Received Feb 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | Y010050 | — |
No symptomatic adverse events were reported.; HCP called to report a Temperature Excursion on case number 02740636. The case is still ongoing and it could not be confirmed if the products were still supported. The HCP reports that PROPQUAD was inadvertently administered after suffering from a T; This spontaneous report was received from a registered nurse (RN) concerning to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT) (reported as "Diluent MRK".) On 09-JAN-2025, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human Albumin (rHA) (PROQUAD) injection, 0.5ml/series, lot #Y010050, expiration date 25-NOV-2025 (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis. The vaccine was inadvertently administered after suffering from a temperature excursion (product storage error.) It was reported that the product reached -11.6 degrees Celsius (c) and was out of range for 3 hours 5 minutes 0 seconds. Previous excursions could not be confirmed and at the reporting time, temperature excursion was ongoing and it was not possible to confirm if the products were still supported. No symptomatic adverse events were reported (no adverse event). No additional information available. This was one of several reports received from the same reporter.; Sender's Comments: US-009507513-2501USA007066: US-009507513-2501USA008866: US-009507513-2501USA008885: US-009507513-2501USA008880: US-009507513-2501USA008935: US-009507513-2501USA008877: US-009507513-2501USA008882: US-009507513-2501USA007047: US-009507513-2501USA007446: US-009507513-2501USA008861:
MERCK STERILE DILUENT