Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Burning mouth syndrome, COVID-19, Dry mouth, Oral discomfort, Renal disorder
Clinical narrative: Kidney problems about 10 months after 2nd Shot; Burning mouth Syndrome  about 11 months after 2nd Shot and after COVID Disease; COVID Disease about 11 months after 2nd Shot; After the 2nd shot he had a burning mouth, Dry Mouth and it goes away and it comes back; After the 2nd shot he had a burning mouth, Dry Mouth and it goes away and it comes back; This spontaneous case was reported by a patient and describes the occurrence of RENAL DISORDER (Kidney problems about 10 months after 2nd Shot) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced ORAL DISCOMFORT (After the 2nd shot he had a burning mouth, Dry Mouth and it goes away and it comes back) and DRY MOUTH (After the 2nd shot he had a burning mouth, Dry Mouth and it goes away and it comes back). In December 2021, the patient experienced RENAL DISORDER (Kidney problems about 10 months after 2nd Shot) (seriousness criterion hospitalization) and COVID-19 (COVID Disease about 11 months after 2nd Shot). In January 2022, the patient experienced BURNING MOUTH SYNDROME (Burning mouth Syndrome  about 11 months after 2nd Shot and after COVID Disease). At the time of the report, RENAL DISORDER (Kidney problems about 10 months after 2nd Shot) and COVID-19 (COVID Disease about 11 months after 2nd Shot) outcome was unknown and ORAL DISCOMFORT (After the 2nd shot he had a burning mouth, Dry Mouth and it goes away and it comes back), DRY MOUTH (After the 2nd shot he had a burning mouth, Dry Mouth and it goes away and it comes back) and BURNING MOUTH SYNDROME (Burning mouth Syndrome  about 11 months after 2nd Shot and after COVID Disease) had not resolved.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment: This spontaneous case concerns a 69 year-old male patient, with a relevant history of diabetes, who experienced the unexpected serious (hospitalization) event of Kidney disorder and unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred approximately 10 months after the second dose of mRNA-1273 vaccine administration. Treatment information was not provided. Underlying history of diabetes and patient's age could be  confounders for the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-614424 (Patient Link).; Sender's Comments: This spontaneous case concerns a 69 year-old male patient, with a relevant history of diabetes, who experienced the unexpected serious (hospitalization) event of Kidney disorder and unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred approximately 10 months after the second dose of mRNA-1273 vaccine administration. Treatment information was not provided. Underlying history of diabetes and patient's age could be  confounders for the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.