From initial information received on 2/19/04 from a literature citation, regarding an adverse event occurring in the USA, it was reported that a female patient received DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE on 5/8/87, 7/8/87, 9/8/87, and 5/18/88; and POLIOMYELITIS VACCINE on 9/8/87, and 5/18/88. The lot numbers, manufacturers, and administration information were not reported. This patient received her scheduled diphtheria, pertussis, and tetanus immunizations on a delayed basis. Her first DPT was administered at age five. She received a total of three doses of DPT at 2 month intervals, with her final dose of DPT given the subsequent year. She had no history of HIV or other immunodeficiency. At the time the onset of symptoms, the patient was previously healthy 19 year old female without significant past medical history who presented to the emergency room complaining of a sore throat, difficulty in swallowing, fever, swollen neck, malaise, and myalgia for three to four days. She denied any recent sick contacts. General exam revealed a lethargic appearing female. Head and neck exam was significant for tender cervical lymph nodes. Her tympanic membranes were normal. Oropharynx contained a homogenous desquamating exudative greenish-black membrane. The regions of the mouth and nose that were involved include the oropharynx, hypopharynx, and nasopharynx with extension to the subglottic region. The lung exam was normal. Cardiac exam revealed a normal S1 and S2 without a rub or murmur. Abdominal exam was benign. The extremity exam was negative for cyanosis and edema. The neurological exam was normal. The patient was transferred from the initial hospital to another hospital after evaluation of her pharynx. Due to severe edema and obstruction, the patient was offered a tracheostomy, but refused. Prior to transfer, the patient received ceftriaxone, ampicillin/sulbactrim, and gentamycin for her pharyngitis symptoms. Upon arrival, the patient was found to have difficulty breathing. Her vital signs were BP 117/68, PO 138 R36 T 98.4. Oxygen saturation was 100% on 4 liters/min. of nasal oxygen. Due to continued respiratory distress, the patient agreed to have a tracheostomy. Post-observation day #1 vital signs were: Pulse 120-150 (sinus tachycardia on monitor) BP 90/60 Temp 103. Pertinent physical findings were tracheostomy collar in palce with ventilatory oxygen support. Diffuse facial swelling was noted with a bull neck appearance. The lungs were clear. The cardiac exam showed muffled heart sounds with no clicks, rubs, or murmurs. The patient had a brisk carotid upstroke and was sedated. The patient was then admitted to the MICU due to worsening respiratory status. Mechanical ventilation was required with respiratory isolation. The patient was seen by a cardiology consult team due to worsening of cardiac function. A 2D echo was performed. A pulmonary catheter was placed to monitor hemodynamics. The 2D echo revealed a mildly dilated left ventricle with severe left ventricular dysfunction, global hypokinesis, and mild mitral regurgitation with EF of 15-20%. At this time, the patient was being supported with inotropic therapy. Hemodynamics included a pulmonary capillary wedge pressure 18-20, cardiac output 4 liters/min. with a systemic vascular resistance of 748. The patient was thought to be in either cardiac tamponade, cardiogenic shock with myocarditis, or septic shock. Infectious Disease was consulted and antibiotics were started for sepsis and pharyngitis. Serology was obtained for diphtheria toxin. Antitoxin was given. The patient was tested for allergic reaction to antitoxin prior to administration of the antitoxin. Additional work up included an immunologic work up which was negative and hematology/oncology consult for neutropenia and coagulopathy due to possible sepsis. Five days after antitoxin administration, a repeat 2D echo revealed improved EF of 65% with normal left ventricular size, function, and thickness. It was felt that the improved cardiac function was most likely due to treatment for diphtheria with antitoxin and antibiotics. Speech pathology was asked to evaluate the patient for dysphagia and pharyngeal edema. A feeding tube was placed to bypass the obstructive process in her oral pharyngeal airway. She received ceftriaxone and flagyl for ocular motor neuritis, otitis media, and strep. pneumonia The patient improved and was discharged. The patient was followed by ENT. Initially the patient was able to talk after her acute illness. She subsequently lost this ability by six weeks post discharge. She was readmitted. She underwent esophagoscopy, esophageal dilation, and laryngeal airway dilation done. Several stents were placed in her airway to maintain patency. The 2D echo in one re-admission revealed an injection fracture of 70%.