Age: 0.18
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Nasal congestion, Oxygen saturation decreased, Pallor, Platelet count normal, Protein urine present
Clinical narrative: Initial report received on 07 February 2007 from an other manufacturer, report number WASES 0701USA03892. This manufacturer had received the original report from a physician. Verbatim from the report: "Information has been received from a physician concerning a nine-week-old female, with no medical history and no allergies, who on 27 December 2006 was vaccinated with a second dose of Rotateq (human-bovine) (Lat#655406/1114F). Concomitant vaccines administered on the same day included a second intramuscular dose in the left leg of HIB conj-hepatitis B vaccine (Lot#654908-0999F), a second intramuscular dose in the left leg of Prevnar (Lot#858849D), a second subcutaneous dose in the right leg of IPOL (Lot#41031), and a second intramuscular dose in the right leg of Infanrix (Lot#AC14B14215A0. It was reported that the patient developed a mild upper respiratory infection with a cough on 25 December 2006. The patient had been given Tylenol after the vaccinations. On the evening of 27 December 2006, at around 11:00 p.m. the patient was noted to have a temperature of 101.0 degrees Fahrenheit. On 28 December 2006, at around 2:30 p.m., the patient was noted to have some difficulty breathing with increased work of breathing, and subsequently vomited one time with a mucous/phelgm appearance. The patient then stopped breathing for about two minutes, went limp, and was noted to have significant pallor. The emergency number was called. During those two minutes, the patient had a period where she was not responding and had decreased tone. There was no seizure-like activity noted. She subsequently was aroused and her color returned to normal. She was brought to the emergency room via ambulance. She did not require any treatments or oxygen during her transport. The patient's mother reported that the patient had nasal congestion and decreased p.o. secondary to the nasal congestion. She also had a decreased amount of wet diapers, about 3-4 times on 28 December 2006, with the last being around 2:00 a.m. The patient had sick contacts. Her sibling had upper respiratory infection symptoms. It was noted that she had never had a similar episode in the past. A complete review of systems was obtained. The patient was positive for fever, vomiting (one time), nasal congestion, cough, and a period of apnea. The patient was negative for diarrhea, rash, and seizure activity. All other included bronchiolitis with apneic episode possibility secondary to a mucus plug versus central apnea versus other infections cause versus possible cardiac versus reflex other respiratory cause and seizure much less likely given no history of seizure type activity. A work-up was done that included a complete blood cell count with differential, blood culture, basal metabolic panel, urinalysis, urine culture and chest x-ray was done. It was reported that given the episode was likely secondary to bronchiolitis a lumbar puncture was deemed necessary at that point. A complete blood cell count was done that showed a normal white count with white blood cells of 11.6, hemoglobin of 9.6, hematocrit of 29.2, platelets of 448 with a differential of 59 polys, 3 bands 28 lymphs, 9 monos, and 1 eosinophil. The basal metabolic panel was notable for slightly elevated glucose at 157, and was otherwise normal with a sodium of 138, potassium of 5.1, chloride of 104, bicarbonate of 24, blood urea nitrogen of 6, creatinine of 0.2, and calcium of 9.9. A urinalysis was done that showed a specific gravity of 1.026, 1+ protein, and negative for glucose, ketones, nitrates, and leukocyte esterase. It showed 20 red blood cells, 25 white blood cells, and moderate bacteria. A chest x-ray was done that showed a slightly streaking bilaterally, no focal infiltrates,a s well as hyperinflation with a slightly flattened diaphragms bilaterally. The decision was made at that point, on 28 December 2006, to adult the patient for bronchiolitis with an apneic episode and an apparent life threatening event. The patient was transferred to the medical unit and required suctioning, however, was relatively un-tachypneic throughout the hospitalization and was able to feed well. On the day of discharge, on 29 December 2006, the patient had not required suction for more than 12 hours and was feeding well. The discharge diagnosis was an acute life threatening event, bronchiolitis, and fever. The discharge plan was to continue bulb suctioning at home as needed, to follow-up with the primary care physician in three days or earlier if symptoms worsened, or to the emergency room if there was trouble breathing. The patient was reported as recovered as 29 December 2006. Acute life-threatening event was considered to be an immediately life threatening event. A lot check has been requested. Additional information is not expected."