Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrioventricular block, Cardiac sarcoidosis, Dyspnoea exertional, Electrocardiogram, Electrocardiogram abnormal
Clinical narrative: EKG changes; Trifascicular block; Further evaluation findings: 2:1 a:v block; imaging consistent with isolated cardiac sarcoidosis; Exertional dyspnea; This is a spontaneous report received from contactable reporter (Physician). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing), notes: other medical history: hypertension. Concomitant medications included: AMLODIPINE; METOPROLOL; VITAMIN B12 [VITAMIN B12 NOS]; VITAMIN D3. Vaccination history included: Fluzone (single dose, lot number: UJ879AB, Anatomical location: Left arm), administration date: 06Oct2022, when the patient was 63-year-old, for Immunization; Bnt162b2 (dose 4 (booster), single, Anatomical location: Left arm), for COVID-19 immunization; Bnt162b2 (dose 3 (booster), single, Anatomical location: Left arm), for COVID-19 immunization; Bnt162b2 (dose 2, single, Anatomical location: Left arm), for COVID-19 immunization; Bnt162b2 (dose 1, single, Anatomical location: Left arm), for COVID-19 immunization. The following information was reported: DYSPNOEA EXERTIONAL (hospitalization, life threatening) with onset 23Oct2022, outcome "recovering", described as "Exertional dyspnea "; ELECTROCARDIOGRAM ABNORMAL (hospitalization, life threatening) with onset 30Dec2022, outcome "recovering", described as "EKG changes"; ATRIOVENTRICULAR BLOCK (hospitalization, life threatening) with onset 30Dec2022, outcome "recovering", described as "Further evaluation findings: 2:1 a:v block"; TRIFASCICULAR BLOCK (hospitalization, life threatening) with onset 30Dec2022, outcome "recovering"; CARDIAC SARCOIDOSIS (hospitalization, life threatening) with onset 30Dec2022, outcome "recovering", described as "imaging consistent with isolated cardiac sarcoidosis". The patient was hospitalized for dyspnoea exertional, electrocardiogram abnormal, trifascicular block, atrioventricular block, cardiac sarcoidosis (hospitalization duration: 10 day(s)). The events "exertional dyspnea ", "ekg changes", "trifascicular block", "further evaluation findings: 2:1 a:v block" and "imaging consistent with isolated cardiac sarcoidosis" required physician office visit. The patient underwent the following laboratory tests and procedures: Electrocardiogram: (30Dec2022) new EKG changes; Evaluation: (30Dec2022) 2:1 a:v block, imaging consistent, notes: with isolated cardiac sarcoidosis; SARS-CoV-2 test: (unspecified date) Positive, notes: post vaccination. Therapeutic measures were taken as a result of dyspnoea exertional, electrocardiogram abnormal, trifascicular block, atrioventricular block, cardiac sarcoidosis.  Clinical course details: Exertional dyspnea onset 2 days after vaccine administered, worsened after covid infection in Dec. Cardiologist appointment 30Dec2022 noted new EKG changes, trifascicular block. Further evaluation findings: 2:1 a:v block, imaging consistent with isolated cardiac sarcoidosis. Pacemaker/ICD implanted, immunosuppressive treatment started.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the temporal association, the causal association between the administration of BNT162B2 and the reported events dyspnoea exertional, electrocardiogram abnormal, trifascicular block, atrioventricular block, cardiac sarcoidosis cannot be completely excluded. This assessment will be updated should additional information become available. 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.,Linked Report(s) : US-PFIZER INC-202300085624 same patient/product, different dose/events;