Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood triglycerides, Cardiolipin antibody, Complement factor C3, Complement factor C4
Clinical narrative: Symptoms resurfaced 3 weeks after patient's second vaccination; Pericarditis and arrythmias secondary to an immune reaction to the vaccine; reappearance of exacerbated CVD (PVCs); fatigue and shortness of breath, the major symptoms that were exacerbated after the second vaccination, are the 2 most common symptoms of long COVID; This is a literature report.  A 35-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hospitalized" (unspecified if ongoing), notes: hospitalized for 3 days, 1 year and 10 months before she was vaccinated; "palpitations" (unspecified if ongoing), notes: 1 year and 10 months before she was vaccinated; "premature ventricular contractions" (unspecified if ongoing), notes: 1 year and 10 months before she was vaccinated; "presyncope" (unspecified if ongoing), notes: hospitalized for 3 days, 1 year and 10 months before she was vaccinated. The patient's family history included: "diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "cardiac cirrhosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (hospitalization, medically significant), 3 weeks after the suspect product(s) administration, outcome "unknown", described as "Symptoms resurfaced 3 weeks after patient's second vaccination"; PERICARDITIS (hospitalization, medically significant), 3 weeks after the suspect product(s) administration, outcome "unknown", described as "Pericarditis and arrythmias secondary to an immune reaction to the vaccine"; VENTRICULAR EXTRASYSTOLES (hospitalization, medically significant), 3 weeks after the suspect product(s) administration, outcome "unknown", described as "reappearance of exacerbated CVD (PVCs)"; POST-ACUTE COVID-19 SYNDROME (hospitalization, medically significant), 3 weeks after the suspect product(s) administration, outcome "unknown", described as "fatigue and shortness of breath, the major symptoms that were exacerbated after the second vaccination, are the 2 most common symptoms of long COVID". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 9 IU/l, notes: indicate that she does not have autoimmune hepatitis; Antibody test (normal high range 4): Less than 1, notes: showed the absence of DS anti- body it can be concluded that the patient does not have SLE, double-stranded DNA (dsDNA) antibody test; Antibody test (normal high range 10): less than 10; Antibody test (normal high range 25): Less than 25; Anti-cyclic citrullinated peptide antibody (normal high range 20): Less than 16; Antineutrophil cytoplasmic antibody (normal high range 1.0): negative; Less than 1, notes: Unit: antibody index. no anti bodies detected; Less than 1, notes: Unit: antibody index. no anti bodies detected; Antinuclear antibody (normal high range 1:40): 1:80, notes: Low anti body level, positive for autoimmune antibodies with a 1:80 titer and nuclear and homogenous pattern; Antinuclear antibody (normal high range 1.0): Less than 1; Antinuclear antibody: negative; negative; Less than 1; Aspartate aminotransferase: 20 IU/l; Beta-2 glycoprotein antibody: Less than 2.0, notes: Antibody not detected; Beta-2 glycoprotein antibody (normal high range 20): Less than 2.0, notes: Antibody not detected; Less than 2.0, notes: Antibody not detected,; Blood alkaline phosphatase: 52 IU/l, notes: indicate that she does not have autoimmune hepatitis; Blood cholesterol (normal high range 200): 192 mg/dl; Blood iron: low, notes: after COVID-19 infection; Blood pressure measurement: decreased; Blood triglycerides (normal high range 150): 65 mg/dl; Cardiolipin antibody (normal high range 20): less than 20, notes: Antibody not detected; Less than 2.0, notes: Antibody not detected,; Less than 2.0, notes: Antibody not detected; Complement factor C3 (83-193): 91 mg/dl; Complement factor C4 (15-57): 21 mg/dl; Echocardiogram: showed trace mitral regurgitation, notes: tricuspid regurgitation, and pericardiale ffusion; Ejection fraction: 62.3 %; Gene mutation identification test: revealed mutations at 6 potential CVD, notes: Exploring 100 genes for CVD and diabetes revealed mutations at 6 potential CVD/diabetes mellitus susceptibility loci APOC1 (rs4420638), CETP (rs3764261), IL4 (rs2243250), AGT(rs5051), and AGT (rs699) for CVD and SLC30A8 (c.973C) for diabetes mellitus suggesting moderate risk for developing CVD and/or diabetes mellitus, but no susceptibility genes for immune system disorder; High density lipoprotein (normal low range 50): 79 mg/dl, notes: increased. 1 month; 65 mg/dl, notes: Over 1 year; Immunology test: Positive, notes: positive for auto immune antibodies; Low density lipoprotein (normal high range 100): 115 mg/dl, notes: high. 1 month; 112 mg/dl, notes: over 1 year; Magnetic resonance imaging heart: showed borderline cardiomegaly with, notes: left ventricle enlargement but no evidence of infarct, fibrosis, or amyloidosis; Non-high-density lipoprotein cholesterol (normal high range 130): 127 mg/dl; SARS-CoV-2 test: positive, notes: 3 weeks later; Serum ferritin: low, notes: after COVID-19 infection; Total cholesterol/HDL ratio (normal high range 5): 3, notes: calculated. Therapeutic measures were taken as a result of disease recurrence, pericarditis, ventricular extrasystoles, post-acute covid-19 syndrome.  Clinical course: Patient with history of cardiovascular disease presented with shortness of breath, lightheadedness, fatigue, chest pain, and premature ventricular contractions 3weeks after her second COVID-19 vaccine. Symptoms subsided following catheter  ablation and ibuprofen except for  chest  pain and fatigue, which persisted following ablation and sub- sequent SARS-CoV-2 infection.  The case suggests causal associations between COVID-19 vaccine/infection and recurrence of cardiovascular disease, including long-COVIDlike symptoms. The patient had a history of cardiovascular disease (CVD), having been hospitalized for 3 days  with palpitations  and premature ventricular contractions (PVCs) at 1 year and 10 months before he r first PfizerSARS-CoV-2vaccination.  Symptoms resurfaced 3weeks after patient's second vaccination and worsened progressively, with multiple hospital admissions that included dual cardiac ablations over a 3-month period. Ibuprofen was prescribed for pericarditis 2 months after the second ablation, and 3 weeks later, the patient tested positive for SARS-CoV-2. The patient took only vitamin D to combat SARS-CoV-2 infection. Shortly after testing positive for SARS-CoV-2, the patient presented again with chest pain when moving or breathing, joint pain, and dermatitis, symptoms that persisted for 6 months.CVD was first evident when the patient was hospitalizedfor3dayswithpresyncope, palpitations, and high burden of PVCs, 1 year and 10 months before she was vaccinated for SARS-CoV-2. Three weeks after receiving her second vaccination, the patient experienced lightheadedness, fatigue, frequent presyncope, shortness of breath, and chest pain, and she was admitted to the hospital with high burden of PVCs. Symptoms improved after the ablations, and echocardiogram showed trace mitral regurgitation, tricuspid regurgitation, and pericardial effusion. Symptoms of chest pain and fatigue were still evident but subside during 2 to 3 weeks treatment with Advil. The differential diagnosis included long COVID-19, arthritis, and systemic lupus erythematosus. The patient is currently stable but still presents with severely restricted physical performance, chest pain, joint pain, and fatigue. She has switched from a vegetarian to nonvegetarian diet as a possible avenue to mitigate fatigue (she was tested for low iron and ferritin levels after COVID-19 infection) and continues to take a vitamin D supplement. The patient was prescribed statin medication for LDL-C and HDL-C but did not take it. The patient remained under observation.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "DISEASE RECURRENCE ","PERICARDITIS" , "VENTRICULAR EXTRASYSTOLES " and "POST-ACUTE COVID-19 SYNDROME". 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.,Linked Report(s) : US-PFIZER INC-PV202300003501 Same article/drug/ patient and different event;