Age: 102.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Oxygen saturation decreased
Clinical narrative: passed away; unable to walk; experienced sudden muscle weakness in his arms and legs; coughing; oxygen levels dropped to the 70s and 80s; Initial information received on 06-Dec-2024 regarding an unsolicited valid  serious case received from patient's daughter.   This case involves a 102 years old male patient whose oxygen levels dropped to the 70s and 80s, coughing, experienced sudden muscle weakness in his arms and legs and unable to walk and passed away after receiving vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Oct-2024, the patient received a  dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, Suspension for injection in pre-filled syringe (lot U8499AA) (expiry and strength: unknown) via intramuscular route in the left arm for influenza immunization.  On 02-OCT-2024 the patient developed a non-serious oxygen levels dropped to the 70s and 80s (oxygen saturation decreased) (latency same day).  On an unknown date in 2024 the patient developed a non-serious experienced sudden muscle weakness in his arms and legs (muscular weakness) unable to walk (gait disturbance) and coughing (cough) (latency: approximately a few days).  On 12-Oct-2024 the patient developed a serious event passed away (death) (latency 10 days). This event was assessed as medically significant and was leading to death.  Reportedly:-Patient was able to walk with his walker, but by the evening after the shot, he could only lie in bed. Although he had muscle weakness in his arms, he could still move them.   Reporter acknowledged that this could just be the timing, coincidental, or related to his advanced age but wanted to report this adverse event as it might be linked to the administration of FLUZONE HD. She also wondered if the dose was too high for his age.  She also wondered if the dose was too high for his age.  Relevant laboratory test results included: Oxygen saturation - On an unknown date:  [oxygen levels dropped to the 70s and 80s,]  Final diagnosis was (fatal) passed away.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (oxygen levels dropped to the 70s and 80s, experienced sudden muscle weakness in his arms and legs, coughing, passed away, unable to walk).  At time of reporting, the outcome was fatal for event passed away and unknown for rest all events  It is unknown if an autopsy was done. The cause of death was reported as Death.; Sender's Comments: Sanofi company comment dated: 09-Dec-2024:- This case involves a 102 years old male patient who was passed away, oxygen levels dropped to the 70s and 80s, coughing, experienced sudden muscle weakness in his arms and legs and unable to walk after receiving vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD]. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be established. However, lack of information of past and concomitant medication, any family history patient past medical history, autopsy details; cause of death and concurrent condition precludes comprehensive case assessment.; Reported Cause(s) of Death: Death