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Life Threatening? No
Write-up: I lost the baby; The initial case was missing the following minimum criteria: there was no indication that patient experienced an adverse event BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). Upon receipt of follow-up information on 27Feb2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient) received by Medical Information Team. This is the maternal report. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The applicant indicated that the first dose of Pfizer''s COVID-19 vaccine was administered. After the application, she discovered that she was pregnant. She wanted to know what Pfizer recommendations have for her. The mother reported she became pregnant while taking bnt162b2. As of 27Feb2021, patient lost the baby and a few days ago they administered the second dose (as reported). The outcome of event was unknown.; Sender''s Comments: Pfizer comment: Based on the information provided by the reporter, it appears unlikely that the suspect drug contributed to the reported event abortion spontaneous, that most likely was due to intercurrent conditions. This case will be reassessed when additional information becomes available. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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