Sex: M
Vaccine: COVID19
Symptoms: Gleason grading score, Prostate cancer
Clinical narrative: received his new Moderna vaccine and has recently been diagnosed with prostate cancer, Gleason 7, PSA 10.9/solid tumors within the prostate only; This spontaneous case was reported by a patient and describes the occurrence of PROSTATE CANCER (received his new Moderna vaccine and has recently been diagnosed with prostate cancer, Gleason 7, PSA 10.9/solid tumors within the prostate only) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Radical prostatectomy (5 years ago had undergone radical prostatectomy).    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 PROSTATE CANCER (received his new Moderna vaccine and has recently been diagnosed with prostate cancer, Gleason 7, PSA 10.9/solid tumors within the prostate only) (seriousness criterion medically significant). At the time of the report, PROSTATE CANCER (received his new Moderna vaccine and has recently been diagnosed with prostate cancer, Gleason 7, PSA 10.9/solid tumors within the prostate only) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Gleason grading score: Gleason 7, PSA 10.9 solid tumors within the prostate.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Reporter questioned 5 years after radical prostatectomy can messenger RNA vaccine therapeutic used to attack the newly elevated return of elevated PSA cancer cells, he just received new Moderna vaccine.   It was reported that his prostate cancer that was confined within his tumor in his prostate (that was not enlarged) would be easy to biopsy via the peritoneal (needle biopsy) to be used to create an individualized therapeutic vaccine to attack the tumor to kill the cancer cells. But if course much more important than helping just his prostate cancer, this could be used to help the most importantly this method can help the hundreds of thousands of men worldwide men who were diagnosed each year.  Treatment information was not provided.  Company comment: This spontaneous case concerns a male patient of unknown age with medical history of radical prostatectomy (5 years prior to current event), who experienced the unexpected serious (medically significant) event of prostate cancer. As reported, after receiving Moderna vaccine and patient has been diagnosed with prostate cancer, Gleason 7, PSA 10.9 which patient believed to be solid tumor within the prostate only. The exact temporal association between the event and a dose of mRNA-1273 is unclear. Reportedly, patient questioned if messenger RNA vaccine therapeutic can be used to attack the newly elevated return of elevated PSA cancer cells 5 years after radical prostatectomy. No further information about the events was provided. Considering the reported information and nature of the reported event with lack of biological plausibility for causality and medical history of radical prostatectomy 5 years prior to event suggesting pre-existing risk causality for prostate cancer is assessed as not related. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-339293 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2024: Live follow-up information received included non-significant information updated event verbatim and added reference numbers in reference section. On 20-Sep-2024: Live follow-up information received included no new information.