Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin, Troponin increased, Unresponsive to stimuli, Vaccination failure
Clinical narrative: DEATH; ACUTE KIDNEY INJURY; PULMONARY FIBROSIS; SEPTIC SHOCK; RESPIRATORY DISTRESS; DEPENDENCE ON RESPIRATOR; APNOEA; ATRIAL FIBRILLATION; BLOOD LOSS ANAEMIA; CHRONIC KIDNEY DISEASE; GASTRIC ULCER PERFORATION; GASTROINTESTINAL FISTULA; PNEUMOPERITONEUM; INTERSTITIAL LUNG DISEASE; METABOLIC ENCEPHALOPATHY; PERITONITIS; PNEUMONIA BACTERIAL; UNRESPONSIVE TO STIMULI; EXPLORATIVE LAPAROTOMY; ELECTROLYTE IMBALANCE; CENTRAL VENOUS CATHETERISATION; INFUSION; EXTUBATION; ENDOTRACHEAL INTUBATION; INTENSIVE CARE; LUNG OPACITY; CHEST X-RAY ABNORMAL; COMPUTERISED TOMOGRAM ABNORMAL; COMPUTERISED TOMOGRAM PELVIS ABNORMAL; COMPUTERISED TOMOGRAM THORAX; ELECTROCARDIOGRAM NORMAL; BLOOD LACTIC ACID; TROPONIN INCREASED; COMPUTERISED TOMOGRAM ABDOMEN ABNORMAL; OXYGEN SATURATION INCREASED; BLOOD CREATININE INCREASED; BLOOD TEST ABNORMAL; BLOOD GASES ABNORMAL; AORTIC ANEURYSM; ATRIOVENTRICULAR BLOCK FIRST DEGREE; BUNDLE BRANCH BLOCK RIGHT; CONDITION AGGRAVATED; ABDOMINAL PAIN; HYPOTENSION; INGUINAL HERNIA; INTRACRANIAL MASS; ISCHAEMIA; METABOLIC ACIDOSIS; PLEURAL EFFUSION; SUPRAVENTRICULAR TACHYCARDIA; MALAISE; RESUSCITATION; COVID-19; SUSPECTED CLINICAL VACCINATION FAILURE; PHYSICAL DECONDITIONING; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) ID: 1663589) concerned a 94-year-old male. The patient's height, and weight were not reported. The patient's past medical history included Blepharoplasty, and physical deconditioning. Concurrent conditions included Dementia, carotid artery narrowing, right bundle branch block, left anterior fascicular block, hypothyroidism, hypothyroidism acquired benign essential hypertension, tension headache, dizziness - light-headed, cerebrovascular accident, erectile dysfunction, gastroesophageal reflux disease, benign prostatic hyperplasia, hyperlipidemia, chronic kidney disease stage iii, depression, anxiety, seasonal allergic rhinitis due to other allergic trigger, and sulfa drug allergy. The patient experienced myalgia when treated with atorvastatin calcium, and pravastatin and nausea when treated with sulfa drugs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: unknown) dose was not reported, administered 1 in total on 05-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, amlodipine besilate, ascorbic acid, calcium/cholecalciferol, camphor, and menthol/methyl salicylate. The patient was initially hospitalized from 11-APR-2021 to 15-April-2021 for physical deconditioning. During that time the patient was diagnosed with dementia with a Montreal Cognitive Assessment (MoCA) score of 6.30. The patient was discharged to rehabilitation where he undergone rehabilitation. On 22-AUG-2021, the patient presented to the emergency department in extremis. The patient was in profound respiratory distress and shock (septic shock), believed to be secondary to covid-19 and possible bacterial pneumonia as well as new onset atrial fibrillation with rapid ventricular response. The patient was tested positive for covid (suspected clinical vaccination failure) at his care facility a couple days prior. It was unclear, if he had been undergoing any kind of treatment for the same. He had significant episodes of non-responsiveness and apnea while the patient was in the emergency department. Additionally, the patient was profoundly hypotensive and tachycardia with new onset rapid atrial fibrillation and rapid ventricular response. The patient was hypothermic and placed on a Bair Hugger. The Patient was started on intravenous fluid and placed on phenylephrine infusion. Conversation with the patient's attender revealed that the patient would not want cardiopulmonary resuscitation or to be placed on a ventilator (dependence on respirator) but they would want to pursue all other aggressive measures. The patient was then transitioned to the emergency department intensive care unit for further management. After arrival to the intensive care unit the patient was