Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, UNK
Symptoms: Malaise, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: Increased nausea, coughing and shortness of breath from baseline; Increased nausea, coughing and shortness of breath from baseline; Increased nausea, coughing and shortness of breath from baseline; Tested positive for COVID (coronavirus disease); Tested positive for COVID (coronavirus disease); Malaise and she could not get out of bed; Achy joints; Fever; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): UNT-2022-015760 (Agency).  An 80-year-old female patient received BNT162b2 (BNT162B2), on 11Jul2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; treprostinil sodium (TYVASO), first regimen since 24Feb2022 (Lot number: 2102171, Expiration Date: 31Aug2023) at 0.6 mg/ml 4x/day, second regimen since 2022 (Lot number: 2102171, Expiration Date: 31Aug2023) at 4x/day (18-72 ug, 4x/day) and third regimen since 2022 (Lot number: 2102171, Expiration Date: 31Aug2023) at 54 mg/ml 4x/day, all nasal for pulmonary arterial hypertension. The patient's relevant medical history included: "primary pulmonary arterial hypertension" (ongoing), notes: Relevant medical history: primary pulmonary arterial hypertension. Concomitant medication(s) included: ELIQUIS; DILTIAZEM. The following information was reported: ARTHRALGIA (non-serious) with onset 12Jul2022, outcome "unknown", described as "Achy joints"; PYREXIA (non-serious) with onset 12Jul2022, outcome "unknown", described as "Fever"; MALAISE (non-serious) with onset 12Jul2022, outcome "unknown", described as "Malaise and she could not get out of bed"; COVID-19 (medically significant) with onset 14Jul2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Tested positive for COVID (coronavirus disease)"; NAUSEA (non-serious), COUGH (non-serious), DYSPNOEA (non-serious), outcome "unknown" and all described as "Increased nausea, coughing and shortness of breath from baseline". The event "tested positive for covid (coronavirus disease)" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2022) Positive, notes: 14Jul2022 SARS-CoV-2 test, Positive. The action taken for treprostinil sodium was unknown. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The reporter did not provide causality for the events of SARS-CoV-2 test positive, nausea, cough, and dyspnoea. On 14Jul2022, 4 months and 21 days after initiating Tyvaso, she went to emergency room and tested positive for COVID and was prescribed Paxlovid (nirmatrelvir). Action taken with Tyvaso was not reported for the events of arthralgia, pyrexia, and malaise. At the time of reporting, the outcome of arthralgia, pyrexia, and malaise was unknown. The reporter did not provide causality for the events of arthralgia, pyrexia, and malaise with Tyvaso.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.