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|History of Changes from the VAERS Wayback Machine|
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH||ER0641 / 2||- / OT|
Administered by: Other Purchased by: ??
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Anaemia, Aspartate aminotransferase increased, Bilirubin conjugated, Blood alkaline phosphatase, Blood bicarbonate, Blood bilirubin, Blood bilirubin unconjugated, Blood calcium, Blood chloride, Blood creatinine, Blood folate, Blood gases, Blood glucose, Blood iron, Blood lactate dehydrogenase, Blood magnesium, Blood osmolarity, Blood parathyroid hormone, Blood phosphorus, Blood potassium, Blood sodium, Blood urea, Body temperature, C-reactive protein, Computerised tomogram, Coombs direct test, Dizziness, Drug ineffective, Fatigue, Fibrin D dimer, Gamma-glutamyltransferase, Genital herpes, Blood urine present, Haemoglobin, Heart rate, Iron binding capacity total, Mean cell haemoglobin concentration, Mean cell volume, Oxygen saturation, Pain, Pneumonia, PO2, Positron emission tomogram, Proteinuria, Prothrombin time, Respiratory rate, Serum ferritin, Thrombocytopenia, Transferrin, Vitamin B12, Urinary tract infection fungal, General physical health deterioration, Bradyphrenia, Protein total, Antineutrophil cytoplasmic antibody, Lipase, Haptoglobin, Leukocyturia, Anti-neutrophil cytoplasmic antibody positive vasculitis, Staphylococcal bacteraemia, Musculoskeletal stiffness, Urinary tract infection bacterial, Bicytopenia, Urine cytology, Fraction of inspired oxygen, Blood 25-hydroxycholecalciferol, Calcium ionised, Renal function test, Scan brain, Troponin, Blood test, Anti-glomerular basement membrane antibody, Blood count, N-terminal prohormone brain natriuretic peptide, Bacterial test, Legionella test, Slow speech, Blood pressure measurement, SARS-CoV-2 test, Suspected COVID-19
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? Yes
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 56
Write-up: anemia; worsening of fatigue; stiffness; dizzy; advanced bilateral multi-lobular pneumonia/respiratory discomfort and fever; evoking in the first place a COVID infection(but 2 PCR negative)/suspected COVID lung disease; evoking in the first place a COVID infection(but 2 PCR negative)/suspected COVID lung disease; vasculitis kidney/pulmonary vasculitis/ ANCA vasculitis with pulmonary and renal (and probable digestive) involvement; multidrug-resistant with Staphylococcal bacteremia which; genital herpes treated; bi cytopenia; thrombocytopenia; urinary tract infection with Candida albicans; urinary infection due to Pseudomonas; painful; bradylalia; bradypsychia; deterioration of the general condition; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB FR-AFSSAPS-2021068755. An 89-year-old female patient received BNT162B2 (COMIRNATY), dose 2 intramuscular on 27Feb2021 (Lot Number: ER0641) as single dose, dose 1 via unknown route of administration on 22Jan2021 (lot number unknown) as single dose for covid-19 immunisation. The patient medical history was not reported, no chronic treatment. No personal or family history reported. Lives alone at home, independent, in good general condition and well surrounded by her children. The patient''s concomitant medications were not reported. The patient experienced vasculitis kidney/pulmonary vasculitis/ ANCA vasculitis with pulmonary and renal (and probable digestive) involvement since 04Mar2021. On 22Jan2021, patient had 1st dose of Comirnaty followed by the onset of fatigue attributed to the death of her sister-in-law 19Feb, 2nd dose of Comirnaty lot ER0641 on 27Feb2021 and then, (in 2021) the patient had worsening of fatigue, appearance of stiffness, then respiratory discomfort and fever. Consulted his attending physician prescribes a laboratory assessment which showed anemia at 7.3 g / dl (10Mar2021) and hospitalized her on 10Mar2021. Information included in the declaration was high fever and very great fatigue very tired and dizzy. CLINICAL EXAMINATION AT THE ENTRY Patient conscious, oriented, temperature 38.4C, blood pressure 14/6, heart rate 114 beats / min, respiratory rate 28, saturation 98%, no signs of heart failure, crackles at the base on the right. ADDITIONAL TESTS Laboratory tests results (10Mar2021): Blood gas: pH at 7.48, pCO2 at 37.4 mmHg, pO2 at 48 mmHg, oxygen saturation at 86.6%, ionized calcium at 1.13, blood glucose at 7.5 mmol / l, HCO3 at 27.5mmol / l, Blood cultures are negative, PCR for SARS COVID 2 is negative twice, Blood count test: white blood cells 10000, Neutrophils 8 600, lymphocytes at 600, monocytes at 800, eosinophils at 0, hemoglobin at 7.3 g / dl, MCV at 84.6 fl, mean corpuscular hemoglobin concentration (MCHC) at 32 g / dl , platelets 372 000, reticulocytes 37.53 G / l, prothrombin time 92%, activated partial thromboplastin time 1.16, new tests of blood cultures: negative, CRP at 330 mg / l, sodium 137 mmol / l, serum potassium at 3.7 mmol / l, calcium at 2.11 mmol/l, Urea at 10.1 mmol / l, creatinine at 118 umol / l, blood glucose at 7.5 mmol / l, Total bilirubin at 9 umol / l, ASAT at 23 IU / l, ALT (ALAT) at 16 IU / l, gGT at 79 IU / l, alkaline phosphatase at 107 IU / l, lipase at 29 IU / l, Troponin 21 ng / l, Pro-BNP 3080 pg / ml. 11Mar2021: D-dimers at 3,770 ng / ml, Ferritin at 312 ng / ml, transferrin at 1.09 g / l, serum iron at 0.4 umol / l, percent saturation at 1%, Phosphorus at 0.82 mmol / l, Magnesium at 0.8 mmol / l, Total binding capacity 27.25 umol / l, Parathormone elevated to 153 pg / ml, Vitamin B12 349 pg / ml, 25 OH D 7.5 ng / ml, Folates 6.4 ng / ml, cytobacteriological urine test: leukocyturia 14.52 / mm3, hematuria 857.12 / mm3, the culture came back negative. The thoraco-abdomino-pelvic scanner made on 11Mar2021 concluded in the absence of occlusive syndrome, advanced bilateral multi-lobular pneumonia of severe form greater than 75%, which leads to evoking in the first place a COVID infection (but 2 PCR negative). OUTCOME Due to a suspected COVID lung disease on the scan appearance, she was transferred to the COVID unit. 12Mar: worsening of anemia with hemoglobin at 6.5 g / dl, MCV at 84.1 fl, mean corpuscular hemoglobin concentration (MCHC) at 32.9 g / dl, white blood cells at 12 500, platelets at 397 000, neutrophils at 10 700, lymphocytes at 900. Blood cells transfusion, initiation of treatment with corticosteroid therapy, double antibiotic therapy and preventive anticoagulation with CALCIPARINE. Saturation 81%, requiring increased oxygen therapy with a high concentration mask. Results from 13Mar: hemoglobin at 10.1 g / dl, cytobacteriological urine test negative with hematuria at 1057.89 / mm3, leukocyturia at 60.81 / mm3. March 14, under high concentration mask at 12 l / min: table of respiratory distress with desaturation despite oxygen therapy under high concentration mask, put on OPTIFLOW on 16Mar. So the presence of the association of lung damage, kidney damage and anemia, with a negative COVID test and the notion of anti-COVID vaccination that has been done. Table suggesting pneumo-renal syndrome or alveolar hemorrhage. The images of the scanner were reviewed by internist, pulmonologist and radiologist, they do not suggest a COVID, they retained the appearance suggestive of intra-alveolar hemorrhage. In this context, increase in corticosteroid therapy and bolus of SOLUMEDROL to 240 mg with hydration and continuation of antibiotic therapy with AUGMENTIN and ROVAMYCINE. 15Mar results: CRP 249 mg / l, plasma sodium concentration 143 mmol / l, serum potassium 3.8 mmol / l, calcemia 2.22 mmol / l, osmolarity 328 mosmol / l, protein 69 g / l, urea 26, 6 mmol / l, creatinine at 185 umol / l, glomerular filtration rate 21 ml / min / 1.73, ASAT 31 IU, alanine aminotransferase 38 IU. Hemoglobin 10.3 g / dl, white blood cells 17 700, platelets 503 000, polymorphonuclear neutrophils 16 000, lymphocytes 600. 17Mar: CRP 201 mg / l, plasma sodium concentration 141 mmol / l, serum potassium 3.5 mmol / l, osmolarity 315 mosmol / l, urea 19.2 mmol / l, creatinine 197 umol / l . 19Mar: white blood cells 21 500, hemoglobin 11.4 g / dl, mean cell volume (MCV) at 86.6 fl, platelets 389 G / l, neutrophils 20 500, lymphocytes 200, monocytes 700, CRP 76 mg / l, plasma sodium concentration 140 mmol / l, serum potassium 3.9 mmol / l, serum calcium 2.07 mmol / l, osmolarity calculated at 322 mosmol / l, urea 25 mmol / l, creatinine 217 umol / l, blood glucose 8 mmol / l, total bilirubin 21 umol / l, direct bilirubin at 9 umol / l, Indirect bilirubin 12 umol / l, alanine aminotransferase at 35 IU / l, gGT at 192 IU / l, alkaline phosphatase at 112 IU / l, C3 dosage at 1.53 g / l, C4 at 0.37 g / l, haptoglobin collapsed at 0.05 g / L, LDH at 690 IU / L, pro-BNP at 10 502 pg / ml, prothrombin time at 88%, activated partial thromboplastin time 0.98. Request for an opinion in internal medicine: complete the assessment for vasculitis, redo the pro-BNP, Improvement of the general and respiratory condition under corticosteroid therapy, which allowed the reduction of oxygen under OPTIFLOW for a weaning goal. The vasculitis assessment on 20Mar: anti-nuclear factors in progress, anti-phospholipid antibodies in progress, ANCA positive with anti-PR3 antibodies greater than 200, suggesting Wegener''s disease, 24 hour proteinuria at 0.57 g / l, with presence of blood, test for soluble urinary antigens Legionnella negative, anti-glomerular basement membrane antibodies negative. On 21Mar: natremia at 146 mmol / l, calcium at 2.13 mmol / l, high osmolarity at 342 mosmol / l, urea at 35.6 mmol / l, creatinine at 239 umol / l, glycemia at 7, 9 mmol / l, Blood count: leukocytes at 73.92 / mm3, hematuria greater than 1600 / mm3. Search for cyroglobulins in progress.Blood gases measured at 23 L/ min with 57% FiO2 , pH 7.4, pCO 47.4 mmHg, pO2 56.2 mmHg, oxygen saturation 89.3%. On 23Mar: hypernatremia 150 mmol / l, serum calcium 2.19 mmol / l, urea 37.9 mmol / l, creatinine 255 umol / l, chlorine 111 mmol / l, serum calcium 2.19 , osmolarity 353 mosmol / l, direct Coombs test returned positive for IgG POS, direct Coombs test C3D negative. Control thoracic CT scan on 22Mar2021: marked improvement in the alveolar-interstitial opacities of the two pulmonary fields, predominantly in the upper lobes of the middle lobe with clearly less extensive lesions in the basal pyramids, in particular on the left. Appearance of bilateral pleural effusion, more marked on the right. Topic discussed again with internists: Table of Wegener''s disease and hemolytic anemia. continue rehydration with LASILIX and corticosteroid therapy. Benefit of immunosuppressive therapy (ENDOXAN)? or plasma exchange with the corticosteroid bolus. Transfer for the management of pneumo-renal syndrome secondary to GPA-type ANCA-positive vasculitis in a post-COVID vaccination context. Weight: 56 kg, Height: 152cm BMI: 24.24. Undernourished patient, conscious, cooperating with a Glasgow 15/15 and afebrile. Constants: Arterial pressure 120/60 mmHg, Heart rate 74 bpm, Saturation 100% under 5L of O2. Laboratory tests: Hypernatremia at 151 mmol / l, Plasma osmolarity at 359 mOsm / l, hyperchloremia at 112 mmol / l. Kalaemia at 4.6 mmol / l, bicarbonatemia at 30 mmol / l. Serum creatinine at 262 umol / l, urea at 41 mmol / l. NT-proBNP 1911, leukocytes 12 G / l with 89% Neutrophils , hemoglobin 10 g / dl, Platelets 228 G / l, CRP at 38 mg / l. Therefore, overall predominantly intracellular dehydration with hypernatremia without neurological disorder in a malnourished patient in whom the diagnosis of ANCA vasculitis with pneumo-renal involvement was made. Rehydration. Corticosteroid therapy and antibiotic therapy. Assessment of the indication for immunosuppression. DEVELOPEMENT IN THE DEPARTMENT: Gradual normalization of serum sodium levels maintained between 135 and 144 mmol / l and euvolemia, under regimen of rehydration by hypotonic solute glucose 2.5% From the point of view of vasculitis: Good progress on corticosteroid on the respiratory plan with eupnea in ambient air and improvement of radiological lesions. Stationary evolution on the renal level. With a creatinine that oscillates between 170 and 260 umol / l As part of the extension assessment, diffuse digestive fixation and 1/3 sup esophageal with the positron emission tomography scan. The brain scan was normal. On the advice of the staff, the kidney biopsy was not done on 29Mar2021. Cyclophosphamide 500 mg bolus was administered Immediate viral (genital herpes treated, 2021) and fungal (urinary tract infection with Candida albicans, 2021) and bi cytopenia with anemia and thrombocytopenia (2021) without externalized bleeding which corrected with stabilization after transfusion appeared as a result. By collegial decision, a second bolus at the 3 rd week at a reduced dose of 360 mg of Cyclophosphamide was administered on 19Apr2021 with, on day15 of the bolus, a urinary infection due to Pseudomonas multidrug-resistant with Staphylococcal bacteremia which has progressed well under CEFTRIAXONE AMIKACIN VANCOMYCIN. CRP fell from 152 to 78 mg / l in 5 days. Reappearance of bicytopenia on day2. The patient became bradylalia and bradypsychia in a context of slip syndrome with refusal of mobilization despite the physiotherapist''s visit, to eat, to take oral medications. A geriatric advisory recommended adding Escitalopram (difficult to get her to take because of the dosage form). Faced with the profound deterioration of the general condition, the palliative care team at the bedside of the patient, who had become painful and uncomfortable, recommended the use of opioids. After consultation with the family, hospitalization with home support was decided. Release 05May2021 Death on 09May2021 In total, ANCA vasculitis with pulmonary and renal (and probable digestive) involvement in a woman in good general condition and without associated pathology, the first signs of which began around day6 (04Mar2021) after dose 2 of Comirnaty. Death following haematological and infectious complications related to corticosteroid and cyclophosphamide boluses. The outcome of event ANCA vasculitis and Staphylococcal bacteremia was fatal, of other events was unknown. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number already obtained.; Reported Cause(s) of Death: vasculitis kidney/pulmonary vasculitis/ ANCA vasculitis with pulmonary and renal (and probable digestive) involvement; Staphylococcal bacteremia
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