Age: 1.35
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Flushing, Otitis media, Pertussis identification test negative, Pneumonia, Sinusitis
Clinical narrative: From initial information received on 4/25/05 from a health care professional regarding an adverse event occurring in the USA, it was reported that a two year old male patient, who had received a Primary DTaP series as an infant, received a fourth dose of TRIPEDIA, lot number U0536DB, and a fourth dose of ACTHIB, lot number UA637AA, administered in combination as the product TriHIBit in the right thigh on 6/21/02. That same day, he also received a fourth dose of PREVNAR, lot number 486802, administered in the left thigh. The routes of administration were not reported for any products. 467 days after vaccination, on 10/1/03, the patient developed a repetitive cough with a whoop. His face would turn red and he had occasional shortness of breath, occasional hoarseness and post-tussive emesis. He was seen at an emergency room on three separate occasions and was treated with antibiotics for presumptive pneumonia and sinusitis. During the third emergency room visit, he was admitted to the hospital secondary to persistent cough, decreased breath sounds, and presumptive pertussis. He was hospitalized for five days. He was treated with erythromycin, Singulair, and Pulmicort. IgE was normal, pertussis DFA was negative, but a pertussis culture was positive. Following discharge, the patient was seen on 12/3/03 for evaluation by an allergist. At that time, he continued to have a cough, which was described as waxing and waning in nature. He also had left otitis media and was being treated with Floxin. The patient's lungs were clear and his respirations were unlabored. He received a Td booster and Pneumovax at that time. No product information was provided. The patient returned to the physician's office on 12/17/03 and it was noted that his symptoms had improved. He still had a whoop-like cough, but had less facial redness and no post-tussive emesis. His activity level was back to normal and there was no evidence to suggest an underlying problem with increased airway hyperactivity. His Pulmicort was discontinued at that time. The patient was seen again by a physician on 1/07/04. At that time it was noted that the patient's quantitative immunoglobulins were essentially normal. He was still having coughing spells at least once a day, but they were less in severity and only occasionally led to post-tussive emesis. There was no whoop noted. He had not had any other infections or problems since his previous visit. It was reported that a PPD in the past was negative. The overall impression was resolving pertussis infection with continued cough. His immune work up was normal. As per the reporter, it is unknown whether the patient recovered from these events. From additional information received on 10/May/2005, it was confirmed that the patient returned to the physician's office on 17/Dec/2003, not 17/Dec/2005 as previously reported. From additional information received on 28/Jul/2005, it was reported that the child recovered four to six months after the onset of symptoms on 01/Oct/2003. Also provided was the responsible physician's name and that the illness was also considered life threatening. Follow-up information received on 19/Aug/2005. It was reported that the physician's office does not have a copy of the patient's hospital discharge summary. The patient was on no concomitant medications at the time of the TRIPEDIA vaccinations and had never been administered immunosuppressive or steroid therapy. The patient exposure and potential source of the pertussis infection is unknown. As per the physician, she has no more information on this case.