Sex: M
Vaccine: FLU3
Symptoms: Decreased appetite, Disability, Gait disturbance, Guillain-Barre syndrome, Hypersomnia
Clinical narrative: in a wheelchair and walker; in a wheelchair and walker; paralysis which started in his right foot and went up his calf; shuffling gait; large amount of pain; pneumonia; reoccurring UTI's; guillain barre syndrome; loss the use of his legs and arms; kidney problems; sleeping 14 - 16 hours a day; lost his appetite; cold symptoms; Initial information regarding an unsolicited valid serious case from a consumer/ non-health care professional (Reference number- 00590860) and transmitted to Sanofi on 06-May-2021.  This case involves a 72-year old male patient who suffered from paralysis which started in his right foot and went up his calf (monoplegia), large amount of pain (pain), shuffling gait (gait disturbance), ), cold symptoms (nasopharyngitis), sleeping 14 - 16 hours a day (hypersomnia), lost his appetite (decreased appetite),  loss of use of his legs and arms (Musculoskeletal disorder), Guillain Barre Syndrome (Guillain-Barre syndrome), be in a wheelchair and walker (wheelchair user and walking aid user), and kidney problems (renal disorder), reoccurring UTI's (Recurrent urinary tract infection) and pneumonia, after he received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On 28-Sep-2018, the patient received an unknown dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE INJECTION (lot number: unknown and expiration date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious paralysis which started in his right foot and went up his calf (monoplegia), large amount of pain (pain), shuffling gait (gait disturbance) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date, the patient developed non-serious cold symptoms (nasopharyngitis), sleeping 14 - 16 hours a day (hypersomnia), lost his appetite (decreased appetite) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On 22-Feb-2019, the patient developed a serious, loss the use of his legs and arms (Musculoskeletal disorder), 4 months 25 days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was admitted on 22-Feb-2019 and discharged (he came home) on 30-Nov-2020. During hospitalization (647 days), he was diagnosed with Guillain Barre Syndrome (Guillain-Barre syndrome)  Patient also reported that his neurologist stated that he would never walk again without a walker.  On an unknown date, the patient developed non-serious kidney problems (renal disorder), (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE  On an unknown date in April 2021, the patient developed a serious, reoccurring UTI's (Recurrent urinary tract infection) and pneumonia, approximately 19 months following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized the entire month sparing 5 days for these events.  On an unknown date, the patient developed a serious event, being in a wheelchair and walker (wheelchair user and walking aid user) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was leading to disability.  It was reported that patient spent over $100,000 in medical expenses with therapist, doctors, hospitals and nursing homes. Caller wanted to know if he can get any help financially.   Seriousness criteria was assessed as medically significant as per important medical event (IME) list for pneumonia, Guillain Barre Syndrome and its associated symptoms.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of the events was unknown.  Information about batch number requested.; Sender's Comments: This case involves a 72-years old male patient who had musculoskeletal disorder, diagnosed with Guillain Barre Syndrome, had decreased appetite, nasopharyngitis, excessive sleep, pneumonia, recurrent Urinary tract infections, required aid of walker or wheelchair, after receiving FLUZONE HD. The time to onset is unknown for most events. Additional information regarding patient's medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.