Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Aortic dissection, Blood pressure measurement, Burning sensation, Dyspnoea
Clinical narrative: Aortic Dissection hemostatic shock; Anaphylactic shock; Paralyze in  the lower half of her body; Clotting; Excessive bleeding; Burning sensation going down to her spine; Difficulty breathing; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock), PARALYSIS (Paralyze in  the lower half of her body), THROMBOSIS (Clotting), HAEMORRHAGE (Excessive bleeding), BURNING SENSATION (Burning sensation going down to her spine), DYSPNOEA (Difficulty breathing) and AORTIC DISSECTION (Aortic Dissection hemostatic shock) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054c21a and 009c21a) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery on 18-May-2021.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criteria death, hospitalization and medically significant), PARALYSIS (Paralyze in  the lower half of her body) (seriousness criteria death, hospitalization and medically significant), THROMBOSIS (Clotting) (seriousness criteria death, hospitalization and medically significant), HAEMORRHAGE (Excessive bleeding) (seriousness criteria death, hospitalization and medically significant), BURNING SENSATION (Burning sensation going down to her spine) (seriousness criteria death and hospitalization) and DYSPNOEA (Difficulty breathing) (seriousness criteria death and hospitalization). On an unknown date, the patient experienced AORTIC DISSECTION (Aortic Dissection hemostatic shock) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized from 22-Jun-2021 to 04-Jul-2021 due to ANAPHYLACTIC SHOCK, BURNING SENSATION, DYSPNOEA, HAEMORRHAGE, PARALYSIS and THROMBOSIS. The patient died on 04-Jul-2021. The reported cause of death was aortic dissection hemostatic shock. An autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jun-2021, Blood pressure measurement: decreased (abnormal) Systolic blood pressure <90 mmHg. On 22-Jun-2021, Heart rate: increased (abnormal) Heart rate >100 beats per min.         No relevant concomitant medications were reported. Oxygen was given as treatment.  She had the second dose on 22JUN2021. 5 hours after the vaccine, she had a burning sensation going down to her spine. Then she was paralyzed in the lower half of her body. She was rush to the local hospital. She was medevac to another hospital. She had clotting and excessive bleeding. She was in the hospital for 13 days. She passed on 04JUL2021  Company comment: This is a case of sudden death in a 75-year-old male subject with hx of open heart surgery, who died 12 days  after receiving second dose of vaccine. Very limited information has been provided at this time. However, recent open heart surgery might have at least partially contributed to the events occurrence.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received- Patient demographics, cause of death, lab data, causality and vaccination details updated.; Sender's Comments: This is a case of sudden death in a 75-year-old male subject with hx of open heart surgery, who died 12 days  after receiving second dose of vaccine. Very limited information has been provided at this time. However, recent open heart surgery might have at least partially contributed to the events occurrence.; Reported Cause(s) of Death: Aortic Dissection hemostatic shock