Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Kidney infection, Nausea
Clinical narrative: KIDNEY INFECTIONS; NAUSEOUS; This spontaneous case was reported by a consumer and describes the occurrence of KIDNEY INFECTION (KIDNEY INFECTIONS) in a 69-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 UPADACITINIB (RINVOQ) tablet for Rheumatoid arthritis.    No Medical History information was reported.   On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2022, 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 UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. In January 2022, the patient experienced KIDNEY INFECTION (KIDNEY INFECTIONS) (seriousness criterion medically significant) and NAUSEA (NAUSEOUS). At the time of the report, KIDNEY INFECTION (KIDNEY INFECTIONS) and NAUSEA (NAUSEOUS) outcome was unknown.            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.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product use was reported.   All doses of vaccine including booster taken one in once.   In Jan-2022, the patient had a lot of kidney infections. Patient was nauseous after taking the Covid booster on 19-Jan-2022.  No treatment information was provided.  The reporter's causality with Rinvoq (Upadacitinib) for the events of kidney infections and nauseous was not provided.  Company comment: This spontaneous case concerns a 69-year-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) event of Kidney infection after receiving the mRNA-1273 vaccine. The event occurred within same month of administration of 3rd dose of mRNA-1273 vaccine along with the non-serious event of nausea. Clinical course and treatment details were not reported. The outcome of event was reported as unknown. Patient received primary series of mRNA-1273 vaccine 31 days apart, and the 3rd dose of mRNA-1273 vaccine was given approximately 6 months later. On unknown date, patient received co-suspect Upadacitinib for rheumatoid arthritis could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69-year-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) event of Kidney infection after receiving the mRNA-1273 vaccine. The event occurred within the same month of administration of 3rd dose of mRNA-1273 vaccine along with the non-serious event of nausea. Clinical course and treatment details were not reported. The outcome of event was reported as unknown. Patient received primary series of mRNA-1273 vaccine 31 days apart, and the 3rd dose of mRNA-1273 vaccine was given approximately 6 months later. On unknown date, patient received co-suspect Upadacitinib for rheumatoid arthritis could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.