Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory distress syndrome, Bronchopulmonary aspergillosis, COVID-19, Chest X-ray
Clinical narrative: Invasive pulmonary aspergillosis; Pneumonia Staphylococcal; Septic shock; Acute renal failure; Profound respiratory acidosis; Acute respiratory distress syndrome; SARS-Cov-2 infection; This literature-non-study case was reported in a literature article and describes the occurrence of BRONCHOPULMONARY ASPERGILLOSIS (Invasive pulmonary aspergillosis), PNEUMONIA STAPHYLOCOCCAL (Pneumonia Staphylococcal), SEPTIC SHOCK (Septic shock), ACUTE KIDNEY INJURY (Acute renal failure), RESPIRATORY ACIDOSIS (Profound respiratory acidosis), ACUTE RESPIRATORY DISTRESS SYNDROME (Acute respiratory distress syndrome) and COVID-19 (SARS-Cov-2 infection) in a 63-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     Concurrent medical conditions included Atrial fibrillation, Hypertension and Obesity.  On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced BRONCHOPULMONARY ASPERGILLOSIS (Invasive pulmonary aspergillosis) (seriousness criteria death, hospitalization and medically significant), PNEUMONIA STAPHYLOCOCCAL (Pneumonia Staphylococcal) (seriousness criteria death, hospitalization and medically significant), SEPTIC SHOCK (Septic shock) (seriousness criteria death, hospitalization and medically significant), ACUTE KIDNEY INJURY (Acute renal failure) (seriousness criteria death, hospitalization and medically significant), RESPIRATORY ACIDOSIS (Profound respiratory acidosis) (seriousness criteria death, hospitalization and medically significant), ACUTE RESPIRATORY DISTRESS SYNDROME (Acute respiratory distress syndrome) (seriousness criteria death, hospitalization and medically significant) and COVID-19 (SARS-Cov-2 infection) (seriousness criteria hospitalization and medically significant). The patient was treated with REMDESIVIR at an unspecified dose and frequency; DEXAMETHASONE (DECADRON [DEXAMETHASONE]) at an unspecified dose and frequency; TOCILIZUMAB at a dose of First dose; TOCILIZUMAB at a dose of Second dose; CEFEPIME at an unspecified dose and frequency; VANCOMYCIN at an unspecified dose and frequency; VORICONAZOLE at an unspecified dose and frequency and CASPOFUNGIN at an unspecified dose and frequency. The patient died on an unknown date. The reported cause of death was invasive pulmonary aspergillosis, pneumonia staphylococcal, Septic shock, Acute renal failure, profound respiratory acidosis and Acute respiratory distress syndrome. It is unknown if an autopsy was performed. At the time of death, COVID-19 (SARS-Cov-2 infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: Initial chest x-ray showed diffuse ground-glass opacities, repeat chest x-ray suggested some improvement but a new left lower lobe airspace haziness and serial chest x-ray revealed increasing diffuse airspace opacities concerning for acute respiratory distress syndrome. On an unknown date, Procalcitonin: Elevated. On an unknown date, SARS-CoV-2 test: (Positive) Positive. On an unknown date, Tracheal aspirate culture: grew coagulase-negative staphylococcus and aspergillosis fumigatus. On an unknown date, White blood cell count: High.   The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient presented with progressively worsening dyspnea for one week. Patient tested positive for COVID about two weeks prior. Patient received a single dose of Moderna vaccine. Patient was intubated on hospital day 3 for worsened hypoxemia. Patient also had new-onset leukocytosis. No clinical improvement was seen. The patient's respiratory status worsened with increasing ventilation requirement. Patient developed septic shock and acute renal failure requiring continuous veno-venous hemofiltration (CVVH). Patient became even more hypotensive after CVVH initiation, and multiple vasopressors were required to maintain patient hemodynamics. Patient continued to deteriorate and developed profound respiratory acidosis. Patient died shortly afterwards after family decided to withdraw care.  Author stated that in addition to superimposed bacterial pneumonia, pulmonary aspergillosis likely also contributed to patient clinical deterioration.  