Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Prostate cancer, Prostatic specific antigen, Prostatic specific antigen increased
Clinical narrative: battling advanced prostate cancer; PSA levels kept climbing to 122 percent; This spontaneous case was reported by a patient and describes the occurrence of PROSTATE CANCER (battling advanced prostate cancer) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Advanced prostate cancer since 03-Sep-2019.    On 17-Jan-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PROSTATE CANCER (battling advanced prostate cancer) (seriousness criterion medically significant) and PROSTATIC SPECIFIC ANTIGEN INCREASED (PSA levels kept climbing to 122 percent). The patient was treated with OLAPARIB (LYNPARZA) ongoing from 04-Sep-2022 for Advanced prostate cancer, at an unspecified dose and frequency; ABIRATERONE from September 2019 to April 2022 for Advanced prostate cancer, at an unspecified dose and frequency; PREDNISONE from September 2019 to April 2022 for Advanced prostate cancer, at an unspecified dose and frequency and ENZALUTAMIDE (XTANDI) from May 2022 to August 2022 at an unspecified dose and frequency. At the time of the report, PROSTATE CANCER (battling advanced prostate cancer) and PROSTATIC SPECIFIC ANTIGEN INCREASED (PSA levels kept climbing to 122 percent) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, Biopsy: CDK12 mutation. On an unknown date, Prostatic specific antigen: kept climbing to 122 percent.         Concomitant medication was not reported.  Medical history relating to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination. Patient was in the Phase 3 Moderna trial for Covid19. He was very pleased. It was told that patient would like to participate in a study which he saw online. He stated that he left the study August 2021, because he received a booster. He does not have lot numbers for primary series received in the study. Started Lynparza 04-Sep-2022 to present, but anticipates that it will stop Dec-2022, at his next appointment unless he finds a clinical trial.  Dose Number: 1 administered on 17Sep2020,Dose Number: 2 administered on 15Oct2020, Dose Number: Booster 1 administered on 17Aug2021.  Company Comment: This spontaneous case reported by a patient concerns a 68-year-old male, with relevant medical history of advance prostate cancer since 2019, who experienced unexpected, serious (medically significant) event progression of prostate cancer after receiving a fourth dose of mRNA-1273.  His prostate specific antigen levels kept on climbing to 122 percent.  Around 7 months post-vaccination, biopsy showed CDK12 mutation, and he was started on treatment with Olaparib.  The medical history of prostate cancer is a confounding factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 14-Nov-2022: Live follow-up received contains no new information.; Sender's Comments: This spontaneous case reported by a patient concerns a 68-year-old male, with relevant medical history of advance prostate cancer since 2019, who experienced unexpected, serious (medically significant) event progression of prostate cancer after receiving a fourth dose of mRNA-1273.  His prostate specific antigen levels kept on climbing to 122 percent.  Around 7 months post-vaccination, biopsy showed CDK12 mutation, and he was started on treatment with Olaparib.  The medical history of prostate cancer is a confounding factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.