Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Headache, Weight
Clinical narrative: 37 pound weight loss; headaches; no energy; diarrhea; no appetite; This is a solicited report received from a contactable reporter (consumer). The reporter is the patient. Other case identifier: UNT-2023-010732. A 78-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; treprostinil sodium (TYVASO), in Apr2023 as 16 ug, qid, inhalation (Batch/Lot number: unknown), in 2023 as 32 ug, 4x/day, qid, inhalation (Batch/Lot number: unknown), in May2023 as 48 ug, qid, inhalation (Lot number: 000343P, Expiration Date: 31Mar2024), in 2023 as 64 ug, qid, inhalation (Lot number: 000343P, Expiration Date: 31Mar2024), in 2023 as 80 ug, inhalation (Lot number: 000360P, Expiration Date: 31Jul2024), on 05Apr2023 (ongoing) (Lot number: 000364P, Expiration Date: 31Aug2024), (Lot number: 000369P, Expiration Date: 31Oct2024), (Lot number: 000384P, Expiration Date: 30Nov2024), (Lot number: 000375P, Expiration Date: 31Oct2024) and as unk, inhalation (Lot number: 000360P, Expiration Date: 31Jul2024) for pulmonary arterial hypertension; nintedanib esilate (OFEV), in 2023 as 150 mg (Batch/Lot number: unknown), in 2023 as 100 mg (Batch/Lot number: unknown), (Batch/Lot number: unknown) and as 300 mg, qd, oral use (Lot number: 106681), all oral for idiopathic pulmonary fibrosis. The patient's relevant medical history included: "pulmonary arterial hypertension" (ongoing), notes: secondary; "idiopathic pulmonary fibrosis" (ongoing). Concomitant medication(s) included: TADALAFIL; AMLODIPINE BESYLATE; PROPRANOLOL HYDROCHLORIDE; ASPIRIN EC; OXYGEN; CRESTOR; LOPERAMIDE HYDROCHLORIDE; VITAMINS NOS; LOPERAMIDE; VITAMIN D2. The following information was reported: WEIGHT DECREASED (medically significant) with onset 2023, outcome "unknown", described as "37 pound weight loss "; DIARRHOEA (non-serious) with onset 2023, outcome "unknown", described as "diarrhea"; HEADACHE (non-serious) with onset 2023, outcome "unknown", described as "headaches"; DECREASED APPETITE (non-serious) with onset 2023, outcome "unknown", described as "no appetite"; ASTHENIA (non-serious) with onset 2023, outcome "unknown", described as "no energy". The patient underwent the following laboratory tests and procedures: weight: (2023) 37 pound weight loss.  Clinical course: Case Description: This case is a solicited report received on 13Apr2023, from a consumer from a patient support program via pharmacy. This 78-year-old, 122 lb, female patient began therapy with Tyvaso DPI (treprostinil inhalation powder) delivered by Tyvaso dry powder inhaler, on 05Apr2023, for secondary pulmonary arterial hypertension. The patient was supplied with Tyvaso DPI 16 ug and the current dose was reported as 16 ug, four times a day (QID) via inhalation (IH) route. On 13Apr2023 (today), 9 days after initiating the Tyvaso DPI, the patient had 2 episodes of diarrhea (diarrhoea). Concomitant medications included tadalafil and Amlodipine (amlodipine besilate). Relevant medical history included secondary pulmonary arterial hypertension. Action taken with Tyvaso DPI was not reported for the event of diarrhoea. At the time of reporting, the outcome of diarrhoea was resolved on 13Apr2023. The reporter did not provide the causality for the event of diarrhoea. Additional spontaneous information was received from a consumer via pharmacy on 18Apr2023. On 18Apr2023, 14 days after initiating Tyvaso DPI, the patient woke up and her palms and bottoms of her feet were red (erythema), had some more shortness of breath (dyspnoea) as well as nausea (nausea). Action taken with Tyvaso DPI was not reported for the events of erythema, dyspnoea and nausea. At the time of reporting, the outcome of erythema, dyspnoea and nausea was unknown. The reporter did not provide causality for the events of erythema, dyspnoea and nausea. Follow-up information was received as solicited information on 20Apr2023, from a consumer's daughter from a patient support program via pharmacy. No new significant information was received. The patient started Tyvaso DPI recently and had not had any side effects. The patient did woke up one night due to not breathing well (dyspnoea previously reported) and her hands and feet were red (erythema previously reported). Follow-up information was received as solicited information on 03May2023, from a consumer's daughter from a patient support program via pharmacy. Additional concentration of 32 ug including lot number and expiration date information and an additional dosage regimen of 32 ug, QID via IH route was added to Tyvaso DPI. Relevant medical history and indication of Tyvaso DPI was updated to