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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||ET1831 / 2||- / OT|
Administered by: Other Purchased by: ??
Symptoms: Activated partial thromboplastin time, Body temperature, Cardiac failure, Cerebrovascular accident, Chest X-ray, Dyspnoea, Electrocardiogram, Fibrin D dimer, Heart rate, International normalised ratio, Mean cell haemoglobin concentration, Oxygen saturation, Physical examination, Platelet count, Prothrombin time ratio, Red blood cell count, Respiratory rate, White blood cell count, Computerised tomogram head, N-terminal prohormone brain natriuretic peptide, Activated partial thromboplastin time ratio, Blood pressure measurement
Life Threatening? Yes
Birth Defect? No
Permanent Disability? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 2
Write-up: stroke suspected; breathlessness progression; decompensation of heart failure; This is as spontaneous report received from a contactable Physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is CZ-CZSUKL-21006893. This case is for the events of the second dose. An 84-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: ET1831), intramuscular on 18Mar2021 (at the age of 84-year-old) as dose 2, single for COVID-19 vaccination. Medical history breathlessness progression with cardial insufficiency from Oct2020 to Oct2020; ischemic heart disease, acute myocardial infarction with ST elevation of inferior wall from Sep2001 to Sep2001; ongoing left-sided cardiac insufficiency in Jan2019 - left ventricle dysfunction with progression, left atrial dilatation with progression, stationary dilatation of right ventricle, diffuse kinetic disorders of left ventricle up to akinesis ramus interventricularis anterior, ejection fraction 33 %; ongoing significant mitral regurgitation since Jan2019; indirect signs of significant pulmonary hypertension (ongoing); ongoing chronic atrial fibrillation; ongoing hypertension grade III (world health organization classification); ongoing impaired glucose tolerance, bruising of leg/after fall from Jul2020 to Jul2020; ongoing Vertebrogenic pain syndrome of lumbosacral spine; ongoing gonarthrosis of grade III lateris dextri in Jul2020; ongoing neurocirculatory asthenia; Mastectomy- mammary carcinoma left-side, left mamma ablation + left axilla exenteration from Nov2006 to Nov2006; chemotherapy; ongoing chronic obstructive pulmonary disease with chronic bronchitis of intermediate grade with no signs of acute exacerbation; cholecystectomy from 1991 to 1991 when 54-years-old; Hysterosalpingo-oophorectomy/hysterectomy + bilateral adnexectomy from 1993 to 1993 due to bleeding; ongoing mobility decreased. Epidemiologic: no tuberculosis, no COVID infection. Family history included: dad - died at 73 years due to testicle carcinoma, mother - died at 81 years due to pulmonary embolism. Allergy: no abuse: non-smoker, abstains from alcohol, gynecologic: 3 labours with no complications, menses till 1993. Concomitant medications included apixaban (ELIQUIS); simvastatin (ZOCOR); beclometasone dipropionate (ECOBEC); theophylline (AFONILUM); furosemide (FUROSEMID); ramipril (TRITACE); itopride hydrochloride (KINITO); metamizole sodium (NOVALGIN) for pain; potassium chloride (KALNORMIN); colecalciferol (VIGANTOL); indometacin (INDOBENE); metoprolol succinate (BETALOC ZOK); furosemide (FURON); oxazepam; digoxin. The patient previously took the first dose of bnt162b2 (COMIRNATY, lot number EK9788) via intramuscular on 25Feb2021 as single dose for COVID-19 immunization and experienced debility, Type II diabetes mellitus, breathlessness and not feeling well. The patient experienced decompensation of heart failure in Mar2021, stroke suspected on unspecified date, hypoxic-ischemic etiology is suspected on unspecified date and breathlessness progression on 18Mar2021. The patient was hospitalized from 27Apr2021 to 29Apr2021. Course of events as follows: On 18Mar the 2nd dose of COMIRNATY was applied and since then there is a shortness of breath progression. According to an ambulance crew there was a breathlessness, saturation 82-86 % which improved after oxygenation therapy. The patient suffers from breathlessness, she wakes up at night because she needs to sit, she does not tolerate horizontal position. Fluidothorax newly according to x-ray examination and auscultation, left-sided cardiac insufficiency. She was hospitalized at intern with a need of oxygenotherapy. She improves a lot after furosemid intravenous administration. She is cardiopulmonally compensated, normotense with no chest pain or breathlessness. She was taken to hospital for long-term sickness where a diuretic therapy, oxygenotherapy, inhalation therapy and Biseptol is continued. Overall bad state progresses, on 05/05 there is an impaired consciousness when hypoxic-ischemic etiology is suspected. On 27Apr2021 she was brought by ambulance, hospitalized till 29Apr2021. On 06May2021 at 4:10 she dies calmly. Tests: On 12Apr2021 - blood pressure 130/80 mmHg, temperature 36.5 C, heart rate 88/min, respiratory rate 12/min, oxygen saturation 90 %, physical examination - no icterus and cyanosis, visually tired, horizontal position is tolerated shortly, breathing on the left side clear alveolar with no side phenomenons, on the right side weakened at right basis, not regular heart rate, calm, heart sounds 2, bounded, legs without swellings and inflammatory changes, palpable peripheral pulse. On 12Apr2021: electrocardiography - atrial fibrillation, frequency 88/min, QRS 0.13 s, left bundle branch block; leukocytes 8.1/nl, erythrocytes 4.86/pl, platelets 145/nl. On 12Apr2021: x-ray of heart and lung - new right shadow fluidothorax-like and atelectasis-like in lower fields, blood congestion smaller than during previous examination, big cardiomegaly. On 27Apr2021 - blood pressure 130/70 mmHg, temperature 36.6 C, heart rate 80/min, respiratory rate 14/min. On 27Apr2021 - electrocardiography - heart rate irregular, atrial fibrillation frequency 68/min, QRS 110 ms, ST isoelectric, repolarization without pathology. On 27Apr2021 - N-terminal fragment brain natriuretic peptide 22 553.0 pg/ml, Oxygen saturation: 84%, international normalized ratio (INR) 1.4, prothrombin time ratio 1.4, activated partial thromboplastin time 34 s, activated partial thromboplastin time ratio - 1.37, D-dimers 2.36 mg/l, leukocytes 5.9/nl, erythrocytes 5.09/pl, mean cell hemoglobin concentration 310 g/l, Platelet count:125/nl. 27Apr2021 12:20 - chest x-ray - bigger shadow right side fluidothorax-like, bigger cardiomegaly. In May2021, INR 1.3, prothrombin time ratio 1.35, activated partial thromboplastin time 31 s, activated partial thromboplastin time ratio 1.24, D-dimers 1.77 mg/l, Platelet count: 118/nl, Platelet count: 106/nl, Platelet count: 102/nl. On 05May2021 computer tomography of brain - native acute - cannot differentiate between tiny subarachnoid bleeding and mere artefact left side highly parietally postcentrally. The patient died on 06May2021. Cause of death was cardiac decompensation, stroke suspected. An autopsy was not performed. The outcome of the event breathlessness progression was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cardiac decompensation, stroke suspected; cardiac decompensation, stroke suspected
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