Age: 0.18
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Cyanosis, Gastrooesophageal reflux disease, Hypotonia, Laboratory test abnormal, Pallor
Clinical narrative: Information has been received from a health professional concerning a 9 week old male patient with no relevant pre-existing medical conditions, who on 8/5/04 at 14:30 PM was vaccinated in the right thigh with a first dose of hepatitis B virus vaccine (lot # 646867/0179P). Other suspect vaccine therapy administered on 8/5/04 at 14:30 PM included a first dose of HIB conjugate vaccine (tet toxoid) (ACTHIB) (lot # UE277AA, other country lot X0806) administered in the right thigh, a first dose of diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (DAPTACEL) (lot # C1663AA) administered in the left thigh, a first dose of poliovirus vaccine inactivated (IPOL) (lot # X0771) administered in the right thigh and a first dose of pneumococcal 4 6B 9V 14 19C 19F 23F conjugate vaccine (PREVNAR) (lot # 495173) administered in the left thigh. The health professional reported that the patient did not have any illnesses at the time of vaccination. It was noted that routes of administration were not reported. Later that day, on 8/5/04, the patient's face turned pale and cyanotic and his lips became cold and clammy. The patient also stopped sucking. He was taken to the emergency room and diagnosed with cyanotic spells and reflux. Laboratory data obtained in the emergency room included urine and blood work, but no results were provided. The patient was seen in the physician's office on 8/6/04 and reportedly seemed fine. There was no redness or swelling noted at the injection sites at that time. The patient's recovery status was reported as unknown. It was noted that the patient developed esophageal reflux and poor reflex. Cyanotic, esophageal reflux and poor sucking reflex are considered to be other important medical events (OMIC). Additional information is expected.  Follow up on 08/27/04 states: "From additional information received on 08/23/04 from another manufacturer, their information number was provided WAES0408USA01162."  Follow up on 09/09/04 states: "From additional information received on 08/31/04 from another manufacturer (reference # WAES0408USA01162), the trade name for Hepatitis B vaccine administered and the lot # were provided. The pt received Recombivax HB, Lot # 646867/0179P."  From additional information received on 18NOV2004 from the initial reporter, the patient's medical records were provided. The patient was seen in the ER on 5AUG2004 and was discharged on 6AUG2004 and was prescribed rantidine 15mg/ml, 0.6ml three time a day. The discharge instructions included keeping the infant upright for 0.5 hour following feedings and elevating the crib mattress. He was seen by the responsible physician for a follow up visit on 6AUG204. His temperature at that time was 99.3 degres Fahrenheit. Per the physician's notes, the patinet had experienced a hypotonic reaction to the DAPTACEL vaccination on 5AUG2004. It was noted in the medical records that the patient was not to receive DTaP, only pediatric DT ad that the physician was in doubt of the reflux diagnosis. The patient has recovered from these events. No futher information is anticipated, this case is considered closed. The reporter of this case is the same reporter as for cases 204-02657, 2004-02658 and 200402659. Follow up 02/07/05: Company remarks: (Medical assessment) It should be necessary to confirm and evaluate the severity of the oesophaeal reflux and it's potential role in the occurrence of these symptoms. OMIC