Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Abdominal wall haematoma, Acute kidney injury, Acute respiratory failure, Anticoagulation drug level above therapeutic
Clinical narrative: DEATH; ARTERIAL CATHETERISATION; ACUTE KIDNEY INJURY; ACUTE RESPIRATORY FAILURE; ACUTE RESPIRATORY FAILURE; CARDIO-RESPIRATORY ARREST; CARDIO-RESPIRATORY ARREST; COVID-19; RENAL IMPAIRMENT; HAEMOGLOBIN DECREASED; RESPIRATORY ARREST; INTENSIVE CARE; ABDOMINAL PAIN; DEATH; ABDOMINAL WALL HAEMATOMA; ACUTE KIDNEY INJURY; COVID-19; ABDOMINAL WALL HAEMATOMA; COUGH; ANTICOAGULATION DRUG LEVEL ABOVE THERAPEUTIC; GENERAL PHYSICAL HEALTH DETERIORATION; COAGULATION TEST ABNORMAL; DYSPNOEA; CENTRAL VENOUS CATHETERISATION; ANTICOAGULATION DRUG LEVEL ABOVE THERAPEUTIC; RENAL IMPAIRMENT; ARTERIAL CATHETERISATION; RESPIRATORY ARREST; BLOOD LACTIC ACID INCREASED; ABDOMINAL PAIN; CENTRAL VENOUS CATHETERISATION; COUGH; CHEST X-RAY NORMAL; GENERAL PHYSICAL HEALTH DETERIORATION; COAGULATION TEST ABNORMAL; DYSPNOEA; COMPUTERISED TOMOGRAM ABNORMAL; RESPIRATORY TRACT CONGESTION; DIALYSIS; BLOOD LACTIC ACID INCREASED; ENDOTRACHEAL INTUBATION; CHEST X-RAY NORMAL; HAEMOFILTRATION; COMPUTERISED TOMOGRAM ABNORMAL; HAEMOGLOBIN DECREASED; DIALYSIS; INTENSIVE CARE; ENDOTRACHEAL INTUBATION; OXYGEN SATURATION DECREASED; HAEMOFILTRATION; RESUSCITATION; SARS-COV-2 TEST POSITIVE; RESPIRATORY TRACT CONGESTION; OXYGEN SATURATION DECREASED; This spontaneous report received from a health care professional by a Regulatory Authority, Vaccine Adverse Event Reporting System (VAERS FDA Inbound Unit, 2509457) concerned a 67 year old male of an unspecified race and ethnicity. Initial information was processed along with additional information received on 28-NOV-2022. The patient's height, and weight were not reported. The patient was diagnosed with prostate cancer on 26-MAR-2020. The patient had recurrent left pleural effusion on 27-MAY-2020 and pericardial effusion on 12-FEB-2021. Skilled rehabilitation for prostate cancer was done from 23-FEB-2021 to approximately 15-MAR-2021. The patient was hospitalized on 17-MAR-2021 and was presented with paroxysmal atrial fibrillation (20-MAR-2021) and was discharged on 24-MAR-2021. The patient's concurrent conditions included: hyperlipidemia, essential hypertension, GERD (gastroesophageal reflux disease), rheumatoid arthritis, mild mitral regurgitation, prediabetes, supraventricular tachycardia, normocytic anemia, prostate cancer metastatic to bone, secondary malignant neoplasm of bone and sulfa drug allergy.  The patient had family history of colon cancer. The patient was on use of long term anticoagulation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070 expiry: unknown) dose was not reported, 1 total, administered on 24-MAR-2021 for an unspecified indication. Age at time of vaccination 67 years old. Concomitant medications included acetylsalicylic acid, colchicine, diltiazem hydrochloride, doxazosin, paracetamol, and salbutamol sulfate. On an unspecified date in OCT-2022, patient had congestion (respiratory tract congestion). On 08-NOV-2022, the patient was admitted with covid-19, acute hypoxic respiratory failure due to covid-19 and acute kidney injury. The patient had symptoms of severe abdominal pain, cough and shortness of breath (dyspnoea). The patient had coughing with sudden development of abdominal pain from coughing. Upon arrival to facility the imaging was performed and it showed large right rectus sheath hematoma (abdominal wall haematoma) without evidence of active bleeding. The patient did take Coumadin (warfarin sodium) at home and was noted to be supratherapeutic on coagulation studies (anticoagulation drug level above therapeutic). Patient was also found to be covid-19 positive with no evidence of pneumonia on chest x-ray. Patient did receive 1 dose of vitamin K in the emergency department for supratherapeutic INR of 8. On 08-NOV-2022, the patient experienced coagulation test abnormal. Patient was initially admitted on oncology service for further treatment and while on the floor he had significant desaturation (coded as oxygen saturation decreased) and ultimately a code blue (cardio-respiratory arrest and respiratory arrest) was called. He received one round of compressions