Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Seizure, Speech disorder developmental
Clinical narrative: This case was reported by a lawyer and described the occurrence of brain damage in an infant male patient who received DTPa-IPV for prophylaxis. Co-suspect products included DTPa vaccine (batch number 514AZ ?, expiry date unknown) for prophylaxis. The patient had a Family History of drug allergy (Mother to antibiotics) and seafood allergy (Father). Concurrent medical conditions included blood group O (O+ or O¹ blood type/gene type), peanut allergy, allergy to antibiotics (neomycin, polymyxin B , streptomycin), lactose intolerance, seafood allergy, allergic rhinitis, allergy (Thimerosal, rubella virus, polio virus, (D antigen), hepatitis A virus, hepatitis B virus), cow's milk allergy, allergy to vaccine (Hib vaccine) and bacterial allergy (capsular polysaccharides of Clostridium tetani, Corynebacterium diphtheria). Concomitant products included NASONEX. Co-suspect vaccines included: 19 October 2005, the patient was administered: MMR (Merck). On 07 July 2003, the patient was administered: Hepatitis A vaccine, (Merck). On 18 July 2002, the patient was administered: Hepatitis A vaccine, (Merck). On 03 December 2001, the patient was administered: Haemophilus influenza type B vaccine, (Pfizer). On 03 August 2001, the patient was administered: MMR (Merck) and VARIVAX (Merck). 03 May 2001, the patient was administered: PCV (Pfizer), Hepatitis B vaccine, (Merck), VAQTA, (Merck). On 30 March 2001, the patient was administered: ACTHIB, (Sanofi Aventis). On 26 January 2001, the patient was administered: IPOL (Sanofi Aventis); ACEL-IMUNE, (Pfizer/Lederle Labs). On 19th October 2005, the patient received DTPa-IPV (this is prior to FDA postmarket approval of GSK KINRIX in 2008). On 3rd December 2001, the patient received DTPa vaccine. On 31st March 2001, 1 day after receiving Hib vaccine [non-GSK], prior to receiving DTPa-IPV and DTPa vaccine, the patient experienced fever and seizure (serious criteria GSK medically significant). On an unknown date, the patient experienced brain damage (serious criteria GSK medically significant), allergic reaction, encephalopathy (serious criteria GSK medically significant), autism spectrum disorder (serious criteria GSK medically significant) and slow speech development. On an unknown date, the outcome of the brain damage, allergic reaction, encephalopathy, autism spectrum disorder, slow speech development and seizure were unknown and the outcome of the fever was recovered/resolved. The reporter [plaintiff] considered the brain damage, encephalopathy, autism spectrum disorder, slow speech development, allergic reaction, fever and seizure to be related to DTPa-IPV and DTPa vaccine. Additional details: This information was received via legal complaint. According to the legal complaint, the plaintiff (patient's mother) stated the male patient suffered allergic reactions from vaccinations during the course of his infancy causing brain damage/brain injury and Autism. Brain injury in the form of Autism Spectrum Disorder (ASD) due to encephalopathy caused by his allergic reaction to components of vaccines such as neomycin sulfate, polymyxin B sulfate, streptomycin contained in DTaP, Hib, MMR, Varicella, and Hepatitis Vaccines. Legal claim states the patient received GSK Vaccines: DTaP administered 03 December 2001 and DTaP+IPV administered 19 October 2005 (this is prior to FDA postmarket approval of GSK KINRIX in 2008). Co-suspect vaccines included: 19 October 2005, the patient was administered: MMR (Merck). On 07 July 2003, the patient was administered: Hep A (Merck). On 18 July 2002, the patient was administered: Hep A (Merck). On 03 December 2001, the patient was administered: Hib (Pfizer). On 03 August 2001, the patient was administered: MMR (Merck) and VARIVAX (Merck). 03 May 2001, the patient was administered: PCV (Pfizer), Hep B (Merck), VAQTA, (Merck). On 30 March 2001, the patient was administered: ACTHIB (Sanofi Aventis). On 26 January 2001, the patient was administered: IPOL (Sanofi Aventis); ACEL-IMUNE, (Pfizer/Lederle Labs). Inherited allergies from parents included: peanuts, antibiotics neomycin, polymyxin B, streptomycin, seafood. Allergy to cow's milk or lactose intolerance. Allergic rhinitis (NASONEX). The legal complaint states Appendices D, E, F, G, H, I, J, K, L, M; however, these were not provided to GSK. Appendix H and I, were noted to contain information on how to administer Influenza and "PEDIARIX"; Influenza vaccine and PEDIARIX were not coded as suspect vaccine, as it is not confirmed the patient received them. A Skin Test Sheet of patient was provided however it was illegible. The claim states that the "substances in vaccine(s) administered to plaintiff's son created serious injury because it contains defect which created a substantial hazard to plaintiff's son O+ or O¹ blood type/gene type". The patient has "sensitivity reaction or allergy to: thiomerosal, neomycin, streptomycin, polymyxin B antibiotics, capsular polysaccharides of Clostridium tetani, Corynebacterium diphtheriae, rubella virus, polio virus (that has D antigen), hepatitis A virus, hepatitis B virus were active ingredients of vaccines administered to plaintiff's son." The claim states the "injury resulted from side effects that were avoidable, if it was accompanied by adverse side effect warnings that states the infant/child with an O+ or O¹ blood type/gene type should not take the vaccine', if the plaintiff had been warned of the risk, she could have chosen not her son take the vaccine(s)." The claim states the patient's current medical condition lacks N-linked glycans and O-linked glycans on the cell envelope/cell surface of white blood cells and red blood cell due to his natural O+ or O¹ blood type/gene type. Upon administration of Hib vaccine on 31 March 2001, allergic reaction occurred manifested by high fever and seizure. Allergic reaction to component of Hib vaccine via injection manifested by high fever for one week that reached up to 103.4 degrees F. Claim states patient's "allergic reaction from vaccines administered to him which contain antibiotics and causes encephalopathy". But also states, the patient was not diagnosed properly for encephalopathy. Additionally, the claim states "DTP vaccine caused the him (plaintiff son) to suffer from fever, seizures, and encephalitis, thereby causing autism". On 17 July 2003, the patient was 2 years and 11 months old and diagnosed with delay in speech during physical exam. At 4 years old he was diagnosed with Autism Spectrum disorder (ASD). At 4 years of age, "delays were noted to plaintiff son, manifestation of his injury due to allergy to substance of vaccines such as antibiotics". The plaintiff states the defective vaccines were injected to plaintiff son's body, repeatedly that put him to injury as evidence by his brain damage or ASD (Autism Spectrum Disorder). Medical information provided in the claim were not official documents from physicians and included references from the internet; therefore, this case is not medically confirmed. No other information was provided.