Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Prostate cancer
Clinical narrative: Immunocompromised patient received dose 2 on 31-Mar-2021 and dose 3 on 04-Sep-2021; diagnosed with Prostate Cancer; This spontaneous case was reported by a patient and describes the occurrence of PROSTATE CANCER (diagnosed with Prostate Cancer) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A, 006B21A, 020F21A, 083J21A and 016B22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Prostatic disorder NOS since 2021 and Immunocompromised.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PROSTATE CANCER (diagnosed with Prostate Cancer) (seriousness criterion medically significant). On 04-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Immunocompromised patient received dose 2 on 31-Mar-2021 and dose 3 on 04-Sep-2021). The patient was treated with Radiotherapy (Radiation in Jul-2021) for Prostate cancer. At the time of the report, PROSTATE CANCER (diagnosed with Prostate Cancer) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Immunocompromised patient received dose 2 on 31-Mar-2021 and dose 3 on 04-Sep-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Patient received Dose 6 of bivalent booster on 26-Oct-2022 with lot number 060D22A. It was reported that patient had symptoms of prostate disease prior to vaccination in 2021. After the primary vaccines in Mar-2021 he was diagnosed with Prostate Cancer. He stated that the vaccine did not make his prostate symptoms worst. He had radiation in Jul-2021 to treat prostate cancer.  On jan-2022 he did not have COVID symptoms and did not tested positive. He continued home testing and continued to be negative for COVID.  Company comment:This Spontaneous case reported by a 67 years old male Patient, with no relevant medical history, who experienced the unexpected serious (medically significant) event of prostate cancer, which occurred 28 days after the first dose of mRNA-1273 vaccination. Patient states that he had symptoms of prostate cancer prior to vaccination in 2021, diagnosed with the Prostate Cancer after the second dose and he also received radiation to treat prostate cancer. Patient travelled in cruise, some passengers had covid they were positive, patient did not had covid symptoms continued to be negative for COVID. At the time of reporting event is not recovered. The benefit-risk relationship of mRNA-1273 vaccination is not affected by this report.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Apr-2023: Follow-up  Live-Significant information accepted (patient age group, narrative update received)