Age: 0.16
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Laboratory test abnormal, Lethargy
Clinical narrative: It was reported that a 2-month-old female receivred an injection of IPOl on 01/08/2001. Reportedly the patient developed tachycardia within seveh hours post-immunization. She was taken to the emergency room and hospitalized for observation the patient recoverred and was discharged. FOLLOW-Up correspondence received on 02/27/2001, per the responsible physician, this adverse event should be classified as lethargy not tachycardia as previuously reported. From additional information received from the manufacturerof the DTaP vaccine which the patient received. Medical history included premature birth at 35 weeks gestation.There were no concomitant medications and no illness at the time of immunization. The infant recived her first injection of Infanrix on 01/08/2001. She also recived injections of inactivasted poliomyelitis virus vaccine (IPOL), hepatitis b vaccine (recombivax HB) and Haemophilus influenzae type b vaccine (brand name unknown)on 01/08/2001. Within seven hours post-immunization, the infant developed tachycardia and lethargy. She was taken to the local emergency room and hospitalized on 01/09/2001 to rule out sepsis. Labs work ruled out sepsis. The infant recovered on 01/11/2001. Without treatment, and was discharged. The most recent information, received 02/22/2001, indicated that the infant remained recovered. FOLLOW-UP correspondence received from the manufacturer of the Hepatitis b vaccine which the patient received. " Information has been received from a health care progfessional concerning a 57 day old Hispanic female with no known allergies, who was frankbreech and delivered prematurely (35 weeks) on 11/12/2000. The child was delivered by C-section due to pregnancy induced hypertension. She also had transient tachypnea of newborn for which she spent time in the neonatal intensive care unit On 01/08/2001, The patient was vaccianted intramuscularly in the LUL with a second dose of hepatitis b vaccine recombinant (yeast) (lot # 6342148/1739J). Concomitant therapy included a first dose intramuscularly in the RUL of poliovirus vaccine (IPOl)(lot #R1437), a first dose intramuscularly in the RUL of diptheria toxoid (+) Hemophilus B conjugate vaccine (Prohibit)(lot # UA522AA) and a first dose of 0.5 ml intramuscularly in the RLL of diptheria toxoid/pertussis vaccine/teta (Infanrix) (lot #ILLEGIBLE). On 01/08/2001 at 6 pm the patient becanme difficult to waken and had taken a total of 5 oz of formula that day. She had 8 wet diapers. She had no fever at home for (?). Physicians notes revealed that the baby was listless but with good color. She cried with stimulation and took one ounce of formula in the office. Temperature was 100.4 on admission rectally,pulse 100, respirations 40. Her eyes were focusing and she went back to sleep when not stimulated. The patient was hospitalized for IV antibiotics and observation due to lethargy, tachycardia, fever, decreased appetite and difficulty to arouse. On 01/11/2001, the patient was 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.  Follow up on 12/16/2003: "From additional information received on 12/08/03 from Merck it was reported that this report was received from the manufacturer and was assigned manufacturer report # INF 2001001746-1.  It was originally reported by a physician.  No further information was reported."