Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Apparent life threatening event, Dyspnoea, Endotracheal intubation, Fatigue, Multiple organ dysfunction syndrome
Clinical narrative: O2 sat 70% on RA; 7 days after getting vaccine patient developed shortness of breath and fatigue, O2 sat 70% on RA, now intubated and in multiorgan failure; 7 days after getting vaccine patient developed shortness of breath and fatigue, O2 sat 70% on RA, now intubated and in multiorgan failure; 7 days after getting vaccine patient developed shortness of breath and fatigue, O2 sat 70% on RA, now intubated and in multiorgan failure; 7 days after getting vaccine patient developed shortness of breath and fatigue, O2 sat 70% on RA, now intubated and in multiorgan failure; This is a spontaneous report from a contactable physician.   A 73-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose intramuscular on 03Jan2021 for Covid-19 immunisation, administered at nursing home/senior living facility. Medical history included alcohol use, diverticulitis, iron deficiency anaemia (IDA), asthma, hypertension, anxiety, recent C. diff infection, allergies to penicillin. She was not pregnant. The patient had not experienced Covid-19 prior vaccination. Concomitant medication included apixaban (APIXABAN), bioflavonoids nos, calcium ascorbate, hesperidin, rutoside, sodium ascorbate, zinc amino acid chelate (VITAMIN C [BIOFLAVONOIDS NOS;CALCIUM ASCORBATE;HESPERIDIN;RUTOSIDE;SODIUM ASCORBATE;ZINC AMINO ACID CHELATE]), cyanocobalamin (B-12), furosemide (LASIX), simethicone (manufacturer unknown), tramadol (manufacturer unknown), vancomycin (manufacturer unknown) oral, omeprazole (PROTONIX), amlodipine (manufacturer unknown), vitamins nos (MULTIVITAMIN), thiamine (manufacturer unknown), aripiprazole (ABILIFY), atorvastatin calcium (LIPITOR), clonazepam (KLONOPIN), folic acid (manufacturer unknown), sertraline hydrochloride (ZOLOFT). The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine.  On 10Jan2021, 7 days after getting vaccine, the patient developed shortness of breath and fatigue, rheumatoid arthritis, O2 sat 70% on RA, now intubated and in multiorgan failure. The events resulted in Emergency room/department or urgent care, hospitalization, life threatening illness for immediate risk of death from the event. The patient was hospitalized for the events for 18 days. Patient received treatment with corticosteroids, antibiotics, antifungals, dialysis, mechanical ventilation, inhaled Epoprostinol. The patient underwent lab tests and procedures which included SARS-CoV-2 test: unknown in Jan2021. Pre / post vaccination, the patient has been tested for COVID-19 with unknown result. The with outcome of events was not recovered.; Sender's Comments: Based on the temporal gap between the vaccination and the event onset, the Company considered that there was not a reasonable possibility that the events were related to suspect vaccine BNT162B2. The patient's advanced age, underlying medical conditions and multiple concomitant medications could be contributory to the events. 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.