On 13May, malaise, myalgia, and diarrhea developed/On 19May, SARS-CoV-2 PCR test was positive/severe COVID-19, ARDS, and respiratory failure; On 13May, malaise, myalgia, and diarrhea developed/On 19May, SARS-CoV-2 PCR test was positive/severe COVID-19, ARDS, and respiratory failure; On 13May, malaise, myalgia, and diarrhea developed/On 19May, SARS-CoV-2 PCR test was positive/severe COVID-19, ARDS, and respiratory failure; On 13May, malaise, myalgia, and diarrhea developed/On 19May, SARS-CoV-2 PCR test was positive/severe COVID-19, ARDS, and respiratory failure; This is a literature report.  An 80-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 10May2021 as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant, life threatening), COVID-19 (hospitalization, medically significant, life threatening), ACUTE RESPIRATORY DISTRESS SYNDROME (hospitalization, life threatening), RESPIRATORY FAILURE (hospitalization, life threatening) all with onset 13May2021, outcome "recovered" (2021) and all described as "On 13May, malaise, myalgia, and diarrhea developed/On 19May, SARS-CoV-2 PCR test was positive/severe COVID-19, ARDS, and respiratory failure". The patient was hospitalized for drug ineffective, covid-19, acute respiratory distress syndrome, respiratory failure (start date: 20May2021, discharge date: 02Jun2021, hospitalization duration: 14 days). The patient underwent the following laboratory tests and procedures: Blood test: (27May2021) Unknown results; Gene sequencing: (unspecified date) 30; (unspecified date) 31; (unspecified date) 31; Nasal Swab: (21May2021) Unknown results; SARS-CoV-2 test: (19May2021) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, acute respiratory distress syndrome, respiratory failure. Additional information: Individual 1 is an 80-year-old man with diabetes and asthma who received the BNT162b2/Pfizer vaccine on 20 April and 10 May 2021. On 13 May, malaise, myalgia, and diarrhea developed. On 19 May, a SARS-CoV-2 polymerase chain reaction (PCR) test was positive, and on 20 May, he presented to a local hospital, had hypoxia, and was admitted for inpatient management. Due to severe COVID-19, acute respiratory distress syndrome (ARDS), and respiratory failure, he required mechanical ventilation. He received remdesivir, dexamethasone, and tocilizumab and improved, was weaned from ventilator, and was discharged on 2 June. Age: 80; Sex: Male; Co-morbidities: Diabetes, Asthma; Vaccine: BNT162b2, Dose 1 date: 20Apr2021, Dose 2 date: 10May2021; Symptom onset: Yes, Date: 13May2021 3 days post second dose, Symptoms: malaise, myalgia, and diarrhea; COVID Test results: 19May2021 9 days post second dose PCR Positive; Hospitalization: 20May2021 to 02Jun2021; Sample collection: Nasal swab on 21May2021, Serum on 27May2021; Pre-sequencing PCR verification (Ct): N gene 31, E gene 30, RNAse P gene (control) 31.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely 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