Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Nausea, Pleural effusion, SARS-CoV-2 test
Clinical narrative: Severe congestive heart failure with 15% ejection rate; my lungs were filled with fluid; feeling very short of breath; nausea; pain towards the bottom of my sternum; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Sep2021 as dose 3 (booster), single (Lot number: FC283) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing); "Gall bladder removed", start date: 29Sep2021 (unspecified if ongoing). Concomitant medication(s) included: HUMIRA; METHOTREXATE; VENLAFAXINE; RESTASIS. Vaccination history included: BNT162b2 (lot number=ER8732, dose number=2, vaccine location=Left arm), administration date: 30Mar2021, when the patient was 53-year-old, for COVID-19 immunization, reaction(s): "heart started in CHF from the first two shots"; BNT162b2 (lot number=EN6198, dose number=1, vaccine location=Left arm), administration date: 09Mar2021, when the patient was 53-year-old, for COVID-19 immunization, reaction(s): "heart started in CHF from the first two shots". Other vaccine in four weeks were no. The patient also received SIMB as medication in two weeks. The patient did not have covid prior vaccination. The patient tested for covid post vaccination. Known allergies: none.  The following information was reported: CARDIAC FAILURE CONGESTIVE (hospitalization, medically significant, life threatening) with onset 03Oct2021, outcome "recovering", described as "Severe congestive heart failure with 15% ejection rate"; DYSPNOEA (hospitalization, life threatening) with onset 03Oct2021, outcome "recovering", described as "feeling very short of breath"; PLEURAL EFFUSION (hospitalization, life threatening) with onset 03Oct2021, outcome "recovering", described as "my lungs were filled with fluid"; NAUSEA (hospitalization, life threatening) with onset 03Oct2021, outcome "recovering"; CHEST PAIN (hospitalization, life threatening) with onset 03Oct2021, outcome "recovering", described as "pain towards the bottom of my sternum". The patient was hospitalized for cardiac failure congestive, pleural effusion, dyspnoea, nausea, chest pain (hospitalization duration: 5 day(s)). The events "severe congestive heart failure with 15% ejection rate", "my lungs were filled with fluid", "feeling very short of breath", "nausea" and "pain towards the bottom of my sternum" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: (unspecified date) showed my lungs were filled; Echocardiogram: (unspecified date) Severe congestive heart failure with 15% ejection; (2019) normal, notes: (i have one every 5 years for my bicuspid valve); Magnetic resonance imaging: (unspecified date) shows no scarring of the heart muscle; SARS-CoV-2 test: (08Oct2021) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of cardiac failure congestive, pleural effusion, dyspnoea, nausea, chest pain included medication.   Clinical course: The patient had her gall bladder removed on 29sep. About 4 days after surgery the patient began feeling very short of breath, nausea and pain towards the bottom of my sternum. When the patient went in to her 10-day checkup the patient explained her symptoms and was sent to the ER. The CT showed her lungs were filled with fluid, and the echo showed the next day severe congestive heart failure with 15% ejection rate. The patient had an echo done in 2019 (the patient has one every 5 years for my bicuspid valve) and her heart was normal. The patient has no risk factors for the CHF and the cardio cath came back normal. MRI shows no scarring of the heart muscle. The patient was a avid cyclist and noticed all last summer my cardio endurance was not very good- we think her heart started in CHF from the first two shots, then receiving IV fluids during surgery 3 weeks after her booster was the tipping point since unknowingly her heart was already in CHF which caused the huge fluid buildup. The patient was making great progress; by february her ejection rate is up to 41%.; Sender's Comments: Based on the information currently available,the casual association between the reported events and suspected vaccine BNT162B2 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.