Your Health. Your Family. Your Choice.
|History of Changes from the VAERS Wayback Machine|
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH||- / 1||- / -|
Administered by: Other Purchased by: ??
Symptoms: Syncope, 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
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19; Comments: Patient is not enrolled in clinical trial Patient is not pregnant, Patient is not currently breastfeeding
Diagnostic Lab Data: Test Date: 20201222; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: Positive COVID-19 test
CDC 'Split Type': GBPFIZER INC2021640786
Write-up: Fainting; This is a solicited report from the RA from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-YCVM-202106012117352480-EJK1K, Safety Report Unique Identifier GB-MHRA-ADR 25401530. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 01Jun2021 at the age of 34-year-old as single dose for covid-19 vaccination. Medical history included suspected covid-19 from 22Dec2020 to 03Jan2021. Patient was not enrolled in clinical trial. Patient was not pregnant. Patient was not currently breastfeeding. Patient last menstrual period was 19May2021. The patient''s concomitant medications were not reported. The patient experienced fainting on 01Jun2021. This event was reported as non-serious by RA. Additional information: This medication is only taken when a severe migraine occurs (unspecified). The patient underwent lab tests and procedures which included COVID-19 virus test: positive covid-19 test on 22Dec2020. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was recovered on 01Jun2021. The reporter''s assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. Sender''s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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 RAs, as appropriate.
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