Sex: M
Vaccine: HIBV
Symptoms: Pyrexia, Rhinitis allergic, Seizure, Speech disorder developmental
Clinical narrative: Information has been received from a lawyer and a consumer on 13-JUL-2018 regarding a case in litigation concerning a male patient (approximately 7 months of age). The patient was reported to have a blood type of O1 or O+ blood type and a history of a high fever for one week, up to 103.4 degrees F after receiving HIB (SANOFI AVENTIS) (30-MAR-2001 also reported as 31-MAR-2001), an allergy to peanut (caused vomiting and stomach pain), skin test positive for peanut sensitivity and allergy to T antigen. The patient's family history included allergy to antibiotics (mother), allergy to seafood (father). Concomitant medications were not provided. On 03-MAY-2001, the patient was vaccinated with Hepatitis A vaccine, Inactivated for prophylaxis (reported lot# 0907L) (dosage and route of administration not specified) and RECOMBIVAX HB (reported lot# 1066J, expiration date unk) (dosage and route of administration not specified). Other suspect vaccine received on 03-MAY-2001 included PCV (PFIZER) (lot#473-342) (dosage and route of administration not specified). On 03-AUG-2001, the patient was vaccinated with M-M-R II, (reported lot# 0022) and varicella virus vaccine live (Oka/Merck) (reported lot# 1295). On 18-JUL-2002, the patient received the second dose of Hepatitis A vaccine, Inactivated (reported lot# 0907L, expiration date unk). On 07-JUL-2003, the patient received the third dose of Hepatitis A vaccine, Inactivated (reported lot# 0272M, expiration date unk). On 19-OCT-2005, the patient was vaccinated with M-M-R II (reported lot#0156R). Other suspect vaccine given on 19-OCT-2005, included: DTap/IPV (GLAXOSMITHKLINE) and IPV (SANOFI AVENTIS). Other suspect vaccines included: 26-JAN-2001: IPV (SANOFI AVENTIS) (lot# T05632) and DTaP (PFIZER) (lot# 11032882); 30-MAR-2001: HIB (SANOFI AVENTIS) (lot# 472388) and ACTHIB (AVENTIS PASTEUR) (lot# 473388, exp. date 30-APR-2002); 03-DEC-2001: DTaP (GLAXOSMITHKLINE) (lot# 514AZ) and Hib (PFIZER) (lot#6100b3A). The patient's mother alleged that her son was injured due to the administration of several vaccines, including but not limited to: RECOMBIVAX HB, M-M-R II; Hepatitis A vaccine, Inactivated, and varicella virus vaccine live (Oka/Merck). It was reported that "the vaccines alleged were not safe under the conditions of its intended use in an infant with O1 or O+ blood type/ gene which caused an allergic reaction to the vaccines administered." According to the patient's mother, he suffered from encephalopathy after he received the DTaP and Hib vaccines in 2001 but was not diagnosed appropriately by the physician and was not given an order to check for encephalopathy (MRI) after seizures. It was also reported at two years and eleven months of age the patient was diagnosed with a delay in speech during his physical examination on 17-JUL-2003. At four years of age he was diagnosed with Autism Spectrum Disorder (ASD). According to legal documents dated 18-DEC-2015, the physician's opinion indicated that he believed the DTP vaccine caused the patient to suffer from fever, seizures, and encephalitis, thereby causing autism. It was alleged by the patient's mother that her son "suffered a 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, hepatitis vaccines." It was reported that the afferent lymphocytes (sinus) were inactivated due to lack of active immunity in the immune system of the patient. Conclusions: 1. "Fatal reactions" to allergic inflammatory response or hypersensitivity to antigen of Hib vaccine. (*Note: There is no evidence or information that the patient suffered a fatal reaction). 2. Blood sugar level rose sharply during stress from allergic response. His blood sugar was not under control and the excess glucose increased his chances of developing a serious related health condition. "The substances in vaccines administered to the patient created serious injury because it contained a defect which created a substantial hazard to the patient's O+ blood type/gene type." Thimerosal, neomycin, streptomycin, polymyxin B antibiotics, capsular polysaccharides of clostridium tetani, Corynebacterium diphtheria, rubella virus, polio virus (that has D antigen), hepatitis A virus, and hepatitis B virus were active ingredients of vaccines administered to the patient in which he had a sensitivity reaction or allergy. The patient's allergic reaction to antibiotics "like neomycin sulfate, polymyxin B, streptomycin," ingredients of vaccine was due to inherited gene from his parents. At four years of age, delays were noted in the patient, manifestations of his injury due to allergy to substances of vaccines such as antibiotics. It was reported that the patient's vaccination information showed several manifestations of allergic reactions that happened to him after vaccination particularly Hib vaccination on 31-MAR-2001 (also reported as 30-MAR-2001). It was also reported that the patient received the following vaccines: PEDIARIX, PROQUAD, and COMVAX via intramuscular injection (dates not specified) as an infant. Information received on 13-JUL-2018 from a lawyer contained the following adverse event: allergic rhinitis treated with NASONEX (onset date unknown). Upon internal review Autism Spectrum Disorder, seizure and encephalopathy were considered medically significant events. Additional information has been requested.