Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ascites, Balance disorder, Blindness, Confusional state, Disorientation
Clinical narrative: ascites; Gradually lost eyesight; Complete kidney shutdown; Confused; Disoriented; Dizzy; Unabalanced; This spontaneous case was reported by a consumer and describes the occurrence of RENAL IMPAIRMENT (Complete kidney shutdown), BLINDNESS (Gradually lost eyesight), ASCITES (ascites), CONFUSIONAL STATE (Confused), DISORIENTATION (Disoriented), DIZZINESS (Dizzy) and BALANCE DISORDER (Unabalanced) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002FZ1A, 001A21A and 031620A) for COVID-19 vaccination.     The patient's past medical history included Paracentesis (5 liters of fluid was drained by paracentesis on 2sep2012) on 02-Sep-2012. Concomitant products included ALBUTEROL [SALBUTAMOL] for COPD.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced CONFUSIONAL STATE (Confused) (seriousness criterion hospitalization), DISORIENTATION (Disoriented) (seriousness criterion hospitalization), DIZZINESS (Dizzy) (seriousness criterion hospitalization) and BALANCE DISORDER (Unabalanced) (seriousness criterion hospitalization). On 08-Sep-2021, the patient experienced RENAL IMPAIRMENT (Complete kidney shutdown) (seriousness criteria hospitalization, disability and medically significant). On 09-Sep-2021, the patient experienced BLINDNESS (Gradually lost eyesight) (seriousness criteria hospitalization, disability and medically significant). On an unknown date, the patient experienced ASCITES (ascites) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 07-Sep-2021 due to ASCITES, BALANCE DISORDER, BLINDNESS, CONFUSIONAL STATE, DISORIENTATION, DIZZINESS and RENAL IMPAIRMENT. At the time of the report, RENAL IMPAIRMENT (Complete kidney shutdown), BLINDNESS (Gradually lost eyesight), ASCITES (ascites), CONFUSIONAL STATE (Confused), DISORIENTATION (Disoriented), DIZZINESS (Dizzy) and BALANCE DISORDER (Unabalanced) outcome was unknown.            No treatment information was provided.  This case concerns a 63-year-old, female patient with previous relevant medical history of chronic obstructive pulmonary disease, (COPD) , paracentesis and use of concomitant medication, who experienced the unexpected events of renal impairment, blindness, ascites, confusional state, disorientation, dizziness and balance disorder. The events occurred approximately 10 days after the third dose of mRNA-1273. The rechallenge was positive due the patient developed ascites after the second dose. The medical history of chronic obstructive pulmonary disease, (COPD), paracentesis and use of concomitant medication remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-320732, MOD-2021-320769 (Patient Link).; Sender's Comments: This case concerns a 63-year-old, female patient with previous relevant medical history of chronic obstructive pulmonary disease, (COPD) , paracentesis and use of concomitant medication, who experienced the unexpected events of renal impairment, blindness, ascites, confusional state, disorientation, dizziness and balance disorder. The events occurred approximately 10 days after the third dose of mRNA-1273. The rechallenge was positive due the patient developed ascites after the second dose. The medical history of chronic obstructive pulmonary disease, (COPD), paracentesis and use of concomitant medication remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.