Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Oxygen saturation, Physical examination, Polymerase chain reaction, Serum ferritin
Clinical narrative: complete AV block; bradycardic; second Pfizer vaccine three months prior/ he was found to be COVID-19 positive; COVID-19 positive; This is a literature report.  An 84-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "coronary artery disease" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "body aches" (unspecified if ongoing), notes: for three days; "malaise" (unspecified if ongoing), notes: for three days; "fatigue" (unspecified if ongoing), notes: for three days; "dyspnea" (unspecified if ongoing), notes: for three days; "Non-tobacco user" (unspecified if ongoing); "non-alcohol user or drug user" (unspecified if ongoing); "transcutaneously paced" (unspecified if ongoing), notes: at a rate of 60 bpm at 70 mA; "nasal cannula" (unspecified if ongoing), notes: between 93 and 100. The patient's concomitant medications were not reported. Past drug history included: Atropine for bradycardic, reaction(s): "supraventricular tachycardia briefly with spontaneous return to a complete AV block", notes: 1.0 mg; Atropine for complete AV block, reaction(s): "supraventricular tachycardia briefly with spontaneous return to a complete AV block", notes: 1.0 mg; Atenolol, reaction(s): "No adverse event", notes: 50 mg daily. The following information was reported: ATRIOVENTRICULAR BLOCK COMPLETE (hospitalization, medically significant), outcome "not recovered", described as "complete AV block"; BRADYCARDIA (hospitalization, medically significant), outcome "not recovered", described as "bradycardic"; Drug ineffective (hospitalization, medically significant), outcome "unknown", described as "second Pfizer vaccine three months prior/ he was found to be COVID-19 positive"; COVID-19 (hospitalization, medically significant), outcome "unknown", described as "COVID-19 positive". The patient was hospitalized for atrioventricular block complete, bradycardia, vaccination failure, covid-19 (hospitalization duration: 6 day(s)). The patient underwent the following laboratory tests and procedures: Atrial pressure: (unspecified date) 128, notes: Units: bpm; Blood calcium: (unspecified date) 8.9 mg/dl; Blood lactate dehydrogenase: (unspecified date) 263 IU/l; Blood pressure measurement: (unspecified date) 96/36; (unspecified date) remained between 140/76 and 162/62; Chest X-ray: (unspecified date) showed pulmonary infiltrates without cardiomegaly, notes: on admission; C-reactive protein: (unspecified date) 51.4 mg/l; Echocardiogram: (unspecified date) showed a new onset of reduced ejection, notes: fraction between 30 and 35%; Electrocardiogram: (unspecified date) showed an atrial rate of 128, notes: without pacing Units: bpm; (May2021) showed sinus rhythm, notes: with left bundle branch block and a prolonged QTc; Electrocardiogram PR interval: (unspecified date) 128; Fibrin D dimer: (unspecified date) 0.35 mg/dl; Heart rate: (unspecified date) ranged between 77 and 99; (unspecified date) 48, notes: Units: bpm; labs test: (unspecified date) showed results; Oxygen saturation: (unspecified date) 82 %; physical evaluation: (unspecified date) He was transcutaneously paced at a rate of 60 bpm, notes: He was transcutaneously paced at a rate of 60 bpm at 70 mA. No audible bruits or murmurs were heard. The lungs were clear to auscultation; Polymerase chain reaction: (unspecified date) positive, notes: No significant electrolyte or other lab abnormalities were noted; Serum ferritin: (unspecified date) 348.4 ng/L; Troponin: (unspecified date) 52 ng/L; (unspecified date) 1699 ng/L, notes: with a peak at six hours after. Therapeutic measures were taken as a result of atrioventricular block complete, bradycardia.  The patient was found to be COVID-19 positive as well as bradycardic with a complete AV block. He was transferred to a tertiary centre for further evaluation and management. However, after transfer, the patient refused further invasive cardiac interventions and after medical therapy was discharged home in complete AV block. The patient had a history of coronary artery disease, hypertension, and hyperlipidemia presented to an urgent care in with body aches, malaise, fatigue, and dyspnea for three days. No other infectious symptoms were endorsed. At the outside facility, he was found to be bradycardic with a complete AV block. Total of atropine 1.0mg was administered at that encounter. Afterwards, the patient went into a supraventricular tachycardia briefly with spontaneous return to a complete AV block. He was placed on transcutaneous pacing and transferred to our facility for further evaluation and management. Upon encounter, he denied any symptoms of lightheadedness, dizziness, palpitations, orthopnea, and chest pain. Patient also noted that he received both doses of the Pfizer vaccine at the beginning and end of April 2021, approximately six months prior to presentation. No booster doses were administered. Furthermore, he was recently seen by his cardiologist approximately a week prior with no abnormalities reported at the time. His previously known heart rate ranged between 77 and 99. Prior PR interval was 128. He had no history of tobacco, alcohol, or drug use. A possible culprit home medication was atenolol 50mg daily which he reported taking as instructed. No other pertinent or new medications were noted in the patients history. On initial evaluation, he appeared comfortable and euvolemic. His blood pressure was 96/36 with an oxygen saturation of 82%. He was transcutaneously paced at a rate of 60 bpm at 70 mA. No audible bruits or murmurs were heard. The lungs were clear to auscultation. No peripheral edema was present. Underlying EKG without pacing showed an atrial rate of 128bpm and a ventricular rate of 48 bpm. His previous EKG in May 2021 showed sinus rhythm with left bundle branch block and a prolonged QTc. Chest X-ray on admission showed pulmonary infiltrates without cardiomegaly. Initial troponin was 52 ng/L with a peak at 1699 ng/L six hours after. Pertinent labs were as follows: calcium 8.9 mg/dL, Ddimer 0.35 mg/L, ferritin 348.4 ng/L, LDH 263 U/L, and CRP 51.4 mg/L. Real-time RT-PCR COVID-19 test (Dia- Sorin Molecular) was positive. No significant electrolyte or other lab abnormalities were noted. Echocardiogram was performed and showed a new onset of reduced ejection fraction between 30 and 35%. He did not have a known history of reduced ejection fraction. His oxygen requirement was 2 L on nasal cannula saturating between 93 and 100%. He was moved to a HCF for further evaluation and management. The patient was started on a low-dose dopamine infusion at 10 mcg/kg/min and dexamethasone 6mg IV QD. Infectious disease team was consulted, and remdesivir was started based on a multidisciplinary team approach. Blood pressure remained between 140/76 and 162/62. The patient remained awake and comfortable. The patient was offered both cardiac catheterization and permanent pacemaker placement; however, after an extensive discussion with the patient and his son, the patient refused all invasive therapeutic intervention. The patient was discontinued off the dopamine infusion as well as transcutaneous pacing; however, he was continued on methylprednisolone and remdesivir. Due to his distant history, the patient did not know whether his right coronary artery was stented or diseased. No prior catheterization report was available as most recent catheterization was 16 years prior out-of-state. On posthospitalization day 6, his symptoms at onset had grossly improved, and given his aversion to testing, no follow-up imaging was conducted. He was discharged safely still in AV block with home oxygen.; Sender's Comments: Considering the nature of the reported events and product profile, a causal role of the suspect BNT162B2 cannot be denied for the reported events.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.