Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Renal impairment, SARS-CoV-2 test
Clinical narrative: Kidney dysfunction; COVID-19; This spontaneous case was reported by a physician and describes the occurrence of RENAL IMPAIRMENT (Kidney dysfunction) and COVID-19 (COVID-19) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A, 015M20A, 017B21A and 041J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Leflunamide and Ibuprofen. Past adverse reactions to the above products included Allergy with Ibuprofen and Leflunamide. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included HYDROXYCHLOROQUINE PHOSPHATE (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]) from 01-Jan-2010 to an unknown date and GOLIMUMAB from 22-Jul-2019 to 02-May-2022 for an unknown indication.   On 14-Jan-2021 at 1:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021 at 11:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022 at 11:00 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RENAL IMPAIRMENT (Kidney dysfunction) and COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 07-May-2022 to 11-May-2022 for COVID-19 vaccination, at an unspecified dose and frequency. At the time of the report, RENAL IMPAIRMENT (Kidney dysfunction) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Day 6 rapid antigen positive., negative (Negative) Day 10 rapid antigen negative, positive (Positive) antigen day 16 positive, positive (Positive) Repeat day 18 positive and positive (Positive) Rapid antigen positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking any medications/products within 2 weeks of starting COVID-19 treatment. Patient was previously received a COVID-19 Vaccine. Patient had some immune suppression due to treatment for Rheumatoid arthritis. The patient developed sore throat, malaise, fever, myalgias, fatigue and congestion starting 06 May. Took Paxlovid for 5 days starting May 7, with resolution of symptoms except fatigue. On day 12-13 developed increased nasal congestion, drainage, sneezing and fatigue. The patient took reduced dose of Paxlovid due to kidney dysfunction and had some immune suppression due to treatment for Rhematoid arthritis.  Company Comment: This is a spontaneous case concerning a 68-year-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 and Renal Impairment which occurred on an unknown date after receiving the fourth dose of mRNA-1273 Vaccine. As reported, patient had sore throat, malaise, fever, myalgias, fatigue, and congestion on May 6 and had positive on rapid antigen test. Started treatment with Paxlovid for 5 days. Rapid antigen positive on day 6, day 16, and day 18. Patient took reduced dose of Paxlovid due to kidney dysfunction. No other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 68-year-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 and Renal Impairment which occurred on an unknown date after receiving the fourth dose of mRNA-1273 Vaccine. As reported, patient had sore throat, malaise, fever, myalgias, fatigue, and congestion on May 6 and had positive on rapid antigen test. Started treatment with Paxlovid for 5 days. Rapid antigen positive on day 6, day 16, and day 18. Patient took reduced dose of Paxlovid due to kidney dysfunction. No other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.