Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Pulmonary oedema
Clinical narrative: COVID-19/Fatigue; Liquid in the lungs/Pain in right lung; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19/Fatigue) and PULMONARY OEDEMA (Liquid in the lungs/Pain in right lung) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In March 2022, the patient experienced COVID-19 (COVID-19/Fatigue) (seriousness criterion hospitalization). In 2022, the patient experienced PULMONARY OEDEMA (Liquid in the lungs/Pain in right lung) (seriousness criteria hospitalization and medically significant). At the time of the report, COVID-19 (COVID-19/Fatigue) outcome was unknown and PULMONARY OEDEMA (Liquid in the lungs/Pain in right lung) had not resolved.            No concomitant and treatment medications were reported.  It was reported that The patient was in the hospital on 04-Jul-2022 and 05-Jun-2022 due to fatigue and liquid in her lungs. She had COVID in Mar 2022 and experienced pain in her right lung, got hospitalized again and never recovered from the fatigue. She also reported of getting blurry vision and believed it was for the HUMIRA therapy. Her hair was also falling out by clumps.  Reporters causality for event hair loss and covid 19 was not reported and for all other events was not related with respect to Humira drug.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 68-year-old female patient, with medical history of rheumatoid arthritis treated with Adalimumab (start date unknown), who experienced the unexpected serious (medically significant and hospitalization) AESI Pulmonary oedema and unexpected serious (hospitalization) AESI COVID-19 after receiving a dose of mRNA-1273 vaccine on an unknow date. Patient had COVID-19 with right chest pain and fatigue and was hosptitalized. Fatigue persisted. Three months later, patient was readmitted due to fatigue and pulmonary edema. Clinical course and treatment details were not reported. The outcome of pulmonary edema was reported as not resolved and COVID-19 unknown. Co-suspect Adalimumab remain as confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 68-year-old female patient, with medical history of rheumatoid arthritis treated with Adalimumab (start date unknown), who experienced the unexpected serious (medically significant and hospitalization) AESI Pulmonary oedema and unexpected serious (hospitalization) AESI COVID-19 after receiving a dose of mRNA-1273 vaccine on an unknow date. Patient had COVID-19 with right chest pain and fatigue and was hosptitalized. Fatigue persisted. Three months later, patient was readmitted due to fatigue and pulmonary edema. Clinical course and treatment details were not reported. The outcome of pulmonary edema was reported as not resolved and COVID-19 unknown. Co-suspect Adalimumab remain as confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.