Sex: F
Vaccine: COVID19
Symptoms: Carbohydrate antigen 15-3, Carbohydrate antigen 19-9, Carbohydrate antigen 27.29, Catheterisation cardiac, Computerised tomogram abdomen
Clinical narrative: Concomitant COVID-19 myocarditis and encephalitis after receiving a booster dose within the year; Concomitant COVID-19 myocarditis and encephalitis after receiving a booster dose within the year; This is a literature report.  A 54-year-old female patient received BNT162b2 (BNT162B2), 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: ENCEPHALITIS (medically significant, life threatening), MYOCARDITIS (medically significant, life threatening), all with latency 1 year after the suspect product(s) administration, outcome "unknown" and all described as "Concomitant COVID-19 myocarditis and encephalitis after receiving a booster dose within the year". 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; Computerized tomogram abdomen: (unspecified date) showed multiple small blastic lesions throughout, notes: the bones, and lytic lesions in several lumbar vertebrae; Computerized 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: combinations of infection and vaccination; 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 (3.8-5.2): (26Oct2022) 3.3, notes: Unit: cm; LVOTd (1.8-2): (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/ml; White blood cell count: (unspecified date) normal.; Sender's Comments: Based on the information currently available, there is a reasonable possibility of a causal  association between the reported adverse events encephalitis, myocarditis and the suspect  product BNT162b2. It was reported that patient experienced myocarditis and encephalitis after receiving a booster dose within the year. This case will be reassessed 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-202300163988 Same article/patient/drug and different event;US-PFIZER INC-202300163988 Same article/patient/drug and different events;