Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Computerised tomogram, Dysuria, Haemorrhage urinary tract, Prostate cancer metastatic
Clinical narrative: Aggressive type prostate cancer; Bleeding with his urine; Restriction with his urine; Having pain with his urine; This spontaneous case was reported by a consumer and describes the occurrence of PROSTATE CANCER METASTATIC (Aggressive type prostate cancer), HAEMORRHAGE URINARY TRACT (Bleeding with his urine) and URINARY RETENTION (Restriction with his urine) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PROSTATE CANCER METASTATIC (Aggressive type prostate cancer) (seriousness criterion medically significant), HAEMORRHAGE URINARY TRACT (Bleeding with his urine) (seriousness criterion medically significant), URINARY RETENTION (Restriction with his urine) (seriousness criterion medically significant) and DYSURIA (Having pain with his urine). At the time of the report, PROSTATE CANCER METASTATIC (Aggressive type prostate cancer), HAEMORRHAGE URINARY TRACT (Bleeding with his urine), URINARY RETENTION (Restriction with his urine) and DYSURIA (Having pain with his urine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) Sharp rise in blood pressure. On an unknown date, Computerised tomogram: abnormal (abnormal) It has spread to lymph node and the bleeding was cause by a breaking through the urethra.. On an unknown date, Prostatic specific antigen: increased (High) PSA number went from 4 to 72..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   His PSA number went from 4 to 72. He has had the PSA test done every year, for the last 8 to 10 years it the number has been 3 or 4. There was no explanation regarding what could have caused the number to go drastically high as it did. It was a very dramatic sudden occurrence. He is currently taking hormone treatment. She gave consent to contact his doctor.   No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. Company Comment  This is a spontaneous case concerning a 71 year old, male patient with no medical history who experienced the unexpected Serious (Medically Significant) Adverse events of, Prostatic Cancer metastatic, and the unexpected non serious adverse events of Urethral haemorrhage, Urinary retention, Dysuria. He had sharp rise in blood pressure that later went away. The events occurred approximately a week or two after getting the 2nd dose of Moderna COVID 19 vaccine. Subject had no previous medical diagnoses. The subject was referred to the urologist and was diagnosed with aggressive type prostate carcinoma. His PSA test values went from 4 to 72. His previous PSA values for the past 8 to 10 years had been 3 to 4. The reason for the sudden rise in PSA values was not known. CT scan revealed metastasis to Lymph nodes and the bleeding was due to breakthrough in urethra.  The events were sudden in occurrence and he is currently taking Harmone treatment. No concomitant medications were reported. Outcome of the events were not reported. The benefit-risk relationship of Spikevax is not affected by this report; Sender's Comments: This is a spontaneous case concerning a 71 year old, male patient with no medical history who experienced the unexpected Serious (Medically Significant) Adverse events of, Prostatic Cancer metastatic, and the unexpected non serious adverse events of Urethral haemorrhage, Urinary retention, Dysuria. He had sharp rise in blood pressure that later went away. The events occurred approximately a week or two after getting the 2nd dose of Moderna COVID 19 vaccine. Subject had no previous medical diagnoses. The subject was referred to the urologist and was diagnosed with aggressive type prostate carcinoma. His PSA test values went from 4 to 72. His previous PSA values for the past 8 to 10 years had been 3 to 4. The reason for the sudden rise in PSA values was not known. CT scan revealed metastasis to Lymph nodes and the bleeding was due to breakthrough in urethra.  The events were sudden in occurrence and he is currently taking Harmone treatment. No concomitant medications were reported. Outcome of the events were not reported. The benefit-risk relationship of Spikevax is not affected by this report