Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTP, HBHEPB, IPV, PNC
Symptoms: Anorexia, Fontanelle bulging, Pyrexia, Somnolence
Clinical narrative: A physician reported the occurrence of bulging fontanel in a *16 wk old male twin w/a history of premature birth (33 wks gestation) who on 10/18/02 was vaccinated with the first dose of Haemophilus B conjugate vax (+) Hep B vax recombinant (yeast) IM. Concomitant therapy that same day included Infanrix.* Other comcomitant therapy included palivizumab (Synagis). On the same date, he received injections of Synagis, IPOL, Prevnar, and Comvax. *The infant was fine after the injections, however after he awoke from his nap, he woke with and became lethargic. Later that day the fever peaked at 102.9 deg F. The infant was taken to the ER. The infant had a septic work-up and a spinal tap that both came back normal. His fever went down and he was discharged on 10/19/02. As of 10/23/02 the infant was recovered. The infants twin sibling had a similar event but was not hospitalized (Synagis).* fever, bulging fontanel, somnolence, and anorexia. He was hospitalized for an unspecified period of time. The Infanrix immunization series was discontinued. As of 10/28/02, the events persisted. The follow up states subsequently the pt was discharged from the hospital. The physician "cannot determine the cause" of these reactions. The physician also provided info regarding another pt, the pt's twin, who experienced the same reactions but was not hospitalized after being vaccinated with the same vaccines (WAES0210USA02944). The pt sought unspecified medical attention. Additional info has been requested. *In f/up dated 10/28/02 the results of a CT scan and ultrasound of the head revealed mild hydrocephalus, 2 small clots (possible) frontal horns. The reporter could not determine which injection caused the event. F/up was received - it was also reported that the infant's twin only received Ipol. Add'l info has been requested. Reported on 02/04/2003: Information has been received from a physician. Wyeth Research (manufacturer report# HQ4918829OCG2002), GlaxoSmithKline (manufacturer report# A0386151A) and an other company's pharmaceutical representative concerning a 16 week old male (also reported as female) who had no adverse events following prior vaccinations who on 10/18/2002 was vaccinated with a dose of Haemophilus B conjugate vaccine (-) hepatitis B vaccine recombinant (yeast) given intramuscularly.  Concomitant therapy, on that same date, included an intramuscular dose of palivizumab (SYNAGIS), an intramuscular dose of poliovirus vaccine (IPOL). A dose of diphtheria toxoid/pertussis vaccine/tetanus toxoid (INFANRIX), and an intramuscular dose of Streptococcus pneumonia vaccine (PREVNAR). On 10/18/2002, the patient developed fever, somnolence, anorexia, and a bulging fontanelle.  It was noted that the patient was not hospitalized.  The physician *cannot determine the cause* of the reactions.  On 10/20/2002 the patient recovered from the fever, bulging fontanelle, somnolence, and anorexia. On 10/25/2002, an ultrasound of the brain was performed which revealed *possible early hydrocephalus*.  The physician also provided information regarding another patient, the patient's twin, who experienced the same reactions but was hospitalized after being vaccinated with the same vaccines (WAES# 020USA02707). The vaccine provider stated that the events were possibly related to the vaccines administered.  Fever, bulging fontanelle, somnolence, and anorexia were considered other important medical events.  Additional information has been requested. A 15-day follow up report received 3/7/2003 adds: Information has been received from a physician, Wyeth Research manufacturer's report #H04918329OCT2002), and an other company's pharmaceutical representative concerning a 16 week old male twin who was born prematurely (at 33 weeks) who on 10/18/2002 was vaccinated with the second dose of Haemophilus B conjugate vaccine (-) hepatitis B vaccine recombinant (yeast) given intramuscularly (lot #643655/0738M). Concomitant vaccinations on that same date included an imtramuscular dose of palivizumab (SYNAGIS), the second dose of poliovirus vaccine (IPOL) given intramuscularly (Lot #W0063), the second dose of diphtheria toxoid/pertussis vaccine/tetanus toxoid (INFANRIX) given intramuscularly (Lot #574A2) and the first dose of Streptococcus pneumoniae vaccine (PREVNAR) given intramuscularly (lot #489839). There was no illness at the time of vaccination. The physician indicated that after the pt was vaccinated in the morning he was fine, however, after his nap on 10/18/2002, the pt developed a fever of 102.9 degrees F, somnolence, anorexia, and a bulging anterior fontenelle. The pt was taken to the ER and was subsequently hospitalized. A sepsis workup was negative and a spinal tap was normal. A head computed axial tomography and ultrasound revealed mild hydrocephalus and three possible small clots. On approximately 10/19/2002, the pt's fever was noted to have 'went down'. On 10/25/2002 an echoencephalograph of the head was performed which showed mild prominence of the entire ventricular system. There were 2 5x2mm echogenic structures in the frontal horns consistent with hemorrhagic clots. There was no periventricular leukomalacia. There was no extra-axial collection or midline shift. The caudothalamic grooves were intact. The impression was that there was mild hydrocephalus with 2 small clots in the frontal horns. On 10/25/2002, a computed axial tomography