이상반응 보고

VAERS ID	2168505
성별	남성
나이
주 코드	FR
제약회사	PFIZER\BIONTECH
로트 번호
예방접종 횟수	2
접종일	2021-07-15
발병일	2021-07-01
상태	입원 사망

증상

피로(Fatigue)
사지의 통증(Pain in extremity)
떨림(Tremor)
식욕 감소(Decreased appetite)
근육통(Myalgia)
불안(Anxiety)
떨어지다(Fall)
의식 소실(Loss of consciousness)
추워요(Feeling cold)
근육 약화(Muscular weakness)
불명 증(Insomnia)
좌골신경통(Sciatica)
국제 표준화 비율(International normalised ratio)
죽음(Death)
전반적인 신체 건강 악화(General physical health deterioration)
혈소판 수(Platelet count)
우울증(Depression)
자기공명영상 척추(Magnetic resonance imaging spinal)
헤모글로빈(Haemoglobin)
백혈구 수(White blood cell count)
절망감(Feeling of despair)
고밀도 지단백질(High density lipoprotein)
저밀도 지단백질(Low density lipoprotein)

이환 중 질병

Arterial occlusive disease; Atherosclerosis; Emphysema pulmonary; Neurological symptom (right-sided, residual after cerebrovascular accident); Penicillin allergy; Tabaquism (10 cigars per day); Type II diabetes mellitus (treated by the diet, care provided)

지병

Medical History/Concurrent Conditions: Cerebrovascular accident (ischemic, residual right-sided symptoms); Inguinal hernia repair (bilateral); Male operative castration (hemicastration, left side); Prostatic operation; Varicose vein operation

기타 의료

TRIAMCINOLONE; DORMICUM [MIDAZOLAM MALEATE]; TRAMAL; EGILOK; ANALGIN [FENPIVERINIUM BROMIDE;METAMIZOLE SODIUM;PITOFENONE HYDROCHLORIDE]; GORDIUS; FAMOSAN; BRUFEN; ROSUCARD

이전 예방접종

알레르기

임상 검사

Test Date: 202109; Test Name: Hemoglobin; Result Unstructured Data: Test Result:139 g/l; Test Date: 202109; Test Name: High density lipoprotein cholesterol; Result Unstructured Data: Test Result:0.
99 mmol/L; Test Date: 202109; Test Name: INR; Result Unstructured Data: Test Result:0.
98; Test Date: 202109; Test Name: Low density lipoprotein cholesterol; Result Unstructured Data: Test Result:3.
25 mmol/L; Test Date: 20210916; Test Name: Magnetic resonance imaging spinal; Result Unstructured Data: Test Result:Spinal stenosis of lumbar region L4/L5; Comments: Spinal stenosis of lumbar region L4/L5 due to vertebrae and discs changes; Test Date: 202109; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:293 x10 9/l; Test Date: 202109; Test Name: White blood cell count; Result Unstructured Data: Test Result:7.
47 x10 9/l

증상 상세

Right lumbar-femoral syndrome with irritation and paresis; Progressive weakness of lower extremities; Loss of consciousness; Pain of the right lower extremity in the cingulum; Repeated fall; Anxiety; Depression; Feeling of despair; Pain legs; Shaking of hands; Thigh muscle pain; Sleeplessness; Inappetence; Feeling cold; Died in sleep; General physical health deterioration; Extreme fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB.
Regulatory number: CZ-CZSUKL-22001864.
A 75 year old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 15Jul2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization.
Relevant medical history included: "Cerebrovascular accident" (not ongoing), notes: ischemic, residual right-sided symptoms; "Penicillin allergy" (ongoing); "Emphysema pulmonary" (ongoing); "Prostatic operation" (not ongoing); "Tabaquism" (ongoing), notes: 10 cigars per day; "Varicose vein operation" (not ongoing); "Type II diabetes mellitus" (ongoing), notes: treated by the diet, care provided; "Arterial occlusive disease" (ongoing); "Male operative castration" (not ongoing), notes: hemicastration, left side; "Atherosclerosis" (ongoing); "Inguinal hernia repair" (not ongoing), notes: bilateral; "Neurological symptom" (ongoing), notes: right-sided, residual after cerebrovascular accident.
Concomitant medication(s) included: TRIAMCINOLONE; DORMICUM [MIDAZOLAM MALEATE]; TRAMAL; EGILOK; ANALGIN [FENPIVERINIUM BROMIDE; METAMIZOLE SODIUM; PITOFENONE HYDROCHLORIDE]; GORDIUS; FAMOSAN; BRUFEN; ROSUCARD.
Vaccination history included: Comirnaty (Dose 1, Batch/lot number: FC2473, Pharmaceutical form (Dosage form): Solution for injection, Route of Administration: Intramuscular), for COVID-19 immunization.
The following information was reported: The following information was reported: DEATH (death, medically significant) with onset 04Sep2021, outcome "fatal", described as "Died in sleep"; SCIATICA (hospitalization) with onset Sep2021, outcome "unknown", described as "Right lumbar-femoral syndrome with irritation and paresis"; MUSCULAR WEAKNESS (hospitalization) with onset Sep2021, outcome "unknown", described as "Progressive weakness of lower extremities"; LOSS OF CONSCIOUSNESS (hospitalization) with onset Sep2021, outcome "unknown", described as "Loss of consciousness"; PAIN IN EXTREMITY (hospitalization) with onset Sep2021, outcome "unknown", described as "Pain of the right lower extremity in the cingulum"; FALL (hospitalization) with onset Sep2021, outcome "unknown", described as "Repeated fall"; ANXIETY (non-serious), outcome "unknown", described as "Anxiety"; DEPRESSION (non-serious), outcome "unknown", described as "Depression"; FEELING OF DESPAIR (non-serious), outcome "unknown", described as "Feeling of despair"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain legs"; TREMOR (non-serious), outcome "unknown", described as "Shaking of hands"; MYALGIA (non-serious), outcome "unknown", described as "Thigh muscle pain"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious) with onset Jul2021, outcome "unknown", described as "General physical health deterioration"; INSOMNIA (non-serious), outcome "unknown", described as "Sleeplessness"; FATIGUE (non-serious), outcome "unknown", described as "Extreme fatigue"; DECREASED APPETITE (non-serious), outcome "unknown", described as "Inappetence"; FEELING COLD (non-serious), outcome "unknown", described as "Feeling cold".
The patient was hospitalized for sciatica, muscular weakness, loss of consciousness, pain in extremity, fall (start date: 13Sep2021, discharge date: 17Sep2021, hospitalization duration: 4 day(s)).
The patient underwent the following laboratory tests and procedures: haemoglobin: (Sep2021) 139 g/l; high density lipoprotein: (Sep2021) 0.
99 mmol/L; international normalised ratio: (Sep2021) 0.
98; low density lipoprotein: (Sep2021) 3.
25 mmol/L; magnetic resonance imaging spinal: (16Sep2021) spinal stenosis of lumbar region l4/l5, notes: Spinal stenosis of lumbar region L4/L5 due to vertebrae and discs changes; platelet count: (Sep2021) 293 x10 9/l; white blood cell count: (Sep2021) 7.
47 x10 9/l.
The patient date of death was 04Sep2021.
The reported cause of death was "Died in sleep".
No autopsy was performed.
Clinical course: 3 months lasting fatigue and exhaustion, inappetence, permanent cold feeling - even in summer, depression, anxiety, desperation, insomnia (slept 4 hours only), the pain of the legs, shaking of the hands.
His health condition worsened rapidly since the vaccination.
The patient was hospitalized from 13th to 17th September 2021 due to 10 days lasting progressive weakness and pain of the right lower leg in the cingulum, repeated falls, loss of consciousness.
Magnetic resonance was done with finding of right lumbar-femoral syndrome with irritation and paresis due to 10 mm spinal stenosis of the lumbar region (L4/L5), caused by vertebrae and discs changes.
After an administration of analgesic infusion, the radicular pain receded.
Furthermore, secondary prevention of cerebrovascular accidents was set.
The patient did not drink alcohol.
No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No further information is expected.
; Reported Cause(s) of Death: Died in sleep