Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Gait disturbance, Heart rate, Illness, Mental status changes
Clinical narrative: sick for a week; Myocarditis; Encephalitis; kidneys are shutting down; has feeding tube; AMS/altered mental status, not talking or walking; not talking or walking; not talking or walking; sporadic breathing; This spontaneous case was reported by a nurse and describes the occurrence of ENCEPHALITIS (Encephalitis), ACUTE KIDNEY INJURY (kidneys are shutting down), FEEDING DISORDER (has feeding tube), MENTAL STATUS CHANGES (AMS/altered mental status, not talking or walking), GAIT DISTURBANCE (not talking or walking), DYSARTHRIA (not talking or walking), RESPIRATION ABNORMAL (sporadic breathing), MYOCARDITIS (Myocarditis) and ILLNESS (sick for a week) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A and 022B218) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jul-2021, the patient experienced ENCEPHALITIS (Encephalitis) (seriousness criteria hospitalization, disability, medically significant and life threatening), ACUTE KIDNEY INJURY (kidneys are shutting down) (seriousness criteria hospitalization, disability, medically significant and life threatening), FEEDING DISORDER (has feeding tube) (seriousness criteria hospitalization, disability and life threatening), MENTAL STATUS CHANGES (AMS/altered mental status, not talking or walking) (seriousness criteria hospitalization, disability and life threatening), GAIT DISTURBANCE (not talking or walking) (seriousness criteria hospitalization, disability and life threatening), DYSARTHRIA (not talking or walking) (seriousness criteria hospitalization, disability and life threatening), RESPIRATION ABNORMAL (sporadic breathing) (seriousness criteria hospitalization, disability and life threatening) and MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization, disability, medically significant and life threatening). On an unknown date, the patient experienced ILLNESS (sick for a week) (seriousness criterion hospitalization). The patient was hospitalized on 24-Jul-2021 due to ACUTE KIDNEY INJURY, DYSARTHRIA, ENCEPHALITIS, FEEDING DISORDER, GAIT DISTURBANCE, ILLNESS, MENTAL STATUS CHANGES, MYOCARDITIS and RESPIRATION ABNORMAL. The patient was treated with Manual therapy (Tube feeding) for Feeding disorder. At the time of the report, ENCEPHALITIS (Encephalitis), ACUTE KIDNEY INJURY (kidneys are shutting down), FEEDING DISORDER (has feeding tube), MENTAL STATUS CHANGES (AMS/altered mental status, not talking or walking), GAIT DISTURBANCE (not talking or walking), DYSARTHRIA (not talking or walking), RESPIRATION ABNORMAL (sporadic breathing), MYOCARDITIS (Myocarditis) and ILLNESS (sick for a week) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) increased. On an unknown date, Electrocardiogram: normal (normal) normal (heart was good). On an unknown date, Heart rate: 140-160 (High) 140-160 beats per minute.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information included 2 antibiotics which seems like it was not working. Prior to the vaccination, the patient did not have any other problems. The patient went to the cardiologist in the week before the admission.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-272977 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.