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VAERS Report 2157182

Case Report Section

Vaer Report Details

Age: NA

Gender: Male

State: Outside US

Patient Died?
No
Vaccine information

Name: COVID19 (COVID19 (PFIZER-BIONTECH))

Type: Coronavirus 2019 vaccine

Manufacturer: PFIZER

Lot: unknown


Date report was received
2022-03-04
Date form completed
Date Vaccinated
2021-08-01
Date of Onset
0
Number of days (onset date – vaccination date)
0
Adverse Event Description

myocarditis associated with covid-19 booster vaccination; this is a literature report. an adult male patient received bnt162b2 (bnt162b2), administration date aug2021 (batch/lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. relevant medical history included: "peri-myocarditis", start date: 2014, stop date: 2015, notes: 2 prior episodes of peri-myocarditis; "hospitalized", start date: 2015 (unspecified if ongoing); "acute viral gastroenteritis" (unspecified if ongoing). the patient's concomitant medications were not reported. vaccination history included: covid-19 vaccine (dose 1 (manufacturer unknown); uneventful course after the first 2 vaccinations), for covid-19 immunisation; covid-19 vaccine (dose 2 (manufacturer unknown); uneventful course after the first 2 vaccinations), for covid-19 immunisation. the following information was reported: myocarditis (hospitalization, medically significant) with onset 2021, outcome "recovered", described as "myocarditis associated with covid-19 booster vaccination". the patient was hospitalized for myocarditis (start date: 2021). the event "myocarditis associated with covid-19 booster vaccination" was evaluated at the emergency room visit. the patient underwent the following laboratory tests and procedures: blood culture: (2021) common alternative causes of myocarditis (eg,, notes: infectious, autoimmune, and toxic) were excluded; chest x-ray: (2021) normal, notes: acute covid-19 infection was ruled out in all patients based on negative polymerase chain reaction swabs and normal chest x-rays; computerised tomogram: (2021) ruled out obstructive coronary artery disease, notes: but demonstrated on delayed scan (6 minutes postinjection) late iodine enhancement in a distribution typical of myocarditis; echocardiogram: (2015) normal; (2021) unknown result; ejection fraction: (2015) slightly reduced; ejection fraction: (2021) unknown results; electrocardiogram st segment: (2021) elevation in ii, iii, and avf or v1 to v2; eosinophil count: (2021) normal; magnetic resonance imaging heart: (2015) showed slightly reduced left ventricular ejection, notes: fraction; (2021) local normal t1 values are 945+/-35 ms, t2 46+/-3, notes: local normal t1 values are 945+/-35 ms, t2 46+/-3 ms. a, short axis oblique view (sao) t2 weighted dark blood (turbo inversion recovery magnitude [tirm]) image showing regional edema (arrows), (b) t2 mapping, showing high signal intensity/ values corresponding to edema as marked by the region of interest (roi: 57) c, sao phase-sensitive inversion recovery showing late gadolinium enhancement (lge) (arrows) (d) sao, showing increased value on native t1 (roi 1038); (2021) resolution; (2015) late gadolinium enhancement was minimal (comparing, notes: to his current cmr); polymerase chain reaction: (2021) negative, notes: cute covid-19 infection was ruled out in all patients based on negative polymerase chain reaction swabs and normal chest x-rays; sars-cov-2 antibody test: (2021) unknown results; (2021) positive; sars-cov-2 test: (2021) negative, notes: negative polymerase chain reaction swabs; serology test: (2021) common alternative causes of myocarditis (eg,, notes: infectious, autoimmune, and toxic) were excluded; stress echocardiogram: (2015) was described as normal; troponin: (2021) elevated; (2021) consistent decrease; troponin (normal high range 2.5): (2021) unknown results, notes: elevated. information about lot/batch number cannot be obtained. no further information expected.; sender's comments: based on the information available and close temporal association, a possible contributory role of the suspect bnt162b2 cannot be excluded for the reported events . the case will be reassessed once new information is 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) : il-pfizer inc-202200330766 same article/ drug/event and different patient;il-pfizer inc-202200333286 same article/ drug/event and different patient

