Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Interleukin-2 receptor assay, International normalised ratio, Lymphocyte count, Neurological examination, Neutrophil count
Clinical narrative: COVID-19 pneumonia; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonia) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     The patient's past medical history included Lymphoma and Renal transplant. Concurrent medical conditions included Congenital heart disease NOS, COPD, End stage renal disease, Common variable immunodeficiency and Immunosuppression.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third 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 death, hospitalization and medically significant). The patient was treated with DEXAMETHASONE for COVID-19 treatment, at an unspecified dose and frequency; REMDESIVIR for COVID-19 treatment, at an unspecified dose and frequency and TOCILIZUMAB for COVID-19 treatment, at an unspecified dose and frequency. The reported cause of death was COVID-19 pneumonia. An autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Activated partial thromboplastin time: 14 secs. On an unknown date, Alanine aminotransferase (10-50 U/L): 18 U/L. On an unknown date, Aspartate aminotransferase (10-50 U/L): 39 U/L. On an unknown date, Autopsy: 1210 g and mean Ct was 20.0 and mean corrected quantification was 3.8 E plus 06 copies/microlitre. On an unknown date, C-reactive protein (0.0-10.0 milligram per litre): 59.8 milligram per litre. On an unknown date, Fibrin D dimer (Unknown-500 ng/mL): 317 ng/mL. On an unknown date, Fluorescent in situ hybridisation: Spike RNA in situ hybridization was negative for frontal, thalamus and medulla regions of brain. On an unknown date, Glomerular filtration rate (59-Unknown millilitre per minute per 1.73 square metre): 117 millilitre per minute per 1.73 square metre. On an unknown date, Immunohistochemistry: (Negative) Nucleocapsid and spike immunohistochemistry was negative for frontal, thalamus and medulla regions of brain. Occasional clusters of intravascular platelets were present, no thrombi were identified in any of the sections. Qualitatively similar degrees of perivascular fibrinogen staining were observed. On an unknown date, Interleukin-2 receptor assay: 770 international unit per millilitre. On an unknown date, International normalised ratio (0.9-1.1): 1.1. On an unknown date, Lymphocyte count (1.00-4.80 thousand per microlitre): 0.86 thousand per microlitre. On an unknown date, Neurological examination: COVID-19 related mild hypoxic ischemic injury. On an unknown date, Neutrophil count (2.50-6.00 thousand per microlitre): 10.26 thousand per microlitre. On an unknown date, SARS-CoV-2 test: (Positive) (premortem nasopharyngeal swab) and (Positive) Amplicon sequencing of autopsy lung tissue confirmed AY.117(Delta lineage). On an unknown date, Serum ferritin (30-400 microgram per litre): 1611 microgram per litre. On an unknown date, White blood cell count (4.00-10.00 thousand per microlitre): 11.95 thousand per microlitre.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient received Moderna 10 days prior to admission and required positive pressure ventilation(PPV). Patient died 9 days after onset of symptoms. Postmortem was done in the interval of 30 hours. Patient gained suboptimal protection due to immunocompromised status.  Patients with positive nasopharyngeal swab SARS-CoV-2 RT-PCR testing with postmortem brain examination at Hospital from 1-Apr-2020 to 15-Feb-2022 were screened for inclusion in this study. Suspected SARS-CoV-2 Delta variant cases were identified by first reported COVID-19 symptoms or positive RTPCR test between 1-Jul-2021 and 15-Dec-2021. Water and pre-COVID-19-era autopsy brain tissue samples were used as negative controls for the extraction. Twelve total Delta variant autopsies were performed, including 10 cases between 12-Jul-2021 and 2-Dec-2022.  Evidence of COVID-19 pneumonia, including acute to organizing diffuse alveolar damage was observed. Median age at death was slightly higher for Omicron variant patients at 67 (interquartile range [IQR] 50-68) years compared to Delta variant (56 [IQR 48-65] years) and non-Delta/non-Omicron variant (53 [IQR 50-63] years) patients.  In this study, neither viral RNA nor protein was identified in brain tissue of the Delta or Omicron variant patients despite evidence of microvascular injury and microglial infiltration, supporting a non-neuroinvasive mechanism of neuropathogenesis.  