Adverse Event Reporting
| VAERS ID | 1428744 |
|---|---|
| Gender | Male |
| Age | |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | |
| Number of vaccinations | 2 |
| Vaccinated | |
| Onset | 2021-02-27 |
| Condition | Hospitalized |
Symptoms
- Chest pain
- Nausea
- Electrocardiogram
- Troponin
- C-reactive protein
- Echocardiogram
- Myocarditis
- Heart valve incompetence
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Milk allergy (As reported - life threatening allergy to milk. Carries an Epipen)
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Test Date: 20210227; Test Name: CRP; Result Unstructured Data: Test Result:4.
9; Comments: As reported; Test Date: 20210227; Test Name: cardiac echo; Result Unstructured Data: Test Result:Details in notes; Comments: thin line of pericardial discharge, also light leak of the mitral valve; Test Date: 20210227; Test Name: ECG; Result Unstructured Data: Test Result:Details in notes; Comments: sinus 80, normal axis, Rises in ST leads V2-V6.
PR dips near lead II, inversion of T on AVR, space QTC 0.
42 seconds.
; Test Date: 20210227; Test Name: Troponin; Result Unstructured Data: Test Result:1649; Comments: As reported
Write-up
perimyocarditis; mediastinal chest pains; nausea without vomiting; light leak of the mitral valve; This is a spontaneous report received from a contactable Other Health Care Professional via Epidemiology department.
A 16 years old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization.
Relevant medical history included life threatening allergy to milk.
Concomitant medications were not reported Patient was admitted on 27Feb2021 for mediastinal chest pains since the day he was admitted that appeared after walking 20 kilometers.
Accompanied by nausea without vomiting.
The patient presented with constant pain on a level of 7/10, increased with deep breathing.
Lab test included: CRP 4.
9.
Troponin 1649.
ECG showed sinus 80, normal axis, Rises in ST leads V2-V6.
PR dips near lead II, inversion of T on AVR, space QTC 0.
42 seconds.
In Cardiac ECHO thin line of pericardial discharge, also light leak of the mitral valve.
At the time of the reporting events outcome was unknown.
No follow-up attempts are possible, information about batch /lot number cannot be obtained.
; Sender's Comments: A possible contributory role of the suspect drug to the reported events "perimyocarditis, mediastinal chest pains, nausea without vomiting and light leak of the mitral valve" cannot be completely excluded based on temporal association.
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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
,Linked Report(s) : IL-PFIZER INC-2021341202 master case