Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Prostate cancer
Clinical narrative: diagnosed with prostate cancer on Aug 2022 and mentioned being immunosuppressed; This spontaneous case was reported by a pharmacist and describes the occurrence of PROSTATE CANCER (diagnosed with prostate cancer on Aug 2022 and mentioned being immunosuppressed) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004m21a, 039f21a, 032l20a and 032l20a) for COVID-19 vaccination.     It was reported that patient had no allergies and had no other medical history relating to mentioned AE at the time of vaccination. Patient never had COVID positive test or diagnosis.  Previously administered products included for Product used for unknown indication: Flu shot (flu shoot 5 or 6 weeks ago) in 2022. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Immunosuppression.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2022, the patient experienced PROSTATE CANCER (diagnosed with prostate cancer on Aug 2022 and mentioned being immunosuppressed) (seriousness criteria hospitalization and medically significant). At the time of the report, PROSTATE CANCER (diagnosed with prostate cancer on Aug 2022 and mentioned being immunosuppressed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. It was reported that patient did seek medical care for AE. Treatment medications were not provided.  Company comment  This spontaneous case reported by a pharmacist, concerns a 70 year old male patient with no relevant medical history reported, who experienced the unexpected, serious (Hospitalization, Medically significant) event of PROSTATE CANCER (diagnosed with prostate cancer on Aug 2022 and mentioned being immunosuppressed) about 02 months after receiving the 04 dose with mRNA-1273 vaccine in the COVID-19 vaccination series. Previously administered products included 3 doses of Moderna vaccines at appropriate intervals and Flu shot (flu shoot 5 or 6 weeks ago) in 2022 with no adverse events reported with Flu shot. Concurrent medical conditions included Immunosuppression. No further information on the comorbidities, risk factors, clinical course, Lab investigations, concomitant and treatment medications was available in the report. Elderly age of the patient was a significant risk factor. The event outcome was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case reported by a pharmacist, concerns a 70 year old male patient with no relevant medical history reported, who experienced the unexpected, serious (Hospitalization, Medically significant) event of PROSTATE CANCER (diagnosed with prostate cancer on Aug 2022 and mentioned being immunosuppressed) about 02 months after receiving the 04 dose with mRNA-1273 vaccine in the COVID-19 vaccination series. Previously administered products included 3 doses of Moderna vaccines at appropriate intervals and Flu shot (flu shoot 5 or 6 weeks ago) in 2022 with no adverse events reported with Flu shot. Concurrent medical conditions included Immunosuppression. No further information on the comorbidities, risk factors, clinical course, Lab investigations, concomitant and treatment medications was available in the report. Elderly age of the patient was a significant risk factor. The event outcome was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.