Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, HIBV, DTAP, IPV, DTAP, DTAP, IPV, MMR
Symptoms: Mood altered, Nuclear magnetic resonance imaging brain normal, Pyrexia, Rash morbilliform, Somnolence
Clinical narrative: This case was received from another manufacturer (reference number A0641938A) on 23 May 2007. The following information is verbatim as it appears in the other manufacturer's report: "This case was reported by the mother of a consumer and described the occurrence of seizure in a 18-month-old male subject who was vaccinated with Infanrix, for prophylaxis. A physician or other health care professional has not verified this report. Concurrent vaccination included IPOL given on 14 February 2006. On 14 February 2006 the subject received a dose of Infanrix at 0.5 ml. This was the 4th dose of DTaP vaccine received by the subject. Previous doses were Aventis brand. On 20 February 2006, 6 days after vaccination with Infanrix, the subject experienced a seizure which resolved the same day. At an unspecified time following vaccination with Infanrix, the subject developed autistic characteristics noted during an evaluation by early developmental specialists. At the time of reporting, the subject was receiving 5 days of therapy for the autistic characteristics. The mother reported that her son was healthy prior to receiving his 18 month vaccinations. This case was assessed as medically serious. At the time of reporting the outcome of the events were was unspecified. Follow up information was received on 10 May 2007 via the physician, who reported that the subject had a history of fever and a measles-like rash following vaccination with MMR administered on an unspecified date. Poliomyelitis vaccine IPV, (manufactured by Aventis) was concurrently administered with Infanrix on 14 February 2006, and was identified as a co-suspect vaccine. On 21 February 2006, 22 February 2006, the subject experienced a seizure that was reportedly witnessed by the subject's mother and was characterized by generalized symptoms including loss of consciousness/ unresponsiveness. The subject presented to the emergency room and was diagnosed with a "probable" febrile seizure. A viral illness was suspected to be the cause of the fever, but could not be confirmed. Per a neurologist's note, the subject exhibited drowsiness upon regaining consciousness following the seizure. A chest x-ray and rapid streptococcal test were normal. On unknown dates in 2006, following the seizure, the subject reportedly experienced deterioration in speech and mood changes. On 05 September 2006, approximately seven months after vaccination with Infanrix, "speech delay issues" were documented during a "well-child" visit. He was diagnosed with autism accompanied by speech and social developmental delays by children's services. In October 2006, diagnostic tests including a serum amino acid screen, urine organic acid screen, electroencephalogram, and magnetic resonance imaging of the brain all yielded normal results. At the time of this report, the Dtpa vaccination series was not discontinued, and the events were unresolved. The physician considered the event of autism with associated speech and developmental delays to be severe or permanently disabling. In the physician's opinion, the probable febrile seizure, autism, and speech/ developmental delays were unrelated to vaccination with Infanrix. The physician indicated that the probable febrile seizure could have been associated with a likely viral illness as a cause of fever."