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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: Initial report received on 28 September 2010 from an investigator participating in a study under the reference number M5A11. An infant male subject who born with an incarcerated inguinal hernia on 29 December 2009. The investigator reported that at 4 months of age the infant received the following vaccines on 30 April 2010: first injection of DAPTACEL, lot number C3139AA; first injection site of ACTHIB, lot number D0870 (UF739AA); first injection of IPOL, lot number D0304; and first injection of pneumococcal vaccine (PNCV7), Wyeth, lot number E15306; and died 15 days post-vaccination. According to the autopsy report, the infant''s medical history included premature birth (25 weeks gestation) with intrauterine growth restriction (395 g birth weight) ascribed to maternal chronic hypertension with super-imposed pre-eclampsia/atypical HELLP syndrome. The infant had a prolonged hospital course with morbidity including respiratory distress with apnea, retinopathy, patency of the ductus arteriosis with attempted surgical closure, hepatic dysfunction and metabolic derangements, and inguinal and umbilical hernias. The infant was discharged to home on 9 May 2010 at a "corrected" gestational age of 42.5 weeks. Repair of his inguinal hernias was planned for around 50 weeks corrected age. On 13 May 2010, the infant became unresponsive following a period of inconsolable crying after a feeding. He could not be resuscitated despite efforts by parents, EMS, and attendings in the ED. The most striking finding in the ED and at autopsy was massive abdominal distension that was not relieved by removal of copious milk from the stomach via NG tube. The large volume of air in the highly distended intestine was sufficient to elevate the diaphragm and increase the intra-abdominal pressure; thus predisposing the infant to reduced cardiac output, increased renal and systemic vascular resistance, decreased venous return to the heart, reduced visceral blood flow, and altered respiratory dynamics. The origin of the intestinal air was most likely a combination of vigorous crying and resuscitative efforts (which included 10 minutes of bag-mask ventilation). Hypertrophy of the right ventricle and pulmonary arterial changes further predisposed him to hypoxia and low cardiac output if venous return were reduced. Obstruction of the terminal ileum in the hernia would be worsened by the intra-abdominal pressure, which would prevent egress of intra-intestinal air. Autopsy internal examination found right inguinal hernia contains 8 cm loop of congested dilated edematous distal-most ileum, along with its hemorrhagic appearing mesentery. There is egress of approximately 10 cc blood tinged clear fluid when the right hernia is reduced (with difficulty). The left hernia contains 8 cm loop of sigmoid colon, which is mildly edematous and mildly dusky and relatively easily reduced. Death was considered multifactorial: acute incarceration of right inguinal hernia, with crying, swallowing of air, and abdominal distension resulting in cardiorespiratory compromise against a background of chronic lung disease with pulmonary hypertension and right ventricular hypertrophy. According to the investigator, the event was not related to the study vaccine. Follow-up information was received on 14 October 2010 from a investigator participating in a trial under the reference number M5A11. The start date of the SAE was changed to the probable date of aggravation of congenital condition (incarceration of inguinal hernia). The start date for the incarcerated inguinal hernia was changed to 13 May 2010 (previously reported as 29 December 2009). According to the investigator, the event remained not related to the study vaccine. Documents held by sender: Autopsy report.
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