Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Intensive care, Mechanical ventilation, Oxygen saturation decreased, Packed red blood cell transfusion, Patient restraint
Clinical narrative: DEATH; CARDIAC ARREST; BLOOD PRESSURE DECREASED; BLOOD GASES; HAEMOGLOBIN DECREASED; GASTROINTESTINAL TUBE INSERTION; PACKED RED BLOOD CELL TRANSFUSION; TREATMENT NONCOMPLIANCE; CONFUSIONAL STATE; AGITATION; PATIENT RESTRAINT; ENDOTRACHEAL INTUBATION; ANXIETY; INFECTION; ANGIOGRAM PULMONARY ABNORMAL; BILEVEL POSITIVE AIRWAY PRESSURE; PULMONARY MASS; ECHOCARDIOGRAM; OXYGEN SATURATION DECREASED; MECHANICAL VENTILATION; INTENSIVE CARE; SARS-COV-2 TEST POSITIVE; HAEMOPTYSIS; EMPHYSEMA; CONDITION AGGRAVATED; COVID-19; SUSPECTED CLINICAL VACCINATION FAILURE; DYSPNOEA; PULMONARY EMBOLISM; ANTICOAGULANT THERAPY; This spontaneous report received from a health care professional via the Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) concerned a 69 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic anticoagulation, chronic systolic heart failure, chronic obstructive pulmonary disease (COPD), pulmonary embolism, depression, and emphysema. The patient has no known drug allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029 and expiry: Unknown) 0.5 ml, frequency time 1 total administered at right arm on 12-MAR-2021 for an unknown indication. Concomitant medications included Baricitinib, Zithromax (azithromycin), Pulmicort (budesonide), Keflex (cefalexin), Celexa (citalopram hydrobromide), Proair HFA (salbutamol sulfate), Ventolin HFA (salbutamol sulfate) and Clonazepam, and Vibra (doxycycline hyclate for an unknown indication, and Oxygen for COPD, and emphysema. In JUL-2021, (1 month ago of admission), the patient pulmonary embolism and received the treatment with anticoagulant therapy Eliquis (apixaban) for pulmonary embolism (PE) and heart failure with reduced ejection fraction (HFrEF) and his home dependency oxygen level was increased with 3L nasal cannula (NC). On 18-AUG -2021, the patient developed breakthrough infection. He was presented in the emergency department (ED) with worsening shortness of breath and hemoptysis. His SARS-CoV-2 test (NR: not provided) was performed which was positive. He was diagnosed with Covid-19 (suspected clinical vaccination failure) and he was admitted to the hospital service for 12 day. After admission, his shortness of breath was worsened increased oxygen demand and work of breathing. Hence, he was transferred to the intensive care unit (ICU) for increased level of care. On 22-AUG-2021, his computed tomography angiography (CTA) for PE was performed which reveled negative but showed severe centrilobular emphysema left lung apex cavitary lesion (infection). He developed pulmonary mass. His infxn vs malignancy echocardiogram was also performed, and result were pending. At 10:05 hours fraction of inspired oxygen (NR: not provided) 70 percent. His oxygen saturation was decrease and he was kept on bilevel positive airway pressure (BiPAP). On 23-AUG-2021, his Baricitinib was on hold due to concern for community-acquired pneumonia (CAP). He received treatment with intravenous (IV) Lasix (furosemide) for HFrEF. At 10: 06 hours, his BiPAP was 80 percent. He was weaned to high-flow nasal cannula (HFNC) plus/ minus non-rebreather mask (NRB) was tolerated. On 24-AUG-2021, he experienced high level of anxiety. He received Buspar (BUSPIRONE HYDROCHLORIDE) as required, and it was effective. However, he was anxious overnight and remains on high-flow nasal cannula (HFNC) (endotracheal intubation). On 25-AUG-2021 (over the daytime), his time transitioned to BiPAP with improvement in oxygenation but no change in respiratory status. On 26-AUG-2021, he had several episodes of removing HFNC or BiPAP. He placed in restraints with mittens on HFNC plus NRB. He developed confusion and agitation. He received treatment with Seroquel (quetiapine fumarate) and HFNC plus NRB 60L for 100 percent. On 27-AUG-2021, CT head was ordered for him, but he was unable to cooperate even with Ativan (lorazepam). He received Precedex (dexmedetomidine hydrochloride) for still agitation. But he was still agitated (treatment noncompliance), therefore, ketamine was added and found improvement in sedation. He was able to tolerate and BiPAP nasogastric tube (NG) placed. In night, his oxygen demand was increased and subsequently intubated and placed on pressure-regulated volume control (PRVC). On 28-AUG-2021, he was changed from PRVC to pressure support (PS) PS with improvements in oxygenation. At 14:10 his PS setting was mid 90. On 29-AUG-2021 (overnight), his blood pressure was dropping despite being on Levophed (Levo; norepinephrine bitartrate) and Vasodilators (Vaso) infusions. Neosynephrine (phenylephrine hydrochloride) was added bedside. His ultrasound was performed which showed approx. 50 percent collapse of inferior vena cava (IVC) on inspiration. His bolused 1L intravenous fluid (IVF) with minimal improvement of blood pressure. Later, he had increased oxygen requirements and his arterial blood gases (ABG) performed which showed low hemoglobin (Hgb) 6.5. His type screened crossmatched and packed red blood cells (PRBC) was transfused. Vancomycin was added for broad spectrum antibiotic coverage spoke for his significant other who came into the hospital to see him. On 30-AUG-2021, his confirms status of do-not-resuscitate order (DNR) with being ok for intubation at 19:57 hours. He was maxed on 4 vasopressors and glasgow coma scale (GCS) was 3. His target heart rate (THR) trended down to asystole, no heart tones (Cardiac arrest) auscultated Time of death 19:57 Significant other notified Discharged Condition: deceased with unknown cause. It was not reported if the autopsy was performed or not. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death, cardiac arrest, pulmonary embolism, dyspnoea, agitation, haemoptysis, emphysema, mechanical ventilation, angiogram pulmonary abnormal, condition aggravated, pulmonary mass, anticoagulant therapy, anxiety, bilevel positive airway pressure, blood gases, blood pressure decreased, Covid-19, confusional state, echocardiogram, endotracheal intubation, gastrointestinal tube insertion, haemoglobin decreased, infection, intensive care, oxygen saturation decreased, packed red blood cell transfusion, patient restraint, sars-cov-2 test positive, suspected clinical vaccination failure and treatment noncompliance on 30-AUG-2021 19:57. This report was serious (Death, Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000195009. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related based on the PQC evaluation/investigation performed.  Additional information received from department on 03-NOV-2021. The following information was updated and incorporated into the case narrative: The Product quality complaint investigation result added.; Sender's Comments: V3: The additional information in this version is the Product quality complaint investigation result. This updated information does not alter the causality of previously reported events.  20210949728-Covid-19 vaccine ad26.cov2.s - Death, Cardiac arrest,  COVID-19, Dyspnoea, Agitation, Haemoptysis, Condition aggravated, Pulmonary mass, Anxiety, Infection, Blood pressure decreased, confusional state, Blood gases, Heamoglobin decreased, Oxygen saturation decreased, Treatment non compliance, Angiogram pulmonary abnormal, Bilevel positive airway pressure, SARS-CoV-2 test positive, Mechanical ventilation, Echocardiogram, Endotracheal intubation, Gastrointestinal tube insertion, Intensive care, Packed red blood cell transfusion, Patient restraint. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210949728-Covid-19 vaccine ad26.cov2.s -SUSPECTED CLINICAL VACCINATION FAILURE. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS  20210949728-Covid-19 vaccine ad26.cov2.s -Pulmonary embolism, Emphysema, Anticoagulant therapy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH