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Life Threatening? No
Write-up: Maternal exposure during pregnancy; Fetus stopped growing on 09Feb21 (8w4d); no heartbeat detected; This is a spontaneous report from a contactable consumer (parent). This consumer reported information for both mother and fetus. This is a fetus report. A patient of unspecified age and gender (fetus) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269), transplacental on 04Feb2021 at 14:00 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included ergocalciferol (VIT D), folic acid (FOLATE), ascorbic acid/betacarotene/calcium sulfate/colecalciferol/cyanocobalamin/ferrous fumarate/folic acid/ nicotinamide/pyridoxine hydrochloride/retinol acetate/riboflavin/thiamine mononitrate/tocopheryl acetate/zinc oxide (PRENATAL VITAMINS) and sertraline hydrochloride (ZOLOFT) at 25 mg, all transplacental. It was reported that OB exam on 03Feb21 showed healthy baby at 7weeks 5days heartbeat detected 152 bpm; no abnormalities identified via ultrasound; labs and hormone levels all within normal ranges. No issues detected. Mother received 1st dose of vaccine on 04Feb2021. Per ultrasound on 20Feb2021, fetus stopped growing on 09Feb2021 (8 weeks 4 days); no heartbeat detected. Miscarriage occurred on 22Feb2021. The fetus died on 22Feb2021. It was not reported if an autopsy was performed.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-2021204433 same drug and reporter, different patient and event; Reported Cause(s) of Death: Fetus stopped growing on 09Feb21 (8w4d); no heartbeat detected; Mother received 1st dose of vaccine 04Feb21. Per ultrasound on 20Feb21, fetus stopped growing on 09Feb21 (8w4d); no heartbeat detected. Miscarriage occurred 22Feb21.
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