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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This retrospective pregnancy case was reported by a consumer and described the occurrence of death nos in a female neonate subject who was exposed to BOOSTRIX (GlaxoSmithKline), ADACEL (non-gsk) during pregnancy. A physician or other health care professional has not verified this report. On 6 September 2011, the 31-year-old mother of the subject received unspecified dose of BOOSTRIX (.5 ml, transplacentary) and unspecified dose of ADACEL (transplacentary). The mother''s last menstrual period was on an unknown date and estimated date the delivery was 01 May 2012. The neonate was exposed to BOOSTRIX during an unknown trimester. Examination results of an "ultrasound 7" showed no evidence of a defect. On 1 May 2012, at an unspecified gestation age, the neonate was delivered by unknown method and weight 3.9 kilograms. Apgar score was not provided. The neonate was diagnosed with pulmonary hypertension and arterial venous malformation. The neonate remained hospitalized and died on 17 May 2012, cause of death was not provided. It was unknown whether an autopsy was performed. The outcome of pulmonary hypertension and arterial venous malformation were not specified. Please see report A0984491A for details regarding the mother case. Follow-up information received via the consumer on 17 July 2012 indicated the lot number for BOOSTRIX as C3947BA with expiration date 03 February 2014.
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