Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Mental status changes, Paraesthesia
Clinical narrative: back pain; blood pressure increased; altered mental status; extremity tingling; severe headache; Fluzone was given in her IV instead of her muscle with no adverse event; Initial information received on 14-Nov-2023 regarding an unsolicited valid serious case received from non-healthcare professional.  This case involves a 67 years old female patient who experienced back pain, extremity tingling, blood pressure increased, altered mental status, severe headache after receiving vaccine Influenza USP Trival A-B High Dose Subvirion vaccine [Fluzone High dose]. fluzone was given in her iv (intravenous) instead of her muscle with no adverse event directly linked with incorrect route of product administration.  The patient's past medical history included Esophageal varices and Angioplasty.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing NASH (Non-alcoholic steatohepatitis), Diabetes and Autoimmune disorder NOS (not otherwise specified).  On 12-Nov-2023, the patient received an unknown dose of suspect Influenza USP Trival A-B High dose Subvirion vaccine Suspension for injection in pre-filled syringe of lot UT8057AA via IV NOS (intravenous not otherwise specified) route in unknown administration site as prophylactic vaccination (immunization).  On 12-Nov-2023, the patient had Influenza USP Trival A-B High Dose Subvirion vaccine was given in her iv instead of her muscle with no adverse event (incorrect route of product administration) (latency: same day).  On 12-Nov-2023, the patient developed back pain, extremity tingling (paraesthesia), blood pressure increased, altered mental status (mental disorder), severe headache (headache) (latency: same day) following the administration of Influenza USP Trival A-B High Dose Subvirion vaccine. These events were leading to disability. The patient was hospitalized for these events.  Relevant laboratory test results included:  Blood pressure measurement - On 12-Nov-2023:  [increased]  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all events.  At time of reporting, the outcome was Unknown for the event fluzone was given in her iv instead of her muscle and was Not Recovered / Not Resolved for rest all 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.; Sender's Comments: Sanofi company comment dated 23-Nov-2023: This case involves a 67 years old female patient who experienced back pain, extremity tingling, blood pressure increased, altered mental status, severe headache  after receiving vaccine Influenza USP Trival A-B High Dose Subvirion vaccine [Fluzone High dose]. All events lead to hospitalization and disability. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Further information regarding previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed for complete assessment of the case. Based upon the reported information, the individual role of the suspect vaccine cannot be assessed.