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Life Threatening? No
Write-up: cardiac death; Acute circulatory failure; Allergy; Acidosis; Discoloured vomit; This case was received via Regulatory Authority (Reference number: 2021TJP069671) on 05-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This case, reported by a physician via a medical representative, and reported to the Regulatory Authority by a physician, was received via the RA (Ref, v21122425). A patient had allergy to kiwi fruits and obesity. On an unknown date, body temperature before the vaccination: unknown. On 02-Aug-2021, around 18:00, the patient received the 1st dose of the vaccine. Around 19:30, the patient did not complain of any symptom. Around 20:00, a gurgling sound was heard from the bed, and a small amount of yellow colored vomit was noted. The patient did not respond to calls and had ill complexion. An emergency call was made, and cardiopulmonary resuscitation was started as instructed by the operations center. At 20:17, on arrival of the ambulance team, the patient was asystole and was transported with intubation and adrenaline administration by a physician. At 20:42, the patient arrived at the hospital. On arrival, JCS was 300, and the patient was asystole, had no spontaneous breathing, both dilated pupils of 6 mm in diameter, and coldness with poor skin tone of the whole body including the face. The patient was obese. Marked acidosis was found on the blood gas measurement. Resuscitation was continued thereafter , but there was no response. At 22:06, the patient was confirmed dead. The result of the SARS CoV-2 antigen test was negative. A whole-body CT scan after death was performed to investigate the cause of the death, which revealed a ground-glass opacity/consolidation in both lungs. However, there was a possibility that changes associated with cardiac massage, pulmonary congestion, or aspiration occurred. In addition, image findings showed a tendency of cardiac enlargement. The right heart strain was particularly suspected by the right sided enlargement. On 03-Aug-2021, the body was moved through the police to the university, and a legal autopsy was performed. The following were the details: 1) there were findings of acute circulatory failure such as congestion of the face, petechiae of the palpebral conjunctiva, cerebral edema, and pulmonary congestion. 2) reportedly, there were findings of suspected allergy such as edema of the epiglottis and submucosal petechiae of the larynx. The exact cause of death was unclear, but acute circulatory failure/acute cardiac death was suspected from the findings in the legal autopsy. The outcome of acute circulatory failure, acute cardiac death, allergy, acidosis, and yellow-colored vomit was reported as fatal. Follow-up investigation will be made.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient''s underlying obesity is a confounder.; Reported Cause(s) of Death: Cardiac death; Acute circulatory failure; Allergy; Acidosis; Vomiting
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