Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abdomen, Computerised tomogram pelvis, Drug ineffective, Echocardiogram, Ejection fraction
Clinical narrative: The patient originally tested positive for COVID-19; The patient originally tested positive for COVID-19; This is a literature report.  A 54-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "lumbar radiculopathy" (unspecified if ongoing); "gastro-esophageal reflux disease" (unspecified if ongoing); "post-concussion syndrome" (unspecified if ongoing); "intractable nausea" (unspecified if ongoing); "intractable vomiting" (unspecified if ongoing); "recurrent episodes of syncope" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Oct2022, outcome "unknown" and all described as "The patient originally tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: Biopsy breast: (Dec2022) diagnosed with invasive lobular carcinoma; Blood pressure diastolic: (10Oct2022) Normal; Blood pressure systolic: (10Oct2022) Normal; Brain natriuretic peptide (normal high range 125): (24Oct2022) 7616 pg/mL; Carbohydrate antigen 15-3 (normal high range 30): (24Oct2022) 16.8 IU/ml; Carbohydrate antigen 19-9 (normal high range 35): (24Oct2022) 7 IU/ml; Carbohydrate antigen 27.29 (normal high range 38.6): (24Oct2022) 21.9 IU/ml; Catheterisation cardiac: (28Oct2022) showed normal coronary arteries; Computerised tomogram abdomen: (unspecified date) showed multiple small blastic lesions throughout, notes: the bones, and lytic lesions in several lumbar vertebrae; Computerised tomogram pelvis: (unspecified date) showed multiple small blastic lesions throughout, notes: the bones, and lytic lesions in several lumbar vertebrae; CSF test: (unspecified date) patients cognition improved; Echocardiogram: (10Oct2022) showed a normal left ventricle; (26Oct2022) showed an ejection fraction of 31% with wall, notes: abnormalities; Ejection fraction: (10Oct2022) 55-60 %; (26Oct2022) 31 %; (28Oct2022) 50-55 %, notes: low-normal; Ejection fraction (54-74): (26Oct2022) 25 %; (26Oct2022) 37 %; Electrocardiogram: (25Oct2022) showed sinus tachycardia, with occasional, notes: premature ventricular complexes with poor precordial lead R wave progression in V1-V3; Electroencephalogram: (27Oct2022) slow posterior dominant rhythm, intermittent, notes: rhythmic slow and generalized EEG activity and a triphasic wave; Immunology test: (unspecified date) showed waning immunity in the patient from prior, notes: showed waning immunity in the patient from prior; IVSd (0.6-0.9): (26Oct2022) 0.8, notes: Unit: cm; LADs (2.7-3.9): (26Oct2022) 2.3, notes: Unit: cm; LV Mass Index (43-95): (26Oct2022) 41.5, notes: Unit: g/m2; LVDd (1.8-2): (26Oct2022) 1.7, notes: Unit: cm; (26Oct2022) 1.7, notes: Unit: cm; Magnetic resonance imaging head: (unspecified date) no acute lesions, and the patient remained, notes: afebrile; SARS-CoV-2 test: (10Oct2022) Positive; Troponin T (normal high range 14): (23Oct2022) 42 ng/L; (27Oct2022) 27 ng/L; Tumour marker test (normal high range 3.4): (24Oct2022) 1.5 ng/L; White blood cell count: (unspecified date) normal. Clinical course: The patient is a 54-year-old female with a past medical history of lumbar radiculopathy, gastro-esophageal reflux disease, post-concussion syndrome and intractable nausea and vomiting who initially presented to Hospital because of failure to thrive and recurrent episodes of syncope. Upon presentation to the emergency department, the patient underwent a CT without contrast of the abdomen and pelvis, which showed multiple small blastic lesions throughout the bones, and lytic lesions in several lumbar vertebrae. A nodular lesion in the left breast was also found, which raised concern for metastatic breast cancer. The oncology team was consulted and recommended obtaining values for CA 15-3, CA 19-9, CA 27.29 and CEA tumor markers, all of which were within the normal range. The breast surgery team was consulted and advised that the patient should follow up on the breast mass on an outpatient basis. The patient was not started on chemotherapy or immunosuppressants during this hospitalization. The patient originally tested positive for COVID-19 on 10 October 2022, when she presented to an outside hospital for syncopal episodes. The patient had received