Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound kidney, Urinary tract infection, Vaginal infection
Clinical narrative: Kidney stone; Vaginitis; Urinary tract infection; had Moderna vaccine and never felt quite right after; kidney mass 4.7 centimeters; thrush infection; Small cyst on kidney; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Kidney stone) in a 52-year-old female 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 Psoriatic arthritis and Panuveitis.    Concurrent medical conditions included Psoriatic arthritis and Panuveitis.   On 01-Jan-2005, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. 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 November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced RENAL CYST (Small cyst on kidney). On an unknown date, the patient experienced NEPHROLITHIASIS (Kidney stone) (seriousness criterion medically significant), VAGINAL INFECTION (Vaginitis), URINARY TRACT INFECTION (Urinary tract infection), MALAISE (had Moderna vaccine and never felt quite right after), RENAL MASS (kidney mass 4.7 centimeters) and CANDIDA INFECTION (thrush infection). At the time of the report, NEPHROLITHIASIS (Kidney stone), MALAISE (had Moderna vaccine and never felt quite right after) and RENAL CYST (Small cyst on kidney) outcome was unknown, VAGINAL INFECTION (Vaginitis), URINARY TRACT INFECTION (Urinary tract infection) and CANDIDA INFECTION (thrush infection) had resolved and RENAL MASS (kidney mass 4.7 centimeters) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Ultrasound kidney: Small cyst. On an unknown date, Ultrasound kidney: 4.7cm kidney mass.         No concomitant medications were reported.   It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event of small cyst on kidney, kidney mass 4.7 centimeters, had Moderna vaccine and never felt quite right after and kidney stone was not provided. The reporter's causality for the event(s) of urinary tract infection, vaginitis and thrush infection with Humira (adalimumab) was a reasonable possibility. The reporter assessed event feeling unwell as possibly related to Moderna Covid-19 vaccine.  The patient's lab data included ultrasound of kidneys in Nov-2021 (results not reported).  No treatment details were 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 52-year-old, female patient with concurrent conditions of psoriatic arthritis and panuveitis treated with adalimumab, who experienced an unexpected, medically significant of Nephrolithiasis in association with a dose of mRNA-1273 vaccine. Exact onset latency of the event relative to vaccination cannot be determined with unknown event's onset date and vaccination dates. Patient received a 2-dose primary series and a 3rd dose of mRNA-1273 vaccine. Within the same month of her 3rd COVID-19 vaccination, an ultrasound revealed smalls cysts in her kidneys. On unknown date, a kidney ultrasound revealed a 4.7 cm kidney mass of unknown laterality. Reportedly, patient never felt quite right after her mRNA-1273 vaccination. She reported urinary tract infection, vaginitis, and thrush infection on unknown dates. Patient's underlying psoriatic arthritis and treatment with adalimumab remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement and the available information.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 52-year-old, female patient with concurrent conditions of psoriatic arthritis and panuveitis treated with adalimumab, who experienced an unexpected, medically significant of Nephrolithiasis in association with a dose of mRNA-1273 vaccine. Exact onset latency of the event relative to vaccination cannot be determined with unknown event's onset date and vaccination dates. Patient received a 2-dose primary series and a 3rd dose of mRNA-1273 vaccine. Within the same month of her 3rd COVID-19 vaccination, an ultrasound revealed smalls cysts in her kidneys. On unknown date, a kidney ultrasound revealed a 4.7 cm kidney mass of unknown laterality. Reportedly, patient never felt quite right after her mRNA-1273 vaccination. She reported urinary tract infection, vaginitis, and thrush infection on unknown dates. Patient's underlying psoriatic arthritis and treatment with adalimumab remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement and the available information.