Received Mar 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | Y013579 | OT / LA |
no adverse event; incorrect product storage; This spontaneous report was received from a registered nurse and refers to a 6-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Havrix (Hepatitis a vaccine inact), Infanrix (Diphtheria vaccine toxoid;Pertussis vaccine acellular 3-component;Tetanus vaccine toxoid), Flucelvax (Influenza vaccine inact sAg 3v). On 01-OCT-2024, the facility received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accommodate the shipment. It was assumed that the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) received could be stored in both the freezer and refrigerator and both state and private Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were moved to the refrigerators where they remained within normal refrigerated temperature range until administration. The dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) administered to the client was received on 13-JAN-2025 and stored in the refrigerator until administered. On 01-Feb-2025, the patient was vaccineated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Injection (lot #Y013579, expiration date: 03-Feb-2026), dose number 2, administered by Subcutaneous route in Left Arm. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT)(lot number and expiry dates were not provided). No additional adverse event (AE) (No adverse event). This case was one of several reports received from the same reporter with the case US-009507513-2254349.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 11/22/2018 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Havrix; Infanrix; Flucelvax; Sterile Diluent