Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: they received a shipment of the vaccine a day late and one of the vaccines was administered to a patient with no reported adverse event; they received a shipment of the vaccine a day late and one of the vaccines was administered to a patient with no reported adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 2 years old male patient and reporter reported temperature excursion for Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent]/ they received a shipment of the vaccine a day late and one of the vaccines was administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A Vaccine Inact (Vaqta) for Prophylactic vaccination.  On 17-Oct-2023, the patient received 0.5 ml total (1 X) dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection (lot number: U8202CA; Expiry date: 30-Jun-2024) (Frequency: once) (Strength: standard) via intramuscular route in the left thigh (Left Vastus Laterallis) for Influenza immunization/prophylactic vaccination (Immunisation).  On an unknown date, the reporter reported temperature excursion for Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent]/ they received a shipment of the vaccine a day late and one of the vaccines was administered to a patient with no reported adverse event (product storage error) (unknown latency).  On 17-Oct-2023, the reporter reported temperature excursion for Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent]/ they received a shipment of the vaccine a day late and one of the vaccines was administered to a patient with no reported adverse event (poor quality product administered) (latency: same day).  It was reported, Practice Administrator calling regarding FLUZONE QIV NP. Caller stated that they received a shipment of the vaccine a day late and one of the vaccines was administered to a patient.. reporting that a shipment of FLUZONE QUADRIVALENT PFS arrived today,17Oct2023, a day late as it was shipped on 14Oct2023. The caller states that 1 dose was administered to a patient. This situation is reported as a medication error due to the administration of a potential compromised product.  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 was received on 17-Oct-2023: Indication verbatim was updated. Collection organization was updated. However, no new significant information was received. Text amended accordingly.