Received Mar 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
Kidney insufficiency; Rising PSA levels; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (Kidney insufficiency) in a 74-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Prostate cancer (prostate cancer survivor) in 2016, Prostate surgery (prostate cancer survivor, having had cancer since 2016 with surgery in 2016) in 2016 and Radiation therapy in 2019. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced RENAL FAILURE (Kidney insufficiency) (seriousness criterion medically significant) and PROSTATIC SPECIFIC ANTIGEN INCREASED (Rising PSA levels). At the time of the report, RENAL FAILURE (Kidney insufficiency) and PROSTATIC SPECIFIC ANTIGEN INCREASED (Rising PSA levels) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, Blood creatinine: 1.1. In 2026, Blood creatinine: 1.36. In 2026, Prostatic specific antigen: rising PSA levels. No concomitant medication was reported. The patient had been taking the Moderna vaccine (Spikevax) every 6 months for the past 3 years. He was currently experiencing rising PSA levels, with a blood test scheduled for 10-Mar-2026. He had kidney insufficiency with creatinine levels rising from 1.1 in 2023 to 1.36 recently but not attributing it to the vaccine. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Medical History/Concurrent Conditions: Prostate cancer (prostate cancer survivor); Prostate surgery (prostate cancer survivor, having had cancer since 2016 with surgery in 2016); Radiation therapy
Test Date: 2023; Test Name: Creatinine; Result Unstructured Data: 1.1; Test Date: 2026; Test Name: Creatinine; Result Unstructured Data: 1.36; Test Date: 2026; Test Name: PSA levels; Result Unstructured Data: rising PSA levels