Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Hepatic cancer metastatic, Immune system disorder, Positron emission tomogram
Clinical narrative: metastatic liver cancer came back/ she got two more 3mm tumors and the tumor that was 3mm increased to 5mm; metastatic liver cancer came back/ she got two more 3mm tumors and the tumor that was 3mm increased to 5mm; COVID-19 Vaccine messed up her immune system; This spontaneous case was reported by a patient and describes the occurrence of HEPATIC CANCER METASTATIC (metastatic liver cancer came back/ she got two more 3mm tumors and the tumor that was 3mm increased to 5mm) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PALBOCICLIB (IBRANCE) for Metastatic liver carcinoma.    The patient's past medical history included Radiation therapy and Mastectomy. Concurrent medical conditions included Metastatic liver carcinoma (cancer came back and metastasized to bones and liver) and Bone cancer metastatic.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and PALBOCICLIB (IBRANCE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HEPATIC CANCER METASTATIC (metastatic liver cancer came back/ she got two more 3mm tumors and the tumor that was 3mm increased to 5mm) (seriousness criterion medically significant) and CONDITION AGGRAVATED (metastatic liver cancer came back/ she got two more 3mm tumors and the tumor that was 3mm increased to 5mm). an unknown date, the patient experienced IMMUNE SYSTEM DISORDER (COVID-19 Vaccine messed up her immune system). At the time of the report, HEPATIC CANCER METASTATIC (metastatic liver cancer came back/ she got two more 3mm tumors and the tumor that was 3mm increased to 5mm), CONDITION AGGRAVATED (metastatic liver cancer came back/ she got two more 3mm tumors and the tumor that was 3mm increased to 5mm) and IMMUNE SYSTEM DISORDER (COVID-19 Vaccine messed up her immune system) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Positron emission tomogram: Cancer was clear.         No concomitant medication was reported.  Reportedly, patient was taking Ibrance for 5 years and recently her metastatic liver cancer came back. Patient had never been on chemo and now was on chemo due to cancer coming back.  Patient had to go off Ibrance to start chemo. Patient believed the COVID-19 vaccine messed up her immune system and that's why the cancer came back. Patient had a 3mm tumor on her liver. Patient clarified she had radiation, a mastectomy, and then the cancer came back and metastasized to bones and liver.  Patient was then put on Ibrance and the bones were fine. Patient had a few millimeter cancer left in her liver, was on Ibrance for 5 years and everything was fine. Right after having the COVID-19 Vaccine she got two more 3mm tumors and the tumor that was 3mm increased to 5mm. Her HCP took her off the Ibrance and put her on chemo. Two months after having the Moderna COVID-9 Vaccine her cancer came back.   Patient was on another drug for 3 years that stopped working before she was put on Ibrance but she forgets the name of that drug.  Treatment included chemo.  Company Comment: This is a spontaneous case concerning a elderly female patient with relevant past medical history of bone cancer metastatic and concurrent medical condition of metastatic liver cancer. The patient has co-suspect medication of Palbociclib (Ibrance). The patient experienced the unexpected serious (medically significant) event of hepatic cancer metastatic along with non-serious events of condition aggravated and immune system disorder. The events hepatic cancer metastatic and condition aggravated occurred approximately 2 months after the unknown dose number of mRNA-1273 vaccine administration. Allegedly the events were described as, the patient had 3-millimeter tumor on her liver. The patient underwent radiation and mastectomy but never underwent chemotherapy then the cancer came back and metastasized to the bones and liver. The patient was treated with Palbociclib (Ibrance) and the bones were fine. However, few millimeters of cancer was left in her liver. The patient was on Palbociclib (Ibrance) for 5 years and allegedly everything was fine. On unknown date, the patient received unknown dose number of mRNA-1273. It was reported that approximately 2 months after having the mRNA-1273 vaccine administration, the patient got two more 3-millimeter tumors and the tumor that was 3-millimeter increased to 5-millimeter. The patient's health care practitioner took her off from Palbociclib (Ibrance) and put her on unspecified chemotherapy. It was reported that the patient's last positron emission tomography (PET scan) was clear. The outcome of the events was unknown. No further clinical information was available for medical review. The medical history of bone cancer metastatic and the concurrent medical condition of metastatic liver cancer remain confounders for the events hepatic cancer metastatic and condition aggravated. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a elderly female patient with relevant past medical history of bone cancer metastatic and concurrent medical condition of metastatic liver cancer. The patient has co-suspect medication of Palbociclib (Ibrance). The patient experienced the unexpected serious (medically significant) event of hepatic cancer metastatic along with non-serious events of condition aggravated and immune system disorder. The events hepatic cancer metastatic and condition aggravated occurred approximately 2 months after the unknown dose number of mRNA-1273 vaccine administration. Allegedly the events were described as, the patient had 3-millimeter tumor on her liver. The patient underwent radiation and mastectomy but never underwent chemotherapy then the cancer came back and metastasized to the bones and liver. The patient was treated with Palbociclib (Ibrance) and the bones were fine. However, few millimeters of cancer was left in her liver. The patient was on Palbociclib (Ibrance) for 5 years and allegedly everything was fine. On unknown date, the patient received unknown dose number of mRNA-1273. It was reported that approximately 2 months after having the mRNA-1273 vaccine administration, the patient got two more 3-millimeter tumors and the tumor that was 3-millimeter increased to 5-millimeter. The patient's health care practitioner took her off from Palbociclib (Ibrance) and put her on unspecified chemotherapy. It was reported that the patient's last positron emission tomography (PET scan) was clear. The outcome of the events was unknown. No further clinical information was available for medical review. The medical history of bone cancer metastatic and the concurrent medical condition of metastatic liver cancer remain confounders for the events hepatic cancer metastatic and condition aggravated. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.