Your Health. Your Family. Your Choice.
Administered by: Other Purchased by: ?
Life Threatening? No
Write-up: congested lung but saturation ok; Vaccination failure; COVID with PCR with identification of the variant; This is a spontaneous report from a contactable pharmacist from the Regulatory Authority (RA), regulatory authority number FR-AFSSAPS-TO20213797. A 92-years-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: EJ6789) via intramuscular on 09Feb2021 as 2nd dose, single and first dose (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: ES6788) via intramuscular on 19Jan2021 as 1st dose, single both for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 07Apr2021 COVID with PCR with identification of the variant. On 12Apr2021 congested lung but saturation ok. On 19Apr2021 still very crowded despite aerosol no cyanosis. On 21Apr2021 transferred to hospitalization unit in the face of worsening clinical condition. On 15May2021 death of the patient in hospital. Evolution: patient died of the consequences on 15May2021 as a result of his infection with COVID 19. An autopsy was not performed. Outcome of events were fatal. Follow-up (21Jun2021): This is a follow-up report from Product Complaint Team. New information provided from division includes: The complaint for LOE/adverse event of PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6789. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: INFECTION COVID 19
Copyright © 2021 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166