Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Kidney infection
Clinical narrative: COVID INFECTION; KIDNEY INFECTION; This spontaneous case was reported by a consumer and describes the occurrence of KIDNEY INFECTION (KIDNEY INFECTION) 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 ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Kidney stones.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Nov-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Nov-2021, the patient experienced KIDNEY INFECTION (KIDNEY INFECTION) (seriousness criterion medically significant). On an unknown date, the patient experienced COVID-19 (COVID INFECTION). At the time of the report, KIDNEY INFECTION (KIDNEY INFECTION) was resolving and COVID-19 (COVID INFECTION) outcome was unknown.            No concomitant medication was reported.  Patient was enrolled in a COVID-19 Vaccine Trial.  Patient received Humira as Solution for injection in pre-filled pen.  The reporter's causality for the event(s) of KIDNEY INFECTION and COVID INFECTION with Humira was not provided.  No treatment information was provided.  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 47-year-old female patient, with relevant medical history of nephrolithiasis, who experienced the unexpected serious (medically significant) event of Kidney infection and unexpected non-serious AESI COVID-19. Kidney infection occurred 7 months and 7 days after receiving the 2nd dose of mRNA-1273 vaccine, and COVID-19 unknown. Clinical course and treatment details were not reported. The outcome of kidney infection was reported as resolving and COVID-19 unknown. Nephrolithiasis and co-suspect Adalimumab for rheumatoid arthritis remain as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 47-year-old female patient, with relevant medical history of nephrolithiasis, who experienced the unexpected serious (medically significant) event of Kidney infection and unexpected non-serious AESI COVID-19. Kidney infection occurred 7 months and 7 days after receiving the 2nd dose of mRNA-1273 vaccine, and COVID-19 unknown. Clinical course and treatment details were not reported. The outcome of kidney infection was reported as resolving and COVID-19 unknown. Nephrolithiasis and co-suspect Adalimumab for rheumatoid arthritis remain as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.