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Life Threatening? No
Write-up: patient was pregnant while taking BNT162B2; patient was pregnant while taking BNT162B2; Miscarriage 11 days post vaccine; This is a spontaneous report from a contactable Nurse. A 39-year-old female nurse reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL0142), into the left arm on 28Dec2020 at 07:30 AM at single dose for COVID-19 immunization. Medical history included asthma and eosinophilic esophagitis and allergies to Keflex ASA. Concomitant drugs were none. At the time of vaccination the patient was pregnant, her last menstrual date was on 20Nov2020, gestational period 6. The patient reported that on 08Jan2021 at 12:00 PM she had miscarriage 11 days post vaccine. The patient was seen at Doctor or other healthcare professional office/clinic visit. At the time of reporting the patient was recovering.; Sender''s Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported miscarriage. However, information is limited, and miscarriage is multifactorial event. In the general population, the estimated background risk of miscarriage in clinically recognized pregnancies is 15% to 20%. 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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