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Life Threatening? No
Write-up: We miscarried not long after; This is a spontaneous report received via COVAES from a contactable nurse (patient). A 32-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 11:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at hospital when 32 years old. Medical history included infertility. Concomitant medication included bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the covid vaccine and was advise not to get pregnant for the next 28 days. The patient suffered from infertility and needed IVF to get pregnant so she didn''t think much more of that but less than 3 weeks later (on 02Apr2021) to her surprise she got pregnant naturally. She miscarried not long after. Might not be related but decided to report it anyways. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination. Information about lot/batch number has been requested.; Sender''s Comments: There are not elements supporting a causative role of BNT162B2 vaccine for the reported miscarriage. The event is deemed to be an intercurrent occurrence. 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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