Age: 14.0
Sex: F
Vaccine: RAB, YF, RAB, YF
Symptoms: Blood bilirubin increased, Decreased appetite, Headache, Nausea, Pyrexia
Clinical narrative: No seriousness criteria was reported. Based upon medical judgment this case is considered serious: medically significant event (OMIC). From initial info received on 2/24/04 from the pt's parent regarding an adverse event, it was reported that a 14 year old female received a YF-VAX vaccination, lot number UB501AA and an Imovax vaccination, lot number not provided, administered on 2/17/04. Six days later the pt developed a severe headache, fever of 101.6 dg F and vomiting. The pt was taken to hospital ER, however, was not admitted. Tests showed she had increased bilirubin and slightly elevated WBC. Morphine was prescribed for headache. The pt's recovery status is reported as not recovered. From additional information received 04Mar04 from an enhanced surveillance program conducted by the Centers for Disease Control and Prevention (VAERS number 216807), it was reported that the pt also experienced nausea. She was hydrated and treated with compazine in the ER. No other information was provided. Additional information received 11Mar04 from the CDC, it was reported that the pt received the vaccinations in preparation for travel. On 23Feb04, the pt experienced nausea, vomiting, severe headache and a fever of 101.4 degrees Farenheit. She was evaluated in the ER and treated with morphine and compazine, then discharged home on ibuprofen and Vicodin. On 24Feb04, she experienced a low grade fever and was on ibuprofen and Vicodin at that time. She remained afebrile on 25Feb04 and 26Feb04, but was still on medication. On 26Feb04 her headache was decreased, but her appetite was poor. All other family members remained well. On 29Feb2004, it was reported that the pt was back to normal and was scheduled for follow up visit on 12Mar04. From additional information received on 12Mar2004 from the pt's responsible physician, it was reported that the pt developed fever, nausea, vomiting and severe headache upon waking on 23Feb04. The lot number for Imovax was reported as U09713 and the pt received it as a first dose administered IM in the left arm. The YF Vax was administered as a first dose subcutaneously in the left arm. The pt fully recovered from these events on 29Feb04. From additional information received on 04Mar04: 23Feb04-LP (clear CSF), WBC of 10, total bilirubin of 2.6, normal alk phosphatase, normal AST and ALT. Labs were sent to CDC. Lab results from CDC: Serum PCR sample is positive for YF 17D RNA. CSF sample PCR is negative for YF 17D RNA. Antibody testing results have not been received yet.  From additional information received on 11Mar04 it was reported that the pt has a history of stomach upsets for which she takes Zantac 105mg twice daily. She had a GI evaluation in the past for diarrhea and abdominal pain and was given a diagnosis of possible irritable bowel syndrome, not GERD. She reportedly has had a good response to Zantac. It was also reported that she experienced hives after receiving azithromycin and experienced 24 hours of screaming following a first dose of DPT in infancy. She has received only DT since then. There is no personal or family history of immune deficiency. A CBC done on 14Jan98 showed WBC 8.54. Hgb 13.6, Hct 40.6%, platelet count 410,000, ESR 9. The pt's mother (age 44 years) and father (age 41 years) and two brothers (ages 11 and 16) all received the yellow fever vaccine from same 5 dose vial. No family members had any unusual symptoms in the days after the vaccine.  From additional information received on 12Mar04, it was reported that the manufacturer of the DTP vaccine the pt received as an infant was BioPort Corporation.