Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Aortic valve stenosis, Body mass index, Chronic lymphocytic leukaemia, Coronary artery disease, Urinary incontinence
Clinical narrative: coronary artery disease; urinary incontinence; Stenosis aortic valve; chronic lymphocytic leukemia of B-cell type not having achieved remission; This is a spontaneous report received from contactable reporter (Other HCP).  An 89-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administration date 15Feb2021 (Lot number: EN6201) at the age of 88 years as dose 2, single and intramuscular, administration date 22Jan2021 (Lot number: EL9262) as dose 1, single for COVID-19 immunization. Relevant medical history included: "Urinary Frequency", start date: 10Nov2015 (unspecified if ongoing); "Lumbar disc disease", start date: 16Aug2017 (unspecified if ongoing); "Hypothyroid", start date: 17May2018 (unspecified if ongoing); "Mixed Hyperlipidemia", start date: 10Nov2015 (unspecified if ongoing); "Insomnia", start date: 19Feb2018 (unspecified if ongoing); "Memory loss", start date: 18Dec2007 (unspecified if ongoing); "Osteoporosis", start date: 17May2018 (unspecified if ongoing); "OSA", start date: 02Feb2017 (unspecified if ongoing); "Urinary Incontinence", start date: 16Aug2017 (unspecified if ongoing); "Obesity", start date: 03Jul2019 (unspecified if ongoing); "Benign essential hypertension", start date: 10Nov2015 (unspecified if ongoing); "Lumbar Spondylosis", start date: 27Sep2017 (unspecified if ongoing); "Body Mass Index", start date: 12Mar2020 (unspecified if ongoing), notes: 35.0-35.9; "gait disturbances", start date: 27Sep2017 (unspecified if ongoing); "Paroxysmal Atrial Fibrillation", start date: 10Nov2015 (unspecified if ongoing); "Carotid Stenosis bilateral" (unspecified if ongoing); "hips Osteoarthritis" (unspecified if ongoing), notes: Primary Osteoarthritis of right hip; "Bilateral primary osteoa", start date: 14Dec2020 (unspecified if ongoing), notes: Bilateral primary Osteoarthritis of knee; "Melanoma of skin", start date: 03Jan2019 (unspecified if ongoing); "Chronic major depressive disorder", start date: 25Mar2019 (unspecified if ongoing), notes: Chronic major depressive disorder recurrent episode; "Adult Body mass index", start date: 28Jul2020 (unspecified if ongoing), notes: 39.0-39.9, 35.0-35.9; "Chronic kidney disease", start date: 20Jun2020 (unspecified if ongoing), notes: Stage 3b. Concomitant medications included: SYNTHROID, start date: 12Apr2018; SERTRALINE HCL, start date: 17Apr2012; PRESERVISION AREDS 2; LOSARTAN POTASSIUM; FISH OIL; APIXABAN, start date: 20Mar2019; DOXAZOSIN MESYLATE; CLOPIDOGREL BISULFATE; AMLODIPINE BESYLATE; AMIODARONE HCL; ALENDRONATE SODIUM, start date: 03Jul2018; TRAMADOL HCL; MECLIZINE HCL, start date: 29Apr2020; VITAMIN D [COLECALCIFEROL]; VITAMIN B12 & FOLIC ACID; TRIAMCINOLONE ACETONIDE, start date: 22Mar2021. Past drug history included: Ciprofloxacin, reaction: "She got a bad cough when she started this", notes: Type : Allergy, Status: Active; Crestor, reaction: "Myalgia", notes: Type : Allergy, Status: Active; Keflex, reaction: "Skin Irritation", notes: Type : Allergy, Status: Active; Lipitor, reaction: "Myalgia", notes: Type : Allergy, Status: Active; Lotrel, reaction: "Rash", notes: Type : Allergy, Status: Active; Pravachol, reaction: "Muscle Cramping", notes: 80mg, Type : Allergy, Status: Active; Sulfamethoxazole, reaction: "Itching", notes: Type : Allergy, Status: Active; Statins, reaction: "Myalgia", notes: Type : Allergy, Status: Active; Zocor, reaction: "Myalgia", notes: Type : Allergy, Status: Active. The following information was reported: CHRONIC LYMPHOCYTIC LEUKAEMIA (medically significant) with onset 20Apr2021, outcome "unknown", described as "chronic lymphocytic leukemia of B-cell type not having achieved remission"; CORONARY ARTERY DISEASE (non-serious) with onset 29Sep2021, outcome "unknown", described as "coronary artery disease"; URINARY INCONTINENCE (non-serious) with onset 29Sep2021, outcome "unknown", described as "urinary incontinence"; AORTIC VALVE STENOSIS (non-serious) with onset 29Sep2021, outcome "unknown", described as "Stenosis aortic valve". The patient underwent the following laboratory tests and procedures: body mass index: 30.0-34.9, notes: BMI- 30.0-34.9; 35.0-35.9, notes: 35.0-35.9; 39.0-39.9, notes: Adult body mass index 39.0-39.9.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and events 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.