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VAERS Report 2157183

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; 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: "bilateral feet hyperkeratosis" (unspecified if ongoing); "prolonged qt interval" (unspecified if ongoing), notes: which later shortened. there were no concomitant medications. vaccination history included: covid-19 vaccine (dose 1, manufacturer unknown, an uneventful course after the first 2 vaccinations), for covid-19 immunization; covid-19 vaccine (dose 2, manufacturer unknown, an uneventful course after the first 2 vaccinations), for covid-19 immunization. the following information was reported: myocarditis (hospitalization, medically significant) with onset 2021, outcome "recovered" (2021), described as "myocarditis". the patient was hospitalized for myocarditis (start date: 2021). the event "myocarditis" 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 exclude; 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) which ruled out obstructive coronary artery, notes: disease, but demonstrated on delayed scan (6 minutes postinjection) late iodine enhancement in a distribution typical of myocarditis; echocardiogram: (2021) unknown result; electrocardiogram st segment: (2021) elevation in ii, iii, and avf or v1 to v2; eosinophil count: (2021) normal; investigation: (2021) revealed a mutation in keratin 16 gene-(nm_005557, notes: revealed a mutation in keratin 16 gene-(nm_005557.4):c.374a>g; p.asn125serkrt16 (not involved in cardiomyopathy but close to krt9 gene involved in naxos syndrome); magnetic resonance imaging heart: (2021) . local normal t1 values are 945+/-35 ms, t2 46+/-, 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:62 ms). c, sao phase-sensitive inversion recovery showing late gadolinium enhancement (lge) (arrows) (d) sao, showing increased value on native t1 (roi:1067); (2021) resolution; polymerase chain reaction: (2021) negative, notes: acute 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; troponin: (2021) elevated; (2021) consistent decrease; troponin (normal high range 2.5): (2021) unknown result. the patient denied recent exposure to new medications/drugs. the patient had not received other vaccinations during that time period.; 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-202200333285 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 exclude; 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:which ruled out obstructive coronary artery; comments: disease, but demonstrated on delayed scan (6 minutes postinjection) late iodine enhancement in a distribution typical of myocarditis; test date: 2021; test name: ecg/echocardiogram; result unstructured data: test result:unknown result; 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: 2021; test name: genetic screening; result unstructured data: test result:revealed a mutation in keratin 16 gene-(nm_005557; comments: revealed a mutation in keratin 16 gene-(nm_005557.4):c.374a>g; p.asn125serkrt16 (not involved in cardiomyopathy but close to krt9 gene involved in naxos syndrome); test date: 2021; test name: cmr; result unstructured data: test result:. local normal t1 values are 945+/-35 ms, t2 46+/-; 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:62 ms). c, sao phase-sensitive inversion recovery showing late gadolinium enhancement (lge) (arrows) (d) sao, showing increased value on native t1 (roi:1067).; test date: 2021; test name: cmr; result unstructured data: test result:resolution; test date: 2021; test name: polymerase chain reaction swabs; test result: negative ; 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: 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: 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 result ng/l
List of symptoms
electrocardiogram st segment investigation myocarditis blood culture polymerase chain reaction chest x-ray computerised tomogram sars-cov-2 test echocardiogram troponin eosinophil count sars-cov-2 antibody test 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