Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Eosinophilia, Gastroenteritis eosinophilic, Histology, Hypertensive heart disease, Polymerase chain reaction
Clinical narrative: Generalized eosinophilia/eosinophilic enteritis; Generalized eosinophilia/eosinophilic enteritis; Cardiomegaly; Pulmonary emphysema; Worsening of hypertensive and atherosclerotic cardiovascular disease; Worsening of hypertensive and atherosclerotic cardiovascular disease; Worsening of hypertensive and atherosclerotic cardiovascular disease; This literature-non-study case was reported in a literature article and describes the occurrence of GASTROENTERITIS EOSINOPHILIC (Generalized eosinophilia/eosinophilic enteritis), EOSINOPHILIA (Generalized eosinophilia/eosinophilic enteritis), CARDIOMEGALY (Cardiomegaly), EMPHYSEMA (Pulmonary emphysema), HYPERTENSIVE HEART DISEASE (Worsening of hypertensive and atherosclerotic cardiovascular disease), ARTERIOSCLEROSIS (Worsening of hypertensive and atherosclerotic cardiovascular disease) and CONDITION AGGRAVATED (Worsening of hypertensive and atherosclerotic cardiovascular disease) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.        Concurrent medical conditions included Obesity, Atherosclerotic cardiovascular disease, Hypertension, Hyperlipidemia, Type 2 diabetes mellitus, Prostate cancer, Coronary artery atherosclerosis and Cerebral atherosclerosis. Concomitant products included ATENOLOL, CHLORTALIDONE (ATENOLOL + CLORTALIDONA), FENOFIBRATE, GLIPIZIDE, LISINOPRIL, METFORMIN and PIOGLITAZONE for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GASTROENTERITIS EOSINOPHILIC (Generalized eosinophilia/eosinophilic enteritis) (seriousness criterion death), EOSINOPHILIA (Generalized eosinophilia/eosinophilic enteritis) (seriousness criterion death), CARDIOMEGALY (Cardiomegaly) (seriousness criteria death and medically significant), EMPHYSEMA (Pulmonary emphysema) (seriousness criteria death and medically significant), HYPERTENSIVE HEART DISEASE (Worsening of hypertensive and atherosclerotic cardiovascular disease) (seriousness criteria death and medically significant), ARTERIOSCLEROSIS (Worsening of hypertensive and atherosclerotic cardiovascular disease) (seriousness criteria death and medically significant) and CONDITION AGGRAVATED (Worsening of hypertensive and atherosclerotic cardiovascular disease) (seriousness criteria death and medically significant). The reported cause of death was generalized eosinophilia/eosinophilic enteritis, hypertensive and atherosclerotic cardiovascular disease, hypertensive and atherosclerotic cardiovascular disease, pulmonary emphysema, Diabetes mellitus, Obesity, generalized eosinophilia/eosinophilic enteritis and Cardiomegaly. An autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Autopsy: the body of a well-developed, well-nourished, morbidly obese  male whose appearance was compatible with the stated age of 76 years. The body was 71 inches long and weighed 325 pounds (body mass index of 45.3). The heart weighed 680 grams, while the left lung was 530 grams, and the right lung was 720 grams. Brain examination revealed an unremarkable adult brain weighing 1300 grams, and the cerebral arteries contained focal areas of mild atherosclerosis. Cardiovascular examination revealed cardiomegaly, mild to severe coronary artery atherosclerosis, and mild to severe aortic atherosclerosis. Respiratory examination revealed a congested and mottled parenchyma. Gastrointestinal system examination revealed grossly unremarkable esophageal mucosa, gastric mucosa, pancreas, liver, small intestines and large intestines. There were adhesions within the abdominal cavity and 1500 mL of serosanguinous fluid within the peritoneal cavity. Genitourinary system examination revealed granular subcapsular surfaces of the kidneys with thinned cortices.. On an unknown date, Histology: abundant eosinophils in tissues, including the small intestines, epicardium and lungs. Within the small intestine, there was an intense lymphoplasmacytic inflammatory infiltrate with numerous eosinophils; eosinophil counts ranged from "normal" to up >30 eosinophils per high-power field, consistent with a diagnosis of eosinophilic enteritis. The presence of numerous eosinophils in other organs (heart and lungs) was concerning for a systemic eosinophilic process. Also, it confirmed the presence of hypertensive and atherosclerotic cardiovascular disease and pulmonary emphysema. Liver examination was normal.. On an unknown date, Polymerase chain reaction: (Negative) Nasopharyngeal and  lung swabs were negative for viral infectious agents, including COVID-19..