Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Sensitivity to weather change, Stress, Weight, Wound
Clinical narrative: Cataracts; Rheumatoid arthritis; rheumatoid in her hands; rheumatoid arthritis is crippling her; Glaucoma; Iron low; Joints and hand pain; Joints and hand pain; legs are constantly in pain and hurt; Feels not as strong; Issues bending over; Overwhelmed and stressed; Overwhelmed and stressed; Poor circulation which is worsened with the cold weather; Poor circulation which is worsened with the cold weather; Diarrhea; Open wound on her left leg near her ankle; open wound ongoing for the past year and has green liquid coming out of it; Open wound on her left leg near her ankle; Open wound ongoing for the past year and has green liquid coming out of it; Fluid retention; Coughing a lot; cough; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): UNT-2021-015386.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; treprostinil sodium (TYVASO), first regimen since 27Feb2015 (Batch/Lot number: unknown) at unk, (inhalation), second regimen (Lot number: 2101964, Expiration Date: 31May2022) at 4x/day (unk, 4x/day (60-120 microgram inhalation)), third regimen (Lot number: 2101994, Expiration Date: 30Nov2022) at unk (inhalation), fourth regimen (Lot number: 2102168, Expiration Date: 31Dec2023) at 4x/day (unk, 4x/day 54-72 microgram inhalation)), fifth regimen (Lot number: 2102311, Expiration Date: 30Nov2023) at 36 ug 4x/day (36 ug, 4x/day (inhalation)), sixth regimen (Lot number: 2102030, Expiration Date: 30Nov2020) at 4x/day (unk, 4x/day 18-72 microgram inhalation)), seventh regimen (Batch/Lot number: unknown) at 54 ug (54 ug, (inhalation)) and eighth regimen (Lot number: 2102010, Expiration Date: 30Nov2022) at 4x/day (unk, 4x/day 54-72 microgram inhalation)) for pulmonary arterial hypertension; bosentan (TRACLEER [BOSENTAN]), (Batch/Lot number: unknown); sulfamethoxazole, trimethoprim (BACTRIM), (Batch/Lot number: unknown) at 500 mg 2x/day. The patient's relevant medical history included: "secondary pulmonary arterial hypertension" (ongoing). Concomitant medication(s) included: ELIQUIS. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: CATARACT (medically significant), outcome "unknown", described as "Cataracts"; RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis; rheumatoid in her hands; rheumatoid arthritis is crippling her"; GLAUCOMA (medically significant), outcome "unknown"; BLOOD IRON DECREASED (non-serious), outcome "unknown", described as "Iron low"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joints and hand pain"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Joints and hand pain; legs are constantly in pain and hurt"; ASTHENIA (non-serious), outcome "unknown", described as "Feels not as strong"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "Issues bending over"; PSYCHIATRIC SYMPTOM (non-serious), STRESS (non-serious), outcome "unknown" and all described as "Overwhelmed and stressed"; POOR PERIPHERAL CIRCULATION (non-serious), outcome "not recovered", SENSITIVITY TO WEATHER CHANGE (non-serious), outcome "unknown" and all described as "Poor circulation which is worsened with the cold weather"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; WOUND (non-serious), outcome "not recovered", described as "Open wound on her left leg near her ankle; open wound ongoing for the past year and has green liquid coming out of it"; LIMB INJURY (non-serious), outcome "unknown", described as "Open wound on her left leg near her ankle"; PURULENT DISCHARGE (non-serious), outcome "unknown", described as "Open wound ongoing for the past year and has green liquid coming out of it"; FLUID RETENTION (non-serious), outcome "unknown"; COUGH (non-serious), outcome "unknown", described as "Coughing a lot; cough". The patient underwent the following laboratory tests and procedures: Blood iron: Low; Weight: 191 lbs. The action taken for treprostinil sodium and bosentan was unknown. The action taken for sulfamethoxazole, trimethoprim was dosage permanently withdrawn. Therapeutic measures were taken as a result of cataract, glaucoma, arthralgia, pain in extremity, Asthenia.  The reporter's assessment of the causal relationship of "cataracts", "rheumatoid arthritis; rheumatoid in her hands; rheumatoid arthritis is crippling her", "glaucoma", "iron low", "joints and hand pain", "joints and hand pain; legs are constantly in pain and hurt", "feels not as strong", "issues bending over", "overwhelmed and stressed", "poor circulation which is worsened with the cold weather", "open wound on her left leg near her ankle; open wound ongoing for the past year and has green liquid coming out of it", "open wound on her left leg near her ankle", "open wound ongoing for the past year and has green liquid coming out of it", "fluid retention" and "coughing a lot; cough" 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 "diarrhea" related to BNT162b2, BNT162b2 omi ba.4-5. Clinical information: On 17Sep2021, it was reported on an unknown date, the patient experienced the events iron low, joints and hand pain and felt not as strong. Per laboratory work, patients iron was low. She was taking prednisone 5 mg, once a day, for five more days for joints and hand pain. Also, she felt not as strong. On 09May2022 it was reported the patient had glaucoma surgery (glaucoma previously reported). The patient had issues bending over. She had rheumatoid in her hands (rheumatoid arthritis previously reported). On 11Apr2023, Patients weight was reported 191 lbs. The patient stated that the rheumatoid arthritis was crippling her (rheumatoid arthritis previously reported). On 11May2023, upon internal case review manufacturer control number # was determined to be follow-up to #, and all the information from # has been merged into # to be retained and # will be logically deleted from companys safety system. Tracleer (Bosentan) was no longer considered as a concomitant medication and was updated to co-suspect medication. Additional co-suspect medications included COVID-19 vaccine and Bactrim (sulfamethoxazole and trimethoprim). It was reported that since Oct2020, the patient had an open wound on her left leg near her ankle (as reported). The open wound was ongoing for the past year and had a green liquid coming out of it (wound and purulent discharge). She was taking Bactrim 500 mg twice a day but stopped it because it made her cough. Additionally, for couple of weeks the patient had been overwhelmed and stressed due to having cataract surgery and poor circulation which was worsened with the cold weather. She also received COVID-19 booster and had diarrhea a couple days after receiving vaccine. Furthermore, she reported that Tracleer caused fluid retention she was taking only 9 breaths of Tyvaso due to coughing a lot and her legs were constantly in pain and hurt. Bactrim was drug withdrawn due to the event of cough.  Case Comment/Senders Comment: The company has assessed the serious adverse event of rheumatoid arthritis, glaucoma, and cataract as not related to IH Treprostinil and TD-300/A device. Rheumatoid arthritis is an autoimmune condition and being an elderly female were risk factors for the development of the same. Glaucoma and cataract are likely to develop in old age which was the likely cause for the reported events.  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 information, the events rheumatoid arthritis, glaucoma, and cataract  is most likely related to an intercurrent or underlying condition which is not related to the suspected drug and events BLOOD IRON DECREASED,ARTHRALGIA, PAIN IN EXTREMITY, ASTHENIA, MOBILITY DECREASED, PSYCHIATRIC SYMPTOM, STRESS, POOR PERIPHERAL CIRCULATION , SENSITIVITY TO WEATHER CHANGE,DIARRHOEA, WOUND ,LIMB INJURY, PURULENT DISCHARGE,  FLUID RETENTION, COUGH are assessed as Related to the suspected drug .   The case will be reassessed if additional information becomes available.