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Life Threatening? No
Write-up: intra-uterine foetal death; Maternal Exposure During Pregnancy, second trimester; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-94496. A 28-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 21May2021 (at the age of 28-years-old) as dose 1, single for COVID-19 immunisation. Medical history included repeated miscarriage due to unknown cause (each time early miscarriage before 12 weeks). The patient''s concomitant medications were not reported. The patient was pregnant at time of vaccination: second trimester (also reported 14 weeks). The patient experienced intra-uterine foetal death. The patient underwent lab tests and procedures which included: placental biopsy, torches screening (toxoplasmosis, cytomegalovirus, herpes, parvo B 19) and placental cultures, all with unknown results. The patient had termination of pregnancy with birth of lifeless foetus and curettage given placental retention. The outcome of event was reported as resolved. Reporter''s Comment: Treatment - Yes termination of pregnancy with birth of lifeless foetus - curettage given placental retention Evolution of the ADR - recovered. Situations - Other: possibly no causal relationship, but still needs to be reported. Examinations - placental biopsy/ placental cultures/ Torches screening in the mother (toxoplasmosis, cytomegalovirus , herpes, parvo B 19. ADR description - intra uterine foetal death the crown torso length of the foetus was 14 weeks which corresponds to the time of administration of the vaccine. Comirnaty Batch/lot number UNKNOWN. Dosage text: First dose administered the crown trunk length of the fetus was 14 weeks, which corresponds to the time of vaccine administration. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Reporter''s Comments: Situations - Other: possibly no causal relationship, but still needs to be reported.
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