Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Biopsy liver, Blood alkaline phosphatase, Blood bilirubin
Clinical narrative: Acute cellular rejection; This literature-non-study case was reported in a literature article and describes the occurrence of TRANSPLANT REJECTION (Acute cellular rejection) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   The patient's past medical history included Non-alcoholic steatohepatitis (Etiology of liver disease), Alpha-1 antitrypsin deficiency (Etiology of liver disease), Iron overload (Etiology of liver disease) and Liver transplantation. Concomitant products included CYCLOSPORINE for Immunosuppressant drug therapy.   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. On an unknown date, the patient experienced TRANSPLANT REJECTION (Acute cellular rejection) (seriousness criteria hospitalization and medically significant). The patient was treated with METHYLPREDNISOLONE (intravenous) at a dose of 1 gram once a day; PREDNISONE (oral) at a dose of tapered and MYCOPHENOLATE MOFETIL at an unspecified dose and frequency. At the time of the report, TRANSPLANT REJECTION (Acute cellular rejection) had resolved. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase: Last pre vaccine -65, Peak postvaccine -72 and Most recent -42. On an unknown date, Aspartate aminotransferase: Last pre vaccine -68, Peak postvaccine -75 and Most recent -49. On an unknown date, Biopsy liver: Liver Biopsy Score- acute cellular rejection (5/9), focal, C4d positive. rejection activity index score n=9). On an unknown date, Blood alkaline phosphatase: Last pre vaccine -172, Peak postvaccine -180 and Most recent -153. On an unknown date, Blood bilirubin: Last pre vaccine -1.7, Peak postvaccine -2.0 and Most recent -1.9. On an unknown date, Histology: Liver histopathology showed features of T cell mediated ACR, including portal inflammation of predominantly mixed activated lymphocytes, portal vein (PV) phlebitis and bile duct injuries.. On an unknown date, Immunohistochemistry: Complement component 4d (C4d) stain positive and showed C4d in the portal vein, portal connective tissue, and small portal capillaries.. On an unknown date, SARS-CoV-2 test: (Positive) Positive and (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered TRANSPLANT REJECTION (Acute cellular rejection) to be related.    Patient had no history of acute cellular rejection (ACR). Time from liver transplant to dose one of vaccine was reported as 578 days. Time from liver transplant to dose two of vaccine was reported as 606 days. Time from liver transplant to reporting was reported as 778 days. Time from first dose of vaccination to elevated liver enzymes was reported as 9 days. Patient received second dose of the COVID-19 vaccine without complication. As an immunosuppression regimen Cyclosporine goal was reported as 80-120, which was increased during treatment of ACR.  Company Comment: This is a literature non-study case concerning 61-year-old female patient with medical history of liver transplantation due to Non-alcoholic steatohepatitis (NASH), Alpha-1 antitrypsin deficiency and Iron overload currently on Cyclosporine A, who was hospitalized due to the unexpected, serious (medically significant) event of Transplant rejection. 9 days after receiving the first dose of mRNA-1273 vaccine, the patient had elevated liver enzymes. Liver biopsy demonstrated typical features of T cellmediated Acute cellular rejection (ACR), including portal inflammation of predominantly mixed activated lymphocytes, portal vein (PV) phlebitis and bile duct injuries. Complement component 4d (C4d) stain by immunohistochemistry was positive in the PV, portal connective tissue and small portal capillaries. Rejection activity index (RAI) score was five of nine. The patient was treated with Methylprednisolone IV for 3 days followed by tapered oral doses of Prednisone, uptitration of the maintenance Cyclosporine A and added Mycophenolate mofetil. The event had resolved at the time of the report. It should be noted that the patient received the second dose of the mRNA-1273 after 28 days without complication. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-621477, US-MODERNATX, INC.-MOD-2022-621440 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2022: Live follow up received by safety on 04-AUG-2022 has Email and contains significant information: Author information, patient details, medical History, lab data, product, concomitant drugs, treatment drugs and event details updated.; Sender's Comments: This is a literature non-study case concerning 61-year-old female patient with medical history of liver transplantation due to Non-alcoholic steatohepatitis (NASH), Alpha-1 antitrypsin deficiency and Iron overload currently on Cyclosporine A, who was hospitalized due to the unexpected, serious (medically significant) event of Transplant rejection. 9 days after receiving the first dose of mRNA-1273 vaccine, the patient had elevated liver enzymes. Liver biopsy demonstrated typical features of T cellmediated Acute cellular rejection (ACR), including portal inflammation of predominantly mixed activated lymphocytes, portal vein (PV) phlebitis and bile duct injuries. Complement component 4d (C4d) stain by immunohistochemistry was positive in the PV, portal connective tissue and small portal capillaries. Rejection activity index (RAI) score was five of nine. The patient was treated with Methylprednisolone IV for 3 days followed by tapered oral doses of Prednisone, uptitration of the maintenance Cyclosporine A and added Mycophenolate mofetil. The event had resolved at the time of the report. It should be noted that the patient received the second dose of the mRNA-1273 after 28 days without complication. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-621440:Patient 1: 71 years male US-MODERNATX, INC.-MOD-2022-621477:Patient 2: 50 years male