Sex: F
Vaccine: ANTH
Symptoms: Alanine aminotransferase increased, Arthralgia, Aspartate aminotransferase increased, Biopsy skin abnormal, C-reactive protein increased
Clinical narrative: Fingers cannot grab small object; Numbness; Sleep disturbance; Bowel issues; Memory issues; Stiffness lasting an hour in morning; Pain in muscles; Pain in joints (ankles, wrist, neck, shoulders); Tingling; Dizziness/ brain fog; Rash; Spontaneous report received on 26SEP2019.   A female patient reported that following the administration of BioThrax on 21FEB2003, 09APR2003, and 15OCT2003, she started developing rash (PT: Rash) in 2011, and in 2016  she started having pain in muscles (PT: Myalgia), pain in joints (PT: Arthralgia), numbness (PT: Hypoaesthesia), tingling (PT: Paraesthesia), dizziness/ brain fog (PT: Dizziness), sleep disturbance (PT: Sleep disorder), bowel issues (PT: Gastrointestinal disorder), , memory issues (PT: Memory impairment), and stiffness lasting an hour in morning (PT: Musculoskeletal stiffness). She also added that "her fingers could not grab small objects" (PT: Disability). She had received all three doses of BioThrax intramuscularly in the right or left arm. All the symptoms were treated, but she did not get any relief and she had disabilities ongoing at the time of the report.   Treatments included plaquinel (200 mg; twice a day) for fibromyalgia and autoimmune disorder, oral Leflunomide (10 mg; daily) for nerve pain (neuropathy), oral ibuprofen (800 mg; as needed), and oral trazodone (25 mg: daily) for sleep disturbances.  Concurrent conditions included fibromyalgia (2016), chronic fatigue syndrome (2017), neuropathy (2017), irritable bowel syndrome (IBS) (2018), and autoimmune disease (2017)   Concomitant medications were flu vaccine in 2003, which causes mild flu symptoms and cold sore flare up (self treated), intramuscular small pox on 09APR2003, intramuscular typhoid on 21FEB2003 and hepatitis A on 21FEB2003. She also received a white small pill (unspecified), once a day for mosquitoes (unspecified) in 2003 or 2004.  Medical history includes severe pain and rash post vaccination with diphtheria tetanus and pertussis (Dtap), at age 37 years.  Laboratory test included small fiber biopsy (positive), C-reactive (high), aspartate aminotransferase (AST; high) and alanine aminotransferase (ALT; high), done in JAN2019 and routine blood work, with result high white blood cells (WBC), done in JUN2019.   Company comment: In this case, the consumer received Biothrax vaccine in 2003 following which the event rash was reported in 2011 and the events "her fingers could not grab small objects, she had pain in muscles, pain in joints, numbness, tingling, dizziness/ brain fog , sleep disturbance, bowel issues, rash, memory issues, and stiffness lasting an hour in morning" were reported in 2016. Based on case scenario, considering multifactorial etiology and significant medical history the causality if the events is assessed as unlikely related to intake of Biothrax.; Sender's Comments: Company comment: In this case, the consumer received Biothrax vaccine in 2003 following which the event rash was reported in 2011 and the events "her fingers could not grab small objects, she had pain in muscles, pain in joints, numbness, tingling, dizziness/ brain fog , sleep disturbance, bowel issues, rash, memory issues, and stiffness lasting an hour in morning" were reported in 2016. Based on case scenario, considering multifactorial etiology and significant medical history the causality if the events is assessed as unlikely related to intake of Biothrax.