Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: COVID PCR returned back positive/ Breakthrough Case of COVID-19 in a Fully Vaccinated Patient; COVID PCR returned back positive/ Breakthrough Case of COVID-19 in a Fully Vaccinated Patient; Acute Respiratory Distress Syndrome from SARS-CoV-2; This is a literature report for the following literature source(s).  An 84-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "chronic obstructive pulmonary disease" (unspecified if ongoing); "Diabetes mellitus type 2" (ongoing); "recurrent mechanical falls" (unspecified if ongoing); "watery diarrhea" (unspecified if ongoing), notes: over the past week. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant, life threatening), COVID-19 (hospitalization, medically significant, life threatening), outcome "unknown" and all described as "COVID PCR returned back positive/ Breakthrough Case of COVID-19 in a Fully Vaccinated Patient"; ACUTE RESPIRATORY DISTRESS SYNDROME (hospitalization, medically significant, life threatening), outcome "unknown", described as "Acute Respiratory Distress Syndrome from SARS-CoV-2". The events "covid pcr returned back positive/ breakthrough case of covid-19 in a fully vaccinated patient" and "acute respiratory distress syndrome from sars-cov-2" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: hypertensive, notes: on admission; Body temperature: afebrile, notes: on admission; Computerised tomogram head: no acute hemorrhage; no acute hemorrhage; Computerised tomogram spine: revealed some chronic degenerative changes; Computerised tomogram thorax: showed no evidence of, notes: pulmonary embolism but was positive for extensive ground glass opacities throughout bilateral upper and lower lobes of the lung; C-reactive protein: 83 mg/l; Fibrin D dimer: 839 ng/ml; SARS-CoV-2 test: positive, notes: returned back. Therapeutic measures were taken as a result of vaccination failure, covid-19, acute respiratory distress syndrome.  Clinical information: 84-year-old-female with past medical history of hypertension, chronic obstructive pulmonary disease, Diabetes mellitus type 2 and recurrent mechanical falls presents to the Emergency Room from an assisted living facility after experiencing an unwitnessed fall. She was hypertensive and afebrile on admission. Her only complaint at the time of admission was watery diarrhea over the past week. CT scan of head and face showed no acute hemorrhage. CT scan of cervical, thoracic and lumbar spine revealed some chronic degenerative changes. Two days after admission, the patient developed acute hypoxic respiratory failure requiring increasing amounts of oxygen. COVID PCR returned back positive. Her CRP was 83 mg/L and D-Dimer was 839 ng/ml. CT-Angiogram of Chest showed no evidence of pulmonary embolism but was positive for extensive ground glass opacities throughout bilateral upper and lower lobes of the lung. Final Diagnosis: Acute Respiratory Distress Syndrome from SARS-CoV-2. Management: Patient was treated aggressively with Remdesivir, high dose intravenous methylprednisolone and tocilizumab. Furthermore, empiric antibiotics with Vancomycin and Cefepime were also initiated. Despite these aggressive measures, her oxygen requirements continued to increase exponentially. A family meeting was held with the patient, her physicians, the palliative care practitioner, nurses and family members to ultimately decide on the direction of management. Finally, the patient was converted to hospice care at behest of family and patient desires.  No follow-up attempts are possible.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162b2 to the reported events Vaccination failure and COVID-19 cannot be ruled out. Based on the available information and implied temporal association, a causal relationship between the reported event Acute respiratory distress syndrome and suspect product BNT162b2 cannot be excluded. 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.