Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Urine antigen test, Viral test, White blood cell count
Clinical narrative: Prolonged COVID-19 Pneumonitis; lung injury/diffuse alveolar damage with hyaline membrane formation; COVID 19; diffuse dural thickening; Mild cerebral edema; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 PNEUMONIA (Prolonged COVID-19 Pneumonitis), BRAIN OEDEMA (Mild cerebral edema), DIFFUSE ALVEOLAR DAMAGE (lung injury/diffuse alveolar damage with hyaline membrane formation) and COVID-19 (COVID 19) in a 43-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:    The patient's past medical history included CAR T-cell therapy. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (13, 12, 11 and and 6 months prior to presentation). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 vaccine. Concurrent medical conditions included Diffuse large B-cell lymphoma (mediastinal DLBCL in remission for 2 years after CAR-T therapy).    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 PNEUMONIA (Prolonged COVID-19 Pneumonitis) (seriousness criterion medically significant), BRAIN OEDEMA (Mild cerebral edema) (seriousness criterion medically significant), DIFFUSE ALVEOLAR DAMAGE (lung injury/diffuse alveolar damage with hyaline membrane formation) (seriousness criterion medically significant), COVID-19 (COVID 19) (seriousness criterion medically significant) and MENINGEAL THICKENING (diffuse dural thickening). The patient was treated with Prednisone at a dose of 40 milligram once a day; Prednisone at a dose of 0.75 mg/kg/day; Posaconazole at an unspecified dose and frequency; Methylprednisolone at an unspecified dose and frequency; Azithromycin dihydrate (Azithromycin) at an unspecified dose and frequency and Ceftriaxone sodium (Ceftriaxone) at an unspecified dose and frequency. At the time of the report, COVID-19 PNEUMONIA (Prolonged COVID-19 Pneumonitis), BRAIN OEDEMA (Mild cerebral edema) and DIFFUSE ALVEOLAR DAMAGE (lung injury/diffuse alveolar damage with hyaline membrane formation) had resolved and COVID-19 (COVID 19) and MENINGEAL THICKENING (diffuse dural thickening) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Aspergillus test: (Positive) on 1 of 2 bronchoalveolar lavage specimens (index value of 0.60 with threshold less than 0.50. On an unknown date, Biopsy lung: revealed diffuse alveolar damage   with hyaline membrane formation. On an unknown date, Blood culture: Negative. On an unknown date, Blood immunoglobulin A (70-400 mg/dl): 38 mg/dl. On an unknown date, Blood immunoglobulin G (700-1600 mg/dl): 406 mg/dl. On an unknown date, Blood immunoglobulin M (40-250 mg/dl): 37 mg/dl. On an unknown date, Bronchoalveolar lavage: (Negative) Negative for bacterial, fungal, mycobacterial and viral infection.. On an unknown date, Bronchoscopy: Negative. On an unknown date, CSF test: normal. On an unknown date, Chest X-ray: normal, On day 51, revealed bilateral ground glass opacities and On day 65, he presented to the hospital again with worsening infiltrate.. On an unknown date, Computerised tomogram head: suggested mild cerebral edema. On an unknown date, Computerised tomogram thorax: normal and On day 65, he presented to the hospital again with worsening infiltrate. On an unknown date, Cytology: Negative. On an unknown date, Gene sequencing: Negative and Negative. On an unknown date, Lymphocyte count: 0.5 thousand per microlitre and 0.6 thousand per microlitre. On an unknown date, Magnetic resonance imaging: confirmed mild cerebral edema, with the addition of diffuse dural thickening. On an unknown date, Neutrophil count: 2.2 thousand per microlitre. On an unknown date, Oxygen saturation: 93 % On day 51, room air at rest, 83 % On day 65 with resting hypoxemia of 83%. and 96 % on 4 liters/minute of supplemental oxygen.. On an unknown date, Respiratory viral panel: Negative. On an unknown date, SARS-CoV-2 test: (Positive) with a cycle threshold of 36.3, (Positive) cycle threshold of 34.5, (Positive) cycle threshold 34.6 and Positive. On an unknown date, Urine antigen test: (Negative) Negative for Legionella pneumophila and Streptococcus pneumoniae. On an unknown date, Viral test: Negative. On an unknown date, White blood cell count: 2.4 thousand per microlitre.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient was presented with cough, myalgia, and headache on day 1. The patient had persistent cough, malaise, and mild exertional dyspnea and then developed a severe diffuse headache. He was presented to hospital again on day 21 of his illness. He was treated symptomatically without remdesivir or steroids, but symptoms persisted with continued fever, chills, non-productive cough, and increasing dyspnea. Respiratory symptoms worsened, and on day 51 and was treated with empiric azithromycin and ceftriaxone. He refused treatment with remdesivir and was given prednisone 40 mg daily (approximately ½ mg/kg/ day) with a 3-week taper with no clinical improvement. Intravenous methylprednisolone at 1 mg/lg/day for 5 days was administered with rapid clinical improvement. He was placed on a prolonged (2 month) prednisone taper starting at 0.75 mg/kg/day with sustained clinical resolution of his symptoms and clearance of the infiltrates on chest x-ray.  Company comment: Considering the infectious nature of event and lack of biological plausibility for causality event of COVID 19 pneumonia (COVID 19 pneumonitis) is assessed as not related. Diffuse alveolar damage is assessed as not related as likely associated with COVID 19 pneumonitis. Events of brain edema and meningeal thickening are also assessed as not related considering non suggestive temporality and concurrent COVID 19 infection as confounding factor. Medical history of DLBCL and CAR-T therapy is additional risk factor. The benefit-risk relationship of product is not affected by this report.