Sex: M
Vaccine: FLUX
Symptoms: Infection, Septic shock
Clinical narrative: septic shock; Initial information received on 10-Dec-2021 regarding an unsolicited valid serious case from consumer's son via pharmacy.  This case involves a 75 years old male patient (weight: 67.131 kg/ 148 lb) who had septic shock, after receiving INFLUENZA VACCINE and TREPROSTINIL SODIUM [TYVASO].  The patient's past medical history included Physical therapy and Occupational therapy.  It was unknown if the patient had any risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing medical history of Pulmonary arterial hypertension.  Concomitant medications included NINTEDANIB ESILATE (OFEV) [other dosing details were not reported.]  On 07-Jul-2021, the patient began therapy with TYVASO (TREPROSTINIL SODIUM), (concentration of 0.6 mg/ml) [lot and expiration date were not reported] delivered by Tyvaso Inhalation Device (TD-300/A) for secondary pulmonary arterial hypertension. The current dose was reported as 18-72 gram (3-12 breaths), four times a day (QID) via inhalation (IH) route.   On an unknown date in November 2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (Total, lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On 19-Nov-2021, the patient developed a serious septic shock, (unknown latency) following the administration of INFLUENZA VACCINE and 4 months 13 days following the administration of TYVASO.   This event was assessed as medically significant and he was hospitalized for this event.  It was unknown if the patient experienced any additional symptoms/events.   There were no lab data/results available.   Action taken with the TREPROSTINIL SODIUM (TYVASO) was not reported for the event of septic shock.    He was started PIPERACILLIN SODIUM, TAZOBACTAM SODIUM (ZOSYN) antibiotic on 19-Nov-2021 and should finish it by 06-Dec-2021.   At the time of reporting, the outcome of septic shock was unknown.  The reporter did not provide causality for the event of septic shock.   Senders Comment: The company has assessed the serious adverse event of septic shock as not related to IH treprostinil and TD300/A device. The event was likely due to infectious process.   Information on the batch number was requested.; Sender's Comments: This case involves a 75 years old male patient who had septic shock, after receiving INFLUENZA VACCINE and TREPROSTINIL SODIUM [TYVASO]. The time to onset is difficult to determine. The event was likely due to infectious process. The patient's past medical history included Physical therapy and Occupational therapy. At the time of the event, the patient has ongoing medical history of Pulmonary arterial hypertension. Concomitant medications included NINTEDANIB ESILATE (OFEV). Further information regarding their previous vaccination tolerance and laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of suspects cannot be assessed.