Report #2869276

Overview

Sex

Male

Age

70 yrs

State

—

Recovered

Not recovered

Vaccinated

—

Onset

Mar 1, 2023

Days to onset

—

Hospital days

—

Symptoms (1)

Symptom narrative

Cholangiocarcinoma/ being diagnosed with cancer/ it was in liver or bile duct/ bile duct cancer; This spontaneous case was reported by a consumer and describes the occurrence of CHOLANGIOCARCINOMA (Cholangiocarcinoma/ being diagnosed with cancer/ it was in liver or bile duct/ bile duct cancer) in a 70-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In March 2023, the patient experienced CHOLANGIOCARCINOMA (Cholangiocarcinoma/ being diagnosed with cancer/ it was in liver or bile duct/ bile duct cancer) (seriousness criterion medically significant). The patient was treated with Ivosidenib (Tibsovo) at an unspecified dose and frequency and Surgery (Underwent surgery for removing half the liver and gallbladder) for Cholangiocarcinoma. At the time of the report, CHOLANGIOCARCINOMA (Cholangiocarcinoma/ being diagnosed with cancer/ it was in liver or bile duct/ bile duct cancer) had not resolved. No concomitant medication was reported. The patient had been receiving Moderna COVID-19 vaccine doses ever since the vaccine came out, had it a couple times, at least 5 times. It was reported that the patient being diagnosed with cancer, discovered it in March 2023. It was in liver or bile duct. The name of the cancer was called cholangiocarcinoma, and it was a bile duct cancer. Reporter stated that medical interventions were done and patient's half liver and gallbladder were removed, and that was through surgery. The patient had received two types of chemotherapy, targeted radiation and then had immunotherapy. The patient was currently on targeted therapy drug called Tibsovo. It was unknown if the patient experienced any additional symptoms or events.; Reporter's Comments: Causality was assessed as not related, due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report.