primary pulmonary arterial hypertension from secondary pulmonary arterial hypertension. On an unreported date in April2023, the patient had fatigue after first week of being on Tyvaso (fatigue), was doing really good. On an unreported date in 2023, she felt like she did before she started Tyvaso (therapy non-responder). Action taken with Tyvaso DPI was not reported for the event of fatigue and therapy non-responder. At the time of reporting, the outcome of fatigue and therapy non-responder was unknown. The reporter's causality for the events of fatigue and therapy non-responder with Tyvaso DPI was considered to be possibly related. Follow-up information was received as spontaneous report on 22May2023 from a consumer via pharmacy. Additional information was received as solicited information on 22May2023 from a consumer's daughter from a patient support program via pharmacy. Additional information was received as spontaneous information on 23May2023 from a consumer's daughter via pharmacy. Co- suspect medication included Ofev (nintedanib esilate). Additional concentration of 48 ug including lot number and expiration date information and an additional dosage regimen of 48 ug, QID via IH route was added to Tyvaso DPI. On an unreported date in 2023, the patient had dry mouth (dry mouth), no energy (asthenia), felt terrible (feeling abnormal) and patient's oxygen levels were lower than normal (oxygen saturation decreased) so her daughter called in requesting assistance. On 21May2023, patient started Ofev and had diarrhea for which she took Imodium (loperamide). She was also increasing Tyvaso DPI dose to 48 ug over the weekend and was having diarrhea daily, felt fatigued and shaky (fatigue, previously reported and nervousness). Action taken with Tyvaso DPI was not reported for the events of dry mouth, asthenia, feeling abnormal, nervousness and oxygen saturation decreased. At the time of reporting, the outcome of dry mouth, asthenia, feeling abnormal, nervousness and oxygen saturation decreased was unknown, and the outcome of diarrhoea was considered as not resolved. The reporter did not provide the causality for the events of dry mouth, asthenia, feeling abnormal, nervousness and oxygen saturation decreased with Tyvaso DPI. The reporter's causality for the event of diarrhoea with Ofev was considered to be possibly related. Follow-up information was received as solicited report on 19Jun2023 from a consumer's daughter from a patient support program via pharmacy. Additional concentration of 64 ug including lot number and expiration date information and an additional dosage regimen of 64 ug (48 ug+16 ug), QID via IH route was added to Tyvaso DPI. On an unreported date in 2023, the patient was having stomach cramps (abdominal pain upper) and diarrhea with Ofev (diarrhoea previously reported). The patient was having seasonal allergies (seasonal allergy). Action taken with Tyvaso DPI was not reported for the events of abdominal pain upper and seasonal allergy. At the time of reporting, the outcome of abdominal pain upper and seasonal allergy was unknown. The reporter did not provide causality for the events of abdominal pain upper and seasonal allergy with Tyvaso DPI. The reporter's causality for the event of abdominal pain upper with Ofev was considered to be possibly related. Follow-up information was received as solicited report on 20Jun2023 from a consumer's daughter from a patient support program via pharmacy. The patient was stuffy after being outside (seasonal allergy previously reported). Follow-up information was received as solicited information on 05Jul2023, from a consumer from a patient support program via pharmacy. On an unreported date in 2023, the patient's weight gone up and down due to summer (weight fluctuation and sensitivity to weather change). In the beginning, she was having complications with the Ofev medication such as it caused diarrhea (diarrhoea previously reported), however now (at the time of reporting) she was not having any problems. But she eats ice cream and dairy and she was told that it could cause problems (dairy intolerance). Action taken with Tyvaso DPI was not reported for the events of weight fluctuation, sensitivity to weather change and dairy intolerance. At the time of reporting, the outcome of weight fluctuation, sensitivity to weather change and dairy intolerance was unknown, and the outcome of diarrhoea was resolved on an unreported date in 2023. The reporter did not provide causality for the events of weight fluctuation, sensitivity to weather change and dairy intolerance with Tyvaso DPI. Follow-up information was received as spontaneous report on 17Jul2023 