Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Cough, Dyspnoea, Malaise, Nasal congestion
Clinical narrative: Increased shortness of breath with wheezing and rhonchi (dyspnoea, wheezing, and rhonchi); Increased shortness of breath with wheezing and rhonchi (dyspnoea, wheezing, and rhonchi); Increased shortness of breath with wheezing and rhonchi (dyspnoea, wheezing, and rhonchi); Not feeling well; Coughing more; Not feeling well with nasal congestion; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. Other Case identifier(s): UNT-2022-002942 (Agency).  A 80 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2022 (Batch/Lot number: unknown) at the age of 80 years as dose number unknown (booster), single for covid-19 immunisation; treprostinil sodium (TREPROSTINIL SODIUM), first regimen since 13Jan2022 (Batch/Lot number: unknown), second regimen (Lot number: 2102099, Expiration Date: 31Mar2023) at 4x/day (unk, 4x/day (18-72 ug, qid, inhalation)), third regimen (Lot number: 2102110, Expiration Date: 31Mar2023) at unk, (inhalation) and fourth regimen (ongoing) (Batch/Lot number: unknown) at unk, (24 ug, inhalation) for pulmonary arterial hypertension. Relevant medical history included: "Pulmonary arterial hypertension" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, DOSE: UNKNOWN), for COVID-19 Immunization. The following information was reported: DYSPNOEA (medically significant) with onset Feb2022, outcome "not recovered", WHEEZING (medically significant), RHONCHI (medically significant) all with onset Feb2022, outcome "unknown" and all described as "Increased shortness of breath with wheezing and rhonchi (dyspnoea, wheezing, and rhonchi)"; MALAISE (medically significant) with onset Feb2022, outcome "unknown", described as "Not feeling well"; COUGH (medically significant) with onset Feb2022, outcome "not recovered", described as "Coughing more"; NASAL CONGESTION (medically significant) with onset Feb2022, outcome "unknown", described as "Not feeling well with nasal congestion". The events "increased shortness of breath with wheezing and rhonchi (dyspnoea, wheezing, and rhonchi)", "not feeling well", "coughing more" and "not feeling well with nasal congestion" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: chest x-ray: (Feb2022) not diagnosed with anything, notes: Not diagnosed with anything. The action taken for treprostinil sodium was unknown.  Additional information: Patient had a covid booster shot and felt like that was the reason she was not feeling well and coughing more. The physician was notified and stated to hold IH Tyvaso at 24ug (4 breaths) for now and would follow up with patient on 07Feb2022 for possible order of chest X-ray. It was reported that the patient went to urgent care over the weekend (Feb2022), due to not feeling well with nasal congestion and coughing (nasal congestion) (malaise and cough previously reported). Further, she had a chest X-ray done and was not diagnosed with anything.  The reporter did not provide causality for the events of dyspnea, wheezing, rhonchi, malaise, and cough, nasal congestion with IH Tyvaso.  The reporter considered "not feeling well" and "coughing more" related to bnt162b2.  The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report for the events shortness of breath, Wheezing, Rhonchi, Nasal congestion. Since no determination has been received, the case is managed based on the company causality assessment.  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 current available limited information in the case provided, the causal association between the events dyspnea, Wheezing, Rhonchi, Nasal congestion, Malaise and cough and the use of suspect product BNT162B2 cannot be fully excluded. The case will be reassessed once further information is available.  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 RAs, Ethics Committees, and Investigators, as appropriate.