Age: 0.13
Sex: M
Vaccine: RV5
Symptoms: Kawasaki's disease
Clinical narrative: Information has been received from a physician concerning a 3 month old patient who was vaccinated with RotaTeq vaccine (lot not provided). Subsequently, the patient experienced Kawasaki disease and was hospitalized. Additional information has been requested. This is one of several reports from the same source. This is in follow-up to report(s) previously submittedon 11/14/2007; 1/15/2008; 3/21/2008. Information has been received on request from the FDA under the information Act and physician regarding a 1 month old (also reported as 10 week old) male infant who was born premature prior to 34 weeks gestation, otherwise healthy who on 05-SEP-2007 was vaccinated with the first dose of oral ROTATEQ. It was reported by the patient's mom that her son recived other immunizations the same day as ROTATEQ (the immunization record was not obtainable but the mom firmly held to this date). There was no illness at the time of vaccination. On 28-SEP-2007 the patient experienced aneurysm, aortic aneurysm, apparent life threatening event, chapped lips, conjunctivitis, convulsion, coronary artery dialation, cough, cyanosis, syspnoea, electroencephalogram abnormal, encephalitis, erythemia, extibation, feeding disorder, gastrointestinal tube insertion, hypotonia, immunoglobulins, intubation, irritability, Kawasaki's disease, lip dry, nasal congestion, oedema peripheral, oxygen saturation decreased, packed red blood cell transfusion, pyrexia, rash, rash macular, respiratory distress, skin exfoliation, tachycardia and vomiting and was hospitalized. It was on 28-Sep-2007 that the patient presented to an OSH with fevers and was being evaluated there when he developed an ALTE. An EEG noted a dense area of R temporal epileptiform activity. The patient was treated for HHV-6 encephalitis but while hospitalized developed conjunctivitis, rash, irritability, hand and foot changes, dry red cracked lips, but no lymph node enlargement. While the patient was hospitalized, he also developed peeling of his hands and feet. The patient required 3 dosed of IVIG before he finally defervenced but developed coronary artery dialationand aneurysm formation as outlined below. Medical records received for date of services 02-Oct-2008 to 23-Oct-2008 with discharge diagnosis of seizures, Kawasaki disease, Aortic Aneurysm, feeding difficulty, and ALTE. The patient presented to the local hospital on 28-Sep-2007 with complaints of fever, poor feeding and fussiness following 1.5 weeks of nasal congestion. The patient was admitted for hydration and sepsis w/u. On hospital day # 3, the patient developed an episode of coughing, emesis and possible seizure. The patient became dusky, hypotonic and was gasping, O2 sats 86%. The patient was then transferred to the PICU at the current facility. The cause of seizure presumed HHV-6. The patient was intubated and treated with IV antibiotic. Patient was tachycardic with heart rate up to 220 while febrile. Extubatedon 04-Oct-2007. On 06-Oct-2007, the patient had an episode of respiratory distress and possible aspiration pneumonia. The patient was put on NG feeds. Conjunctivitis was noted during an ophthalmology consult. Patient then developed diffuse macular rash, red cracked lips, swollenhands and feet and desquamationof skinon fingers and feet. Kawasaki Disease was diagnosed by ID concult. The patient was treated with ASA and IVIG and was transfused with PRBCs for low hemoglobin. Nofurther seizures noted. Labs on 13-OCT-2007 included Wbc 31.1, HgB 10.9, Plts 513, P 79, ESH 58, CRP 12.2 mg/dL and a negative NP and rectal viral cultures. Rota antigen was reported negative on 14-OCT-2007. The most reliable echo was under sedation on 30-OCT-2007 which noted a right coronary artery. The saccular aneurysm at the origin of the right coronary artery thatinvolves the origin of the conus branch has a maximal diameter of 3.3 mm in the A-P and 4.1 mm inthe S-1 dimension, with a length of 4.1 mm. This is smaller than on the previous study (only the A-P dimensionwas measured). For teh rest of its curse in teh anterior atrioventricular groove, teh artery appears slightly irregular, but the dimensions are withinnormal limits. There are two small areas of dilationare within the vessal reaches the mid segment. There is no dialation at the acute margin or inthe posterior atrioventricular grove. The posterior descending is normal in size. Antegrade flow was seen at the posterior descending origin, but was difficult to appreciate more distally because of the small vessel size and tachycardia, B. Left main coronary artery. The vessel appears top normal insize at the origin, and narrows slightly before expanding to 4.4 mm at trifurcation. (There is a ramus intermedius branch which remains mildly dialated) C. Left anterior descending cornary artery. The proximal left anterior descending coronary is upper normal in dismeter at 2.2 mm but expands to 3 mm at the takeoff of the first diagonal branch. The major area of dialationis at the origin of the second diagonal branch where there is a smal fusiform aneurysm of 3.4 mm maximal dimension. This appears smaller than on the previous study. Better visualization of the left anterior descending coronary distal to this aneurysm was achieved-immediately distal to the aneurysm was achieved-immediately distal to the aneurysm, thevessel measures 1.3 mm and appears relatively regular in caliber as far as the apex except for trivial dilation at what is probably the third diagonal origin. Antegrade flow is confirmed in the left anterior descending coronarythroughthe proximal vessel and inthe distal vessel near the apex. D. The proximal circumflex is dialated at its origin, but assumes a top normal size inthe proximal antrioventricular groove and antegrade flow is seen in the proximal vessel. Its more distal segments are not visualized. Prox LAD z-score 6.79, prox RCA z-score 5.43. At the time of the report, the patient had not recovered. The original reporting source was not provided. The VAERS ID # is 301759. Aneurysm, aortic aneurysm, apparent life threatening event, chapped lips, conjunctivitis, convulsion, erythema, extubation, feeding disorder, gastrointestinal tube insertion, hypotonia, immunoglobulino, intubation, irritability, Kawasaki's disease, lip dry, nasal congestion, oedema peripheral, oxygensaturation decreased, packed red blood cell transfusion, pyrexia, rash rash macular, respiratory distress, skin exfoliation, tachycardia and vomiting were considered to be disabling and immediately life-threatening. Follow-up information from a physician and medical records indicated on 13-FEB-2008 the following abstracted event: mild-moderate oral -pharyngeal dyspagia. Additional information has been requested. This is a consolidation of two reports concerning the same patient. This is one of several reports from the same source VAERS # E-20354 and 301759 All available medical records will be provided upon request. It has been determined that WAES #0807USA03773 is being deleted from our files and the reports consolidated into WAES #0710USA04831. Therefore, WAES # 0807USA03773 is being deleted from our files and the reports consolidated into WAES # 0710USA0483.