Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nephrolithiasis, Psoriasis
Clinical narrative: Psoriasis flare-up; She was sick; Kidney stones; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Kidney stones) in a 47-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Psoriasis.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. On 08-Apr-2022, the patient experienced NEPHROLITHIASIS (Kidney stones) (seriousness criterion medically significant) and ILLNESS (She was sick). On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up). At the time of the report, NEPHROLITHIASIS (Kidney stones) and ILLNESS (She was sick) outcome was unknown and PSORIASIS (Psoriasis flare-up) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication mentioned medication for a kidney condition that causes stones NOS. No treatment information mentioned.  Patient reported getting sick after having COVID vaccines and each booster. She had outbreaks during her last Skyrizi treatment.  Reporters causality of events with Skyrizi was no reasonable possibility.  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 47-years-old female patient with concurrent condition of Psoriasis treated with RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]), who experienced the unexpected serious(medically significant) event of Nephrolithiasis and along with the non-serious events of Psoriasis and Illness. The events occurred after receiving the third dose of mRNA-1273 vaccine. Latency cannot be assessed as the vaccination date was not disclosed. The information on clinical course, the concomitant medication and treatment details were not provided. The concurrent condition of Psoriasis treated with RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) could be risk factor for the event Psoriasis. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-623018 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Live Significant follow up. Event added.; Sender's Comments: This spontaneous case concerns 47-years-old female patient with concurrent condition of Psoriasis treated with RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]), who experienced the unexpected serious(medically significant) event of Nephrolithiasis and along with the non-serious events of Psoriasis and Illness. The events occurred after receiving the third dose of mRNA-1273 vaccine. Latency cannot be assessed as the vaccination date was not disclosed. The information on clinical course, the concomitant medication and treatment details were not provided. The concurrent condition of Psoriasis treated with RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) could be risk factor for the event Psoriasis. The benefit-risk relationship of mRNA-1273 is not affected by this report.