Age: 1.4
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC, VARCEL, DTPPHIB, HEPA, MEA, PNC, VARCEL, DTAP, HEPA, HIBV, IPV, MMR, PNC, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC, VARCEL
Symptoms: Decreased eye contact, Diarrhoea, Dysphagia, Motor dysfunction, Pyrexia
Clinical narrative: Information has been received from GlaxoSmithKline and was assigned manufacturer number A0970857B, concerning a 17 month old male patient with symptoms of celiac disease, flour and preservatives sensitivity ("MSG, sodium glycolate, color additives (especially red and yellow)") and with a history of thrush, constipation, drug reaction (psychotic, confused, diarrhea and bloating) to polyethylene glycol 3350 (MSD) who on 23-MAR-2010, was vaccinated with a first dose of Hep A (manufacturer unknown), a dose of MMR (manufacturer unknown), a dose of varicella virus vaccine (manufacturer unknown), a dose of PREVNAR and a dose of DTaP+Hib+IPV (manufacturer unknown) (doses, routes and lot numbers not reported). The patient was born with thrush in mouth and intestines because his mom took antibiotics on and off during pregnancy for tooth abscess. The patient's mother was taking birth control shots every three months when she became pregnant. The mother also took omeprazole for reflux during 3rd trimester. The grandmother reported the patient's mom did have prenatal care, however was unaware of pregnancy initially. The grandmother reported he tolerated antibiotics well for 3 months, but didn't have any flora in his system. The patient had sibling that is 6 years of age, without any medical issues, from different father. The older brother had been adopted to another family. The patient had a reaction to polyethylene glycol 3350 (MSD) for his constipation, previously. The grandmother stated it was due to the polyethylene glycol in the product. He became psychotic, confused, had diarrhea, and bloating that occurred for 2 weeks. A liver panel was drawn and it was normal. The grandmother reported he did not detoxify preservatives - like MSG, sodium glycolate, polyethylene glycol and color additives (especially red and yellow) - these all made him "hyper and difficult". She also reported the patient had been diagnosed with symptoms of celiac disease. Flour worsened his condition. He could tolerate organic milk. The patient had a history of "some of the same events plus some different events" after prior vaccination on 16-DEC-2008, with Hib (manufacturer unknown), DTaP+IPV (manufacturer unknown), rotavirus vaccine (manufacturer unknown) (WAES # 1204USA01193). The reporter stated that less than one week after vaccination with Hep A (manufacturer unknown), MMR  (manufacturer unknown), varicella virus vaccine (manufacturer unknown), PREVNAR, DTaP+Hib+IPV (manufacturer unknown) (in March 2010) the patient experienced high grade fever up to 105, not eating properly (loss of appetite). The patient's physician recommended treating the fever with TYLENOL and sponge baths. It was reported that about 2 to 3 weeks after vaccination with Hep A (manufacturer unknown), MMR (manufacturer unknown), varicella virus vaccine (manufacturer unknown), PREVNAR, DTaP+Hib+IPV (manufacturer unknown) the patient experienced chicken pox and "about" 1 month after, the patient experienced weight loss, loss of fine motor skills, non communicative, dysphagia and loss of making eye contact. It was reported that the patient lost about 50 percent of his weight, lost 80 percent of his fine motor skills. According to the reporter, prior to these vaccinations, at the subject's last physical he was noted as normal growth and development. The reporter stated that about 4 months after vaccination with Hep A (manufacturer unknown), MMR (manufacturer unknown), varicella virus vaccine (manufacturer unknown), PREVNAR, DTaP+Hib+IPV (manufacturer unknown) (in approximately July 2010), the patient experienced autism. At the time of the report, the patient had recovered to about 90 percent and attended a school for special education students. At the time of reporting, the outcome of the events was unspecified except the autism was considered as improved. After the next vaccination with Hep A the event recurred. On 09-MAR-2012 the patient was vaccinated with HAVRIX and experienced some of the same events plus different events. Upon internal review, autism was considered to be disabling. This was originally reported by a consumer, the patient's grandmother. No further information is available.