Age: 58.0
Sex: F
Vaccine: RAB
Symptoms: Cardiomegaly, Chest X-ray abnormal, