Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, FLUX
Symptoms: COVID-19, Drug ineffective, Product use issue, SARS-CoV-2 test
Clinical narrative: patient got both a Covid third booster and a flu vaccine; tested positive for COVID; tested positive for COVID; This is a solicited report received from non-contactable reporter(s) (Other HCP). The reporter is the patient. Other Case identifier(s): UNT-2022-021950.  A 60-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE), on 13Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; treprostinil sodium (TYVASO), since 04Nov2020 (ongoing) (Lot number: 2102215, Expiration Date: 31Oct2023) at 54 ug 4x/day for pulmonary arterial hypertension. The patient's relevant medical history included: "Pulmonary arterial hypertension" (ongoing). Concomitant medication(s) included: REVATIO; OPSUMIT. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 13Sep2022, outcome "unknown", described as "patient got both a Covid third booster and a flu vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "tested positive for COVID". The event "tested positive for covid" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive. Clinical courses: This United States case is a solicited report received on 20Sep2022, from a consumer from a patient support program. This 60-year-old, female patient began therapy with IH Tyvaso (Treprostinil sodium, concentration of 0.6 mg/ml) delivered by Tyvaso Inhalation Device (TD-300/A), on 04Nov2020 for primary pulmonary arterial hypertension. The current dose was reported as 54 ug (9 breaths), four times a day (QID) via inhalation (IH) route. On 13Sep2022, the patient got both a COVID third booster and a flu vaccine and ended up catching COVID (COVID-19) (coronavirus disease) and had to go to urgent care and placed on molnupiravir and medication for COVID. She was using more oxygen than normal while having Covid. On an unreported date, the patient was tested positive for COVID (SARS-CoV-2 test positive). The reporter did not provide causality for the event of COVID-19 with Tyvaso. The reporter's causality for the event of COVID-19 with COVID-19 vaccine and Flu was considered to be possibly related. The action taken for treprostinil sodium was dosage not changed. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The reporter considered "tested positive for covid" related to BNT162b2, BNT162b2 omi ba.4-5.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug ineffective , COVID-19 cannot be excluded for the suspect drug BNT162B2. the case will be reassessed once new information is available.