Age: 14.0
Sex: F
Vaccine: FLUN3, HPV4, VARCEL, FLUN3, HPV4, VARCEL
Symptoms: Thrombocytopenia
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. This was reporting a 14 year old. female. The past medical history included sacralcoccygea teratoma at birth, chronic otitis media (OM) as baby, scarlet fever p episode of strep pharyngitis, fractured foot, neuritis, chronic right foot pain, headache (HA), tympanostomy tubes and no known drug allergies. There was no pre-existing illness. On 11-OCT-2010 the patient was vaccinated IM with the first dose of GARDASIL (lot # 666598/0786Z). Suspected therapy on the same day included the second dose of VARIVAX (Merck), (lot #666727/0639Z) given IM. Concomitant therapy included the second dose of FLUMIST (lot # 501036P). On 29-OCT-2010 the patient experienced thrombocytopenia, bruising, gum bleeding, heavier periods. The following information was obtained through follow-up and/or provided by the government on 08-APR-2011. The consultant records (DOS 17-NOV-2011 - 22-FEB-2011) indicated that the diagnosis was thrombocytopenia and idiopathic thrombocytopenic purpura (ITP). Several office visits (OVs) for chief complaint (CC): easy bruising, increased bruising since November 2010, worsening over time; decreased platelets; bleeding when brushing teeth, fatigue, shortness of breath (SOP), joint pains in knees/ankles/shoulder. Physical examination (PE): multiple bruises et petechiae on arms/legs. On 08-APR-2011 ER records (DOS 27-FEB-2011) was received: diagnosis was ITP. Chief complaint (CC): back pain, dysphagia, menorrhagia, myalgias of anterior neck muscles, arms, abdomen and back. PE: Cushingoid facial swelling et possible fluid retention, mild diffuse abdominal tenderness s guarding/rebound, resolving bruises, recently diagnosed with ITP in November 2010. The patient was prescribed with several courses of steroids. On 11-APR-2011, consultant records (DOS 11-OCT-2010) was received. WCC, the patient received vaccines. The patient returned to clinic (RTC) on 16-NOV-2010 and diagnosed with contusion, thrombocytopenia. CC: random bruising, bleeding gums, heavier/longer menses, sore throat, menorrhagia, nausea. PE: scattered bruises over upper extremities (UEs)/lower extremities (LEs), some lemon sized, petechiae bilateral lower extremities. The patient was referred to haem/onc. On 17-NOV-2010 the patient was seen by haem/onc specialist. Nil new. The patient's initial platelets was 6K, remained low. The last platelets this week was 28K followed Heme Onc has had several courses steroids and IVIG. The following information was obtained through follow-up and/or provided by the government on 08-APR-2011. The consultant records indicated white blood cell count (WBC) was 5.1K. The listing indicated that one or more of the events were considered to be immediately life-threatening. A lot check has been initiated. The original reporting source was not provided. The VAERS ID # is 420527-1. A standard lot check investigation for lot # 666598/0786Z has been finalized. All in-process 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 release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.