three total Pfizer COVID-19 vaccinations, with her most recent booster vaccination in December 2021. Upon arrival, the patient had no symptoms of COVID-19, and therefore received no treatment for COVID-19 while in the hospital. An antibody titer for COVID-19 was run on the patient to see if lasting immunity still existed from the previous booster shot received by the patient a year ago. ELISA lab titration performed for COVID-19 antibodies showed waning immunity in the patient from prior combinations of infection and vaccination. Titer values received were at 1:100, which falls in the low range of antibody detection. While at the outside hospital on 10 October 2022, she received an echocardiogram as part of her syncope workup, which showed a normal left ventricle with an ejection fraction of 5560% and normal systolic and diastolic function. A repeat echocardiogram was ordered on 26 October 2022 while the patient was at hospital, which showed an ejection fraction of 31% with wall motion abnormalities. ProBNP levels were elevated at 7616 pg/mL. Serial troponin levels showed elevated levels that were downtrending, from 42 ng/L on 23 October 2022 to 20 ng/L on 27 October 2022. An EKG on 25 October 2022 showed sinus tachycardia, with occasional premature ventricular complexes, with poor precordial lead R wave progression in V1V3. A cardiac catheterization was performed on 28 October 2022, which showed normal coronary arteries and a lownormal ejection fraction of 5055%. A differential diagnosis of Takutsobo's cardiomyopathy versus COVID-19 cardiomyopathy was made. Takutsobo's cardiomyopathy was included in the differential diagnosis given days before, when the patient had been told that she may have metastatic breast cancer.  The patient was started on goal-directed medical therapy for heart failure while in the hospital, which included ramipril, spironolactone and bisoprolol. Ramipril was eventually discontinued during her hospitalization and, after an appropriate washout period, sacubitril/valsartan was started. Upon discharge, the patient was prescribed aspirin 81 mg, bisoprolol 20 mg, spironolactone 25 mg, atorvastatin 40 mg, sacubitril/valsartan 50 mg and dapagliflozin 5 mg. The neurology team was consulted to evaluate for the possible cause of the patient's syncope, intractable nausea and vomiting and fluctuating levels of consciousness. An MRI of the brain showed no acute lesions, and the patient remained afebrile with a normal white blood cell count. An EEG was conducted on 27 October 2022, which showed a slow posterior dominant rhythm, intermittent rhythmic slow and generalized EEG activity and a triphasic wave. These findings were supportive of a diagnosis of mild to moderate encephalopathy. Cerebrospinal fluid (CSF) analysis was initially deferred by the patient, and, due to the patient's improving cognition, the acute onset of symptoms and the lack of differentiating characteristics between COVID-19-induced encephalitis and other viral encephalopathies, the neurology consult team then deemed it  nnecessary to perform a CSF analysis. Throughout her hospitalization, the patient's cognition improved; however, she continued to display intractable nausea and vomiting, with an inability to tolerate oral intake. Because of this, she was started on a percutaneous endoscopic gastrostomy tube, which was kept upon discharge. As a result of the patient's improving mental status and lack of syncopal episodes over the week of admission, COVID-19 was believed to be the reason for her acute encephalopathy, rather than any autoimmune syndrome related to the patient's metastatic breast cancer. High-dose corticosteroids were withheld due to the patient's risk of acquiring a potentially lethal hospital-acquired infection. The patient was discharged to a rehabilitation facility. Sadly, in December 2022, the patient underwent an ultrasound-guided biopsy of the right breast and was diagnosed with invasive lobular carcinoma.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2 and the reported events covid-19, drug ineffective cannot be excluded.,Linked Report(s) : US-PFIZER INC-PV202300070443 Same article/patient/drug and different events;US-PFIZER INC-PV202300070443 Same article/patient/drug and different event;