Sex: F
Vaccine: COVID19
Symptoms: Vaccine associated enhanced respiratory disease
Clinical narrative: Antibody dependent enhancement; acute respiratory distress syndrome; respiratory failure; multi-system organ failure; hypotension; acute kidney injury; refractory shock; This is a literature report.  A 74-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "COVID-19" (unspecified if ongoing); "increasing shortness of breath" (unspecified if ongoing), notes: two weeks of; "High-flow nasal cannula" (unspecified if ongoing); "BiPAP" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ACUTE RESPIRATORY DISTRESS SYNDROME (death, hospitalization, medically significant, life threatening), outcome "fatal"; RESPIRATORY FAILURE (death, hospitalization, medically significant, life threatening), outcome "fatal"; HYPOTENSION (death, hospitalization, medically significant, life threatening), outcome "fatal"; ACUTE KIDNEY INJURY (death, hospitalization, medically significant, life threatening), outcome "fatal"; SHOCK (death, hospitalization, medically significant, life threatening), outcome "fatal", described as "refractory shock"; MULTIPLE ORGAN DYSFUNCTION SYNDROME (death, hospitalization, medically significant, life threatening), outcome "fatal", described as "multi-system organ failure"; VACCINE ASSOCIATED ENHANCED RESPIRATORY DISEASE (death, hospitalization, medically significant, life threatening), outcome "fatal", described as "Antibody dependent enhancement". The patient underwent the following laboratory tests and procedures: Bacterial test: Negative; Blood immunoglobulin G: Positive, notes: on hospital day thirteen; elevation; Blood immunoglobulin M: Positive, notes: on hospital day thirteen; elevation; Chest X-ray: showed diffuse opacities; Computerised tomogram thorax: three days later, notes: demonstrated extensive bilateral reticular patchy ground-glass densities; Fungal test: Negative; COVID-19 nasal swab: Negative; Negative; Polymerase chain reaction: Negative; SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of acute respiratory distress syndrome, respiratory failure, hypotension, acute kidney injury, shock, multiple organ dysfunction syndrome, vaccine associated enhanced respiratory disease. The patient date of death was unknown. Reported cause of death: "refractory shock". The autopsy revealed "covid-19 infection" (covid-19); "focal acute and proliferative phases of dad" (diffuse alveolar damage); "pulmonary emboli" (pulmonary embolism).  Additional information: The case represents a patient with multi system organ failure with serological evidence of SARS COV-2 IgM and  IgG elevation who received BNT162b2 mRNA COVID vaccination  one week before admission. It is possible that the patient developed ADE following COVID vaccination having recently acquired COVID-19 infection. Two proposed mechanisms for ADE include (a)sub-neutralizing antibodies binding to Fc-gamma receptor IIa expressing phagocytic cells increasing viral entry into and replication within cells and(b)SARSCOV-2 forms immune complexes between sub-neutralizing antibodies and the virus which bind to C1q receptor on airway epithelial cells activating immune cells with production of pro-inflammatory cytokines  which can cause diffuse alveolar damage(DAD) in COVID-19. The patient's autopsy revealed focal acute and proliferative phases of DAD and pulmonary emboli, all described in autopsies following COVID. In support of ADE was a history of vaccination with BNT162b2 mRNA pre hospitalization, possible infection with COVID-19 suggested by IgM and IgG antibodies and CT consistent with COVID-19 despite persistently negative SARSCOV-2PCR. Evidence against ADE includes negative SARSCOV-2 PCR and it is unclear if observed IgM and IgG antibodies were produced against spike protein or nucleocapsid protein of the virus- the latter only produced in response to infection and not vaccination. CONCLUSIONS: In patients  recently vaccinated against COVID-19 and admitted with COVID-19 related ARDS, we must consider ADE as a cause for multi-systemic illness.; Sender's Comments: All these fatal events including Multiple organ dysfunction syndrome, acute respiratory distress syndrome complicated by hypotension, shock and acute kidney injury are due to worsening of COVID 19.  There are theoretical concerns on the occurrence of Enhanced disease following COVID 19 vaccine immunization considering proven association with formalin-inactivated measles/RSV vaccines and Chimeric Yellow Fever Dengue vaccines and findings demonstrated in mouse models SARS/MERS-CoVs vaccine platforms.  More immunological and biomolecular evidence would be needed for deep understanding of the underlying mechanism.  The impact 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: refractory shock; Autopsy-determined Cause(s) of Death: focal acute and proliferative phases of DAD; COVID-19 infection; pulmonary emboli