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|History of Changes from the VAERS Wayback Machine|
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH||- / 2||- / -|
Administered by: Unknown Purchased by: ??
Symptoms: Chest pain, Dyspnoea, Myocarditis, SARS-CoV-2 test
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 4
Write-up: myocarditis; chest pain; shortness of breath; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is the first of two reports. A 16-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06May2021 (Batch/Lot number was not reported) (at the age of 16-year-old) as single dose for COVID-19 immunisation. Medical history was none. Prior to vaccination the patient was not diagnosed with COVID-19. The patient''s concomitant medications were not reported. The patient previously took ceftriaxone and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. On 08May2021, the patient experienced myocarditis, chest pain and shortness of breath. The patient was hospitalized for 4 days due to the events. The patient underwent lab tests and procedures which included COVID-19 test (nasal swab): negative on 09May2021. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen. The patient outcome of the events was recovering. Information on lot/batch number has been requested.; Sender''s Comments: Based on temporal association a contributory role of BNT162B2 to the reported myocarditis, chest pain and shortness of breath cannot be totally excluded. Additional information is needed to better assess the report. 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-2021565275 same reporter/AEs/vaccine, different patient.
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