Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Hepatic cancer stage IV, Ultrasound scan
Clinical narrative: Stage 4 Liver Cancer; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC CANCER STAGE IV (Stage 4 Liver Cancer) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (First dose, Lot number-013A21A and  Expiry Date was unknown) on 04-Mar-2021, Moderna COVID-19 Vaccine (Second dose, Lot number-020A21A and  Expiry Date was unknown) on 01-Apr-2021, Moderna COVID-19 Vaccine (Third dose and Lot number-058F21A and Expiry Date was unknown) on 02-Apr-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Diabetes (For several years) and Blood pressure high (For several years). Concomitant products included LISINOPRIL for Blood pressure high, METFORMIN for Diabetes, ACETYLSALICYLIC ACID (ASPIRIN DC) and MEN for an unknown indication.    On 20-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2022, the patient experienced HEPATIC CANCER STAGE IV (Stage 4 Liver Cancer) (seriousness criteria death and medically significant). The patient was treated with INSULIN at an unspecified dose and frequency. The patient died on 08-Nov-2022. The reported cause of death was stage 4 liver cancer. It is unknown if an autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Blood test: blood work showed Liver problems. In 2022, Computerised tomogram: Liver Cancer. In 2022, Ultrasound scan: Liver Cancer.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that reporter and her husband received fourth dose of Moderna COVID-19 vaccine. He was not taking the Lisinopril all the time, so his blood pressure was not controlled. He visited the doctor every 4 months for routine checkup. In Sep-2022 he visited his doctor for usual checkup. The doctor started him on Insulin, then the Doctor followed with ultrasound and CT scan which showed Liver Cancer. He was diagnosed with stage 4 Liver Cancer in Sep-2022. He had 4 Chemo treatments which did not help. He died on 08-Nov-2022. She stated that her husband also took a baby Aspirin and daily Centrum vitamins for men.  Concomitant and Treatment medication was not provided.  Company comment: This fatal spontaneous case concerns a 69-year-old male patient with medical history  of Diabetes, Blood pressure high, concomitant products included LISINOPRIL and METFORMIN, Previously administered Moderna COVID-19 Vaccine (3 doses without adverse events) who experienced the unexpected seriousness criteria death and medically significant event of Hepatic cancer stage IV approximately 3 months after a dose of mRNA-1273 bivalent vaccine. He was treated by chemotherapy (4 sessions). Death occurred on November, 8, 2022. The cause of death was not reported. It is unknown if an autopsy was performed  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Stage 4 Liver Cancer