Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Lethargy, Listless, Oral intake reduced, Pyrexia, Respiratory rate increased
Clinical narrative: Information has been received from a health professional concerning a 57 day old female who who on 1/8/01, was vaccinated with Hep-B vaccine recombinant (yeast), IM, in LVL (1739J). Also received IPOL, SC, LL (R1437), Hib conjugate IM, in R VLV (UA522AA) and Diphtheria toxoid/petussis vaccine/teta (Infanrix) IM, in RLL (956A2). On 1/8/01, at 18:00, the pt became difficult to waken and has taken a total of 5 oz of formula that day. She has had 8 wet diapers and 2 dirty diapers. She had no fever at home for mom; physician's notes revealed the baby was listless but in good color. She cried with stimulation and took 1 oz of formula in the office. Temperature was 100.4F on admission (rectally), pulse 180, respirations 40. Her eyes were not focusing and she went back to sleep when not stimulated. The pt was hospitalized for IV antibiotics and observation due to lethargy, tachycardia, fever, decreased appetite and difficulty to arouse. On 1/11/01, the pt recovered and was discharged to home. The physician felt it was a probable neurotoxic reaction to acellular pertussis vaccine but was also ruling out an infection. F/U this report was rec'd from Glaxosmithkline and was assigned manufacturer report number INF2001001746-1 was originally reported by a physician. A 15-day follow up report received 12/24/2003 adds: Pt was born frank breech and delivered prematurely (35 weeks) on 11/12/2000. The child was delivered by C-section due to pregnancy induced hypertension. She also had transcient tachypnea of newborn for which she spent time in the neonatal intensive care unit. On 01/08/2001 the pt was vaccinated intramuscularly in the LVL with a 2nd dose of hepatitis b vaccine recombinant (yeast) (lot #634148/1739J). There was no illness at the time of vaccination. Concomitant therapy included a 1st dose subcutaneously in the left thigh of poliovirus vaccine (IPOL) (lot #R1437), a 1st dose intramuscularly in the R VL of Hib conj vaccine (tet toxoid) (ACTHIB) (Lot #UA522AA/R0696-2) and a 1st dose of 0.5ml intramuscularly in the R LL of diphtheria toxoid/pertussis vaccine/teta (Infanrix) (lot #956AZ). On 01/08/2001 at 6 PM the pt became difficult to waken and had taken a total of 5 oz of formula that day. She had 8 wet diapers and 2 dirty diapers. She had no fever at home for mom. Physician notes revealed the baby was listless but with good color. She cried with stimulation and took 1 ounce of formula in the office. Temperature was 100.4 on admission rectally, pulse 180, respirations 40. Her eyes were not focusing and she went back to sleep when not stimulated. Blood cultures, urine cultures, and CSF labs were within normal limits. Urinalysis was normal, specific gravity 1.005, WBC 10.3, HBG 9.9, platelet 530, 000, sodium 136, potassium 7.9 (hemolyzed), chloride 105, BUN 10, creatinine 0.3 and glucose was 90. The pt was hospitalized for IV antibiotics and observation due to lethargy, tachycardia, fever, decreased appetite and difficulty to arouse. On 01/11/2001 the pt recovered and was discharged to home. It was noted that the physician felt it was a probable neurotoxic reaction to acellular pertussis vaccine but was also ruling out an infection. The pt's experience was considered an other important medical event. This is an amended report. The trade name of the Hib conj vaccine has been changed from Prohibit to Acthib. In addition, the serious criteria of other important medical event has been added. This report was received from GlaxoSmithKline and was assigned manufacturer report number INF2001001746-1. It was originally reported by a physician. This is a corrected reported, as amended.