Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Body mass index, Body temperature, COVID-19 pneumonia, Computerised tomogram
Clinical narrative: acute right upper and right lower lobe pulmonary emboli; Pneumonia; SARS-CoV-2 breakthrough infection; lack of drug effect; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 PNEUMONIA (SARS-CoV-2 breakthrough infection), PULMONARY EMBOLISM (acute right upper and right lower lobe pulmonary emboli) and PNEUMONIA (Pneumonia) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.       Concurrent medical conditions included Acute lymphoblastic leukemia. Concomitant products included DEXAMETHASONE and RITUXIMAB for Acute lymphoblastic leukemia, MERCAPTOPURINE, VINCRISTINE, METHOTREXATE and PREDNISONE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 PNEUMONIA (SARS-CoV-2 breakthrough infection) (seriousness criteria hospitalization and medically significant), DRUG INEFFECTIVE (lack of drug effect), PULMONARY EMBOLISM (acute right upper and right lower lobe pulmonary emboli) (seriousness criteria hospitalization and medically significant) and PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 5 days due to COVID-19 PNEUMONIA. The patient was treated with REMDESIVIR for Adverse event, at an unspecified dose and frequency; ENOXAPARIN for Adverse event, at a dose of UNK, bid; CEFEPIME for Pneumonia, at an unspecified dose and frequency; AZITHROMYCIN for Pneumonia, at an unspecified dose and frequency; MICAFUNGIN for Fungal infection, at an unspecified dose and frequency and TOCILIZUMAB (intravenous) for COVID-19, at a dose of 800 milligram. At the time of the report, COVID-19 PNEUMONIA (SARS-CoV-2 breakthrough infection), DRUG INEFFECTIVE (lack of drug effect), PULMONARY EMBOLISM (acute right upper and right lower lobe pulmonary emboli) and PNEUMONIA (Pneumonia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram: abnormal (abnormal) acute right upper and right lower lobe pulmonary emboli with new bilateral consolidative opacities.. On an unknown date, Body mass index: 31.33 31.33. On an unknown date, Body temperature: 102 degree fahrenheit 102 degree Fahrenheit. On an unknown date, Computerised tomogram: abnormal (abnormal) acute right upper and right lower lobe pulmonary emboli with new bilateral consolidative opacities.. On an unknown date, Heart rate: 100bpm exceeding 100bpm. On an unknown date, Oxygen saturation: 87 percent 87 percent. On an unknown date, Respiratory rate: 22breaths/minute exceeding 22breaths/minute. On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 PNEUMONIA (SARS-CoV-2 breakthrough infection), DRUG INEFFECTIVE (lack of drug effect), PULMONARY EMBOLISM (acute right upper and right lower lobe pulmonary emboli) and PNEUMONIA (Pneumonia) to be related.    Patient Treatment history includes HyperCVAD with intrathecal chemotherapy, Rituximab, and finally 6-Mercaptopurine + Vincristine + Methotrexate + Prednisone (POMP) with every two week rituximab. However, rituximab, as part of his treatment plan, was delayed for cycle 1 (February 3, 2021) and cycle 2 (March 9, 2021) of his POMP/rituximab regimen in order to receive the Spike-protein-encoding Moderna COVID- 19 mRNA vaccine series (mRNA-1273, Moderna). Approximately four months later, he presented to the hospital with fevers of 102o Fahrenheit. His physical exam was noteworthy for a body mass index of 31.33, tachycardia with a heart rate exceeding 100bpm, a respiratory rate persistently exceeding 22breaths/minute, and an oxygen saturation of 87%. A comprehensive respiratory viral panel (RVP) was obtained, which resulted positive for SARS-CoV-2 by polymerase chain reaction (PCR). Computed tomography with angiography of the thorax revealed acute right upper and right lower lobe pulmonary emboli with new bilateral consolidative opacities. His laboratory analysis was significant for transaminitis, markedly elevated inflammatory markers, and a profound lymphopenia of 0.15 K/microliter. The patient was admitted for management of COVID-19 pneumonia and pulmonary emboli. He recovered clinically 5 days later and was discharged to complete ten full days of dexamethasone. However, six days post-discharge, the patient returned to the hospital with persistent fevers, worsening dyspnea, hypoxia and chest discomfort  and chest imaging was consistent with ongoing pneumonia. He was re-initiated on dexamethasone at a higher dose of 10 mg intravenously daily with supplemental oxygen. He was also begun on cefepime and azithromycin to cover for a superimposed bacterial pneumonia, along with high-dose micafungin for possible fungal involvement. Despite this therapy the patient's respiratory status worsened, requiring invasive mechanical ventilation.   This case was linked to MOD-2022-467722 (Patient Link).  Company comment: This case concerns a 29-year-old male patient, with medical history of Acute lymphoblastic leukemia, who experienced the unexpected event of COVID 19 pneumonia, pulmonary embolism and pneumonia which occurred approximately 4 months after second dose of mRNA-1273.  Event of drug ineffective was also captured. As reported, the patient was admitted for management of COVID-19 pneumonia and pulmonary emboli. He recovered clinically 5 days later and was discharged to complete ten full days of dexamethasone. However, six days post-discharge, the patient returned to the hospital with persistent fevers, worsening dyspnea, hypoxia and chest discomfort  and chest imaging was consistent with ongoing pneumonia. Cefepime and azithromycin were included to cover for a superimposed bacterial pneumonia, along with high-dose micafungin for possible fungal involvement but despite this therapy the patient's respiratory status worsened, requiring invasive mechanical ventilation. Patient's medical history of acute lymphoblastic leukemia with finding of profound lymphopenia confounds causality for the reported events. Concomitant use of 6 Mercaptopurine + Vincristine + Methotrexate + Prednisone presents an additional confounding factor. Concurrent COVID 19 pneumonia may provide etiology for pulmonary embolism as COVID 19 disease has been associated with thromboembolic events, and also continuation of COVID 19 pneumonia likely caused development of pneumonia which required re-admission, hence causality for events of pneumonia and pulmonary embolism  was assessed as not related per Company. Although PCR test was positive, therapy included additional antibiotics for bacterial and fungal infection, so possibility of superimposed infection could not be excluded. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2022: Follow up received by safety 3-FEB-2022 has Email received from team and contain significant information: Lab data, treatment , Lack of efficacy updated; Sender's Comments: Company comment: This case concerns a 29-year-old male patient, with medical history of Acute lymphoblastic leukemia, who experienced the unexpected event of COVID 19 pneumonia, pulmonary embolism and pneumonia which occurred approximately 4 months after second dose of mRNA-1273.  Event of drug ineffective was also captured. As reported, the patient was admitted for management of COVID-19 pneumonia and pulmonary emboli. He recovered clinically 5 days later and was discharged to complete ten full days of dexamethasone. However, six days post-discharge, the patient returned to the hospital with persistent fevers, worsening dyspnea, hypoxia and chest discomfort  and chest imaging was consistent with ongoing pneumonia. Cefepime and azithromycin were included to cover for a superimposed bacterial pneumonia, along with high-dose micafungin for possible fungal involvement but despite this therapy the patient's respiratory status worsened, requiring invasive mechanical ventilation. Patient's medical history of acute lymphoblastic leukemia with finding of profound lymphopenia confounds causality for the reported events. Concomitant use of 6 Mercaptopurine + Vincristine + Methotrexate + Prednisone presents an additional confounding factor. Concurrent COVID 19 pneumonia may provide etiology for pulmonary embolism as COVID 19 disease has been associated with thromboembolic events, and also continuation of COVID 19 pneumonia likely caused development of pneumonia which required re-admission, hence causality for events of pneumonia and pulmonary embolism  was assessed as not related per Company. Although PCR test was positive, therapy included additional antibiotics for bacterial and fungal infection, so possibility of superimposed infection could not be excluded. The benefit-risk relationship of mRNA-1273 is not affected by this report.