Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Haemorrhage, Loss of consciousness, Pain, Pneumonia
Clinical narrative: PNEUMONIA; COVID; COVID; BLOOD CLOT NEAR HEART AND LUNG; Passed out; HURT SPINE/RUPTURED SPINE THORACIC; PROBLEMS WITH BLEEDING.; STRONG PAIN CAME BACK; URINARY TRACT INFECTION; MARKETING PROGRAM NAME NOT AVAILABLE.  This is a solicited report received from contactable reporters (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-416338.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Batch/Lot number: unknown), on 18Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 18Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 years, all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Lot number: 1159963) till May2022, oral for rheumatoid arthritis; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "recovered" (2022) and all described as "COVID"; PNEUMONIA (hospitalization, medically significant) with onset 01Jun2022, outcome "recovered" (2022); THROMBOSIS (medically significant) with onset 2022, outcome "not recovered", described as "BLOOD CLOT NEAR HEART AND LUNG"; SPINAL CORD INJURY THORACIC (medically significant) with onset 2022, outcome "recovering", described as "HURT SPINE/RUPTURED SPINE THORACIC"; HAEMORRHAGE (medically significant) with onset 2022, outcome "unknown", described as "PROBLEMS WITH BLEEDING."; LOSS OF CONSCIOUSNESS (medically significant) with onset 2022, outcome "unknown", described as "Passed out"; PAIN (non-serious) with onset 2022, outcome "unknown", described as "STRONG PAIN CAME BACK"; URINARY TRACT INFECTION (non-serious) with onset 2022, outcome "unknown". The patient was hospitalized for pneumonia (start date: 01Jun2022, discharge date: Jun2022). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive. The action taken for upadacitinib was dosage permanently withdrawn in May2022. Therapeutic measures were taken as a result of pneumonia, thrombosis. Clinical course: The patient experienced the events of blood clot near heart and lung, pneumonia, passed out, and non-serious covid, hurt spine/ruptured spine thoracic 11, strong pain came back, problems with bleeding, and urinary tract infection with upadacitinib modified-release tablet. There was no reported medical history. The reaction onset date was reported as 2022. The patient had covid-19 in the end of Apr2022 so she went off RINVOQ for a few months at the beginning of May2022. On 01Jun2022, she was hospitalized for two weeks due to pneumonia and was put on antibiotics. She also had urinary tract infection, so she had decided to continue stopping RINVOQ. After recovering from pneumonia, she came home and passed out. She ruptured her spine thoracic 11 during that time and was not on RINVOQ. She was not in pain but a few weeks after the pain came back strong. The physician found that she had a blood clot near her heart and lung. She was put on blood thinners now as of 30Nov2022 and had problems with bleeding. The reactions were abated after stopping the suspect drug and no reappearance of reactions after reintroduction.   Causality: The reporter's causality for the events of blood clot near heart and lung, covid-19, hurt spine/ruptured spine thoracic 11, passed out, pneumonia, problems with bleeding, strong pain came back and urinary tract infection with pfizer biontech covid-19 vaccine (tozinameran) was no reasonable possibility. The reporter's causality for the events of blood clot near heart and lung and hurt spine/ruptured spine thoracic 11 with upadacitinib modified-release tablet was reasonable possibility the reporter's causality for the events of covid-19 and pneumonia with upadacitinib modified-release tablet was no reasonable possibility. The reporter's causality for the events of passed out, problems with bleeding, strong pain came back and urinary tract infection with upadacitinib modified-release tablet was not provided. The reporter's causality for the events of blood clot near heart and lung, covid-19, hurt spine/ruptured spine thoracic 11, passed out, pneumonia, problems with bleeding, strong pain came back and urinary tract infection with moderna covid-19 vaccine (elasomeran) was no reasonable possibility. Company's opinion was that the causality for the events of blood clot near heart and lung, covid-19, hurt spine/ruptured spine thoracic 11, passed out, pneumonia, problems with bleeding, strong pain came back and urinary tract infection with pfizer biontech covid-19 vaccine (tozinameran) was not provided. Company's opinion was that the causality for the events of blood clot near heart and lung, covid-19, hurt spine/ruptured spine thoracic 11, passed out, pneumonia, problems with bleeding, strong pain came back and urinary tract infection with upadacitinib modified-release tablet was no reasonable possibility. Company's opinion was that the causality for the events of blood clot near heart and lung, covid-19, hurt spine/ruptured spine thoracic 11, passed out, pneumonia, problems with bleeding, strong pain came back and urinary tract infection with moderna covid-19 vaccine (elasomeran) was not provided. Company's alternative etiology for hurt spine/ruptured spine thoracic 11 with upadacitinib modified-release tablet: more likely related to injuries sustained from passing out in this elderly age patient with rheumatoid arthritis. Company's alternative etiology for strong pain came back with upadacitinib modified-release tablet: more likely related to underlying rheumatoid arthritis in this elderly age patient, confounded by interruption of rinvoq therapy. Company's alternative etiology for covid-19 with upadacitinib modified-release tablet: more likely related to sars cov 2 global pandemic outbreak in this elderly age patient with rheumatoid arthritis. Company's alternative etiology for passed out with upadacitinib modified-release tablet: more likely related to status post covid-19, pneumonia, urinary tract infection and concurrent blood clot near her heart and lung in this elderly age patient with underlying rheumatoid arthritis.  The information on the batch/lot number for BNT162b2 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 and the suspect drug cannot be excluded and are Related to the suspected drug . 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.