of the head without contrast was performed which showed mild prominence of the ventricular system. There was no extra-axial collection, mass effect, or midline shift. Theh echogenic foci seen in the frontal horns on the ultrasound were not seen. There was no depressed skull fracture. The impression was that the mild ventricular prominence may represent early hydrocephalus. There was no hemorrhage or mass. The posterior fossa had normal size and the corpus callosum was present. Subseuently the pt was discharged from the hospital. Subsequently the pt recovered from his fever, bulging anterior fontanelle, and mild hydrocephalus. The physician 'cannot determine the cause' of these reactions. In follow up on 10/28/2002 the results of a CAT scan and ultrasound of the head revealed mild hydrocephalus, 2 small clots (possible) frontal horns. The reporter could not determine which injection caused the event. In follow up on 11/18/2002, on 10/18/2002, computed axial reveale 'of head mild hydrocephalus, 3 small clots (possible) frontal horns' and on 10/18/2002, an ultrasound revealed 'of head mild hydrocephalus, 3 small clots (possible) frontal horns'. Follow up info received from GlaxoSmithKline for diphtheria toxoid/pertussis vaccine/tetanus toxoid (INFANRIX) indicated that on 10/25/2002 an ultrasound of the brain was performed which revealed 'possible early hydrocephalus'. The vaccine provider stated that the events were possibly related to diphtheria toxoid/pertussis vaccine/tetanus toxoid (INFANRIX) administration and possibly related to the the concomitantly administered vaccines. The vaccine provider considered the events to be non-serious. The physician also provided info regarding another pt, the pt's twin, who experienced the same reactions but was not hospitalized after being vaccinated with the same vaccines (WAES #0210U9102944). This is a consolidation of two reports concerning the same pt. No further information is available. It has been determined that WAES #0211USA00707 is a duplicate of WAES #0210USA02707. Therefore WAES #0211USA00707 is being deleted from our files and the reports consolidated into WAES #0210USA02707.  Reported on 04/04/2003: "Information has been received from a physician and an other company's pharmaceutical representative concerning a 16 week old male (also reported as female) who was premature 33-weeks gestation and had no adverse events following prior vaccinations who on 10/18/2002 was vaccinated with a dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) given intramuscularly.  Conomitant therapy, on that same date, included an intramuscular dose of palivizumab (SYNAGIS), an intramuscular dose of poliovirus vaccine, a dose of diphtheria toxoid/pertussis vaccine/tetanus toxoid, and an intramuscular dose of Streptococcus pneumoniae vaccine.  On 10/18/2002, the patient developed fever, somnolence, anorexia, and bulging fontanelle.  It was noted that the patient was not hospitalized.  The physician "cannot determine the cause" of these reactions.  On 10/20/2002 the patient recovered from the fever, bulging fontanelle, somnolence, and anorexia.  On 10/25/2002 (also reported as 10/20/2002), an ultrasound of the brain was performed which revealed "possible early hydrocephalus."  The physician also provided information regarding another patient, the patient's twin, who experienced the same reactions but was hospitalized after being vaccinated with the same vaccines.  The vaccine provider stated that the events were possibly related to the vaccines administered.  Fever, bulging fontanelle, somnolence, and anorexia were considered other important medical events.  Other business partners include: F2002-02941.  Additional information has been requested. A 15-day follow up report received 04/22/2003 adds: Follow up info indicated that on 10/15/2002 the child was seen in the doctor's office and was diagnosed with an ear infection. The child was prescribed cefprozil (CEFZIL). On 10/19/2002 the child was at the hospital visiting her twin brother (WAES #0210USA02707). While the physician was making rounds on her brother, he noted that the child had 'slightly full fontanelles' and a fever. Blood cultures were obtained that were normal. The physician did not treat the child and she has since fully recovered. A 15-day follow up report received 4/22/2003 adds: Follow-up info was received from Wyeth Ayerst for Streptoccus pneumoniae vaccine (PREVNAR) and was assigned manufacturer control #HQ4918329OCT2002. It was reported that the infant's twin only received poliovirus vaccine (IPOL). Follow-up info was received from a health professional. The pt had all previous vaccinations without any problems. The pt was well at the time of vaccination on 10/18/2002. On 10/19/2002 at 00:04, the pt presented to the local hospital ER and was admitted to the hospital with symptoms of fever, full fontanelles and lethargy. The pt was treated with intravenous ceftriaxone sodium (ROCEPHIN) while hospitalized and was discharged within 48 hours. The pt has since made a full recovery. Additional info has been requested. The follow up received on 4/11/03 states the physician also provided information regarding another pt, the pt's twin, who experienced the same reactions but was hospitalized after being vaccinated with the same vaccines (WAES0210USA02707). The vaccine provider stated that the events were possibly related to the vaccine administration. Fever, bulging fontanelle, somnolence, and anorexia were considered other important medical events (OMIC).