Age: 0.31
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Abnormal behaviour, Grand mal convulsion, Pyrexia
Clinical narrative: From initial information received on 6/16/04 from a patient's parent regarding an adverse event occurring in the USA, it was reported that a four month old male patient received a dose of DAPTACEL, lot number C1387AA; a dose of ACTHIB, lot number UA856AA; a dose of IPOL, lot number W1233 and a dose of PCV-7, lot number 493245, administered on 8/11/03. All the products were administered IM in non-specified sites. Nine days later, on 8/20/03, the patient experienced a grand mal seizure, followed by two seizure free days on 8/21/03 and 8/22/03. He was admitted to the hospital on 8/23/03. Following evaluation by a neurologist, he was placed on a five month treatment with Phenobarb. The patient had blood in his stools at the time of vaccination. His medical history is significant for a milk allergy. The recovery status of the patient was reported as unknown.  Follow Up: From additional information received on 01JUL2004 from another manufacturer (reference number HQWYE504817JUN04), it was reported that the patient experienced seizure activity, fever and behavior changes on 21AUG2003, ten days post immunization. The patient's recovery status is currently unknown. From additional information received on 7/1/04 from another manufacturer, it was reported that the patient experienced seizure activity, fever, and behavior changes on 8/21/03, ten days post immunization. The patient's recovery status is currently unknown. From additional information received on 8/19/04 from another manufacturer, it was initially reported by the patient's parent and a physician that the patient had previously received vaccinations with ACTHIB, TRIPEDIA, and IPOL on 6/17/03 at the age of two months. Later that same day, the patient slept a lot. This information is detailed in case 200402859.  No other information was provided at this time. From additional information received on 11/1/04 from a physician, the patient's name was provided. The patient's birth weight of seven pounds and ten ounces was also provided. Reportedly, the patient was vaccinated at a private doctor's office and the vaccine was purchased with private funds. It was also reported that the patient received IPOL SC, not IM, as previously reported. A waking and sleep EEG were considered normal. No definite paroxysmal discharged, lateralization or seizures were noted. An MRI of the brain with and without contrast was also obtained. No pathological enhancement or structural abnormality was noted. No significant interval change in the mildly dilated subarachnoid spaces over the convexities or change in the size of the ventricles was noted. No pathological enhancement was seen. Patient's age group was previously entered in error as child. It has been changed to infant as the patient was four months old at the time of this event. Reporting physician's address has been changed as a new forwarding address was provided. Follow up 03/23/05: From additional information received on 12/08/04 from a physician, it was reported that no medical follow up was done for the blood in the patient's stools. The results of the patient's blood work and autism testing are not available. Per the reporter, no additional information is available at this time.