Age: 82.0
Sex: M
Vaccine: FLUX, RSV, FLUX, RSV
Symptoms: Death, Dehydration, Diarrhoea, Feeding disorder, Hypotension
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 or drink; Dehydrated; This case is a solicited report received on 11Dec2023, from a consumer from a patient support program.   Additional information was received as a solicited information on 12Dec2023, from a nurse (physician's office) from a patient support program. This 82-year-old, male patient began therapy with Tyvaso DPI (treprostinil inhalation powder) delivered by Tyvaso dry powder inhaler, on 30Nov2023 for primary pulmonary arterial hypertension. The patient was supplied with Tyvaso DPI 16 ug and the patient's dose was reported as 16 ug, four times a day (QID) via inhalation (IH) route. On 06Dec2023, the patient received his respiratory syncytial virus (RSV) vaccine and the flu vaccine. Since then on an unreported date in Dec2023, he had been having issues of nausea (nausea), vomiting (vomiting), diarrhea (diarrhoea), was unable to eat or drink (feeding disorder) and his blood pressure (BP) was 67/50 mm[Hg], he pushed fluids and his BP went up to 90/60 mm[Hg] and had low BP in 90/60's mm[Hg] ranges (hypotension). He got dehydrated (dehydration). On 10Dec2023, he took one dose of Tyvaso DPI and had placed Tyvaso DPI on hold after having issues since he had received the above mentioned vaccines [RSV and Flu vaccine]. He passed away during the night [Dec2023] (death and medically significant). The cause of death was not reported and it was unknown if an autopsy was performed. Co-suspect medications included Flu (influenza vaccine) vaccine and respiratory syncytial virus vaccine. Concomitant medications included Flomax (tamsulosin hydrochloride), levothyroxine sodium, metoprolol tartrate, preservision areds, furosemide, Advair (fluticasone propionate, salmeterol xinafoate), sulfamethoxazole and trimethoprim, Keppra (levetiracetam), Lipitor (atorvastatin calcium), B12 active, albuterol sulfate hydrofluoroalkane [HFA], hydrochlorothiazide, iron, prednisone, oxygen, D3 5000, Prilosec (omeprazole), and warfarin sodium. Relevant medical history included primary pulmonary arterial hypertension. Action taken with Tyvaso DPI was not applicable for the event of death. Action taken with Tyvaso DPI was temporarily withheld due to the events of hypotension, nausea, vomiting, diarrhoea, feeding disorder and dehydration. The outcome of hypotension, nausea, vomiting, diarrhoea, feeding disorder and dehydration was unknown. The reporter did not provide causality for the events of death, hypotension, nausea, vomiting, diarrhoea, feeding disorder and dehydration with Tyvaso DPI. The reporter's causality for the events of hypotension, nausea, vomiting, diarrhoea, feeding disorder and dehydration with flu vaccine and respiratory syncytial virus vaccine was considered to be possibly related.; Sender's Comments: A possibly contributory role of RSV vaccine in triggering the onset of all these events leading to fatal complication might not be fully excluded, considering the temporal relationship.  However, the patient advance old age, underlying  pulmonary arterial hypertension and concurrent use of  Tyvaso DPI and Flu vaccine could also be contributors.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate; Reported Cause(s) of Death: Passed away during the night