Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope, Systemic lupus erythematosus rash, Tremor
Clinical narrative: Based on additional information received on 28 January 2016, this case initially considered as non-serious was upgraded to serious due to important medical event. Initial unsolicited report received from a physician on 21 December 2015. This case involves a 15-year-old female patient who was vaccinated with an intramuscular first dose of MENACTRA (batch number, dose and site of administration was not reported) on 16 December 2015. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. The patient did not receive any concomitant medication. On 16 December 2015, same day following the vaccination, the patient's face flushed she slumped over to her side and couldn't speak and had no memory of about 3 minutes. They laid her on the table flat. The patient was examined by nurse and she was conscious at the time of examination and when they tried to   raise her up form table after 5 minutes, she was unable due to dizziness. After 45 to 60 minutes she was able to leave the office with her mom but, had a headache. It was reported that five days post vaccination patient still had headaches. The patient required Emergency room or doctor visit. BP (blood pressure) was 92/58, heart rate was 84, saturation was 99 percent on RA. Other laboratory test was reported as none. Treatment plan was not provided. The patient had not recovered from the events (face flushed, dizziness and headache) and recovered from the events fall, speech impairment NOS and memory impaired. Follow up information received from a physician on 28 January 2016. Lot number updated as U522BBA and vaccine was administered on the left arm. Patient had a history of chronic asthma and she was born via full term vaginal delivery weighing seven pounds and 11 ounces and did have some jaundice. Mother had fibromyalgia, was on NEXIUM and had hypertension. On 16 December 2015, few minutes following the vaccination patient shook, grown, limped to left side, had stiffness, was stiff as a "board", low blood pressure, had loss of consciousness (LOC). After five minutes she was talking but 20 minutes later was back to baseline. It was reported she had tonic movements. On an unspecified date, three days following the vaccination patient experienced difficulty focusing, red rash on face. Headache was deep and achy not throbbing (4/10 CDH). Rash was worse and headache occurred 2-3 times per day. On an unspecified date, following the vaccination patient also experienced facial rash, lupus-type rash/ /SLE type rash, low BP, she fell, had vasovagal syncope/syncope. Laboratory investigation involved BMI: 24.39, Bovine Serum Albumin (BSA): 1.65, BMI percentile 86% 2-20 weight percentile 80%, 2-20 stature percentile 38% Blood pressure 136/79, LUE sitting, heart rate (HR) 129 b/min, head circumference 54.5 cm, patient upset, cried when talked BP due to being nervous. Corrective treatment included Medrol, Pulmacort and Zapenex. Outcome of events was not recovered for the events vasovagal syncope/syncope, stiffness/stiff, tonic movements, facial rash, lupus-type rash on her face and outcome of event was recovered for LOC, low BP and shook and limp to the left side, falling and outcome was unknown for difficulty focusing. Upon internal review, the company decided to consider the event tonic movements as serious because of important medical event. List of documents held by sender: none. Sender's Comments: Syncope and tonic seizure is expected following MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Time to onset after vaccination is compatible Syncope may evoke partial seizure. However, in absence of final diagnosis no conclusion can be drawn.