Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Hepatic enzyme, Hepatic enzyme increased, Pyrexia, Vomiting
Clinical narrative: Cannot urinate; ALT levels were increased; AOT levels were increased; Bad back pain; Had Fever 102.4 F; Elevated liver enzymes; Was throwing up later; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEPATIC ENZYME INCREASED (Elevated liver enzymes), ANURIA (Cannot urinate), ALANINE AMINOTRANSFERASE INCREASED (ALT levels were increased), ASPARTATE AMINOTRANSFERASE INCREASED (AOT levels were increased), BACK PAIN (Bad back pain) and PYREXIA (Had Fever 102.4 F) in a 47-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.     Concurrent medical conditions included Back pain since 29-May-2021.   On 28-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced VOMITING (Was throwing up later). On 29-May-2021, the patient experienced HEPATIC ENZYME INCREASED (Elevated liver enzymes) (seriousness criteria hospitalization and medically significant), ALANINE AMINOTRANSFERASE INCREASED (ALT levels were increased) (seriousness criteria hospitalization and medically significant), ASPARTATE AMINOTRANSFERASE INCREASED (AOT levels were increased) (seriousness criteria hospitalization and medically significant), BACK PAIN (Bad back pain) (seriousness criterion hospitalization) and PYREXIA (Had Fever 102.4 F) (seriousness criterion hospitalization). On an unknown date, the patient experienced ANURIA (Cannot urinate) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 29-May-2021 due to ALANINE AMINOTRANSFERASE INCREASED, ANURIA, ASPARTATE AMINOTRANSFERASE INCREASED, BACK PAIN and HEPATIC ENZYME INCREASED. At the time of the report, HEPATIC ENZYME INCREASED (Elevated liver enzymes), ANURIA (Cannot urinate), ALANINE AMINOTRANSFERASE INCREASED (ALT levels were increased), ASPARTATE AMINOTRANSFERASE INCREASED (AOT levels were increased), BACK PAIN (Bad back pain), PYREXIA (Had Fever 102.4 F) and VOMITING (Was throwing up later) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase increased: 90 to 7000 (High) ALT level was increased with 90 to 7000. On an unknown date, Aspartate aminotransferase: 1000-2500 (High) The AOT levels were increased from 1000 to 2500. On an unknown date, Body temperature: 102.4 (High) 102.4F. On an unknown date, Hepatic enzyme: 1000-2000 (High) Patient's liver enzymes were spiked to 1000 in the Emergency Room and when admitted in the local hospital it increased to 2000.         The patient's concomitant medication included unspecified medication for back pain and Antidepressants.  No treatment information was provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments.   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.