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Write-up: miscarried at 12 weeks; received first dose of bnt162b2 on 18Dec2020, second dose on 11Feb2021; received first dose of bnt162b2 on 18Dec2020, second dose on 11Feb2021; This is a spontaneous report from a contactable nurse (Patient). A 38-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el3248) intramuscular in right arm on 11Feb2021 17:00 at single dose for covid-19 immunisation. No medical history. No COVID prior to vaccination. Other medications in two weeks include prenatal vitamins. Patient received first dose of bnt162b2 (lot number ek5730) on 18Dec2020 12:00 PM intramuscular in right arm. No other vaccine in four weeks. Patient''s last menstrual date was 01Nov2020. Patient miscarried at 12 weeks after receiving the second dose of vaccine. Dilation and curettage performed. Outcome was recovered with sequel. Nasal Swab COVID tested negative post vaccination on 18Feb2021.; Sender''s Comments: The limited information provided precludes a full clinical assessment of the case. Considering the product-event temporal relationship, a causal association between the reported ''miscarried'' and the administration of bnt162b2 cannot be completely excluded. Case will be reassessed once with additional information. 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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