Your Health. Your Family. Your Choice.
Administered by: Other Purchased by: ?
Life Threatening? No
Write-up: Fatal evolution was done following acute respiratory distress with pulmonary congestion.; Fatal evolution was done following acute respiratory distress with pulmonary congestion.; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency FR-AFSSAPS-GR20210280. This is a report received from the Regulatory Authority. E2B Authority Number was FR-AFSSAPS-GR20210280 An 82-year-old female patient received her 1st dose of BNT162B2 (COMIRNATY, lot EJ6795) at 30 ug single dose on 14Jan2021 intramuscular in left arm for COVID-19 vaccination. Medical history included chronic respiratory failure, and advanced lung cancer (untreated which was known for 2 years as of 19Feb2021). Concomitant drug was not provided. Patient experienced distress respiratory on 28Jan2021. Patient died on 02Feb2021. No autopsy was performed. Fatal evolution was done following acute respiratory distress with pulmonary congestion. The event clinical course was as follows: degradation of the patient''s general condition for several weeks before vaccination, patient was vaccinated on 14Jan2021. From 28Jan2021, patient experienced rapid worsening at the respiratory level. Differential diagnosis included severe respiratory failure and lung cancer. NT ProBNP (Brain Natriuretic Peptide) at 1300 ng / L and disturbed liver function test (usual for the patient). blood count and C reactive protein was within the norm, glomerular filtration rate at 59 mL / min. Patient was implemented of comfort care. Outcome of distress respiratory was fatal. No follow-up attempts are possible; No further information is expected.; Sender''s Comments: A contributory role of Comirnaty administration in the occurrence of the reported events cannot be completely excluded, due to a positive drug-events temporal association, however, medical history of chronic respiratory failure and advanced lung cancer, cannot be also excluded as important factors related to the fatal events that occurred two weeks after the vaccination, in the setting of degradation of the patient''s general condition for several weeks before vaccination. The impacts 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.; Reported Cause(s) of Death: pulmonary congestion; severe respiratory failure; Distress respiratory/acute respiratory distress
Copyright © 2021 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166