Sex: U
Vaccine: DTPPVHBHPB, FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: vaxelis and fluzone qiv np pfs reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes with no reported adverse event; VAXELIS and FLUZONE QIV NP PFS reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes. Both products were administered to patients post excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an adult patient of unknown gender and was reported that Diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (vaxelis) and Influenza quadrival a-b vaccine [fluzone qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes with no reported adverse event and both products were administered to patients post excursion 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 quadrival a-b vaccine Suspension for injection (strength,dose,lot number and expiry date were not reported) via unknown route in unknown administration site for immunization.  On an unknown date, the patient received suspect Diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid not produced by Sanofi Pasteur(strength,dose,lot number and expiry date were not reported) via unknown route in unknown administration site for immunization.  On an unknown date Diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (vaxelis) and Influenza quadrival a-b vaccine [fluzone qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes with no reported adverse event and both products were administered to patients post excursion with no reported adverse event(Product storage error) (Poor quality product administered).   Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  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 Good Pharmacovigilance Practices. 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.  Additional information received on 04-Mar-2023 from other health care professional: number of patient added, classification updated. Text amended accordingly.; Sender's Comments:  US-SA-2023SA057733:01495347