Age: 1.43
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: Psychomotor skills impaired, Pyrexia, Vaccine positive rechallenge, Varicella post vaccine, Weight decreased
Clinical narrative: This is a spontaneous report based on information received by Pfizer from GlaxoSmithKline via the patient's grandmother. Manufacturer control number A0970857B. This report is not verified by a physician or other healthcare professional. A 17-month-old male patient received a dose of PREVENAR, the first dose of Hep A, a dose of MMR, a dose of VARICELLA VIRUS VACCINE, LIVE and a dose of DIPHTHERIA VACCINE, HAEMOPHILUS INFLUENZAE B, PERTUSSIS VACCINE, POLIOMYELITIS VACCINE INACTIVATED, TETANUS VACCINE, all on 23Mar2010. Relevant medical history included thrush, constipation, celiac symptoms nos, flour sensitivity, sensitive to chemicals, and drug reaction. The patient was born with thrush in his mouth and intestines because the mother 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 the 3rd trimester. The grandmother reports the patient's mom did have prenatal care, however was unaware of the pregnancy initially. The grandmother reports he tolerated antibiotics well for three months, but didn't have any flora in his system. The patient has a sibling that is 6 years of age, without any medical issues, from a different father. The older brother has been adopted to another family. The patient had a reaction to MIRALAX for his constipation, previously. The grandmother states it was due to the polyethylene glycol in the product. The patient became psychotic, confused, had diarrhea, and bloating that occurred for two weeks. A liver panel was drawn and normal. The grandmother reports the patient doesn't detoxify preservatives like MSG, sodium glycolate, polyethylene glycol and color additives (especially red and yellow)-these make him hyper and difficult. The grandmother also reports he has been diagnosed with symptoms of celiac disease and flour worsens his condition. The patient can tolerate organic milk. Concomitant medications were not provided. The patient previously received a dose of Hib, a dose of DTaP, a dose of IPV, and a dose of live attenuated human rotavirus vaccine, all on 16Dec2008 (manufacturers unspecified). It was reported that the patient experienced events after DTaP, but it was not further specified. In 2010 (less than one week after vaccinations with the suspect products), the patient developed a high grade fever up to 105 degrees Fahrenheit and was not eating properly (loss of appetite). Therapeutic measures taken as a result of the event fever included treatment with TYLENOL and sponge baths. About two to three weeks later, the patient developed chicken pox. About one month after, the patient experienced weight loss, loss of fine motor skills, was non-communicative, experienced dysphagia, and also loss of eye contact. According to the grandmother, the subject lost about 50 percent of his weight and lost 80 percent of his fine motor skills. It was also noted by the grandmother that his last physical revealed normal growth and development. About four months after vaccination, the patient then developed autism. At the time of this report, the patient was recovering from autism (reported as 90 percent) and was attending a school for special education students. The outcome for the events of pyrexia, decreased appetite, varicella, weight decreased, motor dysfunction, communication disorder, dysphagia, and decreased eye contact was unknown. Further information provided, noted that after the patient's next vaccination with HAVRIX on 09Mar2012, the subject experienced some of the same events plus different events.