Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Urethral haemorrhage, Use of accessory respiratory muscles, Vaccine breakthrough infection, Ventricular dyssynchrony, White blood cell count
Clinical narrative: Death; BLOOD SODIUM DECREASED; Arteriosclerosis coronary artery; HYPOTHERMIA; Agonal respiration; Bronchiolitis; URETHRAL HAEMORRHAGE; Cardio-respiratory arrest; AGITATION; Encephalopathy; BRONCHITIS; Hypothermia; HAEMOFILTRATION; Respiratory arrest; MUCOSAL HYPERTROPHY; Seizure like phenomena; PERIPHERAL ISCHAEMIA; Thrombosis; RED BLOOD CELL TRANSFUSION; Unresponsive to stimuli; SARS-COV-2 TEST POSITIVE; Urethral haemorrhage; SECRETION DISCHARGE; Ventricular dyssynchrony; VACCINE BREAKTHROUGH INFECTION; Acute sinusitis; DEATH; Agitation; ARTERIOSCLEROSIS CORONARY ARTERY; Angiogram cerebral abnormal; BRONCHIOLITIS; Angiogram pulmonary abnormal; CARDIO-RESPIRATORY ARREST; Antibody test positive; ENCEPHALOPATHY; Biopsy bone marrow; RESPIRATORY ARREST; Blood pressure increased; SEIZURE LIKE PHENOMENA; Blood sodium decreased; THROMBOSIS; Blood test; UNRESPONSIVE TO STIMULI; Bronchitis; VENTRICULAR DYSSYNCHRONY; COVID-19; ACUTE SINUSITIS; Catheter placement; ANGIOGRAM CEREBRAL ABNORMAL; Central venous catheterisation; ANGIOGRAM PULMONARY ABNORMAL; Chest pain; ANTIBODY TEST POSITIVE; Chromaturia; BIOPSY BONE MARROW; Computerised tomogram head normal; BLOOD PRESSURE INCREASED; Dyspnoea; BLOOD TEST; Feeling cold; COVID-19; Gastrointestinal tube insertion; CATHETER PLACEMENT; General physical health deterioration; CENTRAL VENOUS CATHETERISATION; Haematocrit; CHEST PAIN; Haemodialysis; CHROMATURIA; Haemofiltration; COMPUTERISED TOMOGRAM HEAD NORMAL; Haemoglobin decreased; DYSPNOEA; Haemorrhoids; FEELING COLD; Headache; GASTROINTESTINAL TUBE INSERTION; Hypervolaemia; GENERAL PHYSICAL HEALTH DETERIORATION; Hyponatraemia; HAEMATOCRIT; Hypotension; HAEMODIALYSIS; Intensive care; HAEMOGLOBIN DECREASED; Livedo reticularis; HAEMORRHOIDS; Mechanical ventilation; HEADACHE; Mucosal hypertrophy; HYPERVOLAEMIA; Nasal flaring; HYPONATRAEMIA; Pain; HYPOTENSION; Peripheral ischaemia; INTENSIVE CARE; Plasmapheresis; LIVEDO RETICULARIS; Red blood cell transfusion; MECHANICAL VENTILATION; SARS-CoV-2 test positive; NASAL FLARING; Secretion discharge; PAIN; Superinfection; PLASMAPHERESIS; Use of accessory respiratory muscles; SUPERINFECTION; Vaccine breakthrough infection; USE OF ACCESSORY RESPIRATORY MUSCLES; White blood cell count increased; This spontaneous report received from a health care professional by a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS), (VAERS reference number 2633017) and concerned a 60 year old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: bipolar disorder, hypertension, and reflux hypothyroidism. The patient previously received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: unknown) dose was not reported, 1 total administered on an unspecified date for an unspecified indication.  No adverse events were observed following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1).  The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of administration were not reported, batch number: FL3209, Expiry: unknown) dose was not reported, 1 total administered on 14-MAY-2021 for an unspecified indication. Age at time of vaccination 60 years old. Concomitant medications included levothyroxine, metoprolol, quetiapine, salbutamol, and trazodone. On 02-JUL-2022, the patient experienced arteriosclerosis coronary artery, agonal respiration, bronchiolitis, cardio-respiratory arrest, encephalopathy, hypothermia, respiratory arrest, seizure like phenomena, thrombosis, unresponsive to stimuli, urethral haemorrhage, ventricular dyssynchrony, acute sinusitis, agitation, angiogram cerebral abnormal, angiogram pulmonary abnormal, antibody test positive, biopsy bone marrow, blood pressure increased, blood sodium decreased, blood test, bronchitis, covid-19, catheter placement, central venous catheterisation, chest pain, chromaturia, computerised tomogram head normal, dyspnoea, feeling cold, gastrointestinal tube insertion, general physical health deterioration, haematocrit, haemodialysis, haemofiltration, haemoglobin decreased, haemorrhoids, headache, hypervolaemia, hyponatraemia, hypotension, intensive care, livedo reticularis, mechanical ventilation, mucosal hypertrophy, nasal flaring, pain, peripheral ischaemia, plasmapheresis, red blood cell transfusion, SARS-COV-2 test positive, secretion discharge, superinfection, use of accessory respiratory muscles, vaccine breakthrough infection and white blood cell count increased (Dose number in series 2).  