Age: 0.53
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Convulsion, Pulmonary oedema, Therapeutic agent toxicity
Clinical narrative: Information has been received from a physician (forensic pathologist) concerning a 6 month old female patient with a birth twin (sister) and no concurrent conditions who on 7/10/01 was vaccinated IM with the third dose of hepatitis B vaccine recombinant (yeast) (lot number 638721/0324L). Concomitant vaccinations on 7/10/01 included the third dose IM of Haemophilus influenzae vaccine (+) tetanus toxoid (ACTHIB (Haemophilus influenzae vaccine (+) tetanus toxoid) (lot number UA577AA), the third dose IM of poliovirus vaccine (IPOL) (lot number T0786), the second dose IM of alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (TRIPEDIA) (P1: March 2001) (lot number U0503AA) and a booster dose (number of previous doses not reported) IM of Streptococcus pneumoniae vaccine (PREVNAR) (lot number 479233). The forensic pathologist reported that the patient developed an ongoing seizure disorder and died in 12/01. It was noted that the patient was hospitalized. Follow up information received from the forensic pathologist provided the autopsy report and the following pathological findings: seizure disorder, caused of death: undetermined, manner of death: undetermined. It was noted that sections of the lungs showed an eosinophilic substance in alveoli (pulmonary edema) along with some red cells and occasional macrophages. An examination of the liver revealed that the hepatocytes appear enlarged with clear cytoplasm containing granular and well defined particles. There was no significant pathologic change noted in the examination of the patient's other organs. The significant toxicological laboratory findings were as follows: drug abuse screen: blood barbiturates-positive; common acidic screen: blood phenobarbital-13 mg/L; quantitative tests: blood alcohol-ethyl, N-propanol, acetone, methanol, isopropyl: negative. The basic metabolic profile was as follows: glucose: 15 mg/dL; BUN: 7 mg/dL; creatinine serum: 0.2 mg/dL; BUN/creatinine ration: 35.0 (H); sodium: 129 mmol/L; potassium: 9.2 mmol/L; chloride: 112 mmol/L; CO2: 10 mmol/L; and calcium: 6.0 mg/dL. See lab section for other insignificant lab findings. Further information received from a licensed visiting nurse indicated that the patient started with seizure a few hours after injections. It was noted that the patient was followed by a pediatric neurologist, and that the patient died on 12/28/01, hr first birthday. The reporter also confirmed that the patient had an identical twin. The forensic pathologist indicated that the patient had a twin sister who also had seizure superior to 24 hours after receiving immunizations. The twin also died within within the first year of life. Information provided by a nurse indicated that the second twin died on 4/15/02. She stated that the report was sent on both twins in July 2001. Follow up correspondence was received on 8/9/02, and additional information was provided. It was confirmed that the autopsy report was received for both twins. No further information is expected. The case is closed.This is an amended report. Additional details concerning the vaccine manufacturer hae been added to the narrative and manufacturer fields. Conflicting info regarding the date of the twin's death was further explained. The adverse experiences have been added for the pt's twin sister, WAES0209USA01957. This was originally reported by a physician (forensic pathologist). this is a corrected report as amended.