Age: 25.0
Sex: F
Vaccine: MEN
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lethargy, Lumbar puncture normal
Clinical narrative: This is a report from a study. This 25-year-old female patient with a relevant medical history of depression and allergy to BENADRYL and pseudoephedrine, received her first dose of vaccination (rLP2086 or placebo) on 20June2013 at 13:00. About one hour later, she developed moderate pain, swelling and redness at the injection site. Two hours later, she felt lightheaded and dizzy. The subject was put in supine position and had her legs elevated. Her blood pressure was 156/95 mmHg and body temperature was normal but she had an increased respiratory rate: 28br/min and tachycardia (heart rate increased from 80 beats per minute to 165 beats per minute). The patient was then noted to have tetanic contraction of her upper extremities. Paramedics were called and she was brought to Emergency Room. She was still experiencing the contractions when she was brought to the emergency room. The subject presented to the emergency room with disorientation, numbness and tingling in hands and feet and rapid breathing. In the ER, she began to have shaking in upper and lower extremities. At 17:36 in the emergency room vital signs were as follows: blood pressure: 151/65 mmHg, heart rate: 165 bpm. The subject neurological assessment was reported as follows: Lethargic. No focal signs. Early warning scores Central Nervous System: Level of consciousness=1 (to voice only). Eye opening=3 (to verbal command), Verbal response=5 (Orientated), Motor response=6 (obeying commands appropriately). Total Glasgow coma score = 14. Orientation: oriented to all. CT scan brain and spinal tap were performed and reported as normal. Initial blood work revealed increased WBC to 21,000 with a mild left shift. She was treated with morphine, HALDOL, and lorazepam. The patient was admitted to hospital for observation, was given IV fluids and monitored. She had an uneventful course overnight. The subject was being discharged when feeling of shaking returned. The subject was monitored for another six hours before being discharged on 21Jun2013. Relevant tests include: white blood cells (20Jun2013): 21.8 K/mm3; segmental neutrophils (20Jun2013): 87%; Lymphocytes (20Jun2013): 8%; Monocytes (20Jun2013): 4%; Eosinophiles (20Jun2013): 0%; Basophiles (20Jun2013): 0%; white blood cells (21Jun2013): 13.5 K/mm3, white blood cells (22Jun2013): 12 K/mm3. Concomitant treatment included PROZAC since 2007 The patient recovered on 21Jun2013. The hospital discharge diagnosis was "adverse drug reaction to dystonic type 2 vaccine for meningitis". On 22Jun2013, the subject returned to the emergency room due to body shaking, tachypnea, tachycardia and anxiety. The action taken with study product due to the SAE was: permanently withdrawn. The investigator considered the event serious for hospitalization and that there was a reasonable possibility that the event dystonic reaction (adverse drug reaction to dystonic type 2 vaccine for meningitis), was related to rLP2086 or placebo, clinical trial procedure, but not related to concomitant drug. On 28Jun2013 the blind code was broken by the Sponsor due to serious, related, unexpected event. Follow-up (02Jul2013): New information received from the investigator includes: course of the event, treatment and lab data. Follow-up (09Jul2013) and follow-up (12Jul2013): New information received from the investigator includes: updating on SAE term to adverse "drug reaction to dystonic type 2 vaccine for meningitis" and outcome. Follow-up (22 Aug2013): New information received from the investigator includes lab data. Follow-up (16Sep2013): New information includes: details on diagnosis. Follow-up (04Oct2013): New information received from the investigator includes: updating on subjects medical history and on recovery date. Follow-up (15Jan2014): New information received from the investigator includes: action taken with study product due to serious adverse event. Follow-up (12Feb2015): New information received from the investigator includes: updating on subjects medical history and vital signs.