Lab Data
test date: 2021; test name: blood cultures; result unstructured data: test result:common alternative causes of myocarditis (eg,; comments: infectious, autoimmune, and toxic) were excluded; test date: 2021; test name: chest x-rays; result unstructured data: test result:normal; comments: acute covid-19 infection was ruled out in all patients based on negative polymerase chain reaction swabs and normal chest x-rays; test date: 2021; test name: cardiac computed tomography; result unstructured data: test result:ruled out obstructive coronary artery disease; comments: but demonstrated on delayed scan (6 minutes postinjection) late iodine enhancement in a distribution typical of myocarditis; test date: 2015; test name: ecg/echocardiogram; result unstructured data: test result:normal; test date: 2021; test name: ecg/echocardiogram; result unstructured data: test result:unknown result; test date: 2015; test name: left ventricular ejection fraction; result unstructured data: test result:slightly reduced; test date: 2021; test name: left ventricular ejection fraction; result unstructured data: test result:unknown results %; test date: 2021; test name: st-segment; result unstructured data: test result:elevation in ii, iii, and avf or v1 to v2; test date: 2021; test name: eosinophil count; result unstructured data: test result:normal; test date: 2015; test name: cmr; result unstructured data: test result:showed slightly reduced left ventricular ejection; comments: fraction; test date: 2021; test name: cmr; result unstructured data: test result:local normal t1 values are 945+/-35 ms, t2 46+/-3; comments: local normal t1 values are 945+/-35 ms, t2 46+/-3 ms. a, short axis oblique view (sao) t2 weighted dark blood (turbo inversion recovery magnitude [tirm]) image showing regional edema (arrows), (b) t2 mapping, showing high signal intensity/ values corresponding to edema as marked by the region of interest (roi: 57) c, sao phase-sensitive inversion recovery showing late gadolinium enhancement (lge) (arrows) (d) sao, showing increased value on native t1 (roi 1038); test date: 2021; test name: cmr; result unstructured data: test result:resolution; test date: 2015; test name: late gadolinium enhancement; result unstructured data: test result:late gadolinium enhancement was minimal (comparing; comments: to his current cmr); test date: 2021; test name: polymerase chain reaction swabs; test result: negative ; comments: cute covid-19 infection was ruled out in all patients based on negative polymerase chain reaction swabs and normal chest x-rays; test date: 2021; test name: covid-19 anti n antibodies; result unstructured data: test result:unknown results; test date: 2021; test name: covid-19 anti s antibodies; test result: positive ; test date: 2021; test name: sars covid-19 test; test result: negative ; comments: negative polymerase chain reaction swabs; test date: 2021; test name: serological test; result unstructured data: test result:common alternative causes of myocarditis (eg,; comments: infectious, autoimmune, and toxic) were excluded; test date: 2015; test name: stress echocardiogram; result unstructured data: test result:was described as normal; test date: 2021; test name: troponin level; result unstructured data: test result:elevated; test date: 2021; test name: troponin level; result unstructured data: test result:consistent decrease; test date: 2021; test name: troponin level; result unstructured data: test result:unknown results ng/l; comments: elevated
List of symptoms
electrocardiogram st segment myocarditis blood culture polymerase chain reaction chest x-ray computerised tomogram sars-cov-2 test echocardiogram stress echocardiogram troponin eosinophil count sars-cov-2 antibody test ejection fraction serology test magnetic resonance imaging heart
Patient Died?
No
Date Died
NA
Birth defect
false
Vaccine Administered By:
Other
Vaccine Purchased By:
Unknown
Patient visit ER?
No
Patient Hospitalized?
Yes
Stay in hospital
No
Days in hospital
Unspecified
Permanent disability?
No
Allergies:
na
Current Illness
na