Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Pain assessment, Pulmonary hypertension, Syncope, Therapy non-responder
Clinical narrative: An episode of syncope and fell forward; passed out; when the Lasix was doubled he passed out; Fractured his eye socket; nose fracture in 2 places; broke his nose;facial fractures; rates pain a 3 out of 10 on pain scale; broken nose and fractured eye socket; Patient fell due to being short of breath; Patient fell due to being short of breath; Got dizzy; dizziness; Pain was rated as 3 out 10 on pain scale; Burning in the center of chest for about an hour or so after his Tyvaso treatments; Eyes dilated and rolled back into head; Eyes dilated and rolled back into head; Not able to walk as much; Blood pressure noted to be 106/76 mmHg, normally around 130/78 mmHg; low blood pressure; Not able to walk 50 feet without heart rate increasing to 130's; Dehydrated; No change in pulmonary hypertension symptoms but feels a little worse; No change in pulmonary hypertension symptoms but feels a little worse; Fluid retention; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 06Jul2021, this case now contains all required information to be considered valid.  This case is a solicited report received on 20Apr2021, from a consumer via (specialty pharmacy). This 72 year old, 277 lb, male patient began therapy with IH Tyvaso (treprostinil sodium, concentration of 0.6 mg/ml), delivered by Tyvaso Inhalation Device (TD-300/A) (device only), on 10Mar2021 for primary pulmonary arterial hypertension. The current dose was reported as 18-54 ug (3-9 breaths) four times a day (QID (four time a day)) via inhalation (IH) route (Lot #: 2101925, Exp. Date: 31Jan2022), then from an unreported date at unknown dose via inhalation (Lot #: 2101925, Exp. Date: 31Jan2022), then from an unreported date to 2021 at unknown dose via inhalation (Lot #: 2101961, Exp. Date: 31Jan2022). On an unreported date in 2021, the patient experienced events of burning in the center of chest for about an hour or so after his Tyvaso treatments (chest pain) and he was taking deep breaths and holding them (wrong technique in product usage process).  Concomitant medication included sildenafil citrate. Relevant medical history included primary pulmonary arterial hypertension.  The patient had a burning in the center of chest for about an hour or so after his IH Tyvaso treatments. It was found that he was taking deep breaths and holding them. The education done on proper inhalation technique.  Action taken with the IH Tyvaso was not reported for the event of chest pain. Action taken with the IH Tyvaso was not applicable for the event of wrong technique in product usage process. At the time of reporting, the outcome of chest pain and wrong technique in product usage process was unknown.  The reporter's causality for the event of chest pain with IH Tyvaso was considered to be possibly related. The reporter did not provide causality for the event of wrong technique in product usage process.   Additional spontaneous information was received from consumer's spouse and consumer on 26Apr2021 via (specialty pharmacy), upgrading the case to serious. Additional follow-up information was received as solicited information on 27Apr2021 from a consumer via (specialty pharmacy). Additional follow-up information was received as solicited information on 28Apr2021 from consumer's wife via (specialty pharmacy).  On 24Apr2021, the patient experienced the event terms of an episode of syncope and fell forward; passed out (syncope, hospitalized and medically significant), fractured his eye socket; nose fracture in 2 places; broke his nose; facial fractures (facial bones fracture, hospitalized and medically significant), patient fell due to being short of breath (dyspnoea hospitalized and fall; medically significant), and got dizzy; dizziness (dizziness, hospitalized). On 24Apr2021, 1 month 15 days, after initiating IH Tyvaso the patient was hospitalized after he got dizziness, passed out and broke his nose. Further it was reported that the patient was hospitalized (25Apr2021) due to injury after a fall and had 11 sutures placed to left eyebrow. Pain was rated as 3 out 10 on pain scale (Apr2021). Now he was on oxygen at night because he could not wear his continuous positive airway pressure therapy (CPAP) due to facial fractures. Further it was reported that on 25Apr2021, the patient fell due to being short of breath. He got dizzy so he sat down on rock wall and had an episode of syncope and fell forward. The patient fractured his eye socket, nose fracture in 2 places and got stitches in forehead. He was hospitalized as of 25Apr2021. The patient was discharged from hospital on 27Apr2021.  Action taken with the IH Tyvaso was not reported for the events of syncope, facial bones fracture, dyspnoea, dizziness and fall. At the time of reporting, the outcome of syncope, facial bones fracture, dyspnoea, and dizziness was unknown, and the outcome of fall was considered as resolved with sequelae on 24Apr2021.  The reporter did not provide causality for the events of syncope, facial bones fracture, dyspnoea, dizziness and fall.  Follow-up information was received as solicited report on 06May2021 from consumer's wife via (specialty pharmacy).   