Your Health. Your Family. Your Choice.
|History of Changes from the VAERS Wayback Machine|
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH||- / 2||- / OT|
Administered by: Other Purchased by: ??
Symptoms: Blood bicarbonate, Blood calcium, Blood creatinine, Blood lactic acid, Blood magnesium, Blood potassium, C-reactive protein, Cardiac failure, Echocardiogram, Electrophoresis protein, Oxygen saturation, PCO2, PO2, Sudden death, White blood cell count, X-ray, pH body fluid, Troponin, Renal impairment, SARS-CoV-2 test, SARS-CoV-2 antibody test
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days:
Write-up: Sudden death; Decompensation cardiac; Cardio-renal decompensation; This is a spontaneous report downloaded from the Regulatory Authority-WEB, regulatory authority FR-AFSSAPS-PC20210241. A contactable physician reported that an 87-year-old female patient received the second dose of BNT162B2 (COMIRNATY) intramuscularly, at single dose, on 05Feb2021, for COVID-19 immunisation. Relevant medical history included moderate cognitive disturbance such as Alzheimer, hypertension arterial, moderate chronic renal failure and chronic auricular fibrillation all from an unspecified date, and unknown if ongoing. The patient was described as being very fit despite her comorbidities, with no respiratory signs. The patient previously, on 15Jan2021, received the first dose of BNT162B2 (COMIRNATY), for COVID-19 immunisation. Concomitant medications were unknown. From 06Feb2021 to 07Feb2021, rapid onset of respiratory signs and deterioration of general condition were observed. The patient did not have a fever. From 07Feb2021, the patient was hospitalized in the emergency room in short-term hospitalization unit. They presented a sudden desaturation motivating a putting under 6L of O2. Relevant laboratory test performed on 07Feb2021, showed the following value: blood bicarbonate (HCO3) 23, blood calcium 25, blood creatinine 200 (renal failure with a creatinine of 200), blood lactic acid 3.8 (blood gas with venous lactates at 3.8), blood magnesium 0.84, blood potassium 4.8, C-reactive protein 113, PCO2 37, pH body fluid normal, pAO2 98 under 6L, troponin stable at 100 and white blood cell count (leucocytes) 8990, no hyperleukocytosis. The PPE (plasma protein electrophoresis) showed alveolointerstitial syndrome. TTE (transthoracic echocardiography) did not show pericarditis and heart failure with preserved LVEF (hypertensive, hypervolemic and rhythmic a priori) was observed.The patient was afebrile and normocardic and she did not present with polypnea. On the X-ray, overload and apical atelectasis without focus were observed. Six hours later (approximately 48 hours after the second injection), in the middle of the night, the patient died suddenly. Specialized resuscitation was carried out from the outset by the teams with support from the SMUR. Note that the constants were normal a few hours earlier. She had no vomiting, bleeding, or cyanosis. It was concluded that it was about a sudden death on a cardio-renal decompensation with a context of inflammatory syndrome of cause not discovered before the death. Cardiac decompensation 24 hours after the second injection, prompting hospitalization 48 hours after the second injection. The notifier specified that the causal link is very uncertain but that the temporal concordance justified the declaration. After the second dose, on 07Feb2021: negative PCR and positive serology at 8.6. It was unknown if autopsy was done. No follow-up attempts are possible, information about lot number cannot be obtained.; Reported Cause(s) of Death: Sudden death; Decompensation cardiac; Renal function aggravated
Copyright © 2021 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166