Age: 15.0
Sex: F
Vaccine: HEPA, MEN
Symptoms: Laboratory test normal, Lip swelling, Lymphocyte percentage decreased, Nausea, Neutrophil percentage increased
Clinical narrative: This is a report from a study. A 15-year-old female subject received blinded study vaccine (meningococcal group b rlp2086/hepatitis A virus vaccine) on 07Jun2013 at 17:12 and presented with event acute anaphylactic reaction on the same day at 19:55. The reported subject's medical history included allergy to KEFLEX, Beta thalassemia minor tract, anxiety and depression. Concomitant medication included ZOLOFT. On 07Jun2013 at 17:12, the subject received her first dose of blinded study vaccine (meningococcal group b rlp2086/hepatitis A virus vaccine) intramuscularly in her left arm. No acute reaction occurred within 30 minute. The patient stated she felt fine and was discharged at 17:45. She then went straight home, didn't eat or drink anything and was not exposed to anything unusual. On the same day, around 19:55, 40 minutes prior to hospital Emergency Room arrival and 2 hours and 45 minutes after vaccination, the patient complained of lip swelling, heart racing, chest hurting, stomach ache with nausea. At 20:35, in the ER, the patient was found with upper lip slightly swollen, tachycardia, palpitations, chest pain, headache, tingling in hands, abdominal pain and nausea. Physical exam in the ER was notable for no respiratory distress. Vital signs on presentation: blood pressure (BP) 138/88 heart rate (HR) 140 20 respirations per minute, Temperature 98.4F. O2 Saturation was 99%. Repeat vital sings in the ER included BP 100/58, HR 95 at 22:00 and BP 106/57 HR 97 at 23:30. EKG indicated sinus tachycardia with a rate of 140 beats per minute. Relevant laboratory tests included WBC 23.3k/ul with neutrophils 85.1% and Lymphocytes 7.0%, normal serum chemistry, C-reactive protein 6.00 mg/dL, Serum albumin 5.2 g/dL, Rapid Influenza A and B negative, Rapid strep A test negative and Urinalysis was 4+ blood with leukocytes. The patient was treated with BENADRYL at 20:55, SOLUMEDROL at 21:10, ZANTAC at 21:12, all per IV and was put under cardiac monitoring. The patient was discharged home from ER on 08Jun2013 at 00:41. Upon discharge she was noted to be without pain with skin warm and pink. Discharge vital signs were BP 98/49, HR 95, RR 29, Temperature 98.4F, O2 Saturation 97.7. (Baseline BP in April 2013 was reported as 102/74). The patient was discharged on oral prednisone 40 mg for 5 days and diphenhydramine 25mg orally as needed. The subject received the first vaccination dose at visit 1, and then was withdrawn from the study prior to receiving any further vaccinations, so they did not complete the immunization schedule. The investigator considered the event acute anaphylactic reaction serious life threatening, and related to study drug but not related to clinical trial procedure and concomitant drug. On 14Jun2013 the blind code was broken by the Sponsor due to serious, related, unexpected event. Follow-up (31Oct14): new information includes: action taken changed from not applicable to permanently withdrawn. Follow-up (21Nov2014) New information includes: additional relevant lab tests from 07Jun2013.