Age: 82.0
Sex: M
Vaccine: FLUX, RSV, FLUX, RSV
Symptoms: Hypotension, Nausea, Vomiting
Clinical narrative: Passed away during the night; Blood pressure [BP] was 67/50 mm[Hg], pushed fluids and his BP went up to 90/60 mm[Hg]; low BP in 90/60's mm[Hg] ranges; nausea; vomiting; diarrhea; unable to eat; dehydration; Initial information received on 16-Dec-2023 regarding an unsolicited valid courtesy serious case received from other health professional.  This case involves 82-year-old male patient (90.7 kg) who had blood pressure [bp] was 67/50 mm[hg], pushed fluids and his bp went up to 90/60 mm[hg]; low bp in 90/60's mm[hg] ranges, nausea, vomiting, diarrhea, unable to eat, dehydration and passed away during the night after receiving Influenza Vaccine, Respiratory Syncytial Virus Vaccine and treprostinil [Tyvaso].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension.  Concomitant medications included tamsulosin hydrochloride (Flomax); Levothyroxine Sodium; Metoprolol Tartrate; ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (Preservision); Furosemide; fluticasone propionate, salmeterol xinafoate (Advair); sulfamethoxazole, trimethoprim (Sulfamethoxazole and Trimethoprim); levetiracetam (Keppra); atorvastatin calcium (Lipitor); mecobalamin (Vitamin B12); salbutamol sulfate (Albuterol Sulfate HFA); Hydrochlorothiazide; Iron; Prednisone; colecalciferol (Vitamin D3); omeprazole (Prilosec); Warfarin Sodium and Oxygen used for unknown indication.  On 30-Nov-2023, the patient started taking tyvaso [Treprostinil] Inhalation powder 16 ug (microgram) QID (four times a day) via inhalational route (with an unknown strength, batch number and expiry date) for Pulmonary arterial hypertension. On 06-Dec-2023, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer and unknown dose of suspect respiratory syncytial virus vaccine not produced by Sanofi Pasteur (strength, form, lot number and expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date in Dec-2023 the patient had blood pressure [bp] was 67/50 mm[hg], pushed fluids and his bp went up to 90/60 mm[hg]; low bp in 90/60's mm[hg] ranges (hypotension), nausea, vomiting, diarrhea (diarrhoea), unable to eat (feeding disorder), dehydration and passed away during the night (death) (unknown latency) following the administration of influenza vaccine, respiratory syncytial virus vaccine and treprostinil.   Relevant laboratory test results included: Blood pressure measurement - In December 2023: 67/50 mmHg then 90/60 mmHg  Final diagnosis was (fatal) passed away during the night.  Action taken with influenza vaccine and respiratory syncytial virus vaccine was not applicable and with treprostinil (Tyvaso) was discontinued on 10-Dec-2023.  It was not reported if the patient received a corrective treatment for the events (Passed away during the night, Blood pressure [BP] was 67/50 mm[Hg], pushed fluids and his BP went up to 90/60 mm[Hg]; low BP in 90/60's mm[Hg] ranges, nausea, vomiting, diarrhea, unable to eat, dehydration).  At time of reporting, the outcome was Fatal for the event passed away during the night, was Unknown for rest of the events. It is unknown if an autopsy was done. The cause of death was reported as Death.  Case Comment/Senders Comment: Pending receipt of additional information, the company has conservatively assessed the serious adverse event of death as possibly related to treprostinil inhalation powder due to limited information in the initial report. However, disease progression of the underlying pulmonary hypertension could not be excluded. The company has assessed the serious adverse event of death as not related to tyvaso DPI inhaler.  Seriousness Criteria: Event passed away during the night (death) was assessed as medically significant and was leading to death.; Sender's Comments: Sanofi Company Comment dated 21-Dec-2023: This case involves 82-year-old male patient who had blood pressure [bp] was 67/50 mm[hg], pushed fluids and his bp went up to 90/60 mm[hg]; low bp in 90/60's mm[hg] ranges, nausea, vomiting, diarrhea, unable to eat, dehydration and passed away during the night after receiving Influenza Vaccine, Respiratory Syncytial Virus Vaccine and treprostinil [Tyvaso].Based upon the reported information, the role of the specific vaccine cannot be assessed. However, lack of information regarding past medical history, treatment(s), family history precludes comprehensive case assessment. Additionally, patient's ongoing medical condition of Pulmonary arterial hypertension and concomitant medications could be the confounding factor.; Reported Cause(s) of Death: Passed away during the night