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Life Threatening? No
Write-up: miscarried; patient was pregnant at the time of the vaccine; patient was pregnant at the time of the vaccine; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration at right arm, at the age of 29-year-old, on 30Jan2021 02:00 AM, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were reported as none. The patient had no known allergies. The patient did not receive any other vaccine in four weeks or any other medications in two weeks. The patient was pregnant at the time of the vaccine 30Jan2021 and miscarried on 01Feb2021. LMP was provided as 01Jan2021, gestation period was reported as 4 weeks and due date was provided as 08Oct2021. The patient did not have covid prior vaccination and was not tested for covid post vaccination. The patient did not receive any treatment in response to the event miscarried. Outcome of the event miscarried was not recovered. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the compatible temporal association, a possible contributory role of suspect vaccine BNT162B2 in triggering the misarrange in this 29-year-old pregnant patient cannot be excluded. Additional information regarding relevant medical history, underlying conditions, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. 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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