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VAERS ID	2166922
성별	남성
나이
주 코드	FR
제약회사	PFIZER\BIONTECH
로트 번호	FC5435
예방접종 횟수	2
접종일	2021-06-29
발병일	2021-12-01
상태	입원 사망

증상

근골격계 흉통(Musculoskeletal chest pain)
떨어지다(Fall)
흉부 엑스레이(Chest X-ray)
척추 통증(Spinal pain)
발작(Seizure)
눈 주위 부종(Periorbital oedema)
산소포화도 감소(Oxygen saturation decreased)
폐 장애(Lung disorder)
부종(Oedema)
뇌파도(Electroencephalogram)
혈압 측정(Blood pressure measurement)
심박수(Heart rate)
산소 포화도(Oxygen saturation)
호흡(Respiratory rate)
황달(Jaundice)
패혈성 쇼크(Septic shock)
신부전(Renal failure)
혈압 이완기 감소(Blood pressure diastolic decreased)
급성 호흡기 장애 증후군(Acute respiratory distress syndrome)
뇌 스캔(Scan brain)
경막하 혈종(Subdural haematoma)
혈역학적 불안정성(Haemodynamic instability)
암모니아(Ammonia)
갈비뼈 골절(Rib fracture)
프로트롬빈 시간 비율(Prothrombin time ratio)

이환 중 질병

Alcoholic cirrhosis (prothrombin ratio at 58%)

지병

Medical History/Concurrent Conditions: Alcoholism (weaned 2 years ago); Ligation of esophageal varices

기타 의료

FUROSEMIDE; SPIRONOLACTONE; CARVEDILOL

이전 예방접종

알레르기

임상 검사

Test Date: 202112; Test Name: blood ammonia; Result Unstructured Data: Test Result:124 mg/l; Comments: hyperammonia; Test Date: 202112; Test Name: blood pressure; Result Unstructured Data: Test Result:106/44 mmHg; Test Date: 202112; Test Name: Chest X-ray; Result Unstructured Data: Test Result:focus of pneumopathy in the right base; Test Date: 202112; Test Name: Electroencephalogram; Result Unstructured Data: Test Result:compatible with a hepatic encephalopathy; Comments: (hyperammonia at 124 mg/L); Test Date: 202112; Test Name: heart rate; Result Unstructured Data: Test Result:65; Comments: Unit: beats per minute (bpm); Test Date: 202112; Test Name: oxygen saturation; Test Result: 90 %; Test Date: 202112; Test Name: prothrombin ratio; Test Result: 58 %; Test Date: 202112; Test Name: respiratory rate; Result Unstructured Data: Test Result:15; Comments: Unit: cycles per minute (cpm); Test Name: Brain scan; Result Unstructured Data: Test Result:slightly increased subdural hematoma; Test Date: 202112; Test Name: Brain scan; Result Unstructured Data: Test Result:left anterior frontal subdural hematoma

증상 상세

fall with rib fractures; rib fractures; rib pain; spinal pain; left periorbital edema; right occipital edema; left anterior frontal subdural hematoma; partial comital seizure of the right hemiface; Acute respiratory distress; hemodynamic instability; Marked cutaneous jaundice; Pneumopathy with meticillin-sensitive Staphylococcus aureus and Escherischia coli; Oligoanuric renal failure, acute renal failure; Septic shock; oxygen saturation 90%; blood pressure 106/44 mmHg; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority and product quality group.
A 68 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 29Jun2021 (Lot number: FC5435, Expiration Date: 31Dec2021) as dose 2, single for covid-19 immunisation.
Relevant medical history included: "Ligation of esophageal varices", start date: 2019 (unspecified if ongoing); "Alcoholic cirrhosis", start date: Oct2021 (ongoing), notes: prothrombin ratio at 58%; "Alcoholism" (not ongoing), notes: weaned 2 years ago.
Concomitant medication(s) included: FUROSEMIDE; SPIRONOLACTONE; CARVEDILOL.
Vaccination history included: Comirnaty (1st dose, lot number: FA7082, intramuscular,), administration date: 19May2021, for COVID-19 immunisation.
The following information was reported: SUBDURAL HAEMATOMA (death, hospitalization) with onset Dec2021, outcome "fatal", described as "left anterior frontal subdural hematoma"; FALL (death, hospitalization) with onset 24Dec2021, outcome "fatal", described as "fall with rib fractures"; RIB FRACTURE (death, hospitalization) with onset 24Dec2021, outcome "fatal", described as "rib fractures"; MUSCULOSKELETAL CHEST PAIN (death, hospitalization) with onset 24Dec2021, outcome "fatal", described as "rib pain"; SPINAL PAIN (death, hospitalization) with onset 24Dec2021, outcome "fatal", described as "spinal pain"; PERIORBITAL OEDEMA (death, hospitalization) with onset 24Dec2021, outcome "fatal", described as "left periorbital edema"; OEDEMA (death, hospitalization) with onset 24Dec2021, outcome "fatal", described as "right occipital edema"; RENAL FAILURE with onset 24Dec2021, outcome "unknown", described as "Oligoanuric renal failure, acute renal failure"; SEPTIC SHOCK with onset 24Dec2021, outcome "unknown", described as "Septic shock"; SEIZURE with onset 01Jan2022, outcome "unknown", described as "partial comital seizure of the right hemiface"; ACUTE RESPIRATORY DISTRESS SYNDROME with onset 24Dec2021, outcome "unknown", described as "Acute respiratory distress"; HAEMODYNAMIC INSTABILITY (non-serious) with onset 24Dec2021, outcome "unknown", described as "hemodynamic instability"; JAUNDICE (non-serious) with onset 24Dec2021, outcome "unknown", described as "Marked cutaneous jaundice"; LUNG DISORDER (non-serious) with onset 24Dec2021, outcome "unknown", described as "Pneumopathy with meticillin-sensitive Staphylococcus aureus and Escherischia coli"; OXYGEN SATURATION DECREASED (non-serious) with onset Dec2021, outcome "unknown", described as "oxygen saturation 90%"; BLOOD PRESSURE DIASTOLIC DECREASED (non-serious) with onset Dec2021, outcome "unknown", described as "blood pressure 106/44 mmHg".
The patient underwent the following laboratory tests and procedures: ammonia: (Dec2021) 124 mg/l, notes: hyperammonia; blood pressure measurement: (Dec2021) 106/44 mmHg; chest x-ray: (Dec2021) focus of pneumopathy in the right base; electroencephalogram: (Dec2021) compatible with a hepatic encephalopathy, notes: (hyperammonia at 124 mg/L); heart rate: (Dec2021) 65, notes: Unit: beats per minute (bpm); oxygen saturation: (Dec2021) 90 %; prothrombin time ratio: (Dec2021) 58 %; respiratory rate: (Dec2021) 15, notes: Unit: cycles per minute (cpm); scan brain: (unspecified date) slightly increased subdural hematoma; (Dec2021) left anterior frontal subdural hematoma.
Therapeutic measures were taken as a result of renal failure, septic shock, acute respiratory distress syndrome, haemodynamic instability, lung disorder.
The patient date of death was unknown.
The reported cause of death was subdural haematoma, fall, rib fracture, musculoskeletal chest pain, spinal pain, periorbital oedema, oedema, oedema.
Clinical courses: On 24Dec2021, fall with rib fractures, absence of neurological deficit, rib and spinal pain.
Oligoanuric renal failure, hemodynamic instability, initiation of norepinephrine 5 mg/h.
Acute respiratory distress, intubation and assisted ventilation, FiO2 at 60%.
Presence of left periorbital and right occipital edema.
Marked cutaneous jaundice.
Probabilistic antibiotic therapy with TAZOCILLINE and ZYVOXID.
Pneumopathy with meticillin-sensitive Staphylococcus aureus and Escherischia coli.
Septic shock with acute renal failure.
Absence of awakening on lifting the sedation.
On 01Jan2022, partial comital seizure of the right hemiface.
Outcome: cessation of resuscitation leading to death.
Conclusion: 68-year-old male, with a medical history of alcoholism and cirrhosis, presents with COVID-19 pneumopathy (during a hospitalization for the management of a fall) after having received a complete vaccination schedule with two doses of Comirnaty less than 6 months ago.
Unfavorable outcome, death of the patient.
No follow-up attempts are possible.
No further information is expected.
; Sender's Comments: Linked Report(s) : FR-PFIZER INC-202200335360 same patient, different dose and events; Reported Cause(s) of Death: left anterior frontal subdural hematoma; fall with rib fractures; fall with rib fractures; rib pain; spinal pain; left periorbital edema; right occipital edema; right occipital edema