On an unreported date in 2021, the patient experienced the event terms of fluid retention (fluid retention), and dehydrated (dehydration). Additional lot and expiration date information reported. Co-suspect medication included: Lasix (Furosemide). The patient was placed on Lasix for fluid retention, but when the Lasix was doubled, he passed out (previously reported syncope). He went to emergency room and had a broken nose and fractured eye socket (previously reported as facial bones fracture). The patient was dehydrated. Prescriber was aware and discontinued Lasix. The patient had more stamina. Action taken with the IH Tyvaso was not reported for the events of fluid retention and dehydration. Action taken with the Lasix was withdrawn due to the events of syncope, facial bones fracture, fluid retention and dehydration. Action taken with the Lasix was not reported for the events of dyspnoea, dizziness, fall, and chest pain. Action taken with the Lasix was not applicable for the event of wrong technique in product usage process. At the time of reporting, the outcome of fluid retention and dehydration was unknown.  The reporter did not provide causality for the events of fluid retention and dehydration.  Follow-up information was received as solicited information on 25May2021 from a consumer's wife via (specialty pharmacy).  On an unreported date in 2021, the patient experienced the events of no change in pulmonary hypertension symptoms but feels a little worse; now on 2 litre per minute oxygen and had to increase to 4 litre per minute when active, not able to walk as much (pulmonary hypertension, medically significant and therapy non-responder) and blood pressure noted to be 106/76 mmHg, normally around 130/78 mmHg; low blood pressure (hypotension). On 21May2021, the patient experienced the events of eyes dilated and rolled back into head (mydriasis and eye movement disorder). On 21May2021, 2 months 12 days after initiating IH Tyvaso, the patient had episode where almost passed out (syncope previously reported) while working with physical therapist and eyes dilated and rolled back into head. The patient's wife put oxygen on patient and he responded quickly. The blood pressure was noted to be 106/76 mmHg and is normally around 130/78 mmHg. The patient had one other episode in Apr2021 and was admitted to the hospital. After fell on face and broke nose, eye socket and cheek bone (facial bones fracture previously reported). The patient was currently on heart monitor but no event recorded during the episode. The patient was awaiting for the call back from physician. The patient reported no change in pulmonary hypertension symptoms but felt a little worse. The patient was now on 2 litre per minute oxygen and had to increase to 4 litre per minute when active, not able to walk as much. Action taken with the IH Tyvaso and Lasix was not reported for the events of pulmonary hypertension, mydriasis, eye movement disorder, hypotension, and therapy non-responder. The outcome of pulmonary hypertension was not resolved. At the time of reporting, the outcome of syncope was resolving and outcome of mydriasis, eye movement disorder, hypotension, and therapy non-responder was unknown.  The reporter did not provide causality for the events of pulmonary hypertension, mydriasis, eye movement disorder, hypotension, and therapy non-responder.  Follow-up information was received as solicited information on 22Jun2021, from a consumer via (specialty pharmacy).  On an unreported date in 2021, the patient was not able to walk 50 feet without heart rate increasing to 130's (heart rate increased). Additional lot and expiration date information was reported. Co-suspect medication included Covid-19 vaccine. The patient reported that he saw prescriber and IH Tyvaso was discontinued as IH Tyvaso was not helping the patient (therapy non-responder previously reported) and increased shortness of breath (dyspnoea previously reported). The patient was not able to walk 50 feet without heart rate increasing to 130's/min. It was suspected that the adverse events started after taking second Covid-19 vaccine. Action taken with IH Tyvaso was not reported for the event of heart rate increased. IH Tyvaso was withdrawn on an unreported date in 2021 due to the events of dyspnoea and therapy non-responder. Action taken with Lasix was not reported for the event of heart rate increased. Action taken with Covid-19 vaccine was not applicable for the events of syncope, facial bones fracture, dyspnoea, dizziness, fall, pulmonary hypertension, chest pain, fluid retention, dehydration, mydriasis, eye movement disorder, hypotension, heart rate increased, therapy non-responder and wrong technique in product usage process. At the time of reporting, the outcome of dyspnoea was not resolved and the outcome of heart rate increased was unknown.   The reporter's causality for the events dyspnoea and therapy non-responder with IH Tyvaso was considered to be possibly related. The reporter did not provide the causality for the event of heart rate increased.  Case Comment/Senders Comment: The company has assessed the serious adverse events of Syncope, facial bones fracture, dyspnoea, dizziness, fall and pulmonary hypertension as not related to IH treprostinil and TD-300/A device. Dyspnoea, dizziness, syncope and pulmonary hypertension resulting in fall was likely secondary to underlying PAH in elderly age. Facial bones fracture was secondary to fall.  Other Relevant History, Including Preexisting Medical Conditions: in Apr2021, Procedure, Suture insertion, in Apr2021, Procedure, Continuous positive airway pressure, Ongoing, Current Condition, Pulmonary arterial hypertension.  The reporter's assessment of the causal relationship of the events with the suspect product Covid-19 vaccine was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Information on the lot/batch number has been requested.; Sender's Comments: Events are assessed as related to the suspect product BNT162B2.  This case will be updated when new information becomes available.