Company Comment: This is a literature non-study case concerning a 27-year-old, male patient with a history of Lymphoma and Renal transplant and Concurrent medical conditions of Congenital heart disease NOS, COPD, End stage renal disease, Common variable immunodeficiency and Immunosuppression, who experienced the serious (due to death, hospitalization and medically significant) Fatal unexpected, event of COVID-19 pneumonia. Patient received Moderna 10 days prior to admission and required positive pressure ventilation (PPV). Patient died 9 days after onset of symptoms. No neurological symptoms were reported. Patient gained suboptimal protection due to immunocompromised status. Relevant diagnostic tests included a positive SARS-CoV-2 test premortem in nasopharyngeal swab and a Positive Amplicon sequencing of autopsy lung tissue confirmed AY.117 (Delta lineage). Other relevant diagnostic tests included C-reactive protein of 59.8 milligram per litre, (Reference range 0.0-10.0 milligram per litre), Interleukin-2 receptor assay of 770 international unit per millilitre (no reference ranges provided), absolute lymphocyte count of 0.86 thousand per microlitre (reference range of 1.00-4.80 thousand per microlitre), absolute neutrophil count of 10.26 thousand per microlitre (reference range of 2.50-6.00 thousand per microlitre), Serum ferritin of 1611 microgram per litre (reference range 30-400 microgram per litre), and White blood cell count of 11.95 thousand per microlitre (reference range 4.00-10.00 thousand per microlitre). COVID-19-associated neuropathological findings included Mild hypoxic ischemic injury. SARS-CoV-2 protein and RNA were not detected in any brain samples by immunohistochemistry, in situ hybridization, or real-time quantitative PCR. Evidence of COVID-19 pneumonia, including acute to organizing diffuse alveolar damage was observed. The event occurred approximately 10 days after the third dose of the mRNA-1273 vaccine. The patient was treated with dexamethasone, remdesivir and tocilizumab. The outcome of the event was reported as fatal. The reported cause of death was COVID-19 pneumonia. An autopsy was performed. The mentioned medical history and underlying conditions remains as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2023-714408 (E2B Linked Report). Sender's Comments: Company Comment: This is a literature non-study case concerning a 27-year-old, male patient with a history of Lymphoma and Renal transplant and Concurrent medical conditions of Congenital heart disease NOS, COPD, End stage renal disease, Common variable immunodeficiency and Immunosuppression, who experienced the serious (due to death, hospitalization and medically significant) Fatal unexpected, event of COVID-19 pneumonia. Patient received Moderna 10 days prior to admission and required positive pressure ventilation (PPV). Patient died 9 days after onset of symptoms. No neurological symptoms were reported. Patient gained suboptimal protection due to immunocompromised status. Relevant diagnostic tests included a positive SARS-CoV-2 test premortem in nasopharyngeal swab and a Positive Amplicon sequencing of autopsy lung tissue confirmed AY.117 (Delta lineage). Other relevant diagnostic tests included C-reactive protein of 59.8 milligram per litre, (Reference range 0.0-10.0 milligram per litre), Interleukin-2 receptor assay of 770 international unit per millilitre (no reference ranges provided), absolute lymphocyte count of 0.86 thousand per microlitre (reference range of 1.00-4.80 thousand per microlitre), absolute neutrophil count of 10.26 thousand per microlitre (reference range of 2.50-6.00 thousand per microlitre), Serum ferritin of 1611 microgram per litre (reference range 30-400 microgram per litre), and White blood cell count of 11.95 thousand per microlitre (reference range 4.00-10.00 thousand per microlitre). COVID-19-associated neuropathological findings included Mild hypoxic ischemic injury. SARS-CoV-2 protein and RNA were not detected in any brain samples by immunohistochemistry, in situ hybridization, or real-time quantitative PCR. Evidence of COVID-19 pneumonia, including acute to organizing diffuse alveolar damage was observed. The event occurred approximately 10 days after the third dose of the mRNA-1273 vaccine. The patient was treated with dexamethasone, remdesivir and tocilizumab. The outcome of the event was reported as fatal. The reported cause of death was COVID-19 pneumonia. An autopsy was performed. The mentioned medical history and underlying conditions remains as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2023-714408:(Patient 20); Reported Cause(s) of Death: COVID-19 pneumonia.