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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||EW1077 / 1||- / OT|
Administered by: Pharmacy Purchased by: ??
Symptoms: 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:
Write-up: Myocarditis; This is a spontaneous report from a contactable pharmacist. A 15-year-old male patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EW1077), at the age of 15 years old, intramuscularly on 17May2021 at single dose for covid-19 immunisation. The patient medical history was reported as none. The patient had no known allergies. The patient was not diagnosed with covid-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient experienced myocarditis on 21May2021. The event resulted in hospitalization for 2 days. The patient was currently still in hospital. The patient had been tested for covid-19 since the vaccination. The patient underwent lab tests and procedures, which included covid-19 test: negative on 22May2021 by nasal swab. Therapeutic measures were taken as a result of myocarditis and included treatment with analgesic. The outcome of event was not recovered. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset. More information such as complete medical history and concomitant medications are needed for fully medical assessment. 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.
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