Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV, DTPIPV, IPV, MMRV
Symptoms: Gingival bleeding, Haematocrit normal, Haemoglobin normal, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy
Clinical narrative: Information has been received from a nurse concerning a patient who on unspecified date was vaccinated with unspecified vaccine. On unspecified date, the patient experienced an adverse experience. It was unknown if the patient sought medical attention. Follow-up information has been received from a physician and medical records concerning a 4 year old female (35 3/4 lbs, 37 inches) with IgA deficiency, allergic rhinitis, reactive airway disease, Clarithromycin allergy, and a history of frequent upper respiratory infections (one year of age), "a couple" of hospitalizations for gastroenteritis (dates unknown), cerebral sulcus arachnoid cyst (November 2008), fever and rash approximately eight days after receiving first dose of PROQUAD (Merck upgrade process) (2009), viral illness (WBC 3.6, plt 139), sinus surgery with bilateral myringotomy tube placement (November 2010) and a family history of von Willebrand's disease (Mother) who on 26-MAY-2011 was vaccinated in the right arm with a second dose of PROQUAD (Merck upgrade process) (lot #667254/1438Z). On the same date, the patient was vaccinated in the left arm with a fifth dose of (Sanofi) DTaP-IPV and a 4th dose of (Sanofi) IPOL in her left arm. Within four days of receiving the vaccines, the patient's parent noted petechial rash on 31-MAY-2011 which progressed within twelve hours to gingival and rectal bleeding and ecchymosis. The patient was hospitalized with a low-grade fever, fatigue and a platelet count of 1000 and subsequently diagnosed with Idiopathic Thrombocytopenic Purpura and transferred to in the Pediatric Intensive Care Unit for IVIG administration and monitoring (secondary to the risk of anaphylaxis). Head computed tomography without contrast on 31-MAY-2011 showed no acute intracranial findings, small rounded area in rt vertex which could be partial voluming of the cerebral sulcus versus small arachnoid cyst (unchanged since prior study on 14-NOV-2008). The patient was seen for an infectious disease consultation on 31-MAY-2011. The physician reported that despite her symptoms, she had been normally active and had no fever or other symptoms. It was noted that when she received her first dose of PROQUAD (Merck upgrade process) in 2009 (See WAES #1108USA00106), she had a fever and rash about eight days after the injection. In the last year she had documented normal platelet counts and complete blood counts. The physician's impression included a patient with selective IgA deficiency, who presented with Idiopathic Thrombocytopenic Purpura. It was likely that this was triggered by her recent PROQUAD (Merck upgrade process) vaccination. It was recommended hematology help the patient manage her Idiopathic Thrombocytopenic Purpura. She was to receive GAMMAGARD SD per protocol in the Pediatric Intensive Care Unit. It was suggested premedicating the patient with BENADRYL and starting the infusion very slowly. Since the patient was so active, it was suggested keeping her calmer with VERSED, at least until her platelet count came up. On 03-JUN-2011, the patient's platelet count was up to 31,000. The patient was transferred to the floor for monitoring. On 04-JUN-2011, the patient was doing well, acting like her normal self with platelets of 69,000 and she was discharged to home. Discharge diagnosis was Idiopathic Thrombocytopenic Purpura. She was to follow up with her Hematologist/Oncologist. On 15-JUN-2011, the patient was seen for follow up. She was doing well with no bleeding, increased bruising or petechiae. Abnormal labs (see labs/diagnostics). Platelets were 276. Assessment included Idiopathic Thrombocytopenic Purpura and IgA deficiency. A medical alert bracelet was advised and Idiopathic Thrombocytopenic Purpura natural course was discussed extensively. The patient was to return the following week for a complete blood count. The reporter felt that Idiopathic Thrombocytopenic Purpura was life threatening and resulted in disability. A lot check has been initiated. All available medical records will be provided upon request. Additional information has been requested.