Symptomtext
inadvertently administered a dose of Fluzone Quadrivalent prefilled syringe that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees F, with no reported adverse event; inadvertently administered a dose of Fluzone Quadrivalent prefilled syringe that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees F, with no reported adverse event; inadvertently administered a dose of Fluzone Quadrivalent prefilled syringe that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees F, with no reported adverse event; Initial information received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 16 years old male patient who was inadvertently administered a dose of Fluzone quadrivalent (influenza quadrival a-b vaccine) prefilled syringe that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f, 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 meningococcal vaccine A/C/Y/W CONJ (TET TOX) (Menquadfi) for Immunisation. On 07-Feb-2023, the patient received a 0.5 ml dose of suspect influenza quadrival a-b vaccine prefilled syringe (lot UT7752MA expiry date: unknown) via intramuscular route in left deltoid with unknown strength for Immunization which was inadvertently administered, that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f, with no reported adverse event (accidental exposure to product) (poor quality product administered) (product storage error) on same day Action taken was not applicable. At time of reporting, the outcome was Unknown for 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.