Patient presented with shortness of breath and discoloration noted. No new medications, otherwise no new changes. He had body aches, headache and chest pain reported. He was sent for CTA (Computed tomography angiography) with result as no evidence of pulmonary embolus and findings were compatible with bronchitis and superimposed bronchiolitis, multi-vessel as coronary artery calcifications. There was no acute intracranial abnormality. There was no evidence for an acute infarct acute hemorrhage, intracranial mass or hydrocephalus and mild mucosal thickening and frothy secretions in the left maxillary sinus, correlate for symptoms of acute sinusitis his records. When patient was in CT (Computed tomography), there was a code blue, however it was more seizure activity and in unresponsiveness, however it was noted that he did have a pulse and breathing spontaneously. On physician arrival, he had continued mottling. His H-H was 5 17. He was hyponatremic per ED (Emergency department) to lab said his blood could not be processed because it may have been too cold and it was hemolyzed. The patient was excepted to the ICU (intensive care unit). On arrival the patient was breathing spontaneously however not able to follow commands or respond hemodynamically stable. He had an elevated blood pressure, however he had diffuse mottling that was progressive very quickly. Patients mother reported that she was concerned for his infections and had recommended plasma exchange. Patients mother was asked for consent for dialysis catheter central line intubation and the plans with plasma pheresis and she agreed dialysis catheter was placed. There was difficulty placing central line but this was eventually placed. After contacting nephrology for plasmapheresis, low sodium levels were reported. Physician reported that this would have to be corrected first because this was decreased with plasma exchange. He was given bolus of hypertonic saline. There was also a delay in the plasma exchange secondary to the hemorrhoids. The dialysis nurse had to calculate the treatment depending on the hematocrit, however the blood draws were all hemolyzed and intact hematocrit was not able to be obtained. However, physician advised to use the hematocrit of 17 that was taken on arrival. Patient became hypotensive and was started on Levophed. Blood was ordered however patient unfortunately had antibodies and this was still pending screening and matching sounds. The blood that was drawn was too hemolyzed and diluted for them to get accurate results. Covid swab was obtained on arrival to the ICU and that was positive. On 03-JUL-2022, patient had on mechanical ventilation and sedation with propofol and fentanyl. He had an area overnight. He was noted to have worsening again of his skin. Mottling his temperature goal was increased. He was given 4 units PRBCs (packed red blood cells) overnight with plans for IVIG (Intravenous immunoglobulins) per hematology, plasma exchange was not able to be performed secondary to not having enough blood volume. he was started on dialysis. He had apparently the last 2 units of available PRBCs which were being given at that time.  Laboratory data included: Angiogram cerebral abnormal, Angiogram pulmonary abnormal, Antibody test Positive, Blood pressure increased, Blood sodium decreased, Blood test pending screening, CT angiography NEG PE bronchitis and superimposed bronchiolitis Hemodialysis placement plasmapheresis repeat, and SARS-CoV-2 test positive Positive. On 04-JUL-2022, Laboratory data included: CT scan negative for changes. Treatment medications (dates unspecified) included: fentanyl, and propofol. Patient had ischemic fingers bilateral. On 04-JUL-2022, head CT was performed which was negative for acute changes. On 06-JUL-2022, patient did not tolerate plasma exchange and continued to hemolyze due to cold temps. CRRT (Continuous renal replacement therapy) was probably contributing to inability to warm him up. On 07-JUL-2022, patients count was improved and was discussed with Heme. Patient continued to be sedated and mechanically ventilated. SBT was planned to be attempted. Temperature was finally controlled off CRRT Tmax 102 WBC (white blood cell) was reported as 13. On 08-JUL-2022, no overnight events were reported. Patient had a lot of subglottic secretions and NG tube was in the esophagus. Some coffee grounds were reported and patient was started on PPI bid (two times a day). Small drop was noted in Hg (blood pressure) but continued to hemolyze by labs. 09-JUL-2022, SBT (Spontaneous breathing trial) was failed and patient was still not following commands. Sedation was reduced and using more precede. Bone marrow biopsy results were seen. On 10-JUL-2022, got agitated off sedation (Dose number in series 1).  