Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Metastases to liver, Positron emission tomogram
Clinical narrative: metastasized /spread to the liver; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021.    This spontaneous case was reported by a consumer and describes the occurrence of METASTASES TO LIVER (metastasized /spread to the liver) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Fluzone High-Dose Quadrivalent influenza in 2021. Past adverse reactions to the above products included No adverse event with Fluzone High-Dose Quadrivalent influenza. Concurrent medical conditions included Immunocompromised and Colon cancer stage IV.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jul-2021, the patient experienced METASTASES TO LIVER (metastasized /spread to the liver) (seriousness criterion medically significant). At the time of the report, METASTASES TO LIVER (metastasized /spread to the liver) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jul-2021, Positron emission tomogram: abnormal (abnormal) the cancer had metastasized and spread to the liver. On an unknown date, Computerised tomogram: inconclusive (Inconclusive) something suspicious was identified in her abdomen.         No concomitant drug details were reported.  Patient received the last chemotherapy treatment on 06-Jul-2021. Company Comment : This spontaneous case concerns a 77 year old female patient  with relevant medical history of Colon Cancer Stage IV, S/P chemotherapy  (on immune compromised state), vaccinated with flu vaccine, who experienced Serious (medically significant), unexpected event of metastases to liver which occurred 3 months , 26 days post vaccination with the 2nd dose of mRNA -1273 vaccine ( Moderna Covid 19 vaccine ) . The re-challenge for this case is not applicable since the outcome of the event is unknown. The current medical condition of Colon CA Stage IV is a confounder for this case . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a 77 year old female patient  with relevant medical history of Colon Cancer Stage IV, S/P chemotherapy  ( on immune compromised state) , vaccinated with flu vaccine , who experienced Serious ( medically significant ) , unexpected event of metastases to liver which occurred 3 months , 26 days post vaccination with the 2nd dose of mRNA -1273 vaccine ( Moderna Covid 19 vaccine ) . The re-challenge for this case is not applicable since the outcome of the event is unknown. The current medical condition of Colon CA Stage IV is a confounder for this case . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.