Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hypoaesthesia, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Injection site pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. On 25-SEP-2009, a 25 year old female was vaccinated in the right arm with the first dose of GARDASIL (lot number 663452/0671Y) (route unknown). Concomitant medication included TRIVORA, once daily and albuterol PRN, for seasonal and pet allergies. Two months later, on 16-NOV-2009 (also reported as 19-NOV-2009), the patient went into her doctor with petechiae (red blood dots) on her legs, excessive bruising on her legs and arms, and mouth lumps (inside lower lip). The patient took a blood lab and when the results came in, the patient was at 8,000 platelet count and told to go to the emergency room (ER) right away. Treatment (steroids alone) lasted for 2 days, and the patient had to go back to the ER, this time with arm numbness/temporary paralysis added to the issue. Treatment with a stronger medication Rho(D) immune globulin (ANTI-D) was administered, but again, two days later, the patient was back in the ER. A third treatment was administered (IVIG), and it lasted two weeks. The patient was scheduled to go back to the hospital for admission to do another dose of this. Aside from pain at the injection site for over a month, the patient had also now been diagnosed with the autoimmune disease thrombocytopenia (low blood platelets) which she had been dealing with for over a month at an aggressive level, and it showed no signs of getting better. During this condition, she has had arm numbness/temporary muscle paralysis, as well. The patient had been admitted into the hospital 3 times, and had to go back again in a few days, as she dropped again. On 23-DEC-2009, PCP medical records received. Service dates 11/19/09 to 12/21109. Included emergency department (ED) visit 21-NOV-2009. Assessment: Idiopathic Thrombocytic Purpura, Patient complained of feeling warm, fatigue, Cough, congestion, Oral contraceptive use, Hematochezia, Paresthesia, Bruising on forearms, Presents at ED with petechiae, Multiple bruises thighs and feet, Bright red blood from nose, Tired, Diarrhea, Bumps in lower lip, Thrombocytopenia. On 28-DEC-2009, Discharge summary, hospital records received. Inpatient Service dates 08-DEC-2009 to 11-NOV-2009. Included Labs from 23-NOV-2009 to 22-DEC-2009. Assessment: Thrombocytopenia, Idiopathic Thrombocytopenic Purpura. Prior hospital admissions 19-NOV-2009 to 23-NOV-2009 for Thrombocytopenia/Idiopathic Thrombocytopenic Purpura, 02-DEC-2009 to 03-DEC-2009 for Thrombocytopenia, weakness, heaviness. Patient presented after follow up labs showed a platelet count of 20, Right arm subjective weakness, headache, and nose. This was originally reported by a consumer. The VAERS ID # is 374854. A lot check has been initiated. A standard lot check investigation has been finalized. All in-progress quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all released specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.