Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory failure, Respiratory rate, SARS-CoV-2 antibody test, SARS-CoV-2 test, Tachypnoea
Clinical narrative: fatal COVID-19 infection; hypoxic respiratory failure; tachypnea/tachypneic; nonproductive cough; intermittent low-grade; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (fatal COVID-19 infection), RESPIRATORY FAILURE (hypoxic respiratory failure) and TACHYPNOEA (tachypnea/tachypneic) in a 76-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.   LITERATURE REFERENCE: Case report: Severe COVID-19 in a kidney transplant recipient without humoral response to SARS-CoV-2 mRNA vaccine series. Transplant Direct. 2021;7(9):e473     The patient's past medical history included Renal transplant (with antithymocyte globulin induction 6 years prior presented with exertional dyspnea, posttransplant course has been uncomplicated without kidney allograft rejection, chronic infection, or hospitalization.) in 2015 and Noninvasive mechanical ventilation (Shortly after admission, noninvasive positive pressure ventilation was initiated for increasing oxygen requirements.) since an unknown date. Concurrent medical conditions included End stage renal disease, IgA nephropathy, Immunosuppression (on stable maintenance immunosuppression) and Exertional dyspnea. Concomitant products included TACROLIMUS and MYCOPHENOLATE MOFETIL for Immunosuppression.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (fatal COVID-19 infection) (seriousness criteria death and hospitalization prolonged), RESPIRATORY FAILURE (hypoxic respiratory failure) (seriousness criteria death, hospitalization prolonged and medically significant), TACHYPNOEA (tachypnea/tachypneic) (seriousness criterion hospitalization prolonged), COUGH (nonproductive cough) and PYREXIA (intermittent low-grade). The patient was hospitalized for 7 days due to COVID-19, RESPIRATORY FAILURE and TACHYPNOEA. The patient was treated with DEXAMETHASONE (intravenous) for COVID-19, at a dose of 6 mg once a day; REMDESIVIR (intravenous) at a dose of 100 mg once a day; PREDNISONE for Cough and Fever, at a dose of 30 milligram; PREDNISONE for Cough and Fever, at a dose of 20 milligram and PREDNISONE for Cough and Fever, at a dose of 10 milligram. The patient died on an unknown date. The reported cause of death was this case of a kidney transplant recipient who developed a fatal covid-19 infection about 11 d after completion of the sars-cov-2 mrna vaccine series and Hypoxic respiratory failure. It is unknown if an autopsy was performed. At the time of death, TACHYPNOEA (tachypnea/tachypneic), COUGH (nonproductive cough) and PYREXIA (intermittent low-grade) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood bicarbonate: high (High) 24.5 mmol/L on presenting to the hospital second time. In 2021, Blood creatinine: 0.9 to 1.0 mg/dl (normal) baseline serum creatinine ranging from 0.9 to 1.0 mg/dL without proteinuria. and normal (normal) serum creatinine, 1.5 mg/dL on admission. In 2021, Blood gases: abnormal (abnormal) Arterial blood gas (FiO2 0.44) confirmed acute hypoxic respiratory failure on presenting to the hospital second time. In 2021, Blood glucose: high (High) Non-fasting glucose was 492 mg/dL. In 2021, Brain natriuretic peptide: normal (normal) BNP, 175 pg/mL on admission. In 2021, Carbon dioxide: low (Low) 30.3 mm Hg on presenting to the hospital second time. In 2021, Chest X-ray: normal (normal) Chest X-ray did not demonstrate any acute findings and abnormal (abnormal) Chest X-ray now showed an interstitial opacity in the left lower lung on presenting to the hospital second time. In 2021, Fibrin D dimer: 557 ng/ml (abnormal) D-dimer, 557 ng/mL on admission. In 2021, Glycosylated haemoglobin: high (High) hemoglobin A1c was 8.2%. In 2021, Lymphocyte count: low (Low) 150/µL (baseline 5 months prior: 550/µL) - On admission. In 2021, Oxygen saturation: low (Low) pulse oximeter reading was 66% on ambient air on presenting to the hospital second time and low (Low) 89.7% despite supplemental oxygen on presenting to the hospital second time. In 2021, PO2: low (Low) 55.5mm Hg on presenting to the hospital second time. In 2021, Respiratory rate: high (High) 30 bpm on presenting to the hospital second time. In 2021, SARS-CoV-2 antibody test: negative (Negative) A SARS-CoV-2 antispike antibody was undetectable (<0.8 units) by semiquantitative immunoassay. In 2021, SARS-CoV-2 test: positive (Positive) COVID-19 was confirmed with a positive nasopharyngeal swab sample by SARS-CoV-2 real-time reverse transcription-polymerase chain reaction with a cycle threshold value for target N2 of 19.5 and positive (Positive) A repeat nasopharyngeal sample obtained 2 days after admission confirmed persistent positivity of SARS CoV- 2 by reverse transcription-polymerase chain reaction with a cycle threshold value for target N2 gene of 15.2. In 2021, Troponin: low (Low) Troponin-I, 0.01 ng/mL on admission. In 2021, Vital signs measurement: normal (normal) Vital signs were notable for tachypnea: body temperature 36.7 °C, blood pressure 127/83 mm Hg, heart rate 83 bpm, respiratory rate 24 bpm, and SatO2 96% on ambient air.. In 2021, White blood cell count: normal (normal) White blood cell count was 7500/µL on admission. In 2021, pH body fluid: high (High) pH 7.49 on presenting to the hospital second time.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered COVID-19 (fatal COVID-19 infection), RESPIRATORY FAILURE (hypoxic respiratory failure), TACHYPNOEA (tachypnea/tachypneic), COUGH (nonproductive cough) and PYREXIA (intermittent low-grade) to be possibly related.    Patient started to develop nonproductive cough and intermittent low-grade fevers. His symptoms gradually worsened, and 5 days before admission, he was evaluated in the emergency department.  Patient was discharged with a 6 day course of glucocorticoid therapy. He was not tested for SARS-CoV-2 at that time because he had been fully vaccinated.  Patient was admitted to the intensive care unit for further treatment after presenting to the hospital the second time where he was found to be tachypneic and severely hypoxic.  Upon admission, his exam was notable for bibasilar crackles in lower lung fields without peripheral edema.  Patient continued to decompensate and died on the seventh day after admission.  Company Comment: Very limited information regarding this event/s has been provided at this time. Further information has been requested. Further information is not expected.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested. Further information is not expected.; Reported Cause(s) of Death: This case of a kidney transplant recipient who developed a fatal COVID-19 infection about 11 d after completion of the SARS-CoV-2 mRNA vaccine series; hypoxic respiratory failure