Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Hydrocephalus, Hypotension, Mass excision, Nausea, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Initial report received on 18 May 2010 from an investigator under the reference number M5A11. A 10-month-old female subject with a history of cerebellar atypical teratoid rhabdoid tumor (ATRT) died due to disease progression 153 days after receiving a third injection of PENTACEL (lot number C3181AA). The subject also received the following vaccines on the same date: a second dose of PREVNAR(lot number D46873), and a second dose of rotavirus vaccine (lot number 1695X). The subject was born with a small pedunculated skin lesion on the left side of the midline at about T3-T4 region. It was initially the size of a  pea, which gradually grew over the next 4-5 months, becoming a pedunculated, multilobulated, cornified, epithelialized lump dangling on the peduncle against the back. She also developed other lesions which were biopsied and described as fibroblastic, myofibrotic, myoblastic lesions with mitotic figures. However, pathology results did not lead to a diagnosis. She behaved normally during this time with the exception of a slight head tilt. An MRI of the neck subsequently indicated that the lesions were related to deeper structures, specifically a large anterior fossa mass, and that the child had significant hydrocephalus. The subject was diagnosed with ATRT on an unspecified date. She underwent a resection with external ventricular drain placed on 30 September 2009. The drain was removed on 07 October 2009. Due to her extremely poor prognosis, the family decided against chemotherapy at that time. She was at home doing well until 05 December 2009, when she developed upper respiratory infection (URI) symptoms and vomiting. She was seen by her primary care physician, diagnosed with otitis media, and treated with amoxicillin. The following date she presented to the emergency department with persistence distress, emesis, and a lack of wet diapers. She was diagnosed with dehydration. Laboratory date included Na=134, K=4.4, CO2=18, CL=101, BCN=7, CR=0.3, RBS=77 (all units unspecified). A CT scan showed enlarged ventricles that had increased in size from her initial post-operative scan. An enlarged posterior fossa fluid collection was noted, with no evidence of transependymal edema. Due to these findings, as well as the dehydration, she was admitted to the hospital on 07 December 2009 for rehydration and possible neurosurgical treatment of hydrocephalus. She had low blood pressure on admission (NBP-94/61), which improved following administration of intravenous fluids (Bolus with normal saline 10 ml/kg, D5NS at 40 ml/hr). In addition, ZOFRAN was prescribed for nausea and vomiting. Diagnostic imaging showed that symptoms had progressed significantly, and the family decided on palliative care only. On 09 December 2009 her code status was changed to "DNR" (do not resuscitate, and she was started on morphine and a transdermal fentanyl patch for pain control. The subject was discharged to home hospice on 14 December 2009, and she expired the following day, on 15 December 2009. No autopsy was performed. According to the investigator, the event was not related to the study vaccine. Documents held by sender: discharge summary, medication records, physician consult.