Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | Y013583 | OT / LL |
No additional adverse event; Proquad were moved to the refrigerators where they remained whthin normal refrigerated temperature range (36 to 46 degrees fahrenheit) from 01-OCT-2024 until administration on 20-NOV-2024; This spontaneous report was received from a Nurse regarding a 2-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Influenza vaccine live reassort 4v (FLUMIST QUADRIVALENT), Pneumococcal vaccine conj 20v (CRM197) (PREVNAR 20), Hepatitis a vaccine inact (HAVRIX) and DTAP IPV HEP B HIB VACCINE Injection (VAXELIS). 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 refrigerator where they remained within normal refrigerated temperature range (36 to 46 degree Fahrenheit) until administration. On 20-NOV-2024, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), dose 1, administered by Subcutaneous route in Left Thigh as prophylaxis (lot number Y013583 has been verified to be a valid number for Measles, Mumps, Rubella and Varicella [Oka-Merck] Virus Vaccine Live [PROQUAD], expiration date 03-FEB-2026; dose and formulation were not reported). No adverse event was reported for the patient. This is one of several reports from the same reporter.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 11/15/2022 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Influenza (seasonal) (FluMist quadrivalent); Pneumo Conjugate (Prevnar 20); Hep A (Havrix); vaxelis