Age: 0.17
Sex: M
Vaccine: 6VAX-F, PNC13, RV5
Symptoms: Urine analysis normal, Ventricular septal defect, Viral test positive, Vomiting, X-ray gastrointestinal tract normal
Clinical narrative: Information has been received from an investigator concerning an 8 week old male with cardiac murmur and a history of mild jaundice who entered a study. On 31-MAY-2011, the patient was randomized to be vaccinated with DTaP+HepB+Hib+IPV at 2 months, 4 months and 6 months of age. On 31-MAY-2011, the patient was vaccinated IM with the first 0.5 ml dose of DTaP+HepB+Hib+IPV (site not reported). Other suspect vaccines include the first 2 ml po dose of ROTATEQ and the first 0.5 ml IM dose of PREVENAR 13 (site not reported), as part of the study to complete the childhood immunization series. There was no concomitant therapy. Previous drug history included a dose of ENGERIX-B IM on 31-MAR-2011, a one time ophthalmic dose of erythromycin eye ointment, 5 mg/g on 31-MAR-2011, and a one time dose phytonadione injection, IM 1mg on 31-MAR-2011. On 31-MAY-2011, the patient experienced ALTE (Apparent Life Threatening Event, intensity severe) and was hospitalized. It was reported subject was brought to the ER via ambulance for ALTE. Per subject's mom, subject was doing fine upon returning home from well check appointment and was breastfeeding without issue. Around 17:00 (approximately 3 hours after last feed), the subject suddenly vomited a large amount of milky/yellow liquid. Subject then became pale (not cyanotic) and limp. Subject's eyes were closed and neck flexed. Per mom, arms were drawn in but there was no rhythmic movement of the extremities, body or face. Subject was not very responsive and was breathing abnormally per mom. Mom called 911, who told the mom to hold the baby's nose and baby started crying. When EMS arrived roughly 5-10 minutes later, subject was noted to be lethargic per EMS note, but perked up with improved color with some "BB" O2 en route. D-stick was 102. Upon arrival in the ED, subject was back to baseline with vitals reported to be within normal limits (WNL). Per medical records, it was reported the subject was vaccinated today and it is possible that the subject had some minor reaction /GI upset with the vaccines, which caused the subject to vomit and then aspirate. On physical exam subject was noted to have a small sacral pit which can be visualized at the base in the gluteal cleft with no hair tuft. On 31-MAY-2011, subject had the following labs and diagnostic tests and results: urinalysis, automated no micro: WNL, chest x-ray, PA and lateral: no evidence of acute process, lungs clear, EKG: sinus rhythm, nl, and a urine culture: results negative. On 02-JUN2011, subject was discharged to home from the hospital with a discharge diagnosis of ALTE. Per discharge note, on hospital day 2, subject was noted to have a murmur that appeared consistent with possible VSD. Per well baby nursery discharge note, baby had murmur that resolved at time of birth with nl 4-limb BPs and pre and post ductal oxygen sats. ECG showed prominent lateral lead Q-waves that maybe suggest of septal hypertrophy. Results discussed with cardiology and echocardiogram was performed on day of discharge (results pending). On 02-JUN-2011, approximately 4 hours after previous discharge, subject was hospitalized after a second ALTE. Subject presented with eye rolling and hypotonia following episode of emesis. Subject was reported to be in state of usual good health and was napping, subject's mother heard subject cry then vomit about 5 ml of breast milk. Mother picked the subject up saw the eyes rolling upwards x2 seconds, then subject went limp and pale (not cyanotic). Mother states subject was limp x 30-45 minutes but able to arouse, however very sleepy and falling asleep each time would be woken. Mother pinched nose as previously instructed by 911 and subject would wake to this but fall asleep immediately thereafter. Subject did not shake at this time or have abnormal movement. Paramedics arrived 10 minutes later, blood sugar was 89. Of note, per paramedics (mother and older sister did not agree as "she" states subject was limp entire ambulance ride). Subject had episode of going limp, pale in extremities, no shaking. Subject on CR monitor at this time with SaO2 dropping to 96% (with 10L BB O2), RR 30 to 18, Hr 120 to 90, subject would look better when stimulated. The subject's exam quickly normalized and there was no recurrence of distress during the hospitalization. Pediatric neurology felt the episodes were not suggestive of seizure and VEEG was normal. A VSD, small muscular but no septal hypertrophy, noted on echocardiogram (on 02-JUN-2011, initial admission) but no evidence of CHF, final report assessed as non-contributory. GERD considered but no prior history of spitting up/vomiting and subject had been growing normally. Possible reflux resulting in vasovagal response or laryngospasm. Viral respiratory culture was positive for parainfluenza type 3 (NSAE). The subject remained afebrile throughout the hospitalization, but was noted to have nasal congestion, slight cough and URI symptoms on admission (positive contact sick father) but no evidence of respiratory distress or clinical bronchiolitis. However, viral infection may have contributed to ALTE as subject was positive for parainfluenza type 3. The subject was observed on CR and O2 SATS monitors, for several days, without event. On approximately 02-JUN-2011, the subject had the following labs and diagnostic tests: VEEG: reported normal per pedi neurology, gastric pH was unable to be obtained, EKG showed VSD, viral respiratory swab showed positive for parainfluenza type 3 and negative for RSV, adenov, influ and pertussis swab, Upper GI reported normal with no obstruction (unable to rule out reflux); Chest X ray reported to be clear, CBC results not reported. OT evaluation during the hospitalization suggested some discoordinated feeding with the need for further follow up after respiratory process has resolved. Final OT evaluation reported suck/swallow/feeding was normal. Positioning issues were addressed, normal exam. On 06-JUN-2011, no murmur heard on exam. On 06-JUN-2011, the subject recovered and was discharged to home in stable condition. Discharge Diagnosis was reported as ALTE with no clear etiology found. The subject was reported to have no further episodes or hospital admissions. At post-hospitalization follow-up clinic appointment (date not reported), subject was reported as well child post hospitalization with return to baseline. The reporting investigator considered ALTE to be immediately life-threatening and felt that the relationship to vaccine although unlikely cannot be ruled out as the first episode occurred 3-4 hours post dose one of study vaccine. The plan for the subject is to remain in the study. On 15-JUN-2011, the parent (mother) requested that her child be withdrawn from the study as the parent no longer wanted to make the commitment and effort required for continued participation. Additional information is not expected. This is amendment information, the relatedness has been changed to not related. This case has been downgraded. This is amendment information, Per reconciliation requested the causality has been changed again to Related.