Received Sep 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | Z008221 | OT |
No additional AE; The leaking product did not get on the patient. Leaking product did get on the gloved hand of the HCP, but did not get on the HCP's skin; reconstituted vaccine came out between the hub and the leur lock; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 05-SEP-2025, when attempting to administer Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Z008221, expiration date: 27-OCT-2026) reconstituted with sterile diluent (lot # 1973253, expiration date: 22-FEB-2026), the plunger was pushed and reconstituted vaccine came out between the hub and the luer lock (Device connection issue). The leaking product did not get on the patient who was to be vaccinated, but did get on the gloved hand of the HCP, but did not get on the HCP's skin (Accidental exposure to product). The patient did not get any of the vaccine from this dose. A different dose was given to the patient so that he received his vaccine. No symptoms and no additional adverse event were reported.
DILUENT MRK