Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Blood smear test, Body temperature, Haemoglobin
Clinical narrative: Immune thrombocytopenic purpura (ITP); Acute liver injury; Petechial rash on her neck and chest associated with increased bruising, particularly on her lower extremities; Arm soreness at the injection site; This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenic purpura (ITP)) and LIVER INJURY (Acute liver injury) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   Previously administered products included for Menstrual cramps: Acetaminophen (lastly took a week prior to hospitalization). Concurrent medical conditions included Menses irregular (on oral contraceptives).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenic purpura (ITP)) (seriousness criteria hospitalization and medically significant), LIVER INJURY (Acute liver injury) (seriousness criterion medically significant), PETECHIAE (Petechial rash on her neck and chest associated with increased bruising, particularly on her lower extremities) and VACCINATION SITE PAIN (Arm soreness at the injection site). The patient was hospitalized for 5 days due to IMMUNE THROMBOCYTOPENIA. The patient was treated with DEXAMETHASONE (intravenous) for Immune thrombocytopenic purpura, at a dose of 40 milligram once a day and N-ACETYLCYSTEINE for Adverse event, at an unspecified dose and frequency. At the time of the report, IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenic purpura (ITP)), LIVER INJURY (Acute liver injury), PETECHIAE (Petechial rash on her neck and chest associated with increased bruising, particularly on her lower extremities) and VACCINATION SITE PAIN (Arm soreness at the injection site) outcome was unknown. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase (10-45): 707 u/l (High) 707 U/L on HD 1 and 1257 u/l (High) 1257 U/L on HD 3,  increased to greater than one thousand, 2 weeks later of vaccine. On an unknown date, Aspartate aminotransferase (10-40): 284 u/l (High) 284 U/L on HD 1 and 446 u/l (High) 446 U/L on HD 3,  increased to greater than one thousand, 2 weeks later of vaccine. On an unknown date, Biopsy liver: normal (normal) no granulomas, steatosis or evidence of necroinflammatory injury, on HD 4. On an unknown date, Blood alkaline phosphatase: 82 u/l (normal) 82 U/L on HD 1. On an unknown date, Blood bilirubin: 1.0 mg/dl (normal) 1.0 mg/dl, on HD 1. On an unknown date, Blood immunoglobulin G (2-96): 100 mg/dl (High) specifically IgG4 measuring 100 mg/dL. On an unknown date, Blood immunoglobulin M: negative (Negative) negative, on HD 3. On an unknown date, Blood smear test: rare schistocytes, giant platelets, no platelet (abnormal) rare schistocytes, giant platelets, no platelet clumping, toxic neutrophils and atypical lymphocytes without immature WBCs or blasts. On an unknown date, Body temperature: normal (normal) normal. On an unknown date, Haemoglobin: normal (normal) normal. On an unknown date, Hepatitis B virus test: positive (Positive) positive. On an unknown date, Platelet count (150-400): 91 (Low) 91 10^9/L, abnormal, 28 (Low) 28 10^9/L, On hospital day (HD) 1 and 213 (normal) 213 10^9/L On hospital day (HD) 5. On an unknown date, Pregnancy test: negative (Negative) negative. On an unknown date, SARS-CoV-2 test: negative (Negative) negative. On an unknown date, Serology test: negative (Negative) including microsomal antibody, antismooth muscle antibody, antimitochondrial antibody, ANA were negative. On an unknown date, Ultrasound abdomen: normal (normal) with Doppler showed normal liver and spleen morphology with no identifiable thrombus. On an unknown date, White blood cell count: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenic purpura (ITP)), LIVER INJURY (Acute liver injury), PETECHIAE (Petechial rash on her neck and chest associated with increased bruising, particularly on her lower extremities) and VACCINATION SITE PAIN (Arm soreness at the injection site) to be possibly related.    It was reported that the patient only had initial side effect after vaccination was arm soreness at the injection site. Approximately 1 week later, developed a petechial rash on her neck and chest associated with increased bruising, particularly on her lower extremities.  The treatment for Immune thrombocytopenic purpura (ITP) included two doses of intravenous immunoglobulin (IVIg) 1 g/kg/day. Treatment was not reported for other events.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded