Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Aspartate aminotransferase, Bilirubin conjugated increased, Blood bilirubin, Blood lactate dehydrogenase, Chromaturia
Clinical narrative: hemolysis aggravated; darkening of urine; total bilirubin rose to 7.1 mg/dL; fatigue; This literature-non-study case was reported in a literature article and describes the occurrence of HAEMOLYSIS (hemolysis aggravated) in a 63-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 Paroxysmal nocturnal hemoglobinuria (diagnosed with PNH 30 years ago), Blood transfusion dependent and Dystonia (smooth muscle dystonia). Concomitant products included RAVULIZUMAB for Paroxysmal nocturnal hemoglobinuria.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 HAEMOLYSIS (hemolysis aggravated) (seriousness criterion medically significant), CHROMATURIA (darkening of urine), BILIRUBIN CONJUGATED INCREASED (total bilirubin rose to 7.1 mg/dL) and FATIGUE (fatigue). At the time of the report, HAEMOLYSIS (hemolysis aggravated), CHROMATURIA (darkening of urine), BILIRUBIN CONJUGATED INCREASED (total bilirubin rose to 7.1 mg/dL) and FATIGUE (fatigue) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Aspartate aminotransferase: 26 u/l (Inconclusive) Pre-vaccination and 24 u/l (Inconclusive) Post-vaccination (dose 1). In 2021, Blood bilirubin: 2.4 mg/dl (Inconclusive) Pre-vaccination and 7.1 mg/dl (Inconclusive) Post-vaccination (dose 1). In 2021, Blood lactate dehydrogenase: 305 u/l (Inconclusive) Pre-vaccination and 312 u/l (Inconclusive) Post-vaccination (dose 1). In 2021, Haemoglobin: 11.9 g/dl (Inconclusive) Pre-vaccination and 10.7 g/dl (Inconclusive) Post-vaccination (dose 1).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HAEMOLYSIS (hemolysis aggravated), CHROMATURIA (darkening of urine), BILIRUBIN CONJUGATED INCREASED (total bilirubin rose to 7.1 mg/dL) and FATIGUE (fatigue) to be possibly related.    It was reported that the last dose of the concomitant medication ravulizumab, was given four weeks prior to dose 1 vaccination and seven weeks prior to dose 2 vaccination.  PNH Clone was reported as 99% RBC, 99% granulocytes.  A week  following the second dose, labs showed >4 g/dL hemoglobin decrease from his baseline.  No treatment medication was reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, more details regarding the subject's additional medical history and concomitant medications are required for further assessment.   This case was linked to  (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, more details regarding the subject's additional medical history and concomitant medications are required for further assessment.