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Life Threatening? No
Write-up: spontaneous abortion; This is a spontaneous report from a contactable physician. A pregnant 31-year-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The moment of vaccination with 1st dose the patient was 4 weeks of amenorrhea. Medical history and concomitant medications were not reported. On 06Apr2021, it was reported that the patient had quickly experienced spontaneous abortion on an unspecified date after receiving the 1st dose of BNT162B2. The reporting physician had no more information since she was not the physician who monitored the pregnancy. The outcome of the event was unknown. Information on the lot number has been requested. Amendment: This follow-up report is being submitted to amend previously reported information: The statement "the moment of vaccination with 1st dose the patient was 4 weeks of amenorrhea" was added on the narrative. The gestation period was populated as 4 weeks and the event "pregnant female patient received BNT162B2" was updated as "pregnant female patient received BNT162B2/ the patient was 4 weeks of amenorrhea" and recoded to maternal exposure during pregnancy, first trimester. Vaccine reporter details was reflected in the corresponding data field. Follow-up (06Apr2021): New information received from a contactable physician includes: reaction data (event was updated to spontaneous abortion). This case was upgraded to serious. Follow-up attempts are completed. No further information is expected.
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