Attempting SBT seemed to be tolerating, however still encephalopathic precluding a safe extubation. Bone marrow was underwhelming as per oncology. Severe volume overload Continued to have a little bleeding and clots in the urethra. Urine was red and no overt hemolysis and relatively stable Hg plus balance Hypothermic and intermittently febrile. 0n 11-JUL-2022, plus 5 2L 24hrs. He was using accessory muscles with breathing on fentanyl. Ischemic hands bilaterally, Tmax:38 3F. CRRT failed due to hemolysis. He received plasmaphoresis x1 which failed due to clotting previously. On 12-JUL-2022, 1 2L 24hrs, he had vent dyssynchrony overnight and required versed fentanyl pushes. He had an agonal breathing pattern when sedation weaned and nasal flaring. On 13-JUL-2022, plus 9, 5L 24hrs, he successfully completed the second plasmapheresis session. On 12-JUL-2022, pending HD (haemodialysis) . At the day of reporting, despite aggressive care, he continued to decline. After discussion with his mother, she understood his prognosis was poor and did not wish for him to go on living in his current condition and she elected to withdraw care and pursue comfort measures. Patient was then transitioned to inpatient hospice and withdrawal of care implemented (Dose number in series 2). The patient ultimately passed away on 13-JUL-2022 at 18:56 (Dose number in series 2). It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 13-JUL-2022 18:56 from arteriosclerosis coronary artery, agonal respiration, bronchiolitis, cardio-respiratory arrest, encephalopathy, hypothermia, respiratory arrest, seizure like phenomena, thrombosis, unresponsive to stimuli, urethral haemorrhage, ventricular dyssynchrony, acute sinusitis, agitation, angiogram cerebral abnormal, angiogram pulmonary abnormal, antibody test positive, biopsy bone marrow, blood pressure increased, blood sodium decreased, blood test, bronchitis, covid-19, catheter placement, central venous catheterisation, chest pain, chromaturia, computerised tomogram head normal, dyspnoea, feeling cold, gastrointestinal tube insertion, general physical health deterioration, haematocrit, haemodialysis, haemofiltration, haemoglobin decreased, haemorrhoids, headache, hypervolaemia, hyponatraemia, hypotension, intensive care, livedo reticularis, mechanical ventilation, mucosal hypertrophy, nasal flaring, pain, peripheral ischaemia, plasmapheresis, red blood cell transfusion, sars-cov-2 test positive, secretion discharge, superinfection, use of accessory respiratory muscles, vaccine breakthrough infection, and white blood cell count increased. This report was serious (Death, and Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000284580.  Additional information was received from central complaint vigilance department on 02-JUN-2023. The following information was updated and incorporated into case narrative: batch number updated for primary vaccine (dose number in series 1).; Sender's Comments: V1: This follow up version updates batch number for primary vaccine (dose number in series 1). This updated information does not alter the causality of previously reported events. 20230567413-death, arteriosclerosis coronary artery, agonal respiration, bronchiolitis, cardio-respiratory arrest, encephalopathy, hypothermia, respiratory arrest, seizure like phenomena, thrombosis, unresponsive to stimuli, urethral haemorrhage, ventricular dyssynchrony, acute sinusitis, agitation, angiogram cerebral abnormal, angiogram pulmonary abnormal, antibody test positive, biopsy bone marrow, blood pressure increased, blood sodium decreased, blood test, bronchitis, catheter placement, central venous catheterization, chest pain, chromaturia, computerised tomogram head normal, dyspnoea, feeling cold, gastrointestinal tube insertion, general physical health deterioration, haematocrit, haemodialysis, haemofiltration, haemoglobin decreased, haemorrhoids, headache, hypervolaemia, hyponatraemia, hypotension, intensive care, livedo reticularis, mechanical ventilation, mucosal hypertrophy, nasal flaring, pain, peripheral ischaemia, plasmapheresis, red blood cell transfusion, secretion discharge, superinfection, use of accessory respiratory muscles, white blood cell count increased. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration. 20230567413-COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.; Reported Cause(s) of Death: ARTERIOSCLEROSIS CORONARY ARTERY; AGONAL RESPIRATION; BRONCHIOLITIS; CARDIO-RESPIRATORY ARREST; ENCEPHALOPATHY; HYPOTHERMIA; RESPIRATORY ARREST; SEIZURE LIKE PHENOMENA; THROMBOSIS; UNRESPONSIVE TO STIMULI; URETHRAL HAEMORRHAGE; VENTRICULAR DYSSYNCHRO