VAERS ID: 1435438

Description

Death; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21115533.The patient was a 73-year-old male. Body temperature before vaccination was 36.4 degrees centigrade. Medical history included hypertension since the school age, surgery for appendicitis and peritonitis (at age of 18), a cataract operation was performed on the bilateral eyes (at age of 66), hypertension and renal impairment were pointed out (24Nov2011), numbness of hands and feet developed (Jan2012), haemodialysis was introduced because of hyperkalaemia (03Feb2012), anaemia and positive occult blood (Aug2017), duodenal submucosal tumour, fundic gland polyp, gastrooesophageal reflux disease (GERD), gastritis atrophic, carotid arteriosclerosis, and coronary artery calcification (Jun2017), occult blood was positive (Mar2018), atrial fibrillation paroxysmal (12Jul2018), fundic gland polyp and duodenal submucosal tumour (SMT) (04Aug2018), oesophageal hiatal hernia, gastric polyps, and duodenal SMT were suspected (14Sep2019), difficulty breathing (18Nov2019), chest pain (23Nov2019), emergency catheterization (23Nov2019), coronary stent placement and intra-aortic balloon pumping (IABP) were done for significant stenosis in left and right coronary arteries and cardiogenic shock (23Nov2019), tachycardia (03Feb2021), underwent percutaneous coronary intervention (PCI) and stent placement in the left anterior descending artery (between 25Dec2019 and 28Dec2019), chronic complete occlusion associated with marked calcification in the right hepatic artery (06Feb2021), obstructive arteriosclerosis of lower extremities (30Mar2020), right femoral thromboendarterectomy under general anaesthesia (31Mar2020), vasodilation procedure was performed for stenosis in the right common femoral artery and near the superficial femoral artery (28Apr2020), tachycardia (27May2020), significant stenosis in the left circumflex was noted (28May2020), drug-eluting balloon was used (28May2020), liver disorder (01Jul2020), pyrexia (22Jul2020), bilateral pneumonia and accumulated pleural effusion (22Jul2020), bilateral extensive pulmonary vein isolation and irrigation and cauterization on the tricuspid valve and the inferior vena cava isthmus (21Dec2020), tachycardia (30Dec2020), stent placement was performed in the stenosis area in the right superficial femoral artery (16Feb2021), bleeding was noted from the branch of the right superficial femoral artery (16Feb2021), red blood cell transfusion was performed at 6 units (16Feb2021), and occult blood was positive (Apr2021). Previously the patient received propafenone hydrochloride (PRONON), bisoprolol (BISOPROLOL) and calcium carbonate and experienced suspected drug-induced liver disorder. Previously the patient received aspirin (BAYASPIRIN), prasugrel hydrochloride (EFIENT), bisoprolol fumarate (MAINTATE), verapamil hydrochloride (VASOLAN) and levofloxacin hydrate (CRAVIT). Family history and concomitant medications were not reported. It was not reported whether there were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 29May2021 (the day of the first vaccination), the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number not reported, Expiration date not reported).On 19Jun2021 at unknown time (the day of the second vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7812, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunisation.On 20Jun2021 at unknown time (1 day after the second vaccination), the patient experienced death.On 20Jun2021 (1 day after the second vaccination), the outcome of the event was fatal. It was not reported whether autopsy was done. The course of the event was as follows: The patient had hypertension since the school age, but it was left untreated. At age of 18, surgery for appendicitis and peritonitis was performed. At age of 66, a cataract operation was performed on the bilateral eyes. On 24Nov2011, hypertension and renal impairment were pointed out. In Jan2012, numbness of hands and feet developed. On 03Feb2012, haemodialysis was introduced because of hyperkalaemia (higher than 9). It was difficult to obtain consent for lowering the dry weight because of foot cramps. Despite anaemia and positive occult blood (Aug2017), lower gastrointestinal tract endoscopy was not performed because of no request. In Jun2017, upper gastrointestinal tract endoscopy revealed duodenal submucosal tumour, fundic gland polyp, GERD, gastritis atrophic, carotid arteriosclerosis, and coronary artery calcification. On 22Jan2018, after changing residence, the patient started haemodialysis at the reporting hospital. In Mar2018, occult blood was positive. On 12Jul2018, the