Age: 0.83
Sex: M
Vaccine: RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Fluid replacement, Gangrene, Hypotension, Immunology test, Inappropriate schedule of drug administration
Clinical narrative: Initial report received on 07 June 2007 from another manufacturer, report# WAES0704USA01627. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 9-month-old male patient with no pre-existing allergies, birth defects, or medical conditions who on 17-JAN-2007 at 13:00 was vaccinated at 4-months-old with a second PO dose of Rotateq (lot number invalid). There was no illness at the time of vaccination. Concomitant therapy that day at 13:00 included a second dose of Tripedia (Lot# C2552AA) administered IM, a second dose of Comvax (Lot# 654992/0984F) administered IM, a second dose of Prevnar (Lot# B36258A) administered IM, and a second dose of IPOL (Lot# Y1031). Subsequently the patient experienced pseudomonas sepsis. The physician did not feel that the Rotateq caused the infection." "Follow-up information received from medical records indicated that on 23-JAN-2007 the patient presented to the emergency room with raised erythematous lesions, URI symptoms, and a fever of 102 degrees. The patient was admitted to the hospital, and three days later developed a watery, non-bloody diarrhea with 10-15 episodes/day. It was noted that the patient received Rotateq three days prior to the onset of diarrhea. Skin lesions had developed on the face and extremities which rapidly grew and developed a central dark region. He was transfered for a higher level of care. Infectious disease (ID) was consulted and fortaz, gentamycin, and vancomycin were started. During the first 24 hours of admission, the lesions went from indurated erythmatous to purpuric with an indurated base. Blood cultures grew pseudomonas seruginosa. ID suspected infection may have been secondary to complications of Rotateq. A primary immunodeficiency problem was considered, but was ruled out by immunologic studies. Dermatology and plastics were consulted because lesions might become necrotic. The infant was hemodynamically stable only requiring a small amount of oxygen via nasal cannula which weaned off in the first 12 hours. On 25-JAN-2007, he was stable and admitted to Peds Basic. He subsequently decompensated, requiring increased oxygen and fluid boluses and the wounds looked progressively worse. He was transferred back to the PICU where he developed septic shock requiring pressors. He then developed respiratory distress and was intubated. His right lower extremity lesion continued to become increasingly indurated and erythematous, and orthopeadic surgery was consulted. He was diagnosed with compartment syndrome and fasciotomies were done. He continued to require vasopressors for hypotension and ionotropes as well. Then he was stabilized and transferred to step down service. Plastic surgery took the patient to the operating room on 06-MAR-2007 and performed and incision and drainage along with Integra placement skin graft. Subsequently, the patient was able to finish the antibiotic course without event. All wounds were healing well at the time of discharge. Discharge diagnosis on 13-MAR-2007 included: pseudomonas aeurginosa sepsis (treated); eothyma gangrenosum, secondary to pseudomonas septic embol (healing well); status post debridement and allograft (wounds healing well); and compartment syndrome, status post fasciotomy (resolved). It was noted that the patient was hospitalized for 6 weeks. There were no adverse events following prior vaccinations." "The events were considered to be life-threatening, disabling, and were an other important medical event by the reporter. The events also resulted in hospitalization (6 weeks) and resulted in prolonged hospitalization. Additional information has been requested. All medical records are available upon request."