Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Prostate cancer, Rash
Clinical narrative: after each one of the vaccines caller experienced an exacerbated rash; prostate cancer; This spontaneous case was reported by a patient and describes the occurrence of PROSTATE CANCER (prostate cancer) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7166B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Transient global amnesia (patient already experienced 2 previous TGA episodes before getting any of the COVID-19 shots. 1st episode between 2011 and 2014 (he did not remember the exact year).), Transient global amnesia (patient already experienced 2 previous TGA episodes before getting any of the COVID-19 shots.2nd episode happened on SEP 2019) in September 2019, Rash and Chemical exposure.    On 23-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In November 2022, the patient experienced PROSTATE CANCER (prostate cancer) (seriousness criterion medically significant). On an unknown date, the patient experienced RASH (after each one of the vaccines caller experienced an exacerbated rash). The patient was treated with TRIAMCINOLONE at an unspecified dose and frequency and Radiotherapy (The patient had been treated with hormones and 28 radiation sessions so far) for Prostate cancer. At the time of the report, PROSTATE CANCER (prostate cancer) had not resolved and RASH (after each one of the vaccines caller experienced an exacerbated rash) had resolved.            The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. It was reported that after each one of the vaccines, the patient experienced an exacerbated rash that the patient had before because the patient was a veteran and was exposed to orange agent, the rash lasted approximately from a couple days to 1 week after each vaccine, and it was treated with Triamcinolone which was a steroid cream to treat topical rashes. On Nov-2022, the patient was diagnosed with prostate cancer and had been treated with hormones and 28 radiation sessions so far. The patient had experienced several health conditions derived from cance.  Company Comment: This is a Spontaneous case concerning a 77-year-old male patient, with medical history of agent orange exposure, who experienced the serious (per medically significant) unexpected event of Prostate cancer. The patient was diagnosed with prostate cancer on the month after a dose of mRNA-1273 BIVALENT .222 received as the fifth dose for COVID-19 Vaccination. Considering the natural ethiopathogenesis of the event of prostate cancer, patient's advanced age and medical history of agent orange exposure as risk factors, causality remains not related. No further clinical information or diagnostic tests results were disclosed for analysis. It was reported that the patient had been treated with hormones and 28 radiation sessions with several derived health conditions. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2023-748572, MOD-2023-748588 (Patient Link).