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Write-up: syncope after injection of second vaccine dose for COVID Pfizer vaccine; FARO This is a non-interventional study report from contactable physician downloaded from the Regulatory Authority-WEB regulatory authority IT-MINISAL02-679162. ANAMNESIS: the guest entered the structure on 25Sep2020. In history of post-infarct ischemic heart disease, aortic valve insufficiency, thalassemia minor, chronic sinusitis, bilateral renal cysts, outcomes of quadrantectomy and radiotherapy for breast cancer, scoliosis, arthrosis, multiple vertebral collapses, osteoporosis, left femur fracture (2014), subclinical hypothyroidism, Bicuspid aortic valv I degree, severe cognitive impairment, hip fracture, sepsis on 10Feb2021. Last multidimensional evaluation (Dec2020): Daily life activity = 1/6; Instrumental Activity of Daily Living= 0/8; Barthel Index = 2/100; Mini-Mental State Examination= not executable; Clinical dementia rating = 3; Frailty Index = 0.57; Clinical Frailty scale = 8/9; Karnofsky Performance Status = 30%. CASE DESCRIPTION: An 85-year-old female subject received second dose of bnt162b2 (COMIRNATY, lot number: EL0725, expiry date: 31Mar2021), intramuscularly on 10Feb2021 15:25 at 0.3 mL, single for COVID-19 immunization. Bnt162b2 composed of 195FL 0.45ML. The patient presented acute symptoms approximately 40 minutes after administration (time of administration: 15:25) of the second dose of bnt162b2 (COMIRNATY) with patient exitus in the following hours. Concomitant medication included ramipril (TRIATEC), acetylsalicylic acid (CARDIOASPIRIN), lansoprazole, sodium chloride for fluid replacement, tiapride hydrochloride (SEREPRILE, strength: 100 mg), lactulose, lorazepam (SERENASE), fentanyl (DUROGESIC), bisoprolol fumarate (SEQUACOR). The subject experienced syncope after injection of second vaccine dose for COVID Pfizer vaccine on 10Feb2021. The subject died on 10Feb2021 around 20:00. The action taken in response to the event for bnt162b2 was not applicable. It was not reported if an autopsy was performed. Clinical course: At approximately 16:00 the host was reported by the nursing staff of a second episode of loss of consciousness (first episode occurred at 14:40 before vaccine administration). The subject appeared pale, skin cold at the extremities and wet with sweat, unresponsive to verbal and painful stimuli, in the absence of side signs (vital signs: Blood Pressure 140/80mmHg; SpO2 96%; Heart Rate not detectable in peripheral; DTX 201 mg/dl). When the rescuers arrived, O2 therapy was set at 2L/min, bringing SpO2 to 99%; Flebocortid 500mg was also administered following the collapse of the BP at 55/38 mmHg with partial benefit. The patient was taken to the Hospital, where she died around 20:00. Information taken from a clinical report drawn up on 12Feb2021. Actions taken (IV cortisone, liquids, access to emergency room). On unspecified date, 120/60 mmHg; 73 bpm; 96% in AA; 140/80 mmHg. Lab tests also included Glycaemia control on 10Feb2021, Heart rate on 25Jan2021, Blood pressure on 25Jan2021, O2 saturation on 25Jan2021, all with unknown results. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on event-vaccine chronological association causality between event syncope and BNT162B2 vaccine 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.; Reported Cause(s) of Death: syncope after injection of second vaccine dose for COVID Pfizer vaccine
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