Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cough, Dysphagia, Fatigue, Haematocrit normal, Haemoglobin normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. It was reported that an 18 year old female patient with an unusual cough, almost asthmatic, that kind of took her breath away. This had started 3 weeks prior and a history of exercised induced asthma and kind of routine occurring sinusitis but not at the time the injections were started who on 29-DEC-2009 was vaccinated intramuscularly with the fourth dose of GARDASIL (Lot # 665607/1332Y). On 10-JAN-2010, the patient started noticing a rash on her lower legs around her ankles, kind of just little red dots. The rash kept spreading and getting worse with bigger red blotches all up and down her legs but most heavily concentrated on her lower legs and feet. So, on 15-JAN-2010 they went to the doctor about the rash, the coughing and an acheness. He didn't know what it was and did some blood work that they wouldn't find out about until Monday (this was Friday). On the evening of 17-JAN-2010, she had swollen up so bad on her lower legs and ankles that you couldn't see any of her ankle bones, etc. Also was saying that she could hardly swallow so the reporter was concerned that throat was swelling like the legs. So, the reporter took her to the emergency room. They did blood work but said nothing showed up. They started tossing out possible things like lupus and auto-immune disease. The reporter didn't think that she told the doctors there about her just having had the 3rd dose GARDASIL. They gave her 60 mg a day of prednisone for 4 days. Electronic records for 18-JAN-2010: DX: Skin rash Patient presented with c/o rash and worsening swelling of legs. The rash had a gradual onset and had started a week ago. Examination noted swelling and tenderness in bilateral lower legs. The rash was described as red slightly raised lesions, which did not blanch when touched. The patient was discharged home and given prescriptions for LORTAB. The patient was counseled to follow-up with PCP in 1-2 days as symptoms. As of 30-JAN-2010, she was in severe pain on her lower legs, fatigued, stomach hurts, and very nauseous which could be from medications. They have been in repeated contact with the doctor and had several changes in doses of prednisone; she was currently doing 40 mg a day. LORTAB as needed for pain and a diuretic. She couldn't go to school Thursday. The days prior she could go but by the end of the day her legs were so swollen and hurt and she could hardly move or use her left one which was the worse. She has now been on the couch or in bed for 3 days straight "records received 01-FEB-2010". On 01-FEB-2010, patient had white blood cells count, blood hemoglobin test, whole blood hematocrit all of them were within normal limits, glucose and serum aspartate aminotransferase were low and bilirubin was high. On 02-FEB-2010, patient had red blood cells count which was within normal limits and hemoglobin test (12). This report was considered serious. The listing indicated that one or more of the events was considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID# is 378882-1. A preliminary lot check investigation was performed. To date our investigation has found that lot number 665607/1332Y conformed to quality release parameters and the manufacturing was typical of a lot of GARDASIL. Additional information will be provided upon finalization of this manufacturing investigation. No further information is available.