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GASTROENTERITIS EOSINOPHILIC (Generalized eosinophilia/eosinophilic enteritis), EOSINOPHILIA (Generalized eosinophilia/eosinophilic enteritis) and CONDITION AGGRAVATED (Worsening of hypertensive and atherosclerotic cardiovascular disease) to be related. No further causality assessments were provided for CARDIOMEGALY (Cardiomegaly), EMPHYSEMA (Pulmonary emphysema), HYPERTENSIVE HEART DISEASE (Worsening of hypertensive and atherosclerotic cardiovascular disease) and ARTERIOSCLEROSIS (Worsening of hypertensive and atherosclerotic cardiovascular disease).    The patient died at home while sitting on the couch witnessed by his wife. He did not have a history of significant gastrointestinal or respiratory disease. The death occurred indoors during late winter and there were no sudden changes to his status in the hours preceding his death. The patient received the Moderna COVID-19 vaccine 9 days prior to his death and experienced abdominal distension soon after vaccination on the same day. The abdominal distension continued to worsen and progressed to include shortness of breath in the days prior to death.  He did not seek medical care for these symptoms. He became unresponsive while watching television with his wife. Cardiopulmonary resuscitation (CPR) was initiated following emergency medical services (EMS) personnel arrival. Resuscitation efforts were unsuccessful, and the patient was pronounced dead. The temporal relationship between vaccination and onset of gastrointestinal symptoms suggested a possible association between the vaccine and the eosinophilic inflammatory process. This case represents a death related to multiple severe preexisting comorbidities, complicated by a history of new-onset gastrointestinal complaints which were temporally associated with recent COVID-19 vaccination and did not subside, but actually worsened prior to death. The eosinophilic inflammatory process was caused by the recent vaccination could be stated with certainty; however, the temporal association between vaccination, symptom onset/progression, and death, and in-light of the literature which suggests a possible association between coronavirus vaccination and eosinophilic reactions leads to the conclusion that this death might have been related to an adverse reaction to COVID-19 vaccination. Autopsy revealed evidence of eosinophilic enteritis, associated with ascites, as well as eosinophilic inflammation elsewhere, including the lungs and heart.  Company Comment: This is a literature non-study case concerning a 76-year-old male patient with Concurrent medical conditions that included Obesity, Atherosclerotic cardiovascular disease, Hypertension, Hyperlipidemia, Type 2 diabetes mellitus, Prostate cancer, Coronary artery atherosclerosis and Cerebral atherosclerosis, who experienced the serious unexpected events of gastroenteritis eosinophilic (reported as generalized eosinophilia/eosinophilic enteritis) (seriousness criterion death), eosinophilia (reported as generalized eosinophilia/eosinophilic enteritis) (seriousness criterion death), cardiomegaly (seriousness criteria death and medically significant), emphysema (seriousness criteria death and medically significant), hypertensive heart disease (reported as worsening of hypertensive and atherosclerotic cardiovascular disease) (seriousness criteria death and medically significant), arteriosclerosis (reported as worsening of hypertensive and atherosclerotic cardiovascular disease) (seriousness criteria death and medically significant) and condition aggravated (reported as worsening of hypertensive and atherosclerotic cardiovascular disease) (seriousness criteria death and medically significant). The events occurred 9 days after receiving a dose of mRNA-1273 vaccine (no events date or vaccination dates). The patient died at home while sitting on the couch witnessed by his wife. He did not have a history of significant gastrointestinal or respiratory disease. The death occurred indoors during late winter and there were no sudden changes to his status in the hours preceding his death.The patient received the Moderna COVID-19 vaccine 9 days prior to his death and experienced abdominal distension soon after vaccination on the same day. The abdominal distension continued to worsen and progressed to include shortness of breath in the days prior to death. He did not seek medical care for these symptoms. He became unresponsive while watching television with his wife. Cardiopulmonary resuscitation (CPR) was initiated following emergency medical services (EMS) personnel arrival. Resuscitation efforts were unsuccessful, and the patient was pronounced dead.  