Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Ejection fraction, Functional residual capacity decreased, Heart rate, Heart rate increased, Palpitations
Clinical narrative: racing heartbeats; short of breath; Symptomatic palpitation; dyspnea exertion; Acute systolic heart failure; decreased functional capacity; chest pain; pleurisy; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 03Dec2021 13:00 (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "LUPUS" (unspecified if ongoing); "Epilepsy" (unspecified if ongoing). No COVID prior vaccination. Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 19Nov2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: HEART RATE INCREASED (disability, life threatening) with onset 08Dec2021 07:00, outcome "not recovered", described as "racing heartbeats"; DYSPNOEA (disability, life threatening) with onset 08Dec2021 07:00, outcome "not recovered", described as "short of breath"; PALPITATIONS (disability, life threatening) with onset 08Dec2021 07:00, outcome "not recovered", described as "Symptomatic palpitation"; DYSPNOEA EXERTIONAL (disability, life threatening) with onset 08Dec2021 07:00, outcome "not recovered", described as "dyspnea exertion"; ACUTE LEFT VENTRICULAR FAILURE (disability, life threatening) with onset 08Dec2021 07:00, outcome "not recovered", described as "Acute systolic heart failure"; FUNCTIONAL RESIDUAL CAPACITY DECREASED (disability, life threatening) with onset 08Dec2021 07:00, outcome "not recovered", described as "decreased functional capacity"; CHEST PAIN (disability, life threatening) with onset 08Dec2021 07:00, outcome "not recovered", described as "chest pain"; PLEURISY (disability, life threatening) with onset 08Dec2021 07:00, outcome "not recovered", described as "pleurisy". The events "racing heartbeats", "short of breath", "symptomatic palpitation", "dyspnea exertion", "decreased functional capacity", "chest pain" and "pleurisy" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: cardiac stress test: (unspecified date) showed severely limited functional; ejection fraction: (unspecified date) 45 %; heart rate: (unspecified date) 173, notes: heart rate 173 bpm at 3 minutes into exercise and test had to be terminated due to chest pain substernal; sars-cov-2 test: (08Dec2021) negative. Therapeutic measures (Metoprolol ER 25mg, increased 50 cardiologist) were taken as a result of heart rate increased, dyspnoea, palpitations, dyspnoea exertional, acute left ventricular failure, functional residual capacity decreased, chest pain, pleurisy. Clinical course: Symptomatic palpitation, racing heartbeats, occurred exactly 4 days after taking the second shot of COVID-19 Pfizer Vaccination. Pounding pulsation in the neck, short of breath, dyspnea exertion, decreased functional capacity, Urgent Clinica and ER. Echo showing ejection fraction 45%, stress test showed severely limited functional capacity, heart rate 173 bpm at 3 minutes into exercise and test had to be terminated due to chest pain substernal, pressure heavy tight, constant, non-radiating, much worse following exercise across chest improved slightly when sat up, worse when leaning back, sharp on right side pain to dull aching but constant at 4-5/10. Activity makes pain worse, sitting still improves pain. Pounding heartbeat improved slightly with implementing Toprol-XL Subjective: Acute systolic heart failure, chest pain consistent with pleurisy short of breath with dyspnea exertion and decreased functional capacity. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the temporal association, a possible contributory role of vaccination with BNT162B2 to the reported events racing heartbeats, short of breath, symptomatic palpitation, dyspnea exertion, acute systolic heart failure, decreased functional capacity, chest pain and pleurisy 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.