Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Illness, Nephrolithiasis, Prostatic disorder, Synovial cyst
Clinical narrative: possible kidney stone; bakers cyst behind knee; Blood in urine; possible prostate tear; broken tooth; Illness; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (possible kidney stone) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2021, the patient experienced ILLNESS (Illness). In 2022, the patient experienced TOOTH FRACTURE (broken tooth). On an unknown date, the patient experienced NEPHROLITHIASIS (possible kidney stone) (seriousness criterion medically significant), SYNOVIAL CYST (bakers cyst behind knee), BLOOD URINE PRESENT (Blood in urine) and PROSTATIC DISORDER (possible prostate tear). At the time of the report, NEPHROLITHIASIS (possible kidney stone) and PROSTATIC DISORDER (possible prostate tear) outcome was unknown, ILLNESS (Illness) was resolving and SYNOVIAL CYST (bakers cyst behind knee), TOOTH FRACTURE (broken tooth) and BLOOD URINE PRESENT (Blood in urine) had not resolved.            Humira (solution for injection in pre-filled pen) was used for the indication of moderate to severe rheumatoid arthritis. Causality for Humira(adalimumab): the reporter's causality for the event(s) of illness, bakers cyst behind knee, possible prostate tear, possible kidney stone, broken tooth and blood in urine was not provided.  No concomitant drug was reported. No treatment drug was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment.  This spontaneous case concerns a 64  year  old male patient, with no relevant medical history, who received three doses of mRNA  1273 vaccine, and experienced the serious medically significant unexpected event of nephrolithiasis. Vaccination date and onset date of the event were not provided; hence latency and temporal association cannot be properly assessed. On an unspecified date, the patient presented blood urine present, which could be related with nephrolithiasis. No further clinical information was available for medical reviewing. Co-suspect product included Adalimumab. The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 64  year  old male patient, with no relevant medical history, who received three doses of mRNA  1273 vaccine, and experienced the serious medically significant unexpected event of nephrolithiasis. Vaccination date and onset date of the event were not provided; hence latency and temporal association cannot be properly assessed. On an unspecified date, the patient presented blood urine present, which could be related with nephrolithiasis. No further clinical information was available for medical reviewing. Co-suspect product included Adalimumab. The benefit risk relationship of mRNA-1273 is not affected by this report.