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Life Threatening? No
Write-up: missed abortion; Exposure during pregnancy; This is a spontaneous report from a contactable healthcare professional received via the Regulatory Authority. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Lot Number: EL1406) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Family history included her sister had 3 miscarriages without a test for hypercoagulability. The patient was pregnant at the time of vaccination (exposure during pregnancy). It was reported that the patient was on week 22+6, and had missed abortion on an unspecified date, fetus suits week 21. Nuchal translucency and early systems inspection were not performed. The patient was admitted to the hospital due to the missed abortion. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The information available in this report of missed abortion is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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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