Information has been received from a physician concerning a 10 year old male with allergic rhinitis who on 1/30/01, 2/27/01 and 6/19/01 was vaccinated with first (lot# 632556/1985J, in the right arm), second (lot #632556/1985J, in the right arm), and third (lot# not provided, in the left arm) doses of Hep B, respectively. This does not comply with the recommended dose schedule. there was no illness at the time of vaccination. On 2/27/01 the patient experienced a "bizarre" reaction. He began to hallucinate, became fearful, phobic and did not know what was going on around him. He also experienced insomnia, stiffness, and personality change. It was noted that this reaction lasted 6 weeks. ON 7/2/01 the patient, again experienced a "bizarre reaction", hallucinations, insomnia, stiffness, and personality change. Unspecified medical attention was sought. It was reported that the patient recovered from the second reaction on 8/15/01. There were no laboratory tests done. Additional follow-up information was received from the child's parents, on 08/15/02. According to them, the child received the first dose Hep B vaccine recombinant on 1/30/01. Seven to ten days post vaccination, the child began having trouble sleeping at night. He bacame "clingy" about an hour before bedtime and wanted his paretns to sit with him until he fell asleep. He would lay awake for hours waiting for his parents to go to bed and then would go to their room "begging" them to let him sleep in their room. They reported that they did not know what the problem was and that the child had always been a good sleeper. They tried "everything" including reading to him, rubbing his back, and lying with him until he relaxed, but nothing worked. He became more agitated each night. He began to have panic attacks about going to bed. His parents reported that they tried to be firm and force hiim to stay in his own room, but he kept getting more upset. They spoke to the physician, who "pressed" them to keep working on getting the child to sleep in his own bed. He reportedly "assured" them that his sleeplessness could not be associated with his Hep B vaccine recombinant shot. They stated they were also told that there was no side effects from "Hep B shots". They also spoke with the child's teacher who noticed a considerable change in his behavior. She indicated that he was "very edgy and highly strung". His schoolwork began to suffer. The child could hardly keep his eyes open during class. He was only getting 2-3 hours of sleep at night. It was reported that this lasted approximately 2 months and that his parents were starting o see "a bit of improvement" when it was time for the second shot. On 2/27/01, the child received the second dose of Hep B recombinant. Again, about 7-10 days post vaccination, he experienced trouble sleeping. They spoke with the physician, again and he "assured" them it could not be related to the shot. He suggested giving the child melatonin, "an over-the-counter sleep-aid". His paretns gave it to him, but "it didn't help". The child became more agitated. It was reported that he became so terrified and overwrought that his parents "finally had to give in a allow him to sleep with his mom just so the family could get some rest". They hoped that a few nights sleep would help get him back on track. It didn't. Once asleep, he began "sleepwalking" darting from one room to another, up and down the stairs. He experienced nightmares, "big and little syndrome", hallucinations, and convulsions. He spoke out of his mind about things that made no sense. He thought people were after him. He spoke of throwing himself down the stairs and throwing himself in the lake. He also attempted to jump up on the bed and catch the ceiling fan. He ground his teeth and spoke in a low, "evil-sounding" voice about killing his parents and sisters. It was also reported that he complained of being very hot (burning up) and had headache. He complained his head was spinning off and wanted his parents to hold his head on. This would culminate into a convulsion, during which the child would flail and then get very rigid. The convulsions would last about 20 minutes. The child would then get calm and wouldn't remember anything that happened. He complained of having more legs and being cold and clammy when it was over. His parents were so distraught by his behavior that when they would finally fall asleep, the "had to sleep with one eye open" because they were afraid of what he would do to himself or someone else in the family. They arranged for the child to meet with the school counselor. It didnt help. They feared that he was going crazy. They also reported that the child had told them over and over that he thought he was going crazy. Then his parents startd to notice a pattern. Although his behavior, while awake, had changed (he was intense and highly-strung), his severe problems only occurred when he was sleeping. It became obvious to his parents that his trouble falling asleep came about because he was afraid of the nightmares he experienced once he fell asleep. During the daytime, he began complaining of a splitting headache. He would lay down and instantly fall asleep. Within minutes, he began sleepwalking adn talking out of his mind. He said the room was spinning and then the episode escalated into a convulsion. Once the convulsion was over, it would be over until the next time he fell asleep. His parents reported that for weeks, they couldn't let the child play with the neighbors and he wasn't allowed to go on or have "overnights". His parents were afraid of what he might do. During the height of the reaction, his mother had to take time off from work because his parents were afraid to leave him alone with his sisters. Things deteriorated so badly at school, that after several meetings with the principal, his parents decided to change schools in the fall. About two months later, the effects wore off. His parent reported that he started to become the "friendly, happy-go-lucky" kid he had always been. As the weeks went on, he became more confident again. At that time, his parents got the most information out of him, pertaining to what he had been experiencing. On 6/19/01, the child received the third dose of Hep B vaccine recombinant. They questioned the physician about the correlation between the previous shots and the child's problems. They were "assured" that they couldn't be related. About 7-10 days post vaccination, the child experienced the same symptoms. His parents reported that they were "now" positive that the shots were the cause of the child's problems. They spoke to the physician again and he reported the events. Still, they were "assured" that the child's reactions were "unique-nothing similar had ever been reported". The reactions follwing the third dose, were "even more dramatic and terrifying than the previous times". He had such a bad episode at 1:00am that his parents could hardly hold him down. His mother was going to call 911 or get the emergency room doctor whom lives next door, when finally the child started to shake and then got calm. They stat that it was the "worst night of [their] lives, but it was the turning point". Slowly the "effects of the shot" began to wear off. His parents were concerned that he wouldn't be able to start at his new school at the end of August. However, the symptoms began to lift sufficiently by that time and he was able to go to school. His parents reported that they still did not allow him to have any "overnights" for several more weeks, until they were sure that he was totally himself again. They further reported that the reaction were so terrifying to their whole family becasue they were "assured" over and over again that there were no reactions to the "Hep B shots", that they wre safe, and couldn't be related to the child's symptoms. In addition, the child "lost out on months of education, putting him especially behind in math". His parents reported that they worked hard to catch him up with the rest of the class.   Upon internal review, the report that the patient's episodes of hallucinations, abnormal behavior, "big and little syndrome", agitation, vertigo, panic attacks, nightmares, mental status changes, headaches, violent thoughts, sleep walking, insomnia, phobia, "convulsions", and feeling hot were determinded to be other important medical events. Additional information has been requested. It has been determined that WAES#0205USA01385 is a duplicate of WAES#01072223. Therefore, WAES#0205USA01385 is being deleted from our files and the reports consolidated into WAES#01072223. (OMIC) Additional follow up info was received from the physician on 8/23/02. He confirmed that following all three doses of hep B vaccine recombinant, the child had bizarre behavior, that he felt was "possibly" related to the vaccine. It was also reported that the child has no medical problems, has not reacted to any other vaccine, and only has allergies such as hay fever. The child is completely normal "now," at the time of report.