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Life Threatening? No
Write-up: abortion; vaginal bleeding; This is a spontaneous report from a contactable physician reporting for mother. A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 29Apr2021 (Batch/Lot Number: unknown) as single dose for COVID-19 immunisation. The patient was a healthy person with 30 years of age without diseases. The patient did not smoke, did not drink, did not take drugs and she had a 2-year-old child. The patient''s concomitant medications were none. The patient experienced abortion on an unspecified date. The patient reported she became pregnant while taking bnt162b2 on 29Apr2021. The mother was due to deliver on 07Jan2022. The patient got the vaccine on 29Apr2021, last period was 02Apr2021 and she had a pregnancy test on 28Apr2021, it was still negative. The patient was pregnant. The patient had bleeding for 1 week and through ultrasound she had an abortion. On 21May2021, she was still with vaginal bleeding. The patient stated "if I had known about the risk, I would not receive the vaccine". The patient underwent lab tests and procedures which included pregnancy test: negative on 28Apr2021, ultrasound: abortion on an unspecified date. The outcome of abortion was unknown. The outcome of vaginal bleeding was not resolved. Information on lot/batch number has been requested.; Sender''s Comments: Based on the temporal association, a causal relationship between the events and bnt162b2 cannot be completely excluded. The case will be reassessed when additional information becomes available. 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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