Sex: U
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Asthenia, Blood alkaline phosphatase, Blood creatine
Clinical narrative: Admitted with severe liver enzyme elevation; severe weakness; COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of HEPATIC ENZYME INCREASED (Admitted with severe liver enzyme elevation) and ASTHENIA (severe weakness) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No previous problem noted.    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 and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2022, the patient experienced HEPATIC ENZYME INCREASED (Admitted with severe liver enzyme elevation) (seriousness criterion hospitalization) and ASTHENIA (severe weakness) (seriousness criterion hospitalization). On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 13-May-2022 to 18-May-2022 for COVID-19, at a dose of UNK, bid (300 mg/100 mg). At the time of the report, HEPATIC ENZYME INCREASED (Admitted with severe liver enzyme elevation) was resolving and ASTHENIA (severe weakness) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2022, Alanine aminotransferase: 3,500 3,500 and 3,573 3,573. On 23-May-2022, Aspartate aminotransferase: 2,024 2,024. On 23-May-2022, Blood alkaline phosphatase: normal (normal) normal. On 23-May-2022, Blood creatine: 5.16 5.16. On 26-May-2022, Alanine aminotransferase: 1,521 1,521. On 26-May-2022, Aspartate aminotransferase: 172 172. On 26-May-2022, Blood creatine: 1.6 1.6.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. Product was not available for evaluation. Patient was admitted to facility on 23-May-2022 with labs which were drawn at local clinic. It was reported as patient had completed a five-day course of paxlovid, patient confirmed had started to feel better then worsened again. Was sent from local clinic to facility for hospital admit with compain of severe weakness. Patient was on room air on arrival and stayed on room air during stay. Patient was vaccinated with 3 times Moderna vaccine. Liver enzymes creat slowly improving each day.  Normal renal on 24May2022. Paxlovid  NDC-69-1085-30.  Company comment: This spontaneous case concerns a of unknown age and gender with no reported medical history who experienced the unexpected, serious (hospitalization) event of Hepatic enzyme increased and Asthenia and the unexpected, non-serious adverse event of special interest of COVID-19. The events occurred unknown number of days after receiving a dose of mRNA1273. Patient was diagnosed with COVID-19 and was prescribed with Nirmatrelvir, Ritonavir (Paxlovid) which the patient started on 13-May-2022 and completed 5 days later. Patient confirmed had started to feel better then worsened again. The patient was advised to consult a hospital after visiting a local clinic 5 days after completing Paxlovid treatment and tested for Alanine aminotransferase with result of 3,500 and 3,573, Aspartate aminotransferase of 2,024 along with complaint of severe weakness, the patient was subsequently admitted. The events have not yet resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a of unknown age and gender with no reported medical history who experienced the unexpected, serious (hospitalization) event of Hepatic enzyme increased and Asthenia and the unexpected, non-serious adverse event of special interest of COVID-19. The events occurred unknown number of days after receiving a dose of mRNA1273. Patient was diagnosed with COVID-19 and was prescribed with Nirmatrelvir, Ritonavir (Paxlovid) which the patient started on 13-May-2022 and completed 5 days later. Patient confirmed had started to feel better then worsened again. The patient was advised to consult a hospital after visiting a local clinic 5 days after completing Paxlovid treatment and tested for Alanine aminotransferase with result of 3,500 and 3,573, Aspartate aminotransferase of 2,024 along with complaint of severe weakness, the patient was subsequently admitted. The events have not yet resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.