from a consumer via pharmacy. An additional dosage regimen of 80 ug (16 ug+64 ug), QID via IH route was added to Tyvaso DPI. Additional lot number and expiration date information was added to concentration of 16 ug and 64 ug of Tyvaso DPI. It was reported that the patient's skin was more wrinkly (skin wrinkling) than it was in the past. She also had a 30-pound weight loss over the past few months (weight decreased). Action taken with Tyvaso DPI was not reported for the events of skin wrinkling and weight decreased. At the time of reporting, the outcome of weight decreased was unknown and the outcome of skin wrinkling was considered as not resolved. The reporter did not provide causality for the events of skin wrinkling and weight decreased with Tyvaso DPI. Follow-up information was received as spontaneous information on 20 Aug 2023 from a consumer's daughter via pharmacy. Additional lot and expiration date information was added to 16 ug and 64 ug concentration of Tyvaso DPI. It was reported that the patient was currently taking Tyvaso DPI 80 ug (16 ug+64 ug), QID and had lost 5 to 6 pounds with nausea and diarrhea (weight decreased previously reported, nausea previously reported, and diarrhoea, previously reported). Her daughter was requesting to down titrate at this time. At the time of reporting, the outcome of diarrhoea was unknown. The reporter's causality for the events of weight decreased, nausea, and diarrhoea with Tyvaso DPI was considered to be possibly related. Follow-up information was received as solicited information on 05Sep2023, from a consumer from a patient support program via pharmacy. Additional lot number and expiration date information was added to 16 ug concentration of Tyvaso DPI. Additional concomitant medications included propranolol, Aspirin (acetylsalicylic acid), oxygen, vitamins, Crestor (rosuvastatin calcium) and loperamide. The patient reported that she had trouble getting Tyvaso DPI through her throat with dose of 80 ug, QID (product use complaint) that was no longer an issue. She also had less appetite (decreased appetite) and 29 pound weight loss (weight decreased previously reported) since her diagnosis. Action taken with Tyvaso DPI was not reported for the event of decreased appetite. At the time of reporting, the outcome of decreased appetite was unknown. The reporter did not provide causality for the event of decreased appetite. Follow-up information was received as spontaneous information on 29Sep2023 from a consumer via other manufacturer. The relevant medical history was added as idiopathic pulmonary fibrosis (IPF). The indication of co-suspect medication Ofev was updated to IPF along with dosing details. Follow-up information was received as solicited information on 20Oct2023, from a consumer from a patient support program via pharmacy. Additional concomitant medication included: vitamin d2. On an unreported date in 2023, the patient had diarrhea, weight loss of 34 pounds (weight decreased, previously reported), and dizziness (dizziness) on Ofev 150 mg dose. Physician was decreasing her dose to 100 mg. Action taken with Tyvaso DPI was not reported for the event of dizziness. Action taken with Ofev was dose decreased on an unreported date in 2023, due to the events of diarrhoea, weight decreased and dizziness. At the time of reporting, the outcome of dizziness was unknown. The reporter did not provide causality for the event of dizziness with Tyvaso DPI. The reporter's causality for the events of weight decreased and dizziness with Ofev was considered to be possibly related. Follow-up information was received as spontaneous report on 03Nov2023 from a consumer via pharmacy. An additional dosage regimen of 48 ug, QID via IH route was added to Tyvaso DPI. Co-suspect medication included COVID-19 vaccine. On an unreported date in 2023, the patient recently received a COVID shot and had been experiencing headaches (headache) ever since, no energy, no appetite (decreased appetite, previously reported), diarrhea, and notes a 37 pound weight loss (weight decreased, previously reported). Action taken with Tyvaso DPI was not reported for the event of headache. At the time of reporting, the outcome of headache was unknown. The reporter did not provide causality for the event of headache with Tyvaso DPI. The reporter's causality for the events of headache, decreased appetite, weight decreased, asthenia, and diarrhoea with COVID-19 vaccine was considered to be possibly related.   The reporter considered "37 pound weight loss ", "headaches", "no energy", "diarrhea" and "no appetite" related to bnt162b2 omi xbb.1.5.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.