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Life Threatening? No
Write-up: This female subject was enrolled in the study sponsored by the National Cancer Institute (NCI). On 20 May 2011, the subject received the 1st dose of CERVARIX and ENGERIX B in her right deltoid. The serious adverse event described below was not experienced by a study subject but her offspring. The study subject or mother was exposed to CERVARIX and ENGERIX B before conception. The mother took concomitant medications iron, folic acid, PROSTIN, oxytocin, iron, indomethacin, IV fluids, folic acid and ampicillin during her pregnancy. The mother had the following relevant medical conditions: SAE of therapeutic miscarriage (see case A0933003A for more details). On 14 October 2011, five months after the mother (subject) took the 1st dose of CERVARIX and the 1st dose of ENGERIX B, the subject''s fetus was diagnosed with multiple congenital malformations. The event was a congenital anomaly, clinically significant (or requiring intervention) and resulted in a fatal outcome. Due to the multiple congenital anomalies elective termination of pregnancy was decided on 17 October 2011. The investigator reported the multiple congenital malformations as possibly related to CERVARIX and ENGERIX B given the short time that elapsed between the last done of the vaccine and the last menstrual period (LMP). Investigator comments: Last menstrual period (LMP): 23 May 2011, total of seven pregnancies, five deliveries and one previous miscarriage. The subject (mother) used oral contraception before becoming pregnant. She only attended one prenatal care appointment. On 16 November 2011, the subject reported by phone that on 14 October 2011 she was hospitalized due to threatened preterm delivery (see serious adverse event number 60411). On 17 October 2011, when she was 21 weeks of gestational age she had induced a vaginal delivery and she gave birth to a preterm female newborn, weight 400 grams, length 23.5 centimeters, Apgar score unknown, who died some minutes after delivery. The medical chart will be reviewed as soon as possible. Diagnosis: prematurity. Investigator comments received on 22 November 2012: To follow up the serious adverse event 60446, with diagnosis of prematurity, on 21 November 2012 the medical chart was reviewed in a local hospital and the following was found: 13 October 20121: Referred from a primary care center to the emergency room (ER): gestational age: 20 weeks, with history of abundant vaginal bleeding. Physical examination: Normal BP, without fever, pelvic exam: 1 cm of dilation, vaginal bleeding (negative), hydrorrhea (positive), fetal heart rate: 161 per minute (min), fetal movements (positive). Diagnostic impression: threatened miscarriage. At the ER: delayed miscarriage. Pelvic exam: 1 cm of dilation, mild vaginal bleeding, fetal heart rate: 151 min. Plan: admission, ward routine, Indomethacin. Diagnosis of admission: delayed threatened miscarriage. 14 October 2011: She had a sonogram performed which showed: alive baby, dimorphic with the following findings: A) cephalic baby with a cephalic circumference that remembers the image of a strawberry, with a extremely this bone table, with a mean gestational age of weeks and with an important skin edema above the skull. At central nervous system as a single finding is observed a decreased differentiation of wrinkles. B) Heart exam: atrial rhythm 156 min, ventricular rhythm 143 min, arrhythmic, it seems to have a disorder due to an atrioventricular node block. Structurally is a heart of 4 chambers with AV and VA concordance, outflow tracts without obstructions and normal aortic arch are observed. C) seems to have a narrow chest with a circumference of 12 cm with levocardia. Diaphragm intact. No pleural or pericardic effusion. D) Important ascytis with intestine with echogenic internal areas, liver with echogenic areas or points, at the examination of the venous ductus is noted "a" negative wave. Spinal cord closed without defects at lumbar or sacral levels. Kidneys of normal aspect. In upper as well as in lower limbs important macromelia. In distal as well as in proximal segments rizomelia and mesomelia. Is not possible the analysis of hands and face due to an important oligohydramnios. Diagnostic impression: 1) considering the findings of narrow chest and macromelia, with a convex forehead and a not oval skull the most probable diagnosis is a thanatophoric dysplasia, 2) severe oligohydramnios, 3) growth of 26 weeks by cephalic circumference, 4) abdominal circumference and longitudinal femoral are not valid. Plan: the progress is explained to the patient, sterile clothe, lab tests. 15 October 2011: Is indicated: temperature measurement curve, ampicillin. 16 October 2011: Informed consent for therapeutic miscarriage is completed. Plan: PROSTIN gel, IV solution and oxytocin. 17 October 2011: She underwent dilation and curettage and biopsy. Pre and post surgical diagnosis: incomplete miscarriage. Plan: post surgical protocol, diclofenac, cephalothin, ampicillin, schedule for bilateral tubal occlusion by request of the patient, transfuse PRBC. On 18 October 2011, 19 October 2011 and 20 October 2011 hospitalized due to bilateral tubal occlusion. Diagnosis of discharge: delayed miscarriage, multiple fetal malformations, premature rupture of membranes, satisfied parity. Diagnosis: female fetus of approximately 21 weeks of gestational age, multiple external malformations, 400 grams (g), 26 centimeters (cm), of macerated aspect, slough skin with low set ears, ogival palate, short limbs. Given the information obtained the onset date and the diagnosis change. Considering that the diagnosis of the event changes to multiple malformations in the participant''s daughter and given the short time elapsed between the vaccination and the LMP we decided to change the relation with the vaccine as "possibly related". Diagnosis: multiple congenital multiple malformations in the participant''s daughter.
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