Age: 18.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Hepatic enzyme increased, Immediate post-injection reaction, Impaired work ability, Local swelling, Pain in extremity
Clinical narrative: Information was received on 10APR2014 from a consumer. A 19 year old male experienced Crohn's disease and underwent a sphincterotomy, considered medically significant by the Sponsor. In 2008, the male received a primary dose of BIOTHRAX. Subsequently on unspecified dates, he received two additional doses of vaccine. He stated that the first two doses had been "conducted improperly, but the damage had already been done". Within two months of the second vaccination he reported the development of "symptoms of Crohn's disease" and subsequently he underwent a sphincterotomy while out of the country. In OCT2012, he was officially diagnosed with Crohn's disease. The related symptoms had been present from 2008 to current. The male stated that a "medical separation from full-time job" was pending due to the development of Crohn's disease. Additional information was received from consumer on 14APR2014 in the form of immunization records and a data collection form. Within months of receiving his first three doses of Anthrax vaccine, the consumer reported that he noticed severe abdominal pain and rectal bleeding. The symptoms continued "until a medical doctor told me I had a fistula and several rectal fissures" which required surgical correction. In AUG2008, surgical correction was performed. His symptoms subsided until 28OCT2008. On 28OCT2008 the consumer received dose four of BIOTHRAX which caused swelling and localized pain to his arm as well as discoloration for several days. He stated that the reaction was reported, but "no action was taken". On 08APR2010 he received dose five of BIOTHRAX (Lot FAV226). Immediately upon receipt of the vaccine, he reportedly "went into shock" and "was unable to breathe and began convulsing". He reported treatment with BENADRYL and TYLENOL. He stated at that time it was suggested that "based on other reactions to vaccines in the past that he may be allergic to a component in the vaccine but this was dismissed" based on non-reaction to previous doses. The consumer reported that on an unspecified date he was hospitalized for one day. Additionally, he reported that he experienced high liver enzymes. At the time of report, he stated that he has been "unable to enter remission" despite treatment with REMICADE. The consumer believed the anthrax vaccination may have activated the Crohn's disease which was not known to previously exist in his family. Medical history included chronic tonsillitis with obstructive sleep apnea (15JUN2008). Concomitant medications were not reported. Vaccination History: Anthrax vaccine: 11APR2008, 28APR2008, 19MAY2008, 28OCT2008, 08APR2010 (Lot FAV226). Typhoid vaccine: 11APR2008, 02SEP2009. Influenza Split vaccine: 18JAN2008, 31OCT2008, 02SEP2009. Influenza (SEAS w/preservatives): 10OCT2013. Influenza, Novel H1N1 09: 29JAN2010. Hepatitis A / B: 25JUL2007, 31AUG2007, 18JAN2008. Meningococcal: 25JUL2007. MMR: 25JUL2007. Polio: 31AUG2007. Tetanus, diphtheria, pertussis: 25JUL2007, 26MAY2009. Vaccine Exemptions Noted: Anthrax (medical permanent), Hepatitis B (medical immune), Hepatitis A (medical immune),  Influenza (medical permanent), smallpox (medical permanent), and varicella (medical immune). Further information has been requested.