Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Multiple organ dysfunction syndrome, Off label use, Renal failure, Vaccination site pain
Clinical narrative: major liver damaged.; He was scared and thought he was dying/horrible; Most of his organs shut down; he had kidney damage; doctor thought it may be due to dehydration; bad reaction to the antibiotics.; flu-like symptoms; Not safe for him to get the second shot right now; his arm hurt for several days; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), LIVER INJURY (major liver damaged.), ANXIETY (He was scared and thought he was dying/horrible), MULTIPLE ORGAN DYSFUNCTION SYNDROME (Most of his organs shut down), RENAL FAILURE (he had kidney damage), DEHYDRATION (doctor thought it may be due to dehydration) and ADVERSE DRUG REACTION (bad reaction to the antibiotics.) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 15-Jun-2021, the patient experienced VACCINATION SITE PAIN (his arm hurt for several days). On 18-Jun-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms) (seriousness criterion hospitalization). On 21-Jun-2021, the patient experienced LIVER INJURY (major liver damaged.) (seriousness criteria hospitalization and medically significant), ANXIETY (He was scared and thought he was dying/horrible) (seriousness criterion hospitalization), MULTIPLE ORGAN DYSFUNCTION SYNDROME (Most of his organs shut down) (seriousness criteria hospitalization and medically significant), RENAL FAILURE (he had kidney damage) (seriousness criteria hospitalization and medically significant), DEHYDRATION (doctor thought it may be due to dehydration) (seriousness criterion hospitalization) and ADVERSE DRUG REACTION (bad reaction to the antibiotics.) (seriousness criterion hospitalization). On an unknown date, the patient experienced OFF LABEL USE (Not safe for him to get the second shot right now). The patient was hospitalized on 21-Jun-2021 due to ADVERSE DRUG REACTION, ANXIETY, DEHYDRATION, INFLUENZA LIKE ILLNESS, LIVER INJURY, MULTIPLE ORGAN DYSFUNCTION SYNDROME and RENAL FAILURE. On 18-Jun-2021, VACCINATION SITE PAIN (his arm hurt for several days) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), LIVER INJURY (major liver damaged.), ANXIETY (He was scared and thought he was dying/horrible), MULTIPLE ORGAN DYSFUNCTION SYNDROME (Most of his organs shut down), RENAL FAILURE (he had kidney damage), DEHYDRATION (doctor thought it may be due to dehydration) and ADVERSE DRUG REACTION (bad reaction to the antibiotics.) outcome was unknown and OFF LABEL USE (Not safe for him to get the second shot right now) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was treated with antibiotics and other medication.  Concomitant medications was not reported.  Company Comment : This case concerns a 41-year-old male patient with no details on past medical history, who experienced the unexpected events of Influenza like illness, Dehydration, Liver injury, Renal Failure, Multiple organ dysfunction syndrome and Adverse reaction to antibiotics after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). Additionally, off label doses frequency has been captured. The onset of the events occurred approximately 3 days after the first dose of Spikevax, and the patient was hospitalized on the fifth day after vaccination. The rechallenge was not applicable since only information about one dose was disclosed. The benefit-risk relationship of Spikevax vaccine is not affected by this report. Adverse drug reaction to antibiotics is assessed as unlikely related to mRNA-1273 and the causal association of Off label dosing frequency is assessed as not applicable. Follow up has been requested. Adverse drug reaction to antibiotics is assessed as unlikely related to mRNA-1273 and the causal association of Off label dosing frequency is assessed as not applicable. Follow up has been requested.; Sender's Comments: This case concerns a 41-year-old male patient with no details on past medical history, who experienced the unexpected events of Influenza like illness, Dehydration, Liver injury, Renal Failure, Multiple organ dysfunction syndrome and Adverse reaction to antibiotics after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). Additionally, off label doses frequency has been captured. The onset of the events occurred approximately 3 days after the first dose of Spikevax, and the patient was hospitalized on the fifth day after vaccination. The rechallenge was not applicable since only information about one dose was disclosed. The benefit-risk relationship of Spikevax vaccine is not affected by this report. Adverse drug reaction to antibiotics is assessed as unlikely related to mRNA-1273 and the causal association of Off label dosing frequency is assessed as not applicable. Follow up has been requested. Adverse drug reaction to antibiotics is assessed as unlikely related to mRNA-1273 and the causal association of Off label dosing frequency is assessed as not applicable. Follow up has been requested.