Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Haemorrhage, Loss of consciousness, Pain, Pneumonia
Clinical narrative: Pneumonia; Passed out; Urinary tract infection; COVID-19; Strong pain came back; Hurt spine/ruptured spine thoracic 11; Problems with bleeding; Blood clot near heart and lung; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia), THROMBOSIS (Blood clot near heart and lung), LOSS OF CONSCIOUSNESS (Passed out), SPINAL CORD INJURY THORACIC (Hurt spine/ruptured spine thoracic 11) and HAEMORRHAGE (Problems with bleeding) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products UPADACITINIB (RINVOQ) modified-release tablet for Rheumatoid arthritis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Rheumatoid arthritis.   On 25-Feb-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In April 2022, the patient experienced COVID-19 (COVID-19). On 01-Jun-2022, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant). In 2022, the patient experienced THROMBOSIS (Blood clot near heart and lung) (seriousness criterion medically significant), SPINAL CORD INJURY THORACIC (Hurt spine/ruptured spine thoracic 11) (seriousness criterion medically significant), HAEMORRHAGE (Problems with bleeding) (seriousness criterion medically significant) and PAIN (Strong pain came back). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant) and URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, PNEUMONIA (Pneumonia) and COVID-19 (COVID-19) had resolved, THROMBOSIS (Blood clot near heart and lung) had not resolved, LOSS OF CONSCIOUSNESS (Passed out), HAEMORRHAGE (Problems with bleeding), URINARY TRACT INFECTION (Urinary tract infection) and PAIN (Strong pain came back) outcome was unknown and SPINAL CORD INJURY THORACIC (Hurt spine/ruptured spine thoracic 11) was resolving.            No concomitant medications were reported. The patient had covid in the end of Apr-2022 so she went off RINVOQ for a few months at the beginning of May-2022. On 01-Jun-2022, 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 30-Nov-2022 and had problems with bleeding. The reporter's causality for the event(s) of blood clot near heart and lung, COVID, 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 event(s) 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 event(s) of COVID and pneumonia with Upadacitinib Modified-Release Tablet was No Reasonable Possibility. The reporter's causality for the event(s) of passed out, problems with bleeding, strong pain came back and urinary tract infection with Upadacitinib Modified-Release Tablet was Not Provided.  Company Comment: This spontaneous case concerns a 73 year old female patient, with no relevant medical history reported , who experienced the unexpected serious (hospitalization/medically significant) event of Pneumonia, unexpected serious (medically significant) events of  Thrombosis (AESI) (reported as Blood clot near heart and lung), Loss of consciousness, Spinal cord injury thoracic (reported as Hurt spine/ruptured spine thoracic 11) and Haemorrhage that occurred unknown days after receiving a dose (reported as booster) of mRNA-1273 vaccine in the COVID-19 vaccination series. Latency could not be assessed as the date of vaccination was not provided. Covid-19 was also reported among other non-serious events. Patient was hospitalized for two weeks due to pneumonia and was put on antibiotics. She also had urinary tract infection. After recovering from pneumonia, she came home , passed out and ruptured her spine thoracic 11. The physician found that she had a blood clot near her heart and lung. She was put on blood thinners and had problems with bleeding. Patient had received three doses of Pfizer vaccine previously (Interchange of vaccine products). No further information regarding the risk factors, additional medical history, concurrent condition, investigations and treatment received were provided. The outcome of the event pneumonia was recovered, thrombosis was not recovered, Loss of consciousness and Haemorrhage was unknown, Spinal cord injury thoracic was recovering. Patient's age could be a risk factors for Loss of consciousness and Spinal cord injury thoracic , non-serious event of Covid-19 remains as a confounder for the event pneumonia. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 73 year old female patient, with no relevant medical history reported , who experienced the unexpected serious (hospitalization/medically significant) event of Pneumonia, unexpected serious (medically significant) events of  Thrombosis (AESI) (reported as Blood clot near heart and lung), Loss of consciousness, Spinal cord injury thoracic (reported as Hurt spine/ruptured spine thoracic 11) and Haemorrhage that occurred unknown days after receiving a dose (reported as booster) of mRNA-1273 vaccine in the COVID-19 vaccination series. Latency could not be assessed as the date of vaccination was not provided. Covid-19 was also reported among other non-serious events. Patient was hospitalized for two weeks due to pneumonia and was put on antibiotics. She also had urinary tract infection. After recovering from pneumonia, she came home , passed out and ruptured her spine thoracic 11. The physician found that she had a blood clot near her heart and lung. She was put on blood thinners and had problems with bleeding. Patient had received three doses of Pfizer vaccine previously (Interchange of vaccine products). No further information regarding the risk factors, additional medical history, concurrent condition, investigations and treatment received were provided. The outcome of the event pneumonia was recovered, thrombosis was not recovered, Loss of consciousness and Haemorrhage was unknown, Spinal cord injury thoracic was recovering. Patient's age could be a risk factors for Loss of consciousness and Spinal cord injury thoracic , non-serious event of Covid-19 remains as a confounder for the event pneumonia. The benefit-risk relationship of mRNA-1273 is not affected by this report.