Age: 3.0
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Poor quality product administered
Clinical narrative: Vaccine was out at room temperature 6 hours longer than the recommended time frame, administered to patient, with no reported adverse event; Initial information received from on 28-Oct-2022 regarding an valid non-serious case received from a consumer/non- healthcare professional (hcp).  This case involves a 3-year-old and unknown gender patient, reported vaccine COVID-19 VACCINE and INFLUENZA VACCINE (QUADRIVALENT) was out at room temperature 6 hours longer than the recommended time frame, administered to patient, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer (strength, formulation, dose: unknown) (lot number: UT7751NA and expiry date: unknown) via intramuscular route in unknown administration site for Prophylactic Vaccination (Immunisation).  On 17-Mar-2021, patient received a dose 1 of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (lot number: EN6199 and expiry date: unknown) in the left deltoid. On 07-Apr-2021, the patient received dose 2 of the same vaccine (lot number: ER8737 and expiry date: unknown) in the left deltoid. On 10-Nov-2021 patient also received dose 3 of the same vaccine (lot number: FE3590 and expiry date: unknown) in the left deltoid as vaccine supplemental (Supplementation therapy).  On an unknown date, a non-serious event reported, vaccine was out at room temperature 6 hours longer than the recommended time frame, administered to patient, with no reported adverse event (poor quality product administered) (unknown latency) following the administration of INFLUENZA VACCINE (QUADRIVALENT) and COVID-19 VACCINE.  It was reported, Is Covid-19 Bivalent Vaccine a Pfizer product? Yes Covid-19 Bivalent Vaccine. Expiry Date of Covid-19 Bivalent Vaccine: 30 Nov 2023 Other Products: Calling regarding the Covid-19 vaccine bivalent that was administered past the timeframe. Was outside the time frame for 6 hours. Caller wanting to know when will it be safe for the patient to receive the bivalent vaccine again. They can give them another dose immediately, but to reach out to he manufacturer for guidance. Wanted to talk to Pfizer to see what the recommendation was. The vial was taken out of the fridge Friday, for 30 minutes drawn up into the syringes on Friday afternoon, 21Oct2022. Staff left Friday and didn't waste what wasn't used. The next shift came in today and an employee gave the injection from Friday to the patient. Went ahead and let the patient leave because she had already spent 20 minutes listening to the EUA recording. Vaccination Was Given: 9:48am. It is unknown if there were lab data/results available.    Action taken with QUADRIVALENT INFLUENZA VACCINE (INFLUENZA VACCINE (QUADRIVALENT)) and COVID-19 VACCINE (COVID-19 VACCINE) was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the  Regulatory Authority. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.