Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Eye pain, Headache, Laboratory test normal, Malaise, Middle ear effusion
Clinical narrative: Information received on 01MAR2016 and 08MAR2016 from an employee. In February 2016 a 28 year old male was diagnosed with Autoimmune (Auto-Inflammatory) Syndrome. In November 2014, ten days after his immunization with BIOTHRAX the subject experienced a global headache, with nausea, occasional dizziness, double vision, and general feeling of being unwell. He also noted weakness with slowed reaction times. At the same time he experienced symptoms of nasal congestion, post-nasal drip, and fluid in his ears for which he was seen in the Urgent Care facility. It was noted that his blood pressure was elevated during his exam. He was treated with Claritin OTC and HCTZ 25 mgs, eventually discontinuing HCTZ and starting lisinopril 10 mgs daily. (Events previously reported in 14AV00017SP). During the next few months his blood pressure was stable on medication and his ear and nose symptoms resolved, while the symptoms of global headache, with nausea, weakness, slowed reaction time and general feeling of being unwell persisted. The double vision and dizziness were intermittent. He experienced pins and needles feelings in his right hand, shoulder and elbow in February 2015. An EMG performed at this time was reported as normal. In May 2015 he received dose number 3 of BIOTHRAX and reports that he does not recall a flare in symptoms at that time. He remembers feeling well through the summer of 2015, though noted he experienced the pins and needles feelings in both hands and arms and in both feet and legs in August. He reports these feelings usually beginning with weakness and progress to pins and needles. The feelings last for several hours when they occur. All symptoms returned at about two weeks following receipt of dose number 4 of BIOTHRAX and a seasonal flu vaccine administered on same day and time on 23NOV2015. The complaints continued intermittently through the winter of 2015/2016. In January 2016, he experienced muscle cramps in both lower calves and in February 2016 he experience a burning stabbing sensation in the right quad muscle, lasting for minutes at a time and recurring intermittently over a three day period. On February 5th, 6th, 7th, 14th, and 21st of 2016, he experienced symptoms of weakness, dizziness, pain behind both eyes, headaches, hand pain, nausea, and vertigo. Each day was accompanied with varying symptoms that lasted for minutes to hours. In January 2016 several laboratory tests (blood and urine) were performed and reported to be normal, with the exception of an elevation of blood creatine phosphokinase (CPK) results and low vitamin D3 results. In February 2016 an MRI was performed and reported as negative for signs of multiple sclerosis. On 29FEB2016 he was referred to a rheumatologist who diagnosed him with Autoimmune (Auto-inflammatory) Syndrome Induced by Adjuvants (ASIA). Vaccine received include: Seasonal influenza vaccine on 17OCT2014; BIOTHRAX vaccine dose #3 on 19NOV2014; Tetanus vaccine on unknown date in 2015; BIOTHRAX vaccine dose #4 on 13MAY2015; Seasonal influenza vaccine on 23NOV2015; BIOTHRAX vaccine dose #5 on 23NOV2015. Treatment medications included Alpha lipoic acid, Vitamin D3,  glutathione, acetylcysteine, Omega 3 (fish oil), MOBIC, Flonase, Claritin, naltrexone, and Dim Detox (nutritional supplement). Concurrent medical conditions reported as historical condition of snoring (14AV00017SP). Concomitant medications reported as none. Relevant laboratory / diagnostics: February 2015 electromyogram (EMG) reported as normal; February 2016 nuclear magnetic resonance imaging (MRI) reported no signs of multiple sclerosis (MS); 15DEC2015 blood creatine phosphokinase (CPK) elevated; blood 25-hydroxycholecalciferol (Vitamin D2 and D3) reported low. All other laboratory tests reported as normal. Additional information is expected. Sender's Comments: This report was received from an employee through the on-site Immunization Clinic.  The information received represents a complicated medical scenario with a provisional diagnosis of autoimmune disorder.  The subject received multiple vaccinations over a extended period of time. Pending additional medical information, the relationship to BIOTHRAX is not assessable.