Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Haemoglobin, Haemolysis, Pyrexia, Vomiting
Clinical narrative: hemolysis aggravated; dark urine; diarrhea; fevers; vomitting; severe 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) (batch nos. unk and unk) 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 (Transfusion dependence) and Dystonia (smooth muscle dystonia). Concomitant products included RAVULIZUMAB for Paroxysmal nocturnal hemoglobinuria.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first 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 (dark urine), DIARRHOEA (diarrhea), PYREXIA (fevers), VOMITING (vomitting) and FATIGUE (severe fatigue). At the time of the report, HAEMOLYSIS (hemolysis aggravated), CHROMATURIA (dark urine), DIARRHOEA (diarrhea), PYREXIA (fevers), VOMITING (vomitting) and FATIGUE (severe fatigue) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Aspartate aminotransferase: 26u/l (Inconclusive) Pre-vaccination and 22u/l (Inconclusive) Post-vaccination (after dose 2). In 2021, Blood bilirubin: 2.4 (Inconclusive) Pre-vaccination and 3 (Inconclusive) Post-vaccination (after dose 2). In 2021, Blood lactate dehydrogenase: 305u/l (Inconclusive) Pre-vaccination and 342u/l (Inconclusive) Post-vaccination (after dose 2). In 2021, Haemoglobin: 11.9 g/dl (Inconclusive) Pre-vaccination and 7.1g/dl (Inconclusive) Post-vaccination (after dose 2).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HAEMOLYSIS (hemolysis aggravated), CHROMATURIA (dark urine), DIARRHOEA (diarrhea), PYREXIA (fevers), VOMITING (vomitting) and FATIGUE (severe 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 reported.  No treatment information was provided.  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 medical history and concomitant medications are required for further assessment.   This case was linked to MOD-2021-151607, MOD-2021-151607 (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 medical history and concomitant medications are required for further assessment.