Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Major depression, Suicidal ideation
Clinical narrative: Initial solicited report received on 19 May 2015 from an investigator participating in a study. A 12-year-old female subject was diagnosed with major depression disorder on 08 May 2015 i.e. 72 days after receiving a first intramuscular dose of blinded therapy in the right deltoid region on 25 February 2015 (batch number: M14024). The event appeared after visit 2. The subject's medical history was not reported and the family history included depression, anxiety, and suicide attempts. Onset of symptoms was gradual and the symptoms might be related to recent death in the family. The subject had no concomitant therapies. The subject had a symptom of suicidal thoughts of 08 May 2015. On 08 May 2015, the subject's parent called with concerns about suicidal thoughts of the subject via a letter. The subject was hospitalized on 10 May 2015 for suicidal concerns due to extreme depression. The subject was admitted to local hospital for 5 days of care and then seen at the time of report at the clinic for follow-up care. The subject was with family and was given outpatient treatment. The subject was receiving medications and counseling. The lab data was not reported. The subject's corrective treatment included PROZAC in the hospital and then placed on Diazepam at the time of report by the provider and continued with outpatient counseling. The event of major depression disorder along with symptom suicidal thoughts were ongoing at the time of report. The subject was discharged from the hospital on 14 May 2015. According to the investigator, the event was not related to the study vaccine or trial procedures. Relationship to investigational product according to company: not associated. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: none. Follow up information received on 22 May 2015. It was confirmed that the event was not related to the study vaccine. Follow up information received on 04 June 2015: The event term was updated to major depression disorder-suicidal indeation from major depression disorder. It was reported that the subject will be following up with therapist and medication provider. The subject had no complementary investigations. Follow up information received on 26 August 2015 and 27 August 2015. The event of major depression disorder-suicidal indeation was resolved on 31 July 2015. Follow up information received on 03 September 2015. The event term was updated to suicidal indeation from Major depression disorder-suicidal indeation. It was reported that the subjects discharge diagnose was Major depression disorder which was not supported by the 'PCP' or events that lead to hospitalization. The subject had just lost grandparents; this is more related to the recent death. At the time of the report subject had no previous issues with depression and on no medications currently. Follow up information received on 12 September 2015: The symptom  of suicide thoughts was resolved on 31 July 2015. Follow-up information received on 25 September 2015: The event term was updated to suicidal ideation from suicidal indeation. The term PCP was elaborated as primary care physician. Follow up information received on 06 October 2015: The diagnosis was updated to major depression disorder (previously reported as suicidal ideation).