Received Dec 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | Z009664 | — |
No AE/additional PQC reported; After reconstituting a second vial of PROQUAD, caller stated that after reconstitution, she noticed particles of rubber in the vial but was able to draw product into syringe to administer, avoiding drawing up the particles; After reconstituting a second vial of PROQUAD, caller stated that after reconstitution, she noticed particles of rubber in the vial but was able to draw product into syringe to administer, avoiding drawing up the particles. Product was administered,; This spontaneous report was received from 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 an unknown date, the reporter stated that after reconstitution, she noticed particles in the syringe of the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD). The nurse did not administer dose. On 22-DEC-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Z009664 who had been verified to be a valid lot number, expiration date was reported and validated as 29-NOV-2026) (0.5 mL) for prophylaxis. The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT). After reconstituting this second vial of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), the reporter stated that after reconstitution, she noticed particles of rubber in the vial but was able to draw product into syringe to administer (liquid product physical issue), avoiding drawing up the particles. Product was administered (Poor quality product administered), no symptoms reported (no adverse event).
Sterile diluent