Age: 0.5
Sex: F
Vaccine: FLU3
Symptoms: Restlessness
Clinical narrative: Initial report received on 09/Nov/2005 from a health care professional. A six month old female had received her first administration (route and site not reported) of Fluzone No. Preservative '2005-'2006 (lot number not reported) on 02/Nov/2005. Per the reporter, at an unspecified time later the mother brought the child in for her well baby check up and it was noted the child was restless. A WBC was drawn and the child had a WBC level of 20,000 with no reported infectious process. The patient had received on 07/Sep/2005 vaccinations with ACTHIB, Dtap, IPV and Prevnar. None of the manufacturer's names, lot number or route and site of administration were reported. The patient had not recovered from this event a the time of this report. Seriousness Criteria: Other Medically Significant (OMIC). This case was upgraded to seriousness due to the diagnosis of anemia. Follow-up information received on 06/Feb/2006 from a health care professional. It was reported that the patient had a yeast infection and a history of GERD at the time of the vaccination. She was vaccinated with Fluzone, lot number U17U3JA, intramuscularly in the left thigh on 02/Nov/2005. At an unspecified time later, the patient experienced greater than three hours of crying that was difficult to console for 48 hours. The child was described as being "wired/irritable and agitated" but had no fever. She would not sleep for 11 hours. There was no visible signs of redness or swelling at the injection site. In retrospect, a similarly reaction occurred at the patient's two month old vaccinations on 12/Jul/2005 with Dtap, Polio, HIB and PCV7, but this was attributed to a bad yeast infection since the baby was breast feeding. The patient did develop a low grade fever and was given Tylenol by the mother and this was reported to the physician on 10/Sep/2005. On 09/Nov/2005, the patient had elevated WBC's and it was felt that the patient was too far out from the vaccination to be related to the vaccine. A repeat CBC with differential, AST, ALT, Cold agglutinins and peripheral smear were completed. The results revealed WBC to be 15.8, Hgb 10.4 and Lymphs 64%. On 18/Nov/2005 the physician felt the current adverse events were compatible with the flu vaccine and not related to the history of GERD, Zantac or Prevacid. On 26/Dec/2005 an upper endoscopy with biopsy was completed and did not show any bleeding. It was recommended that Poly-Vi-Sol with iron be given with food for the anemia. A repeat CBC was to be completed in one month. On 11/Jan/2006 the mother gave up garlic and onions and the patient's screaming stopped for six-seven days. An allergy workup was completed and was negative. On that day her WBC's were 16.9, Hgb 10.2 and Lymphs were 77%. Per the reporter, it is uncertain about the cause of the adverse reaction following the vaccination. The child seems much better since the mother gave up garlic and onions. The physician plans to pre-medicate with Tylenol and Benadryl before the next immunizations. A repeat CBC will be repeated at the next child visit on 08/Feb/2006. At that time the physician will consider a hematology consult. The events were updated per this information. At the time of this report, it was not reported if the patient had fully recovered from these events.