aggressively fluid resuscitated (resuscitation). His blood pressures responded relatively well. Due to pharmacy shortage of the phenylephrine the patient was transitioned to Levophed (norepinephrine) as well as amiodarone infusion. His cognitive status drastically improved from that of the emergency department. The patient was alert and oriented. Initial blood work revealed mild electrolyte abnormalities (Electrolyte imbalance), lactic acid greater than 7, creatinine of 1.9. Suspicious for ongoing covid infection and possible pneumonia the patient's antibiotics were transitioned to cefepime, azithromycin and vancomycin. The patient was started on Remdesivir for covid 19 treatment. Arterial blood gas revealed compensated metabolic acidosis. The patient's lactic acid has improved to 6.5 from 7. Initial troponins were elevated as expected, demanded ischemia from septic shock. Electrocardiogram did not reveal any ST segment changes. The patient did not complain of any chest pain; however, the patient was however complaining of abdominal pain. The patient had a soft right inguinal hernia which was difficult to reduce and had no overlying skin changes. The patient desired aggressive treatment and went forward knowing the high risk of death. On 22-AUG-2021, the patient underwent exploratory laparotomy and was found to have a prepyloric perforation (gastrointestinal fistula) and peritonitis. The patient was intubated along with central line placements. Aggressive treatment continued and patient was extubated. Chest x-ray revealed mild scattered interstitial thickening and lung opacities. Further workup revealed a pneumoperitoneum. The patient had an increasing oxygen demand. Initially he required 6 liter of oxygen in the emergency department and then 100 percent oxygen (oxygen saturation increased) via non-rebreather. At approximately 16:30 while re-evaluating the patient went into a wide complex ventricular tachycardia with an initial heart rate of approximately 240. The patient was not feeling well, his Levophed was shut off and fluids were started. A stat amiodarone infusion of 150 mg was begun. The patient was connected to defibrillator pads. His heart rate responded to the amiodarone infusion, however he subsequently entered into a narrow complex supraventricular tachycardia with a heart rate of approximately 180. His blood pressure remained stable during this time. As continued to monitor in supportive care and continued his amiodarone infusion the patient's heart rate then entered into a normal sinus rhythm with a systolic rate of approximately 90. Unfortunately strips of these rhythms were unable to be captured. Electrocardiography afterwards revealed normal sinus rhythm with a first-degree heart block and previously seen right bundle-branch block. After his amiodarone infusion, no bolus was started or further infusion and continued monitoring Stat. Computed tomography of chest, abdomen and pelvis was obtained. This revealed many things but specifically a pneumoperitoneum. The case was discussed with the on-call general surgeon who evaluated the patient in the intensive care unit. It was decided the patient wanted to pursue aggressive measures including exploratory laparotomy. Risks of surgery including death were shared with the patient. Furthermore, was explicitly stated that he would likely return to the intensive care unit ventilator, dependent with multiple drains and need for central line, continued resuscitation the ultimate outcome of which being still high likelihood of death. Understanding this, the patient and his son still wanted to proceed. Alternatives including comfort care were offered and declined. Of additional findings on computed tomography scan included nodular pulmonary opacities, right with left pleural effusion, small abdominal aortic aneurysm and mild pulmonary fibrosis. On 25-AUG-2021, further findings and repeated computed tomography scans were done, which showed continued leaking from stomach as well as potential cancerous brain mass. On 26-AUG-2021, along with son the family agreed on comfort care initiation. On 28-AUG-2021, the patient died from covid-19 positive/covid-19 virus infection. The patient's discharge diagnosis included perforated gastric ulcer (gastric ulcer perforation), acute blood loss anemia, covid-19, acute kidney injury with chronic kidney disease stage III, acute metabolic encephalopathy. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of, covid-19, apnoea, acute kidney injury, atrial fibrillation, blood loss anaemia, chronic kidney disease, dependence on respirator, gastric ulcer perforation, septic shock, gastrointestinal fistula, respiratory distress, pulmonary fibrosis, pneumoperitoneum, interstitial lung disease, metabolic encephalopathy, peritonitis, pneumonia bacterial, unresponsive to stimuli, aortic aneurysm, atrioventricular block first degree, blood creatinine increased, blood gases abnormal, blood lactic acid, blood test abnormal, bundle branch block right, central venous catheterisation, chest x-ray abnormal, computerised tomogram abdomen abnormal, computerised tomogram abnormal, computerised tomogram pelvis abnormal, computerised tomogram thorax, condition aggravated, electrocardiogram normal, abdominal pain, electrolyte imbalance, endotracheal intubation, explorative laparotomy, extubation, hypotension, infusion, inguinal hernia, intensive care, intracranial mass, ischaemia, lung opacity, metabolic acidosis, oxygen saturation increased, physical deconditioning, pleural effusion, resuscitation, supraventricular tachycardia, troponin increased and malaise on 28-AUG-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, Hospitalization Caused / Prolonged and Life Threatening). This report associated with Quality compliant: 90000193801. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified. Based on the Quality compliant evaluation/investigation performed.  Additional information received from Complaint Vigilance department on 21-OCT-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1-Version Updated Quality compliant result.This doesn't change causality of previously reported event 20210920986-covid-19 vaccine ad26.cov2.s-Death,dependence on respirator,apnoea,atrial fibrillation,blood loss anaemia,gastric ulcer perforation,septic shock,gastrointestinal fistula,respiratory distress,pulmonary fibrosis,pneumoperitoneum,interstitial lung disease,metabolic encephalopathy,peritonitis,pneumonia bacterial,unresponsive to stimuli,Covid19,aortic aneurysm,AV block 1st degree,blood test abnormal,central venous catheterisation,CXR abnormal,CT abdomen abnormal,CT abnormal,CT pelvis abnormal,CT thorax,condition aggravated,ECG normal,abdominal pain,electrolyte imbalance,endotracheal intubation,explorative laparotomy,extubation,hypotension,infusion,inguinal hernia,intensive care,intracranial mass,ischaemia,lung opacity,O2 saturation increased,pleural effusion,resuscitation,supraventricular tachycardia,troponin increased,blood lactic acid,malaise.This event is considered unassessable.The event has a compatible/suggestive temporal relationship,is unlabeled,&has unknown scientific plausibility.There is no information on any other factors potentially associated with the event 20210920986-covid-19 vaccine ad26.cov2.-Suspected clinical vaccination failure.This event is considered not related The event has a compatible/suggestive temporal relationship,is unlabeled,&has unknown scientific plausibility.There are other factors more likely to be associated with the event than the drug Specifically:SPECIAL SITUATION 20210920986-covid-19 vaccine ad26.cov2.s Acute kidney injury,chronic kidney disease,blood creatinine increased,blood gases abnormal,physical deconditioning,bundle branch block right,metabolic acidosis.This event is considered not related.The event has a compatible/suggestive temporal relationship,is unlabeled,&has unknown scientific plausibility.There are other factors more likely to be associated with the event than the drug Specifically:MEDICAL HISTORY,UNDERLYING DISEASE; Reported Cause(s) of Death: COVID-19 POSITIVE/COVID-19 VIRUS INFECTION