Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin abnormal, Injection site discolouration, Injection site reaction, Malignant melanoma stage II, Neoplasm skin
Clinical narrative: advanced metastatic melanoma/melanoma; adenocarcinoma/most likely cholangiocarcinoma that originated on bile duct and grew in the liver (two large masses 10cm on the right and 12 cm on the left of the liver; Currently even 3 months after several strokes; This spontaneous case was reported by a patient family member or friend and describes the occurrence of METASTATIC MALIGNANT MELANOMA (advanced metastatic melanoma/melanoma), CHOLANGIOCARCINOMA (adenocarcinoma/most likely cholangiocarcinoma that originated on bile duct and grew in the liver (two large masses 10cm on the right and 12 cm on the left of the liver) and CEREBROVASCULAR ACCIDENT (Currently even 3 months after several strokes) in a 72-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Nonsmoker.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced METASTATIC MALIGNANT MELANOMA (advanced metastatic melanoma/melanoma) (seriousness criterion medically significant), CHOLANGIOCARCINOMA (adenocarcinoma/most likely cholangiocarcinoma that originated on bile duct and grew in the liver (two large masses 10cm on the right and 12 cm on the left of the liver) (seriousness criterion medically significant) and CEREBROVASCULAR ACCIDENT (Currently even 3 months after several strokes) (seriousness criterion medically significant). At the time of the report, METASTATIC MALIGNANT MELANOMA (advanced metastatic melanoma/melanoma), CHOLANGIOCARCINOMA (adenocarcinoma/most likely cholangiocarcinoma that originated on bile duct and grew in the liver (two large masses 10cm on the right and 12 cm on the left of the liver) and CEREBROVASCULAR ACCIDENT (Currently even 3 months after several strokes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy liver: diagnosed with Adenocarcinoma (most likely cholangiocarcinoma that originated on bile duct and grew in the liver (two large masses 10cm on the right and 12 cm on the left of the liver). On an unknown date, Blood test: diagnosed with Adenocarcinoma (most likely cholangiocarcinoma that originated on bile duct and grew in the liver (two large masses 10cm on the right and 12 cm on the left of the liver). On an unknown date, Skin test: after imaging they found 10 small lesions on lungs and 2 large masses on liver as well as lymph nodes, they testes lymph nodes for melanoma.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that patient was diagnosed first with melanoma in the same place of the Moderna Covid vaccine injection. And that melanoma later removed surgically. After that, patient was diagnosed with advanced metastatic melanoma. Later after blood test and liver biopsy he was diagnosed with Adenocarcinoma most likely cholangiocarcinoma that originated on bile duct and grew in the liver. It was reported that his primary cancer was the one in the liver and the doctor wanted to start him on 2 chemo drugs and 1 immunotherapy as a standard treatment. Patient maintained healthy diet and he was on Mediterranean diet. Currently even 3 months after patient experienced several strokes and he regained walking and movement in his right hand, he exercises daily on a stationary bicycle for about 20-30 minutes.; Reporter's Comments: Company comment: Causality for events metastatic malignant melanoma and cholangiocarcinoma was assessed as not related due to nature of the events. Patient´s age remains as a contributory risk factor for cholangiocarcinoma. The benefit-risk relationship of product is not affected by this report.