The reported cause of death was generalized eosinophilia/eosinophilic enteritis, hypertensive and atherosclerotic cardiovascular disease, hypertensive and atherosclerotic cardiovascular disease, pulmonary emphysema, Diabetes mellitus, Obesity, generalized eosinophilia/eosinophilic enteritis and Cardiomegaly. An autopsy was performed revealed evidence of eosinophilic enteritis, associated with ascites, as well as eosinophilic inflammation elsewhere, including the lungs and heart. Concomitant medications included atenolol, chlortalidone (atenolol + clortalidona), fenofibrate, glipizide, lisinopril, metformin and pioglitazone for an unknown indication. Relevant diagnostic tests included autopsy results which included cardiomegaly, mild to severe coronary artery atherosclerosis, and mild to severe aortic atherosclerosis. Respiratory examination revealed a congested and mottled parenchyma. Gastrointestinal system examination revealed grossly unremarkable esophageal mucosa. Polymerase chain reaction resulted Negative for viral infectious agents, including COVID-19. No treatment medications were reported. The mentioned concurrent conditions remains as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: Company Comment: This is a literature non-study case concerning a 76-year-old male patient with Concurrent medical conditions that included Obesity, Atherosclerotic cardiovascular disease, Hypertension, Hyperlipidemia, Type 2 diabetes mellitus, Prostate cancer, Coronary artery atherosclerosis and Cerebral atherosclerosis, who experienced the serious unexpected events of gastroenteritis eosinophilic (reported as generalized eosinophilia/eosinophilic enteritis) (seriousness criterion death), eosinophilia (reported as generalized eosinophilia/eosinophilic enteritis) (seriousness criterion death), cardiomegaly (seriousness criteria death and medically significant), emphysema (seriousness criteria death and medically significant), hypertensive heart disease (reported as worsening of hypertensive and atherosclerotic cardiovascular disease) (seriousness criteria death and medically significant), arteriosclerosis (reported as worsening of hypertensive and atherosclerotic cardiovascular disease) (seriousness criteria death and medically significant) and condition aggravated (reported as worsening of hypertensive and atherosclerotic cardiovascular disease) (seriousness criteria death and medically significant). The events occurred 9 days after receiving a dose of mRNA-1273 vaccine (no events date or vaccination dates). The patient died at home while sitting on the couch witnessed by his wife. He did not have a history of significant gastrointestinal or respiratory disease. The death occurred indoors during late winter and there were no sudden changes to his status in the hours preceding his death.The patient received the Moderna COVID-19 vaccine 9 days prior to his death and experienced abdominal distension soon after vaccination on the same day. The abdominal distension continued to worsen and progressed to include shortness of breath in the days prior to death. He did not seek medical care for these symptoms. He became unresponsive while watching television with his wife. Cardiopulmonary resuscitation (CPR) was initiated following emergency medical services (EMS) personnel arrival. Resuscitation efforts were unsuccessful, and the patient was pronounced dead.  The reported cause of death was generalized eosinophilia/eosinophilic enteritis, hypertensive and atherosclerotic cardiovascular disease, hypertensive and atherosclerotic cardiovascular disease, pulmonary emphysema, Diabetes mellitus, Obesity, generalized eosinophilia/eosinophilic enteritis and Cardiomegaly. An autopsy was performed revealed evidence of eosinophilic enteritis, associated with ascites, as well as eosinophilic inflammation elsewhere, including the lungs and heart. Concomitant medications included atenolol, chlortalidone (atenolol + clortalidona), fenofibrate, glipizide, lisinopril, metformin and pioglitazone for an unknown indication. Relevant diagnostic tests included autopsy results which included cardiomegaly, mild to severe coronary artery atherosclerosis, and mild to severe aortic atherosclerosis. Respiratory examination revealed a congested and mottled parenchyma. Gastrointestinal system examination revealed grossly unremarkable esophageal mucosa. Polymerase chain reaction resulted Negative for viral infectious agents, including COVID-19. No treatment medications were reported. The mentioned concurrent conditions remains as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Generalized eosinophilia/eosinophilic enteritis; Hypertensive and atherosclerotic cardiovascular disease; Hypertensive and atherosclerotic cardiovascular disease; Pulmonary emphysema; Diabetes mellitus; Obesity; Generalized eosinophilia/eosinophilic