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Write-up: unfortunately she had a miscarriage about 5-6 days before her second dose; positive pregnancy test a few days after the first dose.; positive pregnancy test a few days after the first dose.; This is a spontaneous report from a contactable consumer. A 32-year-old female patient (3 weeks pregnant at time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on left arm on 31Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included iron and minerals nos, vitamins nos (PRENATAL VITAMINS). The patient had a negative pregnancy test in 2020 before getting the first vaccine dose, but then had a positive pregnancy test in Jan2021 a few days after the first dose, but unfortunately she had a miscarriage in Jan2021, about 5-6 days before her second dose. She has an appointment scheduled with OBGYN for the miscarriage. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the miscarriage was recovering.; Sender''s Comments: Based on the temporal relationship, the association between the event miscarriage with BNT162b2 can not be completely excluded. 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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