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Life Threatening? No
Write-up: missed abortion; This is a spontaneous report received from a contactable other HCP via regulatory authority. A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Lot Number: ET2838) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included pregnancy with no miscarriages in the past. The patient''s concomitant medications were not reported. She was hospitalized for observation after a missed abortion at 14 weeks of gestation, this was the second pregnancy with no previous abortions. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. The patient was discharged. The event outcome was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Limited information can not support a complete medical assessment. Based on the information currently available, the event missed abortion most likely represented an intercurrent medical condition and was unrelated to Bnt162b2 vaccine. Case will be re-assessed upon the additional information provided. 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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