Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: C-reactive protein, COVID-19 pneumonia, Lymphocyte count, Neutrophil count, Oxygen saturation
Clinical narrative: COVID-19 Pneumonia; Respiratory failure; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 Pneumonia) and RESPIRATORY FAILURE (Respiratory failure) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.        Concurrent medical conditions included Chronic lymphocytic leukemia and Immunosuppression.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 PNEUMONIA (COVID-19 Pneumonia) (seriousness criteria hospitalization and medically significant) and RESPIRATORY FAILURE (Respiratory failure) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 14 days due to COVID-19 PNEUMONIA and RESPIRATORY FAILURE. The patient was treated with REMDESIVIR at an unspecified dose and frequency; DEXAMETHASONE at an unspecified dose and frequency; SARILUMAB (intramuscular use) at a dose of 4 milligram once a day and BARICITINIB at a dose of 4 milligram once a day. At the time of the report, COVID-19 PNEUMONIA (COVID-19 Pneumonia) and RESPIRATORY FAILURE (Respiratory failure) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: 6.4 mg/dl before baricitinib and 2.0 mg/dl after baricitinib (20hr later). On an unknown date, Lymphocyte count: not less than 500 cells/microL. On an unknown date, Neutrophil count: not less than 500 cells/microL. On an unknown date, Oxygen saturation: less than 92% in room air. On an unknown date, SARS-CoV-2 test: (Positive) Positive naso-pharyngeal swab by RT-PCR.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  This was a retrospective cohort study of patients admitted to Cancer Center with COVID-19 infection between January 2020 and April 2022.  A total of 4 patients admitted to the intensive care unit (ICU) with respiratory failure were identified for the study.  Days from first positive test to sarilumab was 12 days. Days from symptom onset to sarilumab was 12 days. Oxygen flowrate at sarilumab start was 60L/hr (high-flow nasal cannula) Time between sarilumab and baricitinib start was 1.5hr. Baricitinib was given by either oral or enteral route.  Severe infection was defined as SpO2 <94% on room air, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <300 mmHg, a respiratory rate >30 breaths/min, or lung infiltrates >50%.  Patient was diagnosed between December 2021 and January 2022, during which time the omicron variant was predominant in area.  None of the patients who survived developed secondary infections after 12 months of treatment, and their respiratory status and pulmonary images revealed dramatic resolution of symptoms.  This study explores the potential safe combination use of different immune modulators targeting multiple pathways of the inflammatory cascade for severe and refractory COVID-19 respiratory infections in high-risk oncology patients.  Company Comment: This is a literature non-study case concerning a 63-year-old patient of unknown gender with medical history of Chronic lymphocytic leukemia and Immunosupression, who experienced the serious (due to medically significant and hospitalization) unexpected events of COVID-19 pneumonia and respiratory failure. The events occurred on an unknown date, after a second dose of mRNA-1273. The patient was admitted in Intensive Care Unit and was hospitalized for 14 days. The treatment consisted of oxygen supplementation, remdesivir, dexamethasone in addition to sarilumab and baricitinib. The patient had a favorable outcome, supported by a decrease of CRP 24 hs. After therapy initiation and a decrease in oxygen requirements. The outcome was reported as recovered. The mentioned medical history and current pandemic outbreak remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2023: Follow up received by safety on 19-OCT-2023 has email with Agency that contains significant information: Reporter information, literature information, medical history, lab data, treatment medications and event details were updated.; Sender's Comments: Company Comment: This is a literature non-study case concerning a 63-year-old patient of unknown gender with medical history of Chronic lymphocytic leukemia and Immunosupression, who experienced the serious (due to medically significant and hospitalization) unexpected events of COVID-19 pneumonia and respiratory failure. The events occurred on an unknown date, after a second dose of mRNA-1273. The patient was admitted in Intensive Care Unit and was hospitalized for 14 days. The treatment consisted of oxygen supplementation, remdesivir, dexamethasone in addition to sarilumab and baricitinib. The patient had a favorable outcome, supported by a decrease of CRP 24 hs. After therapy initiation and a decrease in oxygen requirements. The outcome was reported as recovered. The mentioned medical history and current pandemic outbreak remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.