patient visited the cardiovascular medicine department of another hospital because of suspected atrial fibrillation; atrial fibrillation paroxysmal was noted, and a follow-up approach was taken. A revisit would be made if atrial fibrillation occurred more frequently. On 04Aug2018, gastrointestinal fiberscope (GIF) revealed fundic gland polyp and duodenal SMT. In Mar2019, the ankle brachial pressure index (ABI) was 0.92 in the right and 0.98 in the left. On 14Sep2019, oesophageal hiatal hernia, gastric polyps, and duodenal SMT were suspected on GIF. On 18Nov2019, the patient complained of difficulty breathing, and the symptom was alleviated with dialysis. On 23Nov2019, the patient had chest pain and was urgently transported to the hospital after dialysis. The patient was hospitalized in the same hospital from the same day until 09Dec2019. On the same day, emergency catheterisation was performed, and coronary stent placement and IABP were done for significant stenosis in left and right coronary arteries and cardiogenic shock. The patient was discharged after rehabilitation, and BAYASPIRIN and EFIENT were added. The patient was hospitalized in the hospital from 25Dec2019 to 28Dec2019. He underwent PCI and stent placement in the left anterior descending artery. The patient was admitted to T. Hospital on 03Feb2021 because of tachycardia during the latter half of the dialysis and stayed in until 11Feb2021. On 06Feb2021, coronary angiography revealed no significant stenosis in the left hepatic artery and no stenosis in the stent. Chronic complete occlusion associated with marked calcification in the right hepatic artery was observed, but favorable collateral circulation from the left coronary artery was present, and there was no ischaemia in the left and right coronary arteries. MAINTATE was added. The patient was hospitalized in the hospital from 30Mar2020 to 05Apr2020 because of obstructive arteriosclerosis of lower extremities. On 31Mar2020, right femoral thromboendarterectomy under general anaesthesia was performed. The patient was hospitalized in the hospital from 27Apr2020 to 29Apr2020. On 28Apr2020, by left 'common aorta' approach, vasodilation procedure was performed for stenosis in the right common femoral artery and near the superficial femoral artery. The patient was urgently transported and admitted to the hospital from 27May2020 to 31May2020 because of tachycardia attack during dialysis. Tachycardia attack improved with VASOLAN. On 28May2020, cardiac catheterisation was performed, and significant stenosis in the left circumflex was noted. Drug-eluting balloon was used, and the dose of MAINTATE was increased. The patient was hospitalized from 01Jul2020 to 18Jul2021 in the hospital because of liver disorder. Drug-related liver disorder was suspected; PRONON was discontinued, HISHIPHAGEN was administered, and BISOPROLOL and CALCIUM CARBONAE were stopped. On 22Jul2020, pyrexia occurred, and chest computerised tomography (CT) showed bilateral pneumonia and accumulated pleural effusion. At the hospital, SARS-Cov-2-Ag was negative, and CRAVIT was prescribed. The patient was hospitalized in the cardiovascular medicine department of the hospital from 20Dec2020 to 23Dec2020. On 21Dec2020, bilateral extensive pulmonary vein isolation and irrigation and cauterization on the tricuspid valve and the inferior vena cava isthmus were performed. Tachycardia settled down temporarily after discharge but started to be noted on 30Dec2020. The patient was hospitalized from 15Feb2021 to 16Feb2021 in the vascular surgery department of the Hospital. On 16Feb2021, stent placement was performed in the stenosis area in the right superficial femoral artery, and the guide wire (GW) could not pass the occluded area in the right popliteal artery. Bleeding was noted from the branch of the right superficial femoral artery, and red blood cell transfusion was performed at 6 units. In Apr2021, occult blood was positive. On 29May2021 (the day of the first vaccination), the patient received the first dose of BNT162b2. On 19Jun2021 (the day of the second vaccination), the patient received the second dose of BNT162b2. On 21Jun2021 (2 days after the second vaccination), the family called and reported the patient's death. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unknown. Other possible cause(s) of the event such as any other diseases was present. The reporting physician commented as follows: There was also severe coronary events, and the sudden change could have occurred even if the vaccine had not been given.; Reported Cause(s) of Death: Unknown cause of death

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