Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | X012418 | OT / LL |
No additional adverse event; ProQuad were moved to the refrigerators where they remained withing normal refrigerated temperature range until administration. The dose administered to this client was one that was removed from the freezer to the refrigerator on October 1, 2024.; This spontaneous report was received from a Nurse regarding a 5-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 01-OCT-2024, a temperature excursion (TE) occurred for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) after the doses were moved to the refrigerators where they remained within normal refrigerated temperature range until administration. On 24-OCT-2024, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (RHA)(PROQUAD), dose 2, administered by Subcutaneous route in Left Thigh for prophylaxis (formulation and dose were not reported; lot number X012418 has been verified to be a valid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live [PROQUAD], expiration date was not reported but upon internal validation it was established as 28-OCT-2024), which was reconstituted with sterile diluent (BAXTER STERILE DILUENT). It was reported that the TE for this dose was in the range of 15 to 46 degree Fahrenheit (-9 to 8 degree Celsius) during 552 (units not provided). No additional adverse event was reported for the patient.
Sterile diluent