Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Bacterial test negative, Blood cholesterol increased, Burning sensation, Dyspnoea
Clinical narrative: he had hypoxia; pain migrated to his hips, knee,  ankles, toes, wrists, and and parts of his fingers; high altitude sickness; shortness of breath and a lower oxygen rate because he was struggling to breathe; couldn't lift his left arm; he first got the initial injection, he couldn't lift his left arm and that he was inoculated in his left arm and for five days he couldn't lift it above his waist, he stated that his neck was on fire and throbbing; his fever was 104 degrees; Initial information received on 01-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves male patient of unknown age who experienced hypoxia (hypoxia), pain migrated to his hips, knee, ankles, toes, wrists, and parts of his fingers (Pain in extremity), high altitude sickness (hypobarism), shortness of breath and a lower oxygen rate because he was struggling to breathe (dyspnoea), couldn't lift his left arm (Mobility decreased), he first got the initial injection, he couldn't lift his left arm and that he was inoculated in his left arm and for five days he couldn't lift it above his waist, he stated that his neck was on fire and throbbing (injection site pain) and his fever was 104 degrees (pyrexia), while he received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient reported that last year he had a similar reaction to the Fluzone shot that had "4 times the antigen" but his reaction was not as severe. He states that last year he had bursitis in both elbows and roaming pain that lasted 6-8 weeks. he has high cholesterol and lipids but otherwise he is healthy. The patient's past medical history, medical treatment(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported via unknown route in the left arm for prophylactic vaccination.  On an unknown date, the patient developed a serious hypoxia (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant  On an unknown date, the patient developed a non-serious pain migrated to his hips, knee, ankles, toes, wrists, and parts of his fingers (Pain in extremity), high altitude sickness (hypobarism), shortness of breath and a lower oxygen rate because he was struggling to breathe (dyspnoea), couldn't lift his left arm (Mobility decreased), he first got the initial injection, he couldn't lift his left arm and that he was inoculated in his left arm and for five days he couldn't lift it above his waist, he stated that his neck was on fire and throbbing (injection site pain) and his fever was 104 degrees (pyrexia), (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  He stated that he went to the hospital over the fever but first he went to his PCP and his fever was 104 degrees (pyrexia) and they gave him steroids that helped a little. He stated that Wednesday of last week his fever shot up again and then Saturday night it shot up to 103.9 degrees and he was told by his PCP to go to the hospital which he did. He stated that he was wheelchaired into the ER because he was in so much pain.  The patient did a urinalysis and blood tests and nothing bacterial or viral was detected.       Steroids was used as corrective treatment for the event fever, and it was not reported if the patient received any corrective treatment for rest of the events. He said the pain was excruciating and ibuprofen wouldn't touch it.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.; Sender's Comments: Sanofi company comment dated 03-Dec-2020: This case concerns a male patient who presented with hypoxia after vaccination with company suspect Fluzone High-Dose Quadrivalent. The time to onset was unknown. Moreover, patient's medical condition and concomitant medication and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.