Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Unresponsive to stimuli, Urine output, Vomiting, White blood cell count, White blood cell count increased
Clinical narrative: Information has been received from a physician concerning an approximately 2 month old white male, with a history of eczema, no known drug allergies, a family history of gastroesophageal reflux in three of the patient's siblings, and a family history of milk protein allergies and eosinophilic gastritis in two of the patient's siblings, who was vaccinated with first and second oral doses of Rotateq reassortant vaccine live (human-bovine) at "2 months," on approximately 19-SEP-2006, and at "4 months" of age, on approximately 19-NOV-2006, respectively. Subsequently, after each dose, the patient experienced diarrhea. On 08-JAN-2007, the patient was vaccinated with a third oral dose of Rotateq (human-bovine) (lot # 655866/1110F). Concomitant vaccines, administered on 08-JAN-2007, included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, influenza virus vaccine (unspecified), a dose of HIB conjugate vaccine (manufacturer unknown) and a dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown). Concomitant therapy included Amoxicillin, from 30-DEC-2006 to 08-JAN-2007, for the treatment Otitis media and Ranitidine hydrochloride (ZANTAC) for gastroesophageal reflux, which was started "about 3 weeks ago", on approximately 18-DEC-2006, and was given inconsistently due to poor tolerance. 24 hours later the patient experienced mucus in stool and also vomiting. The patient was admitted to the hospital, and it was reported that he responded well to treatment with intravenous fluids. The patient was reported to be recovered. No product quality complaint was involved. No other information was provided. Follow up information from a physician via medical records indicated that the patient began with emesis on the morning of 10-JAN-2007, at 8:30am. The patient's mother reported to the physician that the patient vomited 5 times in 45 minutes and that the emesis quickly became bilious with green color. The patient's mother took him to the primary care physician's office. There he was noted to be stable but did have one episode of bilious emesis and was sent to radiology for further testing. He had abdominal x-rays and then an abdominal ultrasound, which revealed no evidence of intussusception. During the ultrasound the patient was noted to be listless and lethargic by his mother. The patient's mother was very worried as was the radiologist, so the patient was taken to the emergency room. There an IV was placed, labs were obtained and a fluid bolus was given. The mother reported that the patient "perked up" after the bolus. He was sent back to radiology for further testing (upper gastrointestinal series) which he tolerated without difficulty. After the upper gastrointestinal series the patient's labs were back which revealed an elevated white blood cell count. This in combination with the previous lethargy led to completion of a rule out sepsis work-up with a lumbar puncture. The patient's mother reported that the patient had been afebrile except for mild temperature elevation of 99 degrees two days prior, which she attributed to his 6 month immunizations which were given on 08-JAN-2007. The patient had not had any upper respiratory infection symptoms and his urine output had been normal. The patient did have 2 loose stools on the day the vaccines were given. He also just completed a course of Amoxicillin for Otitis media on 08-JAN-2007. The patient's mother reported that the patient had non-bloody diarrhea while on antibiotics. The patient's oral intake was decreased that morning and throughout the day, but since the fluids bolus that afternoon he had taken three small feeds without difficulty. There were no known sick contacts, but the patient was around other children the previous weekend at a birthday party and a sibling's basketball game. The patient was discharged on 11-JAN-2007 with a diagnosis of bilious emesis, and was considered to be recovered by the reporter. The patient's dehydration, lethargy/unresponsiveness, mucus in stool, bilious vomiting, and leukocytes high were considered to be other important medical events by the reporter. Bilious vomiting, lethargy/unresponsiveness, dehydration and leukocytes high were considered to be disabling and immediately life-threatening by the reporter. A lot check has been requested. Additional information is not expected. The reporter noted that this case was also reported to VAERS (VAERS # not provided).