Age: 0.6
Sex: U
Vaccine: DTAP, HIBV, PNC
Symptoms: Myelitis transverse
Clinical narrative: Information has been received from a published literature article. In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). From April 14, 2004 until December 31, 2009, 76 AEFI were reviewed on 68 CCCR calls. One patient experienced two separate and different adverse events after two different immunizations and both were evaluated separately. The age of patients ranged from 2 days to 85 years with 52.6% female. A past medical history was available in 71 of 76 cases (93.4%). Of these 71, 27 were previously healthy and the other 44 had current or chronic medical conditions, or were receiving relevant treatments for chronic illnesses. The primary organ system involved with the AEFI was determined. The neurological system was the most commonly affected organ system among these cases and represented a broad range of diagnoses, including transverse myelitis, meningitis, Bell's palsy, and seizures. Other organ systems included 11 multisystem, 11 dermatologic, 6 hematologic, 5 musculoskeletal, 3 cardiac, 2 gastrointestinal, 2 psychiatric and one each endocrine, lymphatic, and vascular. The reviewed AEFI were associated with all routinely recommended vaccines. In 50% of cases reviewed, multiple vaccines were given simultaneously during the vaccine visit prior to the event. For each AEFI, the working group considered whether another cause for the event could be identified (e.g., concurrent viral illness, current medication with similar adverse event profile). In 41 cases (54.0%) another known or likely cause of the adverse event was identified, in 25 (32.9%) there was no other explanation for the event, and in 10 (13.2%) there was insufficient information to assess other possible causes. VAERS searches identified similar AEFI associated with the specific vaccine(s) in 61 (82.9%) cases and the agency literature search resulted in similar AEFI reports with the same vaccine in 38 (50.0%) cases. Two cases did not have sufficient information. Investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Causality assessment using the modified agency criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. Among the 36 neurologic cases, eight met our criteria for possibly vaccine-related, with an appropriate temporal relationship, the literature did not confirm or refute the causal relationship, and more likely known causes were excluded. For example, one case of transverse myelitis occurred 2 weeks after receipt of DTaP, PCV-7, and PEDVAXHIB vaccines. However, the child also had a prior infection and there was not enough evidence to determine if this infection would be considered a "more likely" cause. This report concerning a 7 month ("0.6 year") old healthy infant with a prior infection who on an unspecified date was vaccinated with a dose of PEDVAXHIB (manufacturer unknown). Secondary suspected vaccines received on the same date included DTaP (manufacturer unknown) and PREVNAR 7 (manufacturer unknown). 14 days after vaccination, the patient experienced transverse myelitis. The outcome was unknown. Upon internal review, transverse myelitis was determined to be an other important medical event. According to the modified agency criteria, causality was classified as possibly related to PEDVAXHIB (manufacturer unknown), PREVNAR 7 (manufacturer unknown) and DTaP (manufacturer unknown). This is one of several reports received from the same source. Additional information has been requested.