Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood testosterone, Eastern Cooperative Oncology Group performance status, Imaging procedure, Metastatic neoplasm, Pathology test
Clinical narrative: most recent imaging demonstrates progression of metastatic disease.; This case was received via another Manufacturer (Reference number: NVSC2021US218703_OS) on 27-Sep-2021 and was forwarded to the company on 27-Sep-2021.     This spontaneous case was reported by a physician and describes the occurrence of METASTATIC NEOPLASM (most recent imaging demonstrates progression of metastatic disease.) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Radical prostatectomy on 07-Dec-2010 and Radiation therapy (Salvage radiation treatment) in 2014. Previously administered products included for Chemotherapy: DOCETAXEL from July 2019 to October 2020 and CABAZITAXEL from November 2020 to January 2021; for an unreported indication: ABIRATERONE (CYP171 inhibitor) from 2017 to 2018 and ENZALUTAMIDE (AR-directed therapy) from 2018 to 2019. Concurrent medical conditions included Allergy to antibiotic (Ciprofloaxacin. Patient experienced rash), Hyperthyroidism, Hyperlipidemia, Prostate cancer metastatic since June 2010 and Metastatic disease since 2017. Concomitant products included LEUPRORELIN ACETATE (LUPRON) from an unknown date to 31-Aug-2021 for Androgen therapy.    On 19-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced METASTATIC NEOPLASM (most recent imaging demonstrates progression of metastatic disease.) (seriousness criterion medically significant). At the time of the report, METASTATIC NEOPLASM (most recent imaging demonstrates progression of metastatic disease.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jul-2021, Pathology test: abnormal (abnormal) Seminal vesicle, left, tip of: negative for carcinomae. prostate,radical prostatectomy:1. Prostatic adenocarcinoma, bilateral lobes 2. Prostatic adenocarcinoma involves 20% of right lobe and < 5% of left lobe 3. Prostatic adenocarcinoma gleason pattern 3,3 score of 6, Bilaterally 4. Bilateral high grade prostatic intraepithelial neoplasia (pin) 5. Apical, base, and all margins of resection are negative for carcinoma. On 07-Sep-2021, Positron emission tomogram: negative (Negative) Bilateral vasa deferentia are negative for carcinoma pathologic stage :pt2 pn0 PMX imaging: 68ga-psma pet/ct. On an unknown date, Blood testosterone: low (Low) less than 50 ng/dL. On an unknown date, Oncology Group performance status: abnormal (abnormal) Positive for fatigue, dry mouth, constipation, mild incontinence (2-3 pads/day). Negative for significant pain, lower extremity swelling Castrate resistance: (Testosterone <50 ng/dL). On an unknown date, Imaging procedure: metastatic disease (abnormal) most recent imaging demonstrates progression of metastatic disease.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included Thyroid hormone. Patient involved in a clinical trial Immunotherapy AMG 160 16-Jun-2021-16-Sep-2021 (bispecific T-cell engager) immune therapy that engages patients' own T cells to kill prostate cancer cells by binding CD3 on T cells and prostate-specific membrane antigen (PSMA) on cancer cells.) Lab data included (12jun2021): Negative for extra prostatic extension of carcinoma, Negative for perineural invasion of carcinoma, Negative for vascular invasion of carcinoma, Bilateral seminal vesicles are negative for carcinoma Multiple foci of new and worsening of prior PSMA active lesions in the skull, cervical,thoracic, lumbar spine, bilateral ribs and femur shaft suggestive of osseous metastatic disease. These lesions expressed high PSMA expression activity. Worsening of PSMA activity in the retrocrural, retroperitoneal, bilateral common iliac and presacral lymphnodes consistent with nodal disease progression.  This case concerns a 63 year old male with history of castrate resistant prostate cancer and metastatic disease, who experienced the serious unexpected event of METASTATIC DISEASE (reported as progression of metastatic disease). The event occurred on an unknown date after receiving the third dose of Spikevax. Rechallenge is unknown since no additional dosing will be given. Patient's history of cancer and metastatic disease remain as confounders. The benefit-risk relation of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 63 year old male with history of castrate resistant prostate cancer and metastatic disease, who experienced the serious unexpected event of METASTATIC DISEASE (reported as progression of metastatic disease). The event occurred on an unknown date after receiving the third dose of Spikevax. Rechallenge is unknown since no additional dosing will be given. Patient's history of cancer and metastatic disease remain as confounders. The benefit-risk relation of Spikevax is not affected by this report.