Received Apr 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | Y009347 | — |
No additional information provided. No additional AE/PQC reported; Nurse calling to report inadvertently administering a dose of PROQUAD outside of time frame in the Prescribing Information. Caller stated dose was administered 40 minutes after reconstitution. Caller stated patient reported no symptoms and permission; This spontaneous report was received from nurse and refers to a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On 31-MAR-2025, the patient was vaccinated with a outside of time frame of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD), (lot #Y009347 who had been verified to be a valid lot number, expiration date reported and validated as 11-NOV-2025); and sterile diluent (BAXTER STERILE DILUENT), (lot # and expiration date were not reported) as prophylaxis (product storage error). The reporter stated that, dose was administered 40 minutes after reconstitution. No additional adverse events.
Sterile diluent