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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||FD0809 / 1||LA / OT|
Administered by: Unknown Purchased by: ??
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: Irritable bowel syndrome
Diagnostic Lab Data:
CDC 'Split Type': USPFIZER INC202101234354
Write-up: hives; This is a spontaneous report from a contactable pharmacist. A 24-year-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Deltoid Left on 10Sep2021 (at the age of 24-years-old) (Batch/Lot Number: FD0809) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history included irritable bowel syndrome. The patient''s concomitant medications were not reported. On 13Sep2021, the patient experienced hives (medically significant). The Hives were noticed to be first experienced on the torso on Monday 13Sep2021. The Xifaxan was started on 17Sep2021. On an unspecified date, irritable bowel syndrome disorder. The outcome of the events was unknown.; Sender''s Comments: Based on the temporal relation, the association between the event of Urticaria and the suspect product of BNT162B2 cannot be completely ruled out. 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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