Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Gait disturbance, Pulmonary hypertension, Somnolence
Clinical narrative: pulmonary hypertension; Felt bad/had a strange feeling in her body for days; unable to walk to bathroom without oxygen; sleepy; Feeling tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): UNT-2022-029019.  An 83-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; treprostinil sodium (TYVASO), first regimen since 02Nov2022 (Batch/Lot number: unknown), second regimen from Nov2022 (Lot number: 000290P, Expiration Date: 31Dec2023) to Nov2022 at 48 ug 4x/day and third regimen since Nov2022 (Lot number: 000290P, Expiration Date: 31Dec2023) at 32 ug 4x/day for pulmonary arterial hypertension. The patient's relevant medical history included: "Pulmonary arterial hypertension" (ongoing); "Cardiac failure congestive" (ongoing); "Myocardial infarction" (ongoing); "Stent placement" (unspecified if ongoing); "heart attack" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS taken for pulmonary arterial hypertension. The following information was reported: PULMONARY HYPERTENSION (medically significant) with onset 02Nov2022, outcome "unknown"; FATIGUE (non-serious) with onset Nov2022, outcome "unknown", described as "Feeling tired"; FEELING ABNORMAL (non-serious) with onset Nov2022, outcome "unknown", described as "Felt bad/had a strange feeling in her body for days"; SOMNOLENCE (non-serious) with onset Nov2022, outcome "unknown", described as "sleepy"; GAIT DISTURBANCE (non-serious) with onset Nov2022, outcome "unknown", described as "unable to walk to bathroom without oxygen". The action taken for treprostinil sodium was unknown.  Clinical information: On 22Nov2022 (Tuesday), 21 days after initiating Tyvaso DPI, the patient complained of symptoms starting after increasing Tyvaso DPI to 48 ug dose, the breathing was worse (dyspnoea) with cough (cough) and unable to walk to bathroom without oxygen. She had been walking to bathroom without oxygen on lower dose. The oxygen was increased to 4 liters per minute. On 25Nov2022 (yesterday), 24 days after initiating Tyvaso DPI, the patient missed two Tyvaso DPI doses because of sleeping after increasing her dose she became very sleepy and slept almost 24 hours. (somnolence and product dose omission issue). female patient began therapy with Tyvaso DPI (treprostinil inhalation powder) delivered by Tyvaso dry powder inhaler, on 02Nov2022 for primary pulmonary arterial hypertension. The patient was supplied with Tyvaso DPI 48 ug and the current dose was reported as 48 ug via inhalation (IH) route, four times a day (QID). On an unreported date in Nov2022, the patient was feeling tired (fatigue). At the time of reporting, the outcome of cough, fatigue and somnolence was unknown and the outcome of dyspnoea was not resolved. The reporter's causality for the events of dyspnoea and cough with Tyvaso DPI was considered as possibly related. The reporter did not provide causality for the events of fatigue and somnolence. She was advised to decrease her dose back to 32 ug and was feeling fine at that dose. She was scheduled to try to increase again in two to three weeks. She had not started Adempas (riociguat). Action taken with Tyvaso DPI was dose decreased on an unreported date in Nov2022 due to the events of feeling abnormal, somnolence, dyspnoea and cough. Action taken with Tyvaso DPI was not reported for the event of pulmonary hypertension. At the time of reporting, the outcome of pulmonary hypertension was unknown whereas the outcome of feeling abnormal, somnolence, dyspnoea and cough was considered as resolving. The reporter's causality for the events of feeling abnormal and somnolence with Tyvaso DPI was considered to be possibly related. The reporter did not provide causality for the event of pulmonary hypertension with Tyvaso DPI. The reporter's causality for the event of pulmonary hypertension with COVID-19 vaccine was considered to be possibly related. Case Comment/Senders Comment: The company has assessed the serious adverse event of pulmonary hypertension as not related to treprostinil inhalational powder and tyvaso DPI inhaler. The event was likely due to complications associated with underlying PAH in this 83-year-old elderly patient.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.