Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Fatigue, Feeling abnormal, Hypotension, Loss of consciousness, Movement disorder
Clinical narrative: drug interaction; Passed out while getting up from bed, by that evening she bent over and passed out again; Low blood pressure of 95/49 mmHg, Diagnosed with low blood pressure; Severe dehydration; Layed in bed most of the day; when waking up could not move her legs; felt strange; hard to focus and find the right words; hard to focus and find the right words; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer from Therapeutics (Mfr Report# UNT-2021-011450).   This case is a solicited report received on 16Jun2021, from a consumer from a patient support program via specialty pharmacy. This 66 year old, 260 lb, female patient began therapy with IH Tyvaso (Treprostinil sodium, concentration of 0.6 mg/ml,  Lot#: 2101929, Exp. Date: 31Jan2022) delivered by Tyvaso Inhalation Device (TD-300/A), on 10Mar2020 for primary pulmonary arterial hypertension. The current dose was reported as 60-120 ug (10-20 breaths), four times a day (QID) (off label use) via inhalation (IH) route. On 01Jun2021, the patient experienced events of felt strange (feeling abnormal, hospitalized), hard to focus and find the right words (disturbance in attention, hospitalized and aphasia, hospitalized). On 02Jun2021, the patient experienced events of drug interaction (drug interaction, hospitalized), passed out while getting up from bed, by that evening she bent over and passed out again (loss of consciousness, hospitalized and medically significant), low blood pressure of 95/49 mmHg, diagnosed with low blood pressure (hypotension, hospitalized), severe dehydration (dehydration, hospitalized), layed in bed most of the day (fatigue, hospitalized), and when waking up could not move her legs (movement disorder, hospitalized). Co-suspect medications included Lisinopril, spironolactone, and Covid-19 vaccine. Concomitant medication included Adcirca (Tadalafil). Relevant medical history included primary pulmonary arterial hypertension. Event Description: On 01Jun2021, 1 year 2 months 23 days after initiating IH Tyvaso, the patient felt strange. The patient further stated that it was hard to focus and find the right words. On 02Jun2021 (by the next morning), 1 year 2 months 24 days after initiating IH Tyvaso, the patient passed out while getting up from the bed. The patient had low blood pressure of 95/49 mmHg and laid in bed most of the day. By that evening she bent over and passed out again. When she was waking up, could not move her legs and went to emergency room. The patient was diagnosed with low blood pressure and severe dehydration due to increased dose of blood pressure medications needed after her coronavirus (COVID) vaccine. Her blood pressure medication doses of Lisinopril and spironolactone were decreased. The patient's kidney function was improved and blood pressure stabilized. Action taken with the IH Tyvaso was not reported for the events of feeling abnormal, disturbance in attention, aphasia, drug interaction, loss of consciousness, hypotension, dehydration, fatigue, and movement disorder. Action taken with the Lisinopril and spironolactone was dose decreased due to the events of feeling abnormal, disturbance in attention, aphasia, drug interaction, loss of consciousness, hypotension, dehydration, fatigue, and movement disorder. Action taken with the Covid-19 vaccine was not applicable for the events of feeling abnormal, disturbance in attention, aphasia, drug interaction, loss of consciousness, hypotension, dehydration, fatigue, and movement disorder. At the time of reporting, the outcome of feeling abnormal, disturbance in attention, aphasia, drug interaction, loss of consciousness, dehydration, fatigue, and movement disorder was unknown and outcome of hypotension was resolved on an unreported date in Jun2021. The reporter did not provide causality for the events of feeling abnormal, disturbance in attention, aphasia, drug interaction, loss of consciousness, hypotension, dehydration, fatigue, and movement disorder.  Case Comment/Senders Comment: The company has assessed the serious adverse event of feeling abnormal, disturbance in attention, aphasia, drug interaction, loss of consciousness, hypotension, dehydration, fatigue, and movement disorder as not related to IH Treprostinil and TD-300/A device. Drug interaction, Dehydration, hypotension were likely due to concomitant administration of Lisinopril, spironolactone and all other events were likely a clinical cascade from dehydration and hypotension. Concomitant administration of Covid-19 vaccine also likely contributed.  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.  Pfizer is a marketing authorization holder of COVID-19 Vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID-19 Vaccine has submitted the same report to the regulatory authorities.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the lack of information about the date of administration of the Pfizer suspect product, the clinical setting provided (pulmonary hypertension) and the several confounders (IH Tyvaso, Tadalafil, Lisinopril, spironolactone), the company, at the present time, deems there is not a reasonable possibility that all the reported events are related to COVID-19 Vaccine.