Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Alanine aminotransferase increased, Antibody test negative, Aspartate aminotransferase increased, Blood culture negative, Borrelia test negative
Clinical narrative: Case number PHHO2015US004372, is an initial report received on 16 Mar 2015, from clinical study. This 18-year-old male subject was enrolled in a study. The subject's medical history included asthma. Concomitant medications were not reported. On 06 Sep 2014 at 09:33, the subject received the study vaccine MenB. It was reported that the subject had just returned from a 5-day camping trip with other college students. Approximately at 18:50 hrs the subject was taken to the ER room due to fever, myalgia, malaise and mild neck stiffness. In the emergency room, the subject recovered from the event neck stiffness. The subject was noted with temperature of 101-102 F. ER physician suspected possible meningitis. On the same day lumbar puncture was performed and CSF analysis was not consistent with meningitis. CSF showed WBC-1, glucose was normal, protein was normal and culture showed no growth. On the same day the subject was admitted to the hospital for overnight observation. The other investigations included WBC: normal with normal differential, platelets: normal, ALT was 71, AST was 46 (mildly elevated), blood culture showed no growth, urine analysis was normal, Lyme disease antibody titre was negative, Wright's stain for Ehrlichia showed negative, Ehrlichia IgG antibody titre was <1:64, blood smear showed normal and West Nile virus IgG and IgM antibodies showed negative. On 07 Sep 2014, the subject was discharged from the hospital with a diagnosis of likely tick borne illness and was prescribed with doxycycline as a treatment. On 07 Nov 2014, a follow up serology for tick-borne illness was performed (considering subject's history of a recent camping trip), which included Lyme EIA test which returned negative, Rickettsia rickettsii IgG showed negative, Ehrlichia chaffeensis IgG showed negative, Anaplasma phagocytophilum IgG was negative and Babesia microti AB IFA was negative. It was reported that these negative antibody results, 8 weeks following symptom onset argue against the earlier presumptive diagnosis of a tick-borne illness and hence the symptoms myalgia, malaise and fever were considered as serious (hospitalization). The event mild neck stiffness was considered as non-serious. It was reported that as per the hospital admission notes that the neck stiffness had resolved in the emergency room and it was not included in the treating physician's assessment as an important factor in the clinical decision making and was not indicated as a reason for the hospital admission. The investigator did suspect a causal relationship between the events and study vaccine. Investigator stated that since all antibody tests for tick-borne illness were negative, this suggests that the subject's symptoms were possibly related to rMenB vaccine based on the timing of onset and the absence of an identified alternative cause. Follow up received on 23 Mar 2015, prior to the circulation of previous report: Clinical information related to the seriousness of the event neck stiffness was updated.