Company comment; This literature non-study case concerns a 63-year-old, male patient with underlying atrial fibrillation, hypertension, and obesity, who experienced the unexpected, medically significant, and fatal events of Pneumonia staphylococcal, Invasive bronchopulmonary aspergillosis (IPA), Septic shock, an AESI Acute respiratory distress syndrome, an AESI Acute kidney injury, and Respiratory acidosis, and an unexpected, medically significant event of COVID-19 in association with a single dose of mRNA-1273 vaccine that led to hospitalization. Events' onset dates, vaccination date, and exact date of clinical course were not reported. He presented with progressive dyspnea for one week and was COVID-19 positive about 2 weeks prior. Initial chest radiograph (CXR) showed diffuse ground-glass opacities. Remdesivir, Decadron, and tocilizumab were given. On hospital day 3, he was intubated for worsened hypoxemia. A suspicious superimposed hospital-acquired bacterial infection was supported by repeat CXR showing improvements but with new left lower lobe airspace haziness; serial CXRs that revealed increasing diffuse airspace opacities indicating acute respiratory distress syndrome; leukocytosis; and elevated procalcitonin. A 2nd tocilizumab was given, and Cefepime was started but eventually shifted to vancomycin plus voriconazole and caspofungin upon confirmation of Staphylococcal and Aspergillosis fumigatus in the tracheal aspirate culture. Septic shock and acute renal failure requiring CVVH (continuous veno-venous hemofiltration) developed. He became even more hypotensive and multiple vasopressors were given. Profound respiratory acidosis ensued, and patient died shortly after. Autopsy and cause of death were not reported. Severe COVID-related immune dysregulation, ARDS, high-dose steroid use, and tocilizumab may have predisposed the patient to IPA, per the authors. Patient's multiple comorbidities could also have contributed to the severity of his infection and his fatal outcome. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Events' seriousness assessed per medical judgement. Sender's Comments: This literature non-study case concerns a 63-year-old, male patient with underlying atrial fibrillation, hypertension, and obesity, who experienced the unexpected, medically significant, and fatal events of Pneumonia staphylococcal, Invasive bronchopulmonary aspergillosis (IPA), Septic shock, an AESI Acute respiratory distress syndrome, an AESI Acute kidney injury, and Respiratory acidosis, and an unexpected, medically significant event of COVID-19 in association with a single dose of mRNA-1273 vaccine that led to hospitalization. Events' onset dates, vaccination date, and exact date of clinical course were not reported. He presented with progressive dyspnea for one week and was COVID-19 positive about 2 weeks prior. Initial chest radiograph (CXR) showed diffuse ground-glass opacities. Remdesivir, Decadron, and tocilizumab were given. On hospital day 3, he was intubated for worsened hypoxemia. A suspicious superimposed hospital-acquired bacterial infection was supported by repeat CXR showing improvements but with new left lower lobe airspace haziness; serial CXRs that revealed increasing diffuse airspace opacities indicating acute respiratory distress syndrome; leukocytosis; and elevated procalcitonin. A 2nd tocilizumab was given, and Cefepime was started but eventually shifted to vancomycin plus voriconazole and caspofungin upon confirmation of Staphylococcal and Aspergillosis fumigatus in the tracheal aspirate culture. Septic shock and acute renal failure requiring CVVH (continuous veno-venous hemofiltration) developed. He became even more hypotensive and multiple vasopressors were given. Profound respiratory acidosis ensued, and patient died shortly after. Autopsy and cause of death were not reported. Severe COVID-related immune dysregulation, ARDS, high-dose steroid use, and tocilizumab may have predisposed the patient to IPA, per the authors. Patient's multiple comorbidities could also have contributed to the severity of his infection and his fatal outcome. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Events' seriousness assessed per medical judgement.; Reported Cause(s) of Death: Invasive pulmonary aspergillosis; Pneumonia staphylococcal; Septic shock; Acute renal failure; Profound respiratory acidosis; Acute respiratory distress syndrome.