Age: 0.3
Sex: U
Vaccine: DTPHIB, HIBV, OPV, DTPHIB, OPV, DTPHIB, HEP, OPV, DTPHIB, HIBV, OPV, HEP
Symptoms: Irritability, Otitis media
Clinical narrative: On the day following the birth, a 1st dose of Hep-B vaccine was given. Between 5 and 6 weeks, post vax, this girl was admitted to hospital for increased irritability and to rule out possible sepsis or meningitis. She was empirically treated with a combination of ampicillin and cefotaxime. She received a loading dose and 2 subsequent doses of cefotaxime before it was discontinued the following day. Ampicillin was continued for 7 more days. The pt was discharged from the hospital after 2 days in good condition with a final dx of otitis media. At 2 months of age, she received the 1st doses of Tetramune, IM, OPV and the 2nd dose of HBV vaccine with no complications. At 4 months of age, she received her 2nd doses of OPV and Tetramune. Four days, post vax, this girl presented a low-grade fever, lethargy and decreased oral intake. Results of a urine leukocyte esterase test were positive and she was given Rocephin 250mg IM, Bactrim 3/4 tsp every 12 hour po and acetaminophen for a possible urinary tract infection. Results of urine cultures were negative. Three days later, on 2/4/97, the girl was admitted to the hospital with severe anemia and a hemoglobin level of 2.3 g/dl, WBC count of 65000/mm3, platelets of 275000/mm3, and lactate dehydrogenase level of 3.185 U/l. At that time, she was unresponsive, ventilator dependent and showed evidence of disseminated intravascular coagulation. A warm auto-antibody (panagglutinin), optimally reactive at 27C and without demonstrable specificity, was identified in both the serum and the red cell eluate. She was treated with transfusion (2 units of red blood cells, 1 unit of platelets, 2 units of cryoprecipitate and 2 units of fresh frozen plasma). She was also treated with IV immune globulin (IVIG 2.8g), ampicillin 700mg IV (X 1 dose), then 350mg IV every 12 hours (X 2-4 doses), and Solu-Medrol 350mg IV every 6 hours X 8 doses, after a loading dose. Severe hemolysis continued and on 2/8/97, 41 hours after admission, the infant died 41 hours after admission. The autopsy demonstrated cerebral edema and diffuse subarachnoid hemorrhage but was otherwise noncontributory. In the discussion of the referenced article, it was mentioned that "after excluding other causes, we think that the development of warm AIHA in this pt suggests a causal relationship to the 2nd DTP vaccination". F/U received on 9/26/01 from the reporting physician, it was mentioned that he considered the death to be related to the DTP vaccine (Tetramune) and possibly related to the Hep-B vaccine. A complete autopsy report is not available. A follow up report received 2/20/2002 adds: This report describes the occurrence of a severe acute autoimmune hemolytic anemia and subsequent death in a 4 month old girl receiving Hepatitis B vaccine.  On the day following the birth, a 1st dose of Hepatitis B vaccine (SC) (brandname unknown) was given.  Between 5 and 6 weeks after vaccination, this girl was admitted to hospital for increased irritability, and to rule out possible sepsis or meningitis. She was empirically treated with a combination of ampicillin and cefotaxime. She received a loading dose and 2 subsequent doses of cefotaxime before it was discontinued the following day. Ampicillin was continued for 7 more days. The pt was discharged from the hospital after 2 days in a good condition with a final diagnosis of otitis media.  At 2 months of   age, she received the 1st doses of Tetramune (DTaP-Hib vaccine-Wyeth) (IM), OPV (oral polio vaccine-Wyeth) and the 2nd dose of HBV vaccine with no complication.  At 4 months of age, she received her 2nd doses of OPV and Tetramune (DTaP-Hib). Four days after receiving these vaccines, this girl presented a low-grade fever, lethargy and decreased oral intake. Results of a urine leukocyte esterase test were positive. She was given ceftriaxone (Rocephin 250 mg IM), trimethroprim/sulfamethoxazole (Bactrim 3/4 tsp every 12 h o) and acetaminophen for a possible urinary tract infection. Results of urine culture were negative. Three days later, on 02/04/1997, the girl was admitted to the hospital with severe anemia and a hemoglobin level of 2.3 g/dl, WBC count of 65000/mm3, platelets of 275000/mm3, and lactate dehydrogenase level of 3.185 U/l. At that time, she was unresponsive, ventilator dependent, and showed evidence of disseminated intravascular coagulation (prothrombin tmie 45 sec, partial thromboplastin time 92.8 sec, 6-dimer > 8000 ng/mL). The direct antiglobulin test (DAT or Coombs test) was positive for anti-IgG (3+), anti-C3bd (1+) and negative for anti-IgM and anti-IgA. A warm autoantibody (panagglutinin), optimally reactive at 37 C, and without demonstrable specificity, was identified in both the serum and the red cell oluate. She was treated with transfusion (2 units of red blood cells, 1 unit of platelets, 2 units of cryoprecipitate, and 2 units of fresh frozen plasma). She was also treated with IV immune globulin (IVIG, 2.8g), ampicillin 700 mg IV (Xl dose), then 350 mg IV every 12 hours (X2-4 doses), and Solumedrol 350 mg IV every 6 hours (x 8 doses) after a loading dose. Red blood cell antibody to ceftriaxone, Ham test, blood cultures, viral serologies (HBV, RBV, CMV, HIV) and latex agglutination tests for Haemophilus influenza, Streptococcus pneumoniae and Neisseria meningitidis were all negative or noncontributory.  Severe hemolysis continued and on 02/08/1997, 41 hours after admission, the infant died.  The autopsy demonstrated cerebral edema and diffuse subarachnoid hemorrhage but was otherwise noncontributory.  In the discussion of the referenced article, it was mentioned that "after excluding other causes, we think that the development of warm AIHA in this pt suggests a causal relationship to the second DTP vaccination".  In a follow-up received on 09/26/2001 from the reporting physician, it was mentioned that he considered the death to be related to the DTP vaccine (Tetramune) and possibly related to the Hepatitis B vaccine).  A complete autopsy report is not available.