Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Respiratory rate increased, Swelling face
Clinical narrative: Initial and follow up information has been received regarding a case in litigation, from a consumer and a healthcare worker, concerning the consumer's 57 day old grandson, who on 01-NOV-2007 was vaccinated with the first dose of COMVAX (lot # 657380/0377U). Concomitant therapy included the first dose in the left leg of DAPTACEL (lot # C2607AA), the first dose in the right leg of IPOL vaccine (lot #Z1009), the first dose in the right leg of PREVNAR (lot # B70143D), and the first dose, oral of ROTATEQ vaccine (lot #657668/1390U). On 01-NOV-2007, the infant developed fever, had a hard time breathing and was very lethargic. The infant was taken to an emergency room and underwent catheter insertion, a spinal tap and "many other tests" (no results reported). The patient was treated with unspecified antibiotics and steroids and was released. At the time of this report, the patient was recovered. Follow up information in the form of hospital records, was received from the grandfather of the infant (original reporter). The  infant's grandfather indicated that the ER doctors "appeared worried about (his grandson's) survival." The hospital records indicated that the infant's birth occurred at 36 weeks gestation. the records documented a history for 01-NOV-2007: TYLENOL was administered at 1:00 pm, prior to the infant's vaccinations at 2:30 pm, again at 6:00 pm and then at 10:00pm. At 11:54 pm, the infant was brought to the ER. The emergency department records recorded the clinical impression of "acute febrile." Admitting diagnosis was lethargy, fever and difficulty breathing. Respiration were clear to auscultation, without use of retractive muscles. temperature (rectal) was recorded as 100.4, pulse 145, and respiration 63. The infant was noted to have no cough, decreased oral intake and normal wet diaper and bowel movements. A hospital note (12:15 am, 02-NOV-2007) indicated the child had a swollen face and his eyes were puffy. a blood culture was negative (12:35). A beside glucose test (12:39 am) was 59 ng.dL (70-100), and a repeat glucose (1:45 am) was 11 mg/dL. A chest Xray (1:32 am) revealed hyperexpanded but clear lungs. A urinalysis (2:35 am) was obtained via a catheter and indicated only a red blood cell count of 1/mm3 (0-0) as abnormal. Additional labs (02-NOV-2007 at 2:43 am) included a spinal tap that revealed an elevated cerebrospinal fluid protein of 80 mg/dL (14-45 mg/dL), a negative CSF culture, and a normal CSF glucose. Treatment involved and IV saline lock for DEXAMETHASONE (unspecified), ROCEPHIN. At 3:20 am, the infant was resting. On 02-NOV-2007, at 4:15 am, the infant was discharged, and if he was "looking sicker." Follow up was recommended with the child's physician. On 13-DEC-2007, the grandfather of the infant became aware of the recalled lots for COMVAX vaccine. Follow up information received from the physician's office, indicated that a parent of the child called on the night that the vaccine was given, to report a fever of 101.5 and respiratory distress. The physician referred the parent to the emergency department, as reported above. On 02-NOV-2007, the child was seen in the office, and had a normal exam, with no distress noted. The physician indicated the child had recovered at the visit. The records of testing prior to release of the lot in question, have been rechecked and found t be satisfactory. The lot complies with the standards of the agency and released. No further information is available.