Age: 52.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bacterial test, Bacterial test positive, Bladder spasm, Blood urine, Blood urine present
Clinical narrative: urinary tract infection; Urinary tract infection like symptoms which was bladder spasm; Kidney cancer; Mass on right kidney; Blood in urine; bacteria urine identified; Flank pain; This spontaneous case was reported by a physician and describes the occurrence of RENAL CANCER (Kidney cancer) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PANCREATIN (CREON) for Pancreatic exocrine insufficiency.    Previously administered products included for Product used for unknown indication: CIPROFLOXACIN, NUBAIN, kefzol, MORPHINE and CHLORHEXIDINE. Past adverse reactions to the above products included No adverse event with CHLORHEXIDINE, CIPROFLOXACIN, MORPHINE, NUBAIN and kefzol. Concurrent medical conditions included Tobacco user (15 cigarette sticks a day.) since 1988, Latex allergy (Manifested by rash, tongue swells and anaphylactic reaction.), Contrast media allergy (Manifested by rash, tongue swells, anaphylactic reaction and end up on a ventilator.), Shellfish allergy (Manifested by anaphylactic reaction.), Drug allergy (Morphine allergy manifested by anaphylactic reaction.), Penicillin allergy (Manifested by hives.), Drug allergy (Kefzol allergy manifested by rash.), Drug allergy (Ciprofloxacin allergy manifested by rash.) and Drug allergy (Nubain allergy manifested by vomiting).   In 2019, the patient started PANCREATIN (CREON) (Oral) 3600 unit. On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced FLANK PAIN (Flank pain). On 16-Apr-2021, the patient experienced RENAL MASS (Mass on right kidney), BLOOD URINE PRESENT (Blood in urine) and BACTERIAL TEST POSITIVE (bacteria urine identified). On 04-May-2021, the patient experienced RENAL CANCER (Kidney cancer) (seriousness criterion medically significant). On 07-May-2021, the patient experienced BLADDER SPASM (Urinary tract infection like symptoms which was bladder spasm). On 11-May-2021, the patient experienced URINARY TRACT INFECTION (urinary tract infection). At the time of the report, RENAL CANCER (Kidney cancer), FLANK PAIN (Flank pain), RENAL MASS (Mass on right kidney), BLADDER SPASM (Urinary tract infection like symptoms which was bladder spasm), URINARY TRACT INFECTION (urinary tract infection), BLOOD URINE PRESENT (Blood in urine) and BACTERIAL TEST POSITIVE (bacteria urine identified) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Bacterial test: positive (Positive) Positive. On 16-Apr-2021, Blood urine: present (Inconclusive) Present. On 16-Apr-2021, Urine analysis: inconclusive (Inconclusive) Showed blood in urine, Showing some bacteria..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered RENAL CANCER (Kidney cancer), BLADDER SPASM (Urinary tract infection like symptoms which was bladder spasm) and URINARY TRACT INFECTION (urinary tract infection) to be not related. No further causality assessments were provided for FLANK PAIN (Flank pain), RENAL MASS (Mass on right kidney), BLOOD URINE PRESENT (Blood in urine) and BACTERIAL TEST POSITIVE (bacteria urine identified).    Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.