Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Asthenia, CSF protein increased, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Could be Guillain -Barre syndrome; Paresthesia in his 4th and 5th toe; Protein Cerebrospinal fluid - 110.2; Weak as well; Balance is off/wobbles when he walks; Cramps throughout his body/calves fell like they are in knots; He has no strength; Hand grip was decreased; Lost 10 pounds in 2 weeks; Ambulating with a cane; This case was retrieved from a VAERS download on 14MAY2019.  A 24 year old male patient experienced multiple adverse events following the administration of BioThrax (anthrax vaccine adsorbed).  On26FEB2019, the patient received BioThrax, dose#3 (FAV570), intramuscularly in an unknown site.  On 27FEB2019, the patient noticed paresthesia in his fourth and fifth toe. His symptoms gradually worsened every day after. It is reported that he can hardly walk. The patient also reported having cramps throughout his body, especially when he turned his upper body and occurred anywhere from his mid-section to his whole back. It also included all over his chest as well.   On Sunday, the male patient had a normal MRI Brain and C-spine.  A cerebrospinal fluid sample was taken to measure protein and the result was 110.2. It is reported that "they thought is could be Guillain -Barre syndrome". The patient experienced weakness that started as a little weak in his legs and he really noticed it when his hand grip was decreased.  It has worsened and affected his entire body. It was reported he has no strength and everything is difficult, including lifting a book bag, using utensils, writing , fine motor tasks and walking. The patient wobbled when he walked and his balance was off. He experienced feeling like his calves were constantly in knots.  He began using a cane to ambulate. The patient lost 10 pounds in two weeks.  It was reported that the patient had no diplopia, bulbar symptoms, bowel/bladder incontinence, tick exposures or rashes.  The outcome at the time of report is unrecovered/unresolved.  No medical history or allergies reported.  Concomitant medications include "Creatinine Powder; protein supplements - stopped taking 28 Feb once illness started".  Company Comment: This report originated from the VAERS database and no further information is currently available. The provisionary diagnosis of Guillain-Barre Syndrome is not listed as a known event to follow BioThrax or any other non-live vaccine. The symptoms including asthenia, muscle spasms, balance disorder, muscular weakness paraesthesia, gait disturbance with use of walking aid, decreased grip strength and increased cerebrospinal fluid protein increased were reported to have begun appearing 1-day post immunization with BioThrax and continued to progress. Guillain-Barre Syndrome is an auto-immune disorder that typically follows within days or weeks of a respiratory or digestive tract infection. It is rarely triggered by surgery or immunizations. The time frame of 1 day from vaccination to onset is noted to be short. The provisional diagnosis of Guillain-Barre is not medically confirmed and there are no medical records or history to evaluate whether the patient had a recent infection prior to immunization. A definitive causality assessment cannot be made nor can its relationship to BioThrax cannot be excluded; therefore causality is deemed possible.  Follow-up information received on 21JUN2019: An internal investigation was completed for lot FAV570.  A review of production documentation related to BioThrax lot FAV570 noted no issues or deviating events that had impact to critical process parameters of critical quality attributes.  All requirements for lot release were met and the lot was released for distribution by Quality Assurance. No signals have been identified for the event of Guillain-Barre, nor have there been any safety issues identified for lot FAV570.  Company Comment: In follow-up received 21JUN2019, an investigation of the involved lot (FAV570) revealed no findings; all requirements for lot release were met.  The overall causality assessment remains unchanged (possibly related).; Sender's Comments: This report originated from the VAERS database and no further information is currently available. The provisionary diagnosis of Guillain-Barre Syndrome is not listed as a known event to follow BioThrax or any other non-live vaccine. The symptoms including asthenia, muscle spasms, balance disorder, muscular weakness paraesthesia, gait disturbance with use of walking aid, decreased grip strength and increased cerebrospinal fluid protein increased were reported to have begun appearing 1-day post immunization with BioThrax and continued to progress. Guillain-Barre Syndrome is an auto-immune disorder that typically follows within days or weeks of a respiratory or digestive tract infection. It is rarely triggered by surgery or immunizations. The time frame of 1 day from vaccination to onset is noted to be short. The provisional diagnosis of Guillain-Barre is not medically confirmed and there are no medical records or history to evaluate whether the patient had a recent infection prior to immunization. A definitive causality assessment cannot be made nor can its relationship to BioThrax cannot be excluded; therefore causality is deemed possible.  Company Comment: In follow-up received 21JUN2019, an investigation of the involved lot (FAV570) revealed no findings; all requirements for lot release were met.  The overall causality assessment remains unchanged (possibly related).