Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Product administered to patient of inappropriate age, Swelling
Clinical narrative: after the administration this year, she experienced severe body aches; slightly upset stomach; experiences some injection site pain; fatigue after receiving her annual flu vaccine; nausea; malaise; administration of FLUZONE HD QIV to a patient younger than the approved age indicated for this product.; swelling; Initial information received on 22-Sep-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 64 years old female patient who experienced swelling, after the administration this year, she experienced severe body aches, slightly upset stomach, experiences some injection site pain, fatigue after receiving her annual flu vaccine, nausea, malaise and administration of fluzone hd qiv to a patient younger than the approved age indicated for this product after receiving Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included paracetamol (tylenol); and ibuprofen (ibuprofen).  On 20-Sep-2023, the patient received an unknown dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine (lot number: UT8069MA) (Expiry date: 30-Jun-2024) via unknown route at unknown administration site for immunization.  On 20-SEP-2023, the patient developed events of swelling, slightly upset stomach (abdominal discomfort), some injection site pain (vaccination site pain),  fatigue after receiving her annual flu vaccine (fatigue), nausea, malaise and administration of fluzone hd qiv to a patient younger than the approved age indicated for this product.  (product administered to patient of inappropriate age) (latency: same day).  On an unknown date, the patient developed event of after the administration this year, she experienced severe body aches (pain) (unknown latency).  It was reported, Patient calling on behalf of herself. She received what she believed was the FLUZONE HD QIV. She was told by her work that this was the highest and most protective flu vaccine available. Caller stated that she normally experiences some injection site pain and fatigue after receiving her annual flu vaccine. After the administration this year, she experienced severe body aches, swelling, fatigue, nausea and slightly upset stomach, and malaise. She has noticed some improvement in body aches over time. Caller was concerned and want to speak directly to the manufacturer to see if this reaction is normal. Caller confirmed that she believed she received the FLUZONE HD QIV.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the reported events.  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.