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This is VAERS ID 1589007

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History of Changes from the VAERS Wayback Machine

First Appeared on 8/20/2021

VAERS ID: 1589007
VAERS Form:2
Age:
Sex:Female
Location:Foreign
Vaccinated:2021-06-09
Onset:2021-06-27
Submitted:0000-00-00
Entered:2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other      Purchased by: ??
Symptoms: Acute disseminated encephalomyelitis, Blood creatine, Blood creatine phosphokinase, Blood potassium, Blood urea, C-reactive protein, Cardiac index, Computerised tomogram, CSF cell count, Echocardiogram, Electroencephalogram, Electrophoresis, Haemoglobin, HIV test, Lumbar puncture, Oxygen saturation, Prothrombin level, Polymerase chain reaction, Brain natriuretic peptide, Cytomegalovirus test, Coma scale, Chlamydia test, Varicella virus test, Magnetic resonance imaging

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2021-07-23
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DOLIPRANE; ESOMEPRAZOLE; ALPRAZOLAM; GAVISCON [CALCIUM CARBONATE;SODIUM ALGINATE]; PAROXETINE [PAROXETINE HYDROCHLORIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholecystectomy; Depression; Fibromyalgia; Fracture of vertebra; GERD; Hypertension arterial; Hysterectomy; Renal impairment; Spinal operation
Allergies:
Diagnostic Lab Data: Test Date: 20210627; Test Name: creat; Result Unstructured Data: Test Result:531; Test Date: 20210627; Test Name: creatine phosphokinase; Result Unstructured Data: Test Result:18000; Test Date: 20210627; Test Name: iono k; Result Unstructured Data: Test Result:5.1; Test Date: 20210627; Test Name: urea; Result Unstructured Data: Test Result:26; Test Date: 20210627; Test Name: Brain natriuretic peptide; Result Unstructured Data: Test Result:56000; Test Date: 20210627; Test Name: index cardiac; Result Unstructured Data: Test Result:49; Test Name: chlamydial serology; Test Result: Positive ; Comments: positive chlamydial serology in IgG and IgM, rickettsi serology positive at the threshold, serology of old measles and mumps neg, serology lyme neg, IgG mycoplasma neg; Test Date: 20210709; Test Name: glasgow scale; Result Unstructured Data: Test Result:5 at best; Test Date: 20210719; Test Name: glasgow scale; Result Unstructured Data: Test Result:E2M1V4 at best with eye wandering, reactive interm; Comments: E2M1V4 at best with eye wandering, reactive intermediate pupils.; Test Name: Computed tomography thorax-abdomen-pelvis scans; Result Unstructured Data: Test Result:Excavated pneumonia and polyviceral failure; Test Date: 20210627; Test Name: Computed tomography thorax-abdomen-pelvis scans; Result Unstructured Data: Test Result:possibly anoxic encephalopathy; Comments: found areas of possibly anoxic encephalopathy and areas of occipital ischemia with doubt about a neurological infectious process. Associated with pulmonary cavities: inhalation pneumonia.; Test Date: 20210627; Test Name: crp; Result Unstructured Data: Test Result:332; Test Date: 20210709; Test Name: cerebrospinal fluid; Result Unstructured Data: Test Result:25 cells, 92% lympho, prot 0.44g / l no hypoglycor; Comments: 25 cells, 92% lympho, prot 0.44g / l no hypoglycorachia, culture neg,; Test Name: PCR CMV; Result Unstructured Data: Test Result:positive blood; Test Name: trans-thoracic echocardiography; Result Unstructured Data: Test Result:formamen ovale permeable but no vegetation.; Test Date: 20210719; Test Name: EEG; Result Unstructured Data: Test Result:reactive with absence of epileptogenic activity.; Test Name: electrophoresis of serum proteins; Result Unstructured Data: Test Result:Globulinemia at 5g / l; Test Date: 20210627; Test Name: Hb; Result Unstructured Data: Test Result:11.9; Test Name: HIV serology; Test Result: Negative ; Test Date: 20210627; Test Name: lumbar puncture; Result Unstructured Data: Test Result:without nucleated element; Comments: without nucleated element with a few red blood cells and a non-purulent appearance which precludes the diagnosis of infectious encephalitis. no elements, prot at 0.42g / l, no hypoglycorachia, PCR enterovirus neg, universal PCR neg,; Test Date: 20210709; Test Name: lumbar puncture; Result Unstructured Data: Test Result:brings back some elements in favor of an Inflammat; Comments: brings back some elements in favor of an Inflammation with in particular the presence of polymorphonuclear cells unlike the 1st lumbar puncture.; Test Date: 20210628; Test Name: Cerebral MRI; Result Unstructured Data: Test Result:large ischemic areas of the white matter on the up; Comments: large ischemic areas of the white matter on the upper and sub-tentorial stages as well as on the corpus callosum and the pallidums, not systematized, aspecific but in favor of a toxic cause of the carbon monoxide type; Test Date: 20210719; Test Name: Cerebral MRI; Result Unstructured Data: Test Result:decrease in edema and the pseudo-tumoral appearanc; Comments: decrease in edema and the pseudo-tumoral appearance of supra and intratentorial leukoencephalopathy lesions. Appearance of necrotizing-looking areas and in places where hemosiderin is deposited: acute hemorrhagic leukoencephalopathy? Another hyperacute demyelinating disorder? other?; Test Date: 20210627; Test Name: oxygen saturation; Test Result: 60 %; Test Name: multiplex PCR; Test Result: Negative ; Comments: (E COli / haemophilius / listeria / neisseria / strepto agalactiae, pneumoniae / CMV / Enterovirus / HHV6 / HSV & et 2 / VVZ / cryptococcus / parechovirus); Test Date: 20210627; Test Name: prothrombin; Test Result: 61 %; Test Name: VZV; Test Result: Negative
CDC 'Split Type': FRPFIZER INC202101038943

Write-up: necrotico-hemorrhagic acute disseminated encephalomyelitis; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-LY20218843. A 64-year-old female patient received BNT162B2 (COMIRNATY), dose 1 intramuscular on 09Jun2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. Medical history included fibromyalgia, HTA (hypertension arterial), moderate renal impairment (creatinine 95umol/L), depressive syndrome, GERD with treated H Pylori, dorsal vertebrae fracture operated on L5-S1 in 2010, cholecystectomy and hysterectomy. Concomitant medications included paracetamol (DOLIPRANE), esomeprazole, alprazolam, calcium carbonate, sodium alginate (GAVISCON [CALCIUM CARBONATE;SODIUM ALGINATE]), paroxetine hydrochloride (PAROXETINE [PAROXETINE HYDROCHLORIDE]), all taken for an unspecified indication, start and stop date were not reported. The patient experienced necrotico-hemorrhagic acute disseminated encephalomyelitis (ADEM) on 27Jun2021. Clinical course was reported as On 27Jun2021: patient was found unconscious in her bed with 60% saturation, vomiting and stools; coma of indefinite duration and undetermined etiology. Computed tomography thorax-abdomen-pelvis scans found areas of possibly anoxic encephalopathy and areas of occipital ischemia with doubt about a neurological infectious process. Associated with pulmonary cavities: inhalation pneumonia. A lumbar puncture returns without nucleated element with a few red blood cells and a non-purulent appearance which precludes the diagnosis of infectious encephalitis. Biology: Gds PH7 with PCO2 60mmHg, Hb: 11.9, prothrombin: 61%; iono k: 5.1, creatine: 531 and urea: 26. Major hepatic cytolysis, creatine phosphokinase 18000; Brain natriuretic peptide: 56,000, high index cardiaque: 49, CRP: 332. The patient also presented with multi-visceral failure after prolonged stationary ground secondary to impaired consciousness. (Following hospitalization, organ failures (hemodynamic, renal, respiratory and hepatic) have completely regressed and can be part of a table of significant dehydration + rhabdomyolysis linked to the ground station). Additional tests: Cerebral MRI (28Jun2021): large ischemic areas of the white matter on the upper and sub-tentorial stages as well as on the corpus callosum and the pallidums, not systematized, aspecific but in favor of a toxic cause of the carbon monoxide type. Brain MRI (19Jul2021): decrease in edema and the pseudo-tumoral appearance of supra and intratentorial leukoencephalopathy lesions. Appearance of necrotizing-looking areas and in places where hemosiderin is deposited: acute hemorrhagic leukoencephalopathy? Another hyperacute demyelinating disorder? other? Differential diagnosis: no detection of carbon oxide (CO) at the sensor, no gas heating, little argument for CO poisoning during treatment. In addition, on GDS entry on 27Jun2021 at 11 a.m., HbCO is dosed at 0.8. Negative toxic balance. Patient with intense relational life, no dark thoughts. Trans-thoracic echocardiography: formamen ovale permeable but no vegetation. Computed tomography thorax-abdomen-pelvis: Excavated pneumonia and polyviceral failure. Initial lumbar punction 27Jun2021: no elements, prot at 0.42g/l, no hypoglycorachia, PCR enterovirus neg, universal PCR neg, PCR HSV VZV neg LBA and hemoc pos in strepto anginosus. HIV negative serology, electrophoresis of serum proteins hypogammaGlobulinemia at 5g/l, positive chlamydial serology in IgG and IgM, rickettsi serology positive at the threshold, serology of old measles and mumps neg, serology lyme neg, IgG mycoplasma negative, cerebrospinal fluid on 09Jul2021: 25 cells, 92% lympho, prot 0.44g / l no hypoglycorachia, culture negative, PCR Whipple negative, negative multiplex PCR (E COli / haemophilius / listeria / neisseria / strepto agalactiae, pneumoniae / CMV / Enterovirus / HHV6 / HSV & et 2 / VVZ / cryptococcus / parechovirus), PCR CMV positive blood. EVOLUTION: 09Jul2021: No neurological improvement, patient glasgow 5 at best. She remained non-stimulable despite stopping the sedations on 06/30. The 2nd lumbar puncture today brings back some elements in favor of an Inflammation with in particular the presence of polymorphonuclear cells unlike the 1st lumbar puncture. 16Jul2021: Neuro opinion: The clinical picture is very suggestive of a necrotico-hemorrhagic type ADEM (form of HURST) whose prognosis is poor. It is an acute inflammatory disease with microvascular vasculitis. The etiology may be postinfectious or post vaccination. Corticosteroid therapy 1g / d in the event of an ADEM. 19Jul2021: patient glasgow E2M1V4 at best with eye wandering, reactive intermediate pupils. EEG appears to be reactive with absence of epileptogenic activity. Decrease in corticosteroid therapy to 2 mg/kg/day. 21Jul2021: Neurological opinion: extremely unfavorable neurological and functional prognosis without the prospect of recovery despite treatment, extensive necrosis lesions formed on MRI. In agreement with a discontinuation of active therapies. 23Jul2021: death of the patient. In total, a necrotico-hemorrhagic ADEM table whose etiology may be post-infectious or post-vaccination on D18 of D1 of the BNT162B2 vaccine. The patient died on 23Jul2021. It was not reported if an autopsy was performed. No follow-up attempts possible. Information on lot and batch numbers cannot be obtained. No further information expected. ; Reported Cause(s) of Death: necrotico-hemorrhagic acute disseminated encephalomyelitis

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