (once, into the patient's arm), administered by intramuscular route as prevention. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot #Y015508, expiration date: 25-Feb-2027). While injecting into the patient's arm, the syringe needle fell off of the prefilled syringe (Needle issue). Only half of the medication went into the arm because the needle just fell off. This caused half the product to leak out (Device leakage). The patient had to be revaccinated, so the patient had to be poked twice. "Was Anyone Injured Using the Product? Yes, the patient was injured" (Injury associated with device). No other adverse events. At the reporting time, the outcome of the events was unknown. The action taken with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) was not applicable.
DILUENT MRK