Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphocyte count, Lymphopenia, Nausea, Pyrexia, Vaccination complication
Clinical narrative: She felt really sick; chills; fever; nausea; headache; laid me really flat; lymphopenia; liver damage; This spontaneous case was reported by a consumer and describes the occurrence of LIVER INJURY (liver damage) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced LIVER INJURY (liver damage) (seriousness criterion medically significant). 2021, the patient experienced LYMPHOPENIA (lymphopenia). On 30-Oct-2021, the patient experienced VACCINATION COMPLICATION (laid me really flat), ILLNESS (She felt really sick), PYREXIA (fever), NAUSEA (nausea) and HEADACHE (headache). 30-Oct-2021, the patient experienced CHILLS (chills). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form and DIPHENHYDRAMINE, PARACETAMOL (EXTRA STRENGTH TYLENOL PM) at a dose of 2 extra strength Tylenol. At the time of the report, LIVER INJURY (liver damage), VACCINATION COMPLICATION (laid me really flat), LYMPHOPENIA (lymphopenia), ILLNESS (She felt really sick), CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2021, Blood test: elevated alt and ast which is indicative of liver (High) ALT increased she had blood work which showed an elevated ALT and AST which is indicative of liver damage.. On 01-Nov-2021, Lymphocyte count: low (Low) She also had some lymphopenia as her lymphocyte count was low.. On 04-Nov-2021, Blood test: counts were improving (normal) counts were improving.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient after receiving the booster dose it laid  really flat. patient felt really sick with chills, fever, nausea, and headache and  took 2 extra strength Tylenol, then took an additional 2 extra strength Tylenol 6 hours later. patient  also took an Aleve the following morning.On Monday 1NOV2021 patient had blood work which showed an elevated ALT and AST which is indicative of liver damage. patient also had some lymphopenia as the lymphocyte count was low. The primary care doctor of patient  advised her to stop taking her statins, NSAIDS, and Vitamins. patient  had additional blood work on 4NOV2021 which showed these counts were improving  Company's comment: This is a spontaneous case concerning a 66-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of liver injury. The events occurred approximately 1 day after the third dose of using mRNA-1273 . The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of using mRNA-1273  is not affected by this report.   This case was linked to MOD-2021-378182, MOD-2021-378200, MOD-2021-378201 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 66-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of liver injury. The events occurred approximately 1 day after the third dose of using mRNA-1273 . The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of using mRNA-1273  is not affected by this report.