Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; hepatotoxicity; This spontaneous case was reported by a physician and describes the occurrence of HEPATOTOXICITY (hepatotoxicity) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056M21A, 033F21A, 032B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient not had any allergies.  The patient's past medical history included Tumour resection (Glioblastoma tumor in front right lobe was resected) in February 2021 and Chemotherapy (chemo drug 3 times in a row, like a Monday, Tuesday & Wednesday) since an unknown date. Concurrent medical conditions included Glioblastoma (Patient had glioblastoma. He had it for about a year.).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (sore arm). In May 2022, the patient experienced HEPATOTOXICITY (hepatotoxicity) (seriousness criterion medically significant). At the time of the report, HEPATOTOXICITY (hepatotoxicity) outcome was unknown and PAIN IN EXTREMITY (sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, Alanine aminotransferase: 329 (High) 329 (normal range is 54). On 18-May-2022, Aspartate aminotransferase: 103 (High) 103 (normal range is 30 or 40). On 23-May-2022, Alanine aminotransferase: 316 (High) 316 (normal range is 54). On 23-May-2022, Aspartate aminotransferase: 95 (High) 95 (normal range is 30 or 40). In 2022, AST/ALT ratio: showed 5 times more than normal elevation of ast/a (High) showed 5 times more than normal elevation of AST/ALT enzymes. In 2022, Blood alkaline phosphatase: 3 times the normal levels of the alkaline phosphat (High) 3 times the normal levels of the alkaline phosphatase enzyme.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HEPATOTOXICITY (hepatotoxicity) to be related. No further causality assessment was provided for PAIN IN EXTREMITY (sore arm).    Patient had been in a clinical trial for a brain tumor chemo medication with no side effects for more than 6 months. He got the chemo drug 3 times in a row, like a Monday, Tuesday & Wednesday. This would go on for about 4 weeks, & sometimes 5weeks if the month was longer.   He had both doses of Moderna Covid-19 vaccine & 2 booster doses of Moderna Covid-19 vaccine during chemo clinical trials. After the second booster dose of Moderna vaccine received on 14-May-2022, the patient showed 5 times more than normal elevation of AST/ALT enzymes and 3 times the normal levels of the alkaline phosphatase enzyme.  On 18-May-2022, ALT was 329 and AST was 103 which was 9-10 points higher. The blood work on 23-May-2022, showed that ALT was 316 (normal was 54) and AST was 95 (normal was 30 or 40).   This AE caused patient to seek medical care from clinical trials team. He was always in the standard range. He was going to be kicked out of the clinical trials if these labs did not come back down. He was given a 2 week grace period. Currently he had only 1 week left.  Patient had not received any new concomitant medication, he was followed up very closely and never showed before any hepatotoxicity related to the chemotherapy. T  he HCP mentioned that he suspected that the patient might have hepatotoxicity related to the vaccine.   No treatment information was provided.  Company Comment: This spontaneous case concerns a  69-year-old male patient, with relevant medical history of Tumor resection for Glioblastoma and subsequent Chemotherapy, who experienced the unexpected serious(medically significant) AESI of Hepatotoxicity. The event occurred on the same month of receiving the fourth dose of mRNA-1273 Vaccine (Primary doses and 1 booster - Moderna). It was reported that the AST/ALT ratio was 5 times more than normal levels and the alkaline phosphatase was 3 times above normal values. The patient had both doses of Moderna Covid-19 vaccine & 2 booster doses of Moderna Covid-19 vaccine during chemo clinical trials. The patient would undergo chemotherapy 3 times a week that went on for 4 to 5 weeks. The outcome of the event was reported as unknown. The patient's medical history of chemotherapy remain as a confounder for the occurrence of the event. The reporter considered Hepatotoxicity to be related to the product. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2022: Significant follow-up received: Case seriousness updated, reporter information added, patient details updated, event added, and I-narrative updated.; Sender's Comments: This spontaneous case concerns a  69-year-old male patient, with relevant medical history of Tumor resection for Glioblastoma and subsequent Chemotherapy, who experienced the unexpected serious(medically significant) AESI of Hepatotoxicity. The event occurred on the same month of receiving the fourth dose of mRNA-1273 Vaccine (Primary doses and 1 booster - Moderna). It was reported that the AST/ALT ratio was 5 times more than normal levels and the alkaline phosphatase was 3 times above normal values. The patient had both doses of Moderna Covid-19 vaccine & 2 booster doses of Moderna Covid-19 vaccine during chemo clinical trials. The patient would undergo chemotherapy 3 times a week that went on for 4 to 5 weeks. The outcome of the event was reported as unknown. The patient's medical history of chemotherapy remain as a confounder for the occurrence of the event. The reporter considered Hepatotoxicity to be related to the product. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.