이상반응 보고

VAERS ID	2466254
성별	남성
나이	25세
주 코드	FR
제약회사	PFIZER\BIONTECH
로트 번호	ACB8491
예방접종 횟수	2
접종일	2022-01-26
발병일	2022-01-26
상태	사망

증상

부적절한 제품 관리 일정(Inappropriate schedule of product administration)
혈액 검사(Blood test)
SARS-CoV-2 테스트(SARS-CoV-2 test)
흉부 엑스레이(Chest X-ray)
컴퓨터 단층 촬영(Computerised tomogram)
자기 공명 영상(Magnetic resonance imaging)
혈당(Blood glucose)
신경학적 검사(Neurological examination)
전문상담(Specialist consultation)
뇌파도(Electroencephalogram)
사구체 여과율(Glomerular filtration rate)
C 반응성 단백질(C-reactive protein)
혈압 측정(Blood pressure measurement)
호중구 수(Neutrophil count)
평균 세포 헤모글로빈(Mean cell haemoglobin)
심실성 부정맥(Ventricular arrhythmia)
혈액 크레아티닌(Blood creatinine)
혈액 요소(Blood urea)
림프구 수(Lymphocyte count)
단핵구 수(Monocyte count)
체온(Body temperature)
심장비대(Cardiomegaly)
폐부종(Pulmonary oedema)
심박수(Heart rate)
산소 포화도(Oxygen saturation)
신체 검사(Physical examination)
엑스레이 사지(X-ray limb)
아밀라아제(Amylase)
혈소판 수(Platelet count)
혈액 가스(Blood gases)
검시(Autopsy)
적혈구 분포 폭(Red cell distribution width)
알라닌 아미노전이효소(Alanine aminotransferase)
아스파르테이트 아미노전이효소(Aspartate aminotransferase)
혈액 칼륨(Blood potassium)
헤모글로빈(Haemoglobin)
평균 세포 헤모글로빈 농도(Mean cell haemoglobin concentration)
백혈구 수(White blood cell count)
자기공명영상 헤드(Magnetic resonance imaging head)
헤마토크릿(Haematocrit)
심근염(Myocarditis)
혈액 빌리루빈(Blood bilirubin)
심실세동(Ventricular fibrillation)
호염기구 수(Basophil count)
호산구 수(Eosinophil count)
폐활량 측정(Spirometry)
평균 혈소판 부피(Mean platelet volume)
혈액 나트륨(Blood sodium)
혈액 염화물(Blood chloride)
적혈구 분석(Red blood cell analysis)
복부 스캔(Abdomen scan)
심장 비대(Cardiac hypertrophy)
정형 검진(Orthopaedic examination)
적혈구 수(Erythroblast count)

이환 중 질병

지병

Medical History/Concurrent Conditions: Anxiety; Apathy; Asthenia; Chest discomfort; COVID-19 (with light cough and mild cold, without taste or smell alteration or fever); Depression; Insomnia

기타 의료

SERTRALINE; XANAX; XANAX; ZOLPEDUAR

이전 예방접종

알레르기

임상 검사

Test Date: 20211210; Test Name: Abdomen Echo; Result Unstructured Data: Test Result:normal; Comments: Regular liver free from obvious suspicious solid focal lesions.
Normo-distended gallbladder, without stones.
Non-dilated biliary tract.
Not expanded in pancreatic lodge.
Not splenomegaly.
Abdominal aorta of regular caliber.
Kidneys in regular place for morphology and parenchymal thickness.
No evident cystic or macroscopic stones formations.
Not hydronephrosis.
The bilateral renal pelvic hypotonia is stable, with a current maximum anteroposterior diameter of about 20 mm on the right and 15 mm on the left.
No stones found.
The ureters in the pre-vesical area are not dilated.
Repleted bladder exerted by hyperechoic endoluminal projections.
Prostate within the limits for transverse diameter, the previously described utricular cyst is not clearly identifiable.
No free abdominal or perirenal effusion.
; Test Date: 20220105; Test Name: ALT; Result Unstructured Data: Test Result:183; Test Date: 20220105; Test Name: s-amylases; Result Unstructured Data: Test Result:41 IU/l; Test Date: 20220105; Test Name: AST; Result Unstructured Data: Test Result:36; Test Date: 20220201; Test Name: Autopsy; Result Unstructured Data: Test Result:see results below; Comments: Heart globular shape and doubled volume due to ectasia of the atrioventricular cavities.
Pale, homogeneous myocardium, flaccid consistency and uniform complexion, thickened at the level of the right ventricle, where the wall of 7 mm.
Aorta and coronaries: NN.
Heart histology: Muscle cells of increased size with central nucleus, hypertrophic and hyperchromic.
Marked pulmonary congestion.
CNS and organs ok.
Pathological diagnosis: Global dilated hypertrophy of the heart.
Acute pulmonary edema.
Conclusion: diagnosis: The boy after COVID and after the first vaccination (months later) after periods of asthenia and in therapy with sertraline, had syncope at home.
After a brief hospitalization in the ED and another epileptic-like episode, he was discharged.
Subsequently and a few days after the second vaccine he suffered sudden death.
A autopsy finding large cardiac / ventricular dilatation with probable histological outcomes myocarditis.
In Mar2021 the heart was normal on chest x-ray and an inflammatory reaction was present from the blood tests on 04Jan2022.
The cause of death is therefore likely to be a ventricular arrhythmia secondary to myocarditis progressively evolved and arose after COVID and after the first vaccine, never investigated, which led to severe progressive cardiac dilation and secondary arrhythmias such as VF.
No abnormalities were found in the brain.
; Test Date: 20220105; Test Name: Basophils; Test Result: 0.
1 %; Test Date: 20220105; Test Name: Bilirubin; Test Result: 0.
90 mg/dl; Test Date: 20220105; Test Name: s-chlorine; Result Unstructured Data: Test Result:103 mEq/l; Test Date: 20220105; Test Name: s-Creatinine; Test Result: 1.
06 mg/dl; Test Date: 20220105; Test Name: blood gas analysis; Result Unstructured Data: Test Result:modest rise in lactates; Comments: pH: 7.
382 pCO2: 42.
1 mmHg pO2: 24.
5 mmHg HCO3-: 23.
0 mEq/L Basic excess: 0.
00 Na+: 143 mEq/L K+: 3.
9 mEq/L Ca+: 1.
26 mmol/L CL-: 106 mmol/L Lactate: 2.
6 mmol/L Glucose: 116 mg/dL Hb: 15.
8 g/dL FCOHb: 0.
7 % FMetHb: 0.
4 % Bilirubin: 0.
00 mg/dL Haematocrit: 48%; Test Date: 20220105; Test Name: s-glucose; Test Result: 114 mg/dl; Test Date: 20220105; Test Name: s-potassium; Result Unstructured Data: Test Result:4.
30 mEq/l; Test Date: 20220104; Test Name: blood pressure; Result Unstructured Data: Test Result:130/90 mmHg; Test Date: 20220105; Test Name: blood pressure; Result Unstructured Data: Test Result:155/75 mmHg; Test Date: 20220105; Test Name: s-sodium; Result Unstructured Data: Test Result:141 mEq/l; Test Date: 20220104; Test Name: blood tests; Result Unstructured Data: Test Result:inflammatory reaction; Test Date: 20220105; Test Name: s-Urea; Test Result: 33 mg/dl; Test Date: 20220104; Test Name: body temperature; Result Unstructured Data: Test Result:36.
5 Centigrade; Test Date: 20220105; Test Name: body temperature; Result Unstructured Data: Test Result:36.
8 Centigrade; Test Date: 20210324; Test Name: Lung x-ray; Result Unstructured Data: Test Result:regular; Comments: post COVID-19 check.
There is no evidence of frank parenchymal thickening with an outbreak in progress.
Hili with vascular plot within the limits.
Cardio-mediastinal image suited to the patient's age and habit.
No pleural effusion.
Not pneumothorax.
Biapical fibrotic outcomes; Test Date: 20220105; Test Name: brain CT scan; Result Unstructured Data: Test Result:no focal lesions.
Median structure in axis; Comments: The tomodensitometric investigation did not reveal focal lesions of current significance in the cerebral, cerebellar and in correspondence of the brain trunk.
Median structures in axis.
Regular amplitude of the periencephalic spaces and the ventricular system.
No fractures of the vault or skull base.
; Test Date: 20220105; Test Name: C-reactive protein; Result Unstructured Data: Test Result:36.
8; Test Date: 20220105; Test Name: EEG; Result Unstructured Data: Test Result:irritative activity; Comments: irritative activity of 3-4 Hz in the right frontal area.
Dysfunctions of epileptogenic nature, probably focal in the right frontal area.
Background rhythm of 9 Hz frequency of medium amplitude and constancy.
During the recording, on several occasions, appearance of peaks and slow waves of great amplitude with a frequency of 3-4 Hz in the predominantly right frontal seat with diffusion to all homo and contralateral areas.
Hyperpnea (HP) not performed due to lack of cooperation.
Intermittent light stimulation (SLI) is not meaningful.
; Test Date: 20220105; Test Name: eosinophils; Test Result: 0.
1 %; Test Date: 20220105; Test Name: erythroblasts; Result Unstructured Data: Test Result:0.
0; Comments: %WBC; Test Date: 20220105; Test Name: estimation of the GFR; Result Unstructured Data: Test Result:84.
5 ml/min; Test Date: 20220105; Test Name: haematocrit; Test Result: 42.
9 %; Test Date: 20220105; Test Name: Haemoglobin; Result Unstructured Data: Test Result:14.
4; Test Date: 20220104; Test Name: HR; Result Unstructured Data: Test Result:110 bpm; Test Date: 20220105; Test Name: HR; Result Unstructured Data: Test Result:110 bpm; Test Date: 20220105; Test Name: lymphocytes; Test Result: 11.
7 %; Test Date: 20210914; Test Name: right knee/leg NMR; Result Unstructured Data: Test Result:Regular; Comments: Examination performed without paramagnetic contrast agent with dedicated Artro-scan 0.
2T equipment, by means of SE and GE sequences weighed in T1, T2 / DP and STIR and acquired on the sagittal, coronal and axial planes.
There was no evidence of fracture lesions in correspondence of both menisci, in place and regular in thickness and signal intensity.
The femoro-tibial and femoro-patellar articular fiqrocartilages are also regular in terms of thickness and signal intensity.
Regular the signal intensity in the various weighings of the skeletal structures investigated, in particular not subchondral osteolesive areas or signs of edema suffering from intramedullary overload.
The cruciate and collateral ligaments are intact, as well as the patellar, popliteal and distal quadriceps femoral tendons.
Hoffa's adipose body is homogeneous.
Patella centered in the femoral trochlea.
No intra-articular effusion.
Not bunions in the popliteal fossa.
; Test Date: 20220109; Test Name: Brain MRI; Result Unstructured Data: Test Result:no appreciable pathological alteration; Comments: Investigation performed in the three planes of space with SE, FSE and IR sequences weighted in T1 and T2.
After administration of paramagnetic contrast medium (Dotarem lot 21GD058A02), T1-weighted sequences were performed.
There are no appreciable pathological alterations in the intensity of the sub and supratentorial brain signal.
The midline structures are aligned.
The ventricular system and the sulci of the cerebral convexities are symmetrical and of normal amplitude.
Normal configuration of periaxial cisterns.
The main intracranial arterial vessels are recognizable and patent.
After intravenous administration of paramagnetic contrast medium, no pathological impregnations or vascular malformations are recognized.
Hypertrophy of the right turbinates.
; Test Date: 20220105; Test Name: average Hb content; Test Result: 28.
4 pg; Test Date: 20220105; Test Name: mean Hb concentration; Result Unstructured Data: Test Result:33.
6 g/dl; Test Date: 20220105; Test Name: platelets mean volume; Result Unstructured Data: Test Result:10.
7; Comments: fL; Test Date: 20220105; Test Name: Monocytes; Test Result: 8.
3 %; Test Date: 20220105; Test Name: neurological examination; Result Unstructured Data: Test Result:regular; Comments: alert patient, correct speech, collaborative, responds in tone to questions.
Oriented in space and time.
Cranial nerves free on clinical examination.
No objective neurological deficits.
Not pathological signs.
Intrinsic and extrinsic ocular motility and other cranial nerves undamaged.
Not stenic deficit on the four limbs.
Coordination and standing in the norm.
Simmerical and lively osteotendinous reflexes; Test Date: 20220105; Test Name: neutrophils; Test Result: 79 %; Test Date: 20220105; Test Name: neutrophils; Test Result: 79.
8 %; Test Date: 20210902; Test Name: Orthopedic consulation; Result Unstructured Data: Test Result:Right knee pain; Comments: Right knee pain recently exacerbated in the absence of significant trauma.
X-ray negative.
Clinically pain on the lateral hemirima with meniscal signs + -.
To be reviewed with MRI in suspected lesion of the external meniscus.
; Test Date: 20210303; Test Name: oxygen saturation; Test Result: 99 %; Test Date: 20220104; Test Name: oxygen saturation; Test Result: 95 %; Test Date: 20220105; Test Name: oxygen saturation; Test Result: 95 %; Comments: 4 L per minute; Test Date: 20220105; Test Name: physical examination; Result Unstructured Data: Test Result:regular; Comments: No cranial nerve deficit.
Pupils isochoric, lysocyclic, normoreactive to light and accommodation.
Not nystagmus.
Not stenic deficits.
Symmetrical osteotendinous reflexes.
Romberg negative.
Normal walking.
Kernig and Brudzinski negative.
No nuchal rigor.
; Test Date: 20220105; Test Name: platelets; Result Unstructured Data: Test Result:249; Comments: 10*3/mmc; Test Date: 20220105; Test Name: erythrocytes; Result Unstructured Data: Test Result:5.
07 10*6/mmc; Test Date: 20220105; Test Name: mean erythrocyte volume; Result Unstructured Data: Test Result:84.
6; Comments: fL; Test Date: 20220105; Test Name: erythrocyte anisocytosis index; Result Unstructured Data: Test Result:13.
2; Test Date: 20220104; Test Name: COVID-19 swab; Test Result: Negative ; Test Date: 20220105; Test Name: COVID-19 swab; Test Result: Negative ; Test Date: 20210324; Test Name: Pulmonologist consultation; Result Unstructured Data: Test Result:regular; Comments: post COVID-19 check; Test Date: 20210324; Test Name: Spirometry; Result Unstructured Data: Test Result:regular; Comments: post COVID-19 check; Test Date: 20220105; Test Name: leukocytes; Result Unstructured Data: Test Result:14.
38; Comments: 10*3/mmc; Test Date: 20210902; Test Name: right knee x-ray; Result Unstructured Data: Test Result:Normal; Comments: examination performed in the two orthogonal projections.
Morphological and Structural bones feature normal.
Mild thinning of the internal femoral-tibial space.
; Test Date: 20220105; Test Name: right shoulder x-ray; Result Unstructured Data: Test Result:negative for fracture

증상 상세

cause of death is therefore likely to be a ventricular arrhythmia secondary to myocarditis/severe progressive cardiac dilation and secondary arrhythmias such as VF; cause of death is therefore likely to be a ventricular arrhythmia secondary to myocarditis/severe progressive cardiac dilation and secondary arrhythmias such as VF; cause of death is therefore likely to be a ventricular arrhythmia secondary to myocarditis/severe progressive cardiac dilation and secondary arrhythmias such as VF; cause of death is therefore likely to be a ventricular arrhythmia secondary to myocarditis/severe progressive cardiac dilation and secondary arrhythmias such as VF; Global dilated hypertrophy of the heart; pulmonary edema; inappropriate schedule of vaccine administered; This is a spontaneous report received from contactable reporters (Consumer and Physician).
The reporter is the parent.
A 26-year-old male patient received BNT162b2 (COMIRNATY), on 26Jan2022 as dose 2, single (Lot number: ACB8491) at the age of 25 years for covid-19 immunisation.
The patient's relevant medical history included: "COVID-19 (mild form)", start date: Nov2020, stop date: Nov2020, notes: with light cough and mild cold, without taste or smell alteration or fever; "discomfort in the right side of the chest", start date: 2020 (unspecified if ongoing); "asthenia", start date: 2020 (unspecified if ongoing); "apathy", start date: 2020 (unspecified if ongoing); "insomnia", start date: 2020 (unspecified if ongoing); "anxiety", start date: 2020 (unspecified if ongoing); "depression", start date: 2020 (unspecified if ongoing).
Concomitant medications included: SERTRALINE taken for depression, start date: Dec2021; XANAX taken for anxiety, start date: Dec2021; XANAX taken for anxiety, start date: Dec2021; ZOLPEDUAR taken for depression.
Past drug history included: Versatis, start date: Sep2021, for right knee pain, notes: 1x.
day for 12 h for 20 days.
Vaccination history included: comirnaty (DOSE 1; Lot number: FE2625), administration date: 25Jun2021, for COVID-19 immunization, reactions: "right leg pain", "episode of fainting with vomiting and epileptic seizure", "episode of fainting with vomiting and epileptic seizure", "episode of fainting with vomiting and epileptic seizure", "new tonic-clonic seizures", "right knee pain", "complains of mild headache", "diffuse myalgia", "trauma of right shoulder", "White blood cell count 14.
38 10*3", "Neutrophil count 79.
8%", "C-reactive protein 36.
8", "Blood urea 33mg/dl", "Modest rise in lactase", "Alanine aminotransferase 183", "Heart rate 110bpm".
The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 26Jan2022, outcome "unknown", described as "inappropriate schedule of vaccine administered"; CARDIAC HYPERTROPHY (death) with onset 31Jan2022, outcome "fatal", described as "Global dilated hypertrophy of the heart"; VENTRICULAR ARRHYTHMIA (death), MYOCARDITIS (death), CARDIOMEGALY (death), VENTRICULAR FIBRILLATION (death) all with onset 31Jan2022, outcome "fatal" and all described as "cause of death is therefore likely to be a ventricular arrhythmia secondary to myocarditis/severe progressive cardiac dilation and secondary arrhythmias such as VF"; PULMONARY OEDEMA (death) with onset 31Jan2022, outcome "fatal", described as "pulmonary edema".
The patient underwent the following laboratory tests and procedures: Abdomen scan: (10Dec2021) normal, notes: Regular liver free from obvious suspicious solid focal lesions.
Normo-distended gallbladder, without stones.
Non-dilated biliary tract.
Not expanded in pancreatic lodge.
Not splenomegaly.
Abdominal aorta of regular caliber.
Kidneys in regular place for morphology and parenchymal thickness.
No evident cystic or macroscopic stones formations.
Not hydronephrosis.
The bilateral renal pelvic hypotonia is stable, with a current maximum anteroposterior diameter of about 20 mm on the right and 15 mm on the left.
No stones found.
The ureters in the pre-vesical area are not dilated.
Repleted bladder exerted by hyperechoic endoluminal projections.
Prostate within the limits for transverse diameter, the previously described utricular cyst is not clearly identifiable.
No free abdominal or perirenal effusion; Alanine aminotransferase: (05Jan2022) 183; Amylase: (05Jan2022) 41 IU/l; Aspartate aminotransferase: (05Jan2022) 36; Autopsy: (01Feb2022) see results below, notes: Heart globular shape and doubled volume due to ectasia of the atrioventricular cavities.
Pale, homogeneous myocardium, flaccid consistency and uniform complexion, thickened at the level of the right ventricle, where the wall of 7 mm.
Aorta and coronaries: NN.
Heart histology: Muscle cells of increased size with central nucleus, hypertrophic and hyperchromic.
Marked pulmonary congestion.
CNS and organs ok.
Pathological diagnosis: Global dilated hypertrophy of the heart.
Acute pulmonary edema.
Conclusion: diagnosis: The boy after COVID and after the first vaccination (months later) after periods of asthenia and in therapy with sertraline, had syncope at home.
After a brief hospitalization in the ED and another epileptic-like episode, he was discharged.
Subsequently and a few days after the second vaccine he suffered sudden death.
A autopsy finding large cardiac / ventricular dilatation with probable histological outcomes myocarditis.
In Mar2021 the heart was normal on chest x-ray and an inflammatory reaction was present from the blood tests on 04Jan2022.
The cause of death is therefore likely to be a ventricular arrhythmia secondary to myocarditis progressively evolved and arose after COVID and after the first vaccine, never investigated, which led to severe progressive cardiac dilation and secondary arrhythmias such as VF.
No abnormalities were found in the brain; Basophil count: (05Jan2022) 0.
1 %; Blood bilirubin: (05Jan2022) 0.
90 mg/dl; Blood chloride: (05Jan2022) 103 mEq/l; Blood creatinine: (05Jan2022) 1.
06 mg/dl; Blood gases: (05Jan2022) modest rise in lactates, notes: pH: 7.
382.
pCO2: 42.
1 mmHg.
pO2: 24.
5 mmHg.
CO3-: 23.
0 mEq/L.
Basic excess: 0.
00.
Na+: 143 mEq/L.
K+: 3.
9 mEq/L.
Ca+: 1.
26 mmol/L.
CL-: 106 mmol/L.
Lactate: 2.
6 mmol/L.
Glucose: 116 mg/dL.
Hb: 15.
8 g/dL.
FCOHb: 0.
7 %.
FMetHb: 0.
4 %.
Bilirubin: 0.
00 mg/dL.
Haematocrit: 48%; Blood glucose: (05Jan2022) 114 mg/dl; Blood potassium: (05Jan2022) 4.
30 mEq/l; Blood pressure measurement: (04Jan2022) 130/90 mmHg; (05Jan2022) 155/75 mmHg; Blood sodium: (05Jan2022) 141 mEq/l; Blood test: (04Jan2022) inflammatory reaction; Blood urea: (05Jan2022) 33 mg/dl; Body temperature: (04Jan2022) 36.
5 Centigrade; (05Jan2022) 36.
8 Centigrade; Chest X-ray: (24Mar2021) regular, notes: post COVID-19 check.
There is no evidence of frank parenchymal thickening with an outbreak in progress.
Hili with vascular plot within the limits.
Cardio-mediastinal image suited to the patient's age and habit.
No pleural effusion.
Not pneumothorax.
Biapical fibrotic outcomes; Computerised tomogram: (05Jan2022) no focal lesions.
Median structure in axis, notes: The tomodensitometric investigation did not reveal focal lesions of current significance in the cerebral, cerebellar and in correspondence of the brain trunk.
Median structures in axis.
Regular amplitude of the periencephalic spaces and the ventricular system.
No fractures of the vault or skull base; C-reactive protein: (05Jan2022) 36.
8; Electroencephalogram: (05Jan2022) irritative activity, notes: irritative activity of 3-4 Hz in the right frontal area.
Dysfunctions of epileptogenic nature, probably focal in the right frontal area.
Background rhythm of 9 Hz frequency of medium amplitude and constancy.
During the recording, on several occasions, appearance of peaks and slow waves of great amplitude with a frequency of 3-4 Hz in the predominantly right frontal seat with diffusion to all homo and contralateral areas.
Hyperpnea (HP) not performed due to lack of cooperation.
Intermittent light stimulation (SLI) is not meaningful; Eosinophil count: (05Jan2022) 0.
1 %; Erythroblast count: (05Jan2022) 0.
0, notes: %WBC; Glomerular filtration rate: (05Jan2022) 84.
5 ml/min; Haematocrit: (05Jan2022) 42.
9 %; Haemoglobin: (05Jan2022) 14.
4; Heart rate: (04Jan2022) 110 bpm; (05Jan2022) 110 bpm; Lymphocyte count: (05Jan2022) 11.
7 %; Magnetic resonance imaging: (14Sep2021) Regular, notes: Examination performed without paramagnetic contrast agent with dedicated Artro-scan 0.
2T equipment, by means of SE and GE sequences weighed in T1, T2 / DP and STIR and acquired on the sagittal, coronal and axial planes.
There was no evidence of fracture lesions in correspondence of both menisci, in place and regular in thickness and signal intensity.
The femoro-tibial and femoro-patellar articular fiqrocartilages are also regular in terms of thickness and signal intensity.
Regular the signal intensity in the various weighings of the skeletal structures investigated, in particular not subchondral osteolesive areas or signs of edema suffering from intramedullary overload.
The cruciate and collateral ligaments are intact, as well as the patellar, popliteal and distal quadriceps femoral tendons.
Hoffa's adipose body is homogeneous.
Patella centered in the femoral trochlea.
No intra-articular effusion.
Not bunions in the popliteal fossa; Magnetic resonance imaging head: (09Jan2022) no appreciable pathological alteration, notes: Investigation performed in the three planes of space with SE, FSE and IR sequences weighted in T1 and T2.
After administration of paramagnetic contrast medium (Dotarem lot 21GD058A02), T1-weighted sequences were performed.
There are no appreciable pathological alterations in the intensity of the sub and supratentorial brain signal.
The midline structures are aligned.
The ventricular system and the sulci of the cerebral convexities are symmetrical and of normal amplitude.
Normal configuration of periaxial cisterns.
The main intracranial arterial vessels are recognizable and patent.
After intravenous administration of paramagnetic contrast medium, no pathological impregnations or vascular malformations are recognized.
Hypertrophy of the right turbinates; Mean cell haemoglobin: (05Jan2022) 28.
4 pg; Mean cell haemoglobin concentration: (05Jan2022) 33.
6 g/dl; Mean platelet volume: (05Jan2022) 10.
7, notes: fL; Monocyte count: (05Jan2022) 8.
3 %; Neurological examination: (05Jan2022) regular, notes: alert patient, correct speech, collaborative, responds in tone to questions.
Oriented in space and time.
Cranial nerves free on clinical examination.
No objective neurological deficits.
Not pathological signs.
Intrinsic and extrinsic ocular motility and other cranial nerves undamaged.
Not stenic deficit on the four limbs.
Coordination and standing in the norm.
Simmerical and lively osteotendinous reflexes; Neutrophil count: (05Jan2022) 79 %; (05Jan2022) 79.
8 %; Orthopaedic examination: (02Sep2021) Right knee pain, notes: Right knee pain recently exacerbated in the absence of significant trauma.
X-ray negative.
Clinically pain on the lateral hemirima with meniscal signs + -.
To be reviewed with MRI in suspected lesion of the external meniscus; Oxygen saturation: (03Mar2021) 99 %; (04Jan2022) 95 %; (05Jan2022) 95 %, notes: 4 L per minute; physical examination: (05Jan2022) regular, notes: No cranial nerve deficit.
Pupils isochoric, lysocyclic, normoreactive to light and accommodation.
Not nystagmus.
Not stenic deficits.
Symmetrical osteotendinous reflexes.
Romberg negative.
Normal walking.
Kernig and Brudzinski negative.
No nuchal rigor; Platelet count: (05Jan2022) 249, notes: 10*3/mmc; Red blood cell analysis: (05Jan2022) 5.
07 10*6/mmc; (05Jan2022) 84.
6, notes: fL; Red cell distribution width: (05Jan2022) 13.
2; SARS-CoV-2 test: (04Jan2022) negative; (05Jan2022) negative; Specialist consultation: (24Mar2021) regular, notes: post COVID-19 check; Spirometry: (24Mar2021) regular, notes: post COVID-19 check; White blood cell count: (05Jan2022) 14.
38, notes: 10*3/mmc; X-ray limb: (02Sep2021) Normal, notes: examination performed in the two orthogonal projections.
Morphological and Structural bones feature normal.
Mild thinning of the internal femoral-tibial space; (05Jan2022) negative for fracture.
The patient date of death was 31Jan2022.
Reported cause of death: "cause of death is therefore likely to be a ventricular arrhythmia secondary to myocarditis/severe progressive cardiac dilation and secondary arrhythmias such as VF", "Global dilated hypertrophy of the heart", "pulmonary edema".
Clinical course: the patient was given dose 2 of the vaccine on 26Jan2022 at a vaccination center, where he reported to the medical officer in charge of collecting clinical data and anamnesis both the assumption of pharmacological therapy in progress, and of the serious clinical episode occurred on 04Jan2022.
The physician did not considered it appropriate to postpone the vaccination.
He was found dead lying prone on the bathroom floor.
The doctors who intervened did not practice resuscitation maneuvers, putting the patient in cardiocirculatory arrest and with rigor mortis already established.
On 31Jan2022, patient died noting his death at 15:55.
; Sender's Comments: Based on the available information in the case, the causal association between the fatal events a ventricular arrhythmia, myocarditis,cardiac dilation, , Ventricular Fibrillation", " hypertrophy of the heart", "pulmonary edema".
and the suspect drug BNT162B2 cannot be excluded.
The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.
Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
,Linked Report(s) : IT-PFIZER INC-202201193439 same patient & product different dose and events;; Reported Cause(s) of Death: cause of death is therefore likely to be a ventricular arrhythmia secondary to myocarditis/severe progressive cardiac dilation and secondary arrhythmias such as VF; cause of death is therefore likely to be a ventricular arrhythmia secondary to myocar