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Life Threatening? Yes
Write-up: This case was reported by a physician and was a prospective report of vaccine exposure during pregnancy in a 26-year-old female subject who was vaccinated with HAVRIX 1440 (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of HAVRIX 1440. The subject was found to be pregnant in the third or fourth week of gestation. Follow-up information was received on 09 July 2008. Concurrent medical conditions included pollinosis. There was no relevant anamnesis in the mother or her family. The patient was pregnant for the first time. On 9 May 2008 the subject received a dose of HAVRIX 1440 (intramuscular, unknown) for basic immunisation. At the time of follow-up the subject was in 11 weeks of gestation after normal congestion. The date of her last menstrual period was unknown. The estimated date of delivery was 23 January 2009. Last prenatal examination was performed on 04 July 2008. There were no complications or signs for defects. Follow-up information was received on 27 January 2009. Concurrent medical conditions of the mother included house dust mite allergy. HAVRIX was given on 12 May 2008. On 18 January 2009, after 40 weeks of pregnancy the patient gave birth to a healthy male infant weighing 3750 g, with a size of 55 cm, a head circumference of 36 cm and an Apgar score of 8/9/10, by induced vaginal delivery. Follow-up information was received on 04 February 2009. Concurrent medications included TELFAST for pollinosis until 7 weeks of gestation. Co-suspect vaccination included 3rd dose of GARDASIL (non-gsk), given on 15 May 2008 (intramuscular, unknown deltoid). On 12 May 2008 the subject received 2nd dose of HAVRIX 1440 (intramuscular, unknown deltoid). During delivery the mother developed severe bleeding with haemoglobin decrease to 7.0 and a hypotensive crisis in postpartal phase. Additionally the placenta was separating incompletely and uterine curettage had to be performed. The physician considered the events were life threatening. The case was upgraded to serious. At the time of reporting the events were resolved. The physician considered the causality was not assessable. In 22 weeks of gestation plexus cyst was found. Please see case D0057605B for the baby.
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