Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Immunisation reaction, Pulmonary fibrosis
Clinical narrative: Had been hospitalized for a few days due to a possible reaction to the covid booster; Short of breath; increased shortness of breath; Pulmonary fibrosis; A cough after Tyvaso DPI treatment; ongoing cough; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient. Other Case identifier(s): UNT-2023-001589.  A 79-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Jan2023 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation; treprostinil (TREPROSTINIL), first regimen since Jan2023 (Batch/Lot number: unknown) at 16 ug 4x/day, second regimen since Jan2023 (Batch/Lot number: unknown) at 32 ug 4x/day and third regimen since 10Jan2023 (Batch/Lot number: unknown), all nasal for pulmonary arterial hypertension; treprostinil sodium (TYVASO), first regimen since 10Jan2023 (Lot number: 000310P, Expiration Date: 31Dec2023) at 16 ug and second regimen (Lot number: 000310P, Expiration Date: 31Dec2023) at 32 ug, all nasal for pulmonary arterial hypertension. The patient's relevant medical history included: "primary pulmonary arterial hypertension" (ongoing). Concomitant medication(s) included: OFEV. Vaccination history included: Covid-19 vaccine (Series of primary immunization completed. Unknown manufacturer), for Covid-19 immunization. The following information was reported: IMMUNISATION REACTION (hospitalization, medically significant) with onset Jan2023, outcome "unknown", described as "Had been hospitalized for a few days due to a possible reaction to the covid booster"; DYSPNOEA (hospitalization, medically significant) with onset 19Jan2023, outcome "recovering", described as "Short of breath; increased shortness of breath"; COUGH (medically significant) with onset 23Jan2023, outcome "not recovered", described as "A cough after Tyvaso DPI treatment; ongoing cough"; PULMONARY FIBROSIS (medically significant) with onset 23Jan2023, outcome "unknown". The patient was hospitalized for dyspnoea (start date: 20Jan2023, discharge date: 21Jan2023, hospitalization duration: 2 day(s)); for immunisation reaction (start date: Jan2023). Clinical course: This case is a solicited report received on 17Jan2023, from the consumer from a patient support program via [Facility name withheld]. This 79-year-old, 103 lb, female patient began therapy with Tyvaso DPI (treprostinil inhalation powder) delivered by Tyvaso dry powder inhaler on an unreported date for primary pulmonary arterial hypertension. The patient was supplied with Tyvaso DPI 16 ug and the current dose was reported as 16 ug, via inhalation (IH) route, four times a day (QID). The patient had pulmonary fibrosis (pulmonary fibrosis, medically significant) and she reported during nurse visit that she had a cough after Tyvaso DPI treatment (cough). The reporter did not provide causality for the events of pulmonary fibrosis. Co-suspect medication included COVID-19 vaccine. The start date of Tyvaso DPI was updated to 10Jan2023. The onset date for pulmonary fibrosis and cough was updated to Jan2023. It was reported that on 19Jan2023, the patient received COVID shot and felt short of breath. On 20Jan2023, 11 days after initiating Tyvaso DPI, the patient was hospitalized due to being short of breath (dyspnoea) and was discharged on 21Jan2023. The patient had ongoing cough (cough previously reported) and was on prednisone therapy. Additional concentration of 32 ug and an additional dosage regimen of 32 ug, QID via IH route was added to Tyvaso DPI. On an unreported date in Jan2023, the patient had been hospitalized for a few days due to possible reaction to the COVID booster (immunisation reaction). She had increased shortness of breath (dyspnoea previously reported). They put her on a prednisone titration and felt much better. The dates of hospital admission was not provided. The reporter's causality for the event of cough with Tyvaso DPI was considered to be possibly related. The reporter did not provide causality for the event of dyspnoea. The reporter did not provide causality for the event of immunisation reaction with Tyvaso DPI. The reporter's causality for the event of immunisation reaction with COVID-19 vaccine was considered to be possibly related. The action taken for treprostinil and treprostinil sodium was unknown. Therapeutic measures were taken as a result of dyspnoea, immunisation reaction, cough. Senders Comment: The company has assessed the serious adverse events of pulmonary fibrosis, dyspnoea and immunisation reaction with COVID-19 vaccine as not related to treprostinil inhalation powder and Tyvaso DPI inhaler. The event was likely patient's concurrent medical condition. The event of dyspnoea was likely due to complications associated with underlying PAH. The event of immunization reaction with COVID-19 vaccine can be attributed to Covid booster vaccine.  The reporter's assessment of the causal relationship of "short of breath; increased shortness of breath" and "pulmonary fibrosis" with the suspect product(s) BNT162b2, BNT162b2 omi ba.4-5 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. The reporter considered "a cough after Tyvaso dpi treatment; ongoing cough" related to BNT162b2, BNT162b2 omi ba.4-5.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2, BNT162b2 omi ba.1, and the reported events Dyspnea, immunization reaction,  cough and pulmonary fibrosis cannot be excluded. 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.