Received Mar 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | Y013579 | OT / LL |
Improper storage of produc in use; No additional AE; This spontaneous report was received from a registered nurse referring to a 7-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Hepatitis a vaccine inact (HAVRIX), Elasomeran (MODERNA COVID-19 VACCINE), Hepatitis b vaccine rHBsAg (yeast) (ENGERIX), Influenza vaccine inact split 4v (FLUARIX QUADRIVALENT), Iodinated glycerol (IPOL) and Diphtheria vaccine toxoid;Pertussis vaccine acellular 3- 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. On 08-JAN-2025, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot#: Y013579, expiration date: 03-FEB-2026, that was verified to be valid vial, administered subcutaneously with sterile diluent in the left thigh for prophylaxis (strength and dose were not reported) (product storage error). The administered dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was received and stored in the refrigerator that experienced a temperature excursion (on 13-NOV-2024) for a Total time of 1344 in the range 15°Fto 46°F. 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 : 04/16/2017 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Prophylaxis
COVID19(Moderna); Hep A (Havrix); Hep B (Engerix-B); Influenza (Seasonal) (fluarix quadrivalent); Inactivated Polio Virus (IPOL); Tdap (Boostrix); Sterile diluent