Age: 6.0
Sex: F
Vaccine: MEN
Symptoms: Biopsy bone marrow abnormal, Contusion, Fall, Idiopathic thrombocytopenic purpura, Increased tendency to bruise
Clinical narrative: Case number PHHO2014US000484, is an initial report received on 03 Jan 2014 from clinical study. This 06 year old female subject was enrolled in a study. The child's medical history included asthma and concomitant medications included Albuterol and Budesonide. It was unknown if the child had any history of viral infection or other infections. The child's family history was unknown. The child received the first dose of study vaccination on 30 Nov 2012 at 12:15 hrs. On 29 Jan 2013 at 16:42hrs, the child received second dose of study vaccination. According to the mother the child experienced easy bruising at unspecified dates prior to Apr 2013. Due to mother's concern, the subject was brought to hospital on 04 Apr 2013. According to mother child's history also included clinical signs of bilateral facial bruising with ecchymosis, and scleral hemorrhage (left) on 10 Nov 2012 following a bike accident. On 12 Apr 2013, the subject had another fall from her bike and experienced second episode of bruising which resulted in the examination at hospital emergency room on the same day. On 12 Apr 2013, platelet count was reported to be 17 K/UL. The child was referred to hematologist for further follow-up and bone marrow biopsy. The child was started on Dexamethasone 20 mg BID monthly for 5 days. Diagnostic intervention began following this incident. On 20 Feb 2014, follow-up information was received from a new investigator who did not see the child during initial visit. On an unspecified date in May 2013, the subject experienced an episode of bruising. It was reported that the child's platelet count on 07 May 2013 was low at 15 K/UL. Marrow biopsy on 13 May 2013 revealed typical but mild megakaryocyte hyperplasia without other cellular precursor abnormality noted as a finding that may be seen in "immune thrombocytopenia". There was no myelodysplasia. A second marrow biopsy on 17 Jul 2013, suggested "possibility" of immune thrombocytopenia with platelet count at 25 (units not specified). However the investigator confirmed the final diagnosis as thrombocytopenia with cause unknown (idiopathic thrombocytopenia). Bone marrow biopsy also showed no evidence of involvement by acute leukemia or marrow failure, pan-cellular. As per the records of Nov 2013, there was evidence of improvement while on steroid therapy and the last recorded platelet count was 165 (low normal range, units unspecified). There was no significant follow-up information received beyond Nov 2013, despite multiple efforts to contact the mother. The subject's outcome as of Nov 2013 was condition improving. The investigator considered the event as serious (medically significant). As per the investigator it is possible that a pre-existing condition of possible immune association could be exacerbated by the 2nd injection and immune thrombocytopenia is just a possibility and says the event is "idiopathic thrombocytopenia". The investigator stated that the causal relationship between the event and study vaccination was unknown, as the clinical history suggested a pre-study disorder but diagnostic confirmation was post-study and the insufficient information from the mother regarding the progression of disease contributes to this uncertainty. Follow up received on 29 Jan 2014: Updated medical history, concomitant medications, laboratory value and treatment medication. Follow up received on 04 Feb 2014: Updated the event term, medical history, seriousness, event outcome and treatment. Follow up report received on 21 Feb 2014: Final diagnosis (thrombocytopenia), causality assessment with the study vaccination, laboratory details were updated. Follow up report received on 25 Feb 2014, prior to the circulation of previous report: subject's medical history, confirmation of final diagnosis and rationale for the causality assessment were updated.