Age: 1.2
Sex: M
Vaccine: DTAP, HIBV, IPV, DTAP, HIBV, IPV, DTAP, HIBV, IPV
Symptoms: Erythema, Eye swelling, Fatigue, Somnolence, Speech disorder
Clinical narrative: A report from Lederle Labs (HQ8028206MAR2001) regarding events in Florida. "A mother reported that her 14 month old son received Acel-Imune, Hib-Titer, and IPV vaccines on 08/02/00, He has a history of flu-like symptoms and had not been able to receive the rest of his vaccine schedule until 08/00. He was reportedly developing normally and active, as well as interacting and following directions very well. He was saying words at 9 months of age. He was healthy at the time of his 2nd dose and that was why his physician felt it was good time to be immunized. A few hours post-immunization, he was very tired, and did not want to do anything. The next morning, he woke up and his eyes were swollen, and he had red spots on his upper torso. His mother did not feel this was a rash. He continued to be lethargic, had no appetite, was not making eye contact, and was not functioning normally. He was also withdrawn, was not talking, and was not making any noise at all. The child was seen by several doctors for evaluation; however, 'none of whom could determine what the cause was'. One health care practitioner stated he was showing signs of autism. As of 03/02/01, he was just recently beginning to make ' noises not words' again and making some eye contact. The reporter stated that this event was reported directly to VAERS. F/U from mailed follow up correspondence rec'd on 6/29/01, it was reported that the pt was not seen by serveral doctors for evaluation until 11/16/00. The pt was vaccinated on 8/2/00 but his mother didn't seek medical attention at the time of reported reaction. The pt recovered from this experience. Additional vaccine, pt vaccine administrator and responsible physician information were also provided. Follow-up information was received on 21-JAN-2004 from a consumer which provided information regarding vaccine administration and additional adverse even information. A mother reported that her 14 month old son received Acel-Imune, Hib-Titer, and IPV vaccines on 02-AUG-2000. He has a history of flu-like symptoms following his first immunization. He had been sick from other causes and had not been able to receive the rest of his vaccine schedule until August, 2000. He was reportedly developing normally and active, as well as interacting and following directions very well. He was saying workds at 9 months of age. He was healthy at the time of his second dose and that was why his physician felt it was a good time for him to be immunized. A few hours post immunization, he was very tired and did not want to do anything. The next morning, he woke up and his eyes were swollen, and he had red spots on his upper torso. His other did not feel this was a rash. He continued to be lethargic, had no appetite, was not making eye contack and was functioning normally. He was also withdrawn, was not talking and was not making any noises at all. The child was seen by several doctors for evaluation; however, "none of whom could determine what the cause was". One health care practitioner stated he was showing signs of autism. As of 02-MAR-2001, he was just recently beginning to make "noises not words" again and making some eye contact. The reporter stated that this event was reported directly to VAERS. A copy of this report has been forwarded to Aventis, manufacturer of IPV vaccine. Additional information received from the physician on 17-APR-2002 provided lot numbers of vaccines. Additional information received from the physician on 22-MAY-2001 indicated that the child was seen over three months post-immunization, and that he recuperated from the reaction. The rash and lethargy resolved, and he had begun to vocalize again. Additional information was received from the child's mother on 14-MAR-2002.  She reported that her child still does not pay attention and has only started to make eye contact with her 4 months ago. She also reported that these symptoms occurred in her six other children, however, she declined to provide further information on the children. Follow-up information receivedon 21-JAN-2004 from the child's mother indicated that the she did not agree with the information provided by the physician. According to the mother, she reported that the physician indicated that her son "fully recovered", however, she states he "did not fully recover." Her son experienced "flu-like symtoms after receiving Hib-TITIER. This occurred "each time other vaccines were given." The symptoms were described as not eating, "running" a temperature (degree unknown), "runny" nose and "not being responsive." She reported that her son "would begin to feel better after about one month post vaccne, but would then receive his next vaccine and the symptoms would begin again." At 2 months of age, the mother stated tat her son received Hib-TITER. Acel-Immune, and an polio vaccine from a Canadian company." The mother reported that the "Acel-Imune was given alone at ages 8 months and 15 months and the Hib-TITER he had difficulty breathing and was treated with albuterol nebulization. At that same time, he also experienced the "above mentioned symptoms." She reported that prior to his 15 month vaccne, he was beginning to "successfully potty train and was speaking normally." After the 15 month vaccine, the child "could not speak." Currently, he is receiving speech therapy. As of 21-JAN-2004, the child is "not speaking normally and is still not potty trained." She indicated that the patient experienced "flu-like symptoms with each of these injections."