and epinephrine and ROSC (return of spontaneous circulation) was achieved. He was intubated (endotracheal intubation) and required multiple pressors for circulatory support. Upon admission to the ICU (intensive care unit) the patient had a central and arterial line (central venous catheterisation and arterial catheterisation) placed. He was found to have a 3g Hbg drop (haemoglobin decreased) and had increasing pressor requirements. During his stay in the ICU he eventually required CRRT (continuous renal replacement therapy) (haemofiltration) for worsening kidney function (renal impairment). He required 4 pressors and stress dose steroids. On 08-NOV-2022, the patient experienced general physical health deterioration and computerised tomogram was abnormal. Laboratory data included: Blood lactic acid increased, Chest X-ray normal, no evidence of pneumonia, Coagulation test abnormal, Computerised tomogram abnormal, Haemoglobin decreased (3g Hbg drop), Oxygen saturation decreased, and SARS-CoV-2 test positive, Anticoagulation drug level above therapeutic (supratherapeutic INR of 8).  On 11-NOV-2022 resident team called sister to discuss ongoing need for dialysis and raising pressor requirements despite adequate volume resuscitation. They agreed not to repeat resuscitation with chest compressions and code status was changed to do not resuscitate. Around 20:00 on the same day patient's pressor requirements increased and lactate continued to up trend (blood lactic acid increased). On 12-NOV-2022, at around 03:00 am resident team called to bedside to pronounce patient death. Patient was seen and examined and time of death was 03:25 am on 12-NOV-2022. It was unknown if an autopsy was performed. The patient had visited emergency room. The number of days of hospitalization was 4 days.  On 12-NOV-2022, the patient died from abdominal pain, abdominal wall haematoma, acute kidney injury, acute respiratory failure, anticoagulation drug level above therapeutic, arterial catheterisation, blood lactic acid increased, covid-19, cardio-respiratory arrest, central venous catheterisation, chest x-ray normal, coagulation test abnormal, computerised tomogram abnormal, cough, death, dialysis, dyspnoea, endotracheal intubation, general physical health deterioration, haemofiltration, haemoglobin decreased, intensive care, oxygen saturation decreased, renal impairment, respiratory arrest, respiratory tract congestion, resuscitation, and sars-cov-2 test positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000260963. 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. Batch and lot tested and found within specifications based on the PQC evaluation/investigation performed.  Additional information received from Central Complaint Vigilance department on 21-DEC-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1: The follow up adds- Product quality complaint investigation result. This new information does not change prior causality assessment.  20221160740- Death, Acute kidney injury, Acute respiratory failure, Cardio-respiratory arrest, Renal impairment, Respiratory arrest, Abdominal pain, Abdominal wall haematoma, Covid-19, Cough, General physical health deterioration, Dyspnoea, Respiratory tract congestion, Anticoagulation drug level above therapeutic, Arterial catheterization, Blood lactic acid increased, Central venous catheterization, Chest x-ray normal, Coagulation test abnormal, Computerised tomogram abnormal, Dialysis, Endotracheal intubation, Haemofiltration, Haemoglobin decreased, Intensive care, Oxygen saturation decreased, Resuscitation, Sars-cov-2 test positive. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration. (Additionally patient's significant medical history of prostate cancer metastatic to bone, secondary malignant neoplasm of bone, hyperlipidemia, essential hypertension, rheumatoid arthritis, mild mitral regurgitation, prediabetes provide more plausible explanation for the events than vaccine.); Reported Cause(s) of Death: ABDOMINAL PAIN; ABDOMINAL WALL HAEMATOMA; ACUTE KIDNEY INJURY; ACUTE RESPIRATORY FAILURE; ANTICOAGULATION DRUG LEVEL ABOVE THERAPEUTIC; ARTERIAL CATHETERISATION; BLOOD LACTIC ACID INCREASED; COVID-19; CARDIO-RESPIRATORY ARREST; CENTRAL VENOUS CATHETE