Symptomtext
fluzone quadrivalent np administered to a patient that has been exposed to a temperature excursion with no reported adverse event; fluzone quadrivalent np administered to a patient that has been exposed to a temperature excursion with no reported adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited valid non-serious case received from a Nurse. (Agency Inquiry Number: 01228367) This case involves a 21-year-old female patient who has been administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] after being exposed to a temperature excursion 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 Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Boostrix) for Immunization; Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for Immunization; and Varicella Zoster Vaccine (Varicella Vaccine) for Immunization. On an unknown date, reportedly fluzone quadrivalent np has been exposed to a temperature excursion with no reported adverse event (product storage error). On 09-Aug-2022, the patient has been administered fluzone quadrivalent np at dose 0.5ml once via intramuscular route in the left deltoid (lot U7684BA, expiry date: 30-Jun-2023) after being exposed to a temperature excursion with no reported adverse event (poor quality product administered) same day latency. It was not the first-time vaccine was administered. Action taken: Not applicable. The patient was not using the product at time of report. Corrective treatment: not reported. At time of reporting, the outcome was Unknown for both 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.