Sex: U
Vaccine: COVID19-2
Symptoms: Liver disorder, Renal disorder
Clinical narrative: spot in the liver; spot in the kidney; This spontaneous case was reported by a consumer and describes the occurrence of LIVER DISORDER (spot in the liver) and RENAL DISORDER (spot in the kidney) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. ASKU, ASKU and ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Moderna COVID-19 Vaccine on 30-Mar-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.   On 30-Mar-2021, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIVER DISORDER (spot in the liver) and RENAL DISORDER (spot in the kidney). At the time of the report, LIVER DISORDER (spot in the liver) and RENAL DISORDER (spot in the kidney) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was reported.  It was reported that patient mentioned that she got the MRI to check a spot in the liver and a spot in the kidney to see "if it was benign.  Company Comment: This is a spontaneous case concerning an adult patient of unknown gender, with no reported medical history, who experienced the non-serious unexpected, events of liver disorder and renal disorder, which occurred on an unknown date after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as the booster dose of COVID-19 vaccination schedule. Temporal association cannot be assessed due to lack of information on onset date of the events and vaccination date. Patient reported a magnetic resonance being performed to check a spot in the liver and a spot in the kidney and confirm if they were benign. The outcome of the events was not reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report. No treatment medication information was reported. Sender's Comments: Company Comment: This is a spontaneous case concerning an adult patient of unknown gender, with no reported medical history, who experienced the non-serious unexpected, events of liver disorder and renal disorder, which occurred on an unknown date after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as the booster dose of COVID-19 vaccination schedule. Temporal association cannot be assessed due to lack of information on onset date of the events and vaccination date. Patient reported a magnetic resonance being performed to check a spot in the liver and a spot in the kidney and confirm if they were benign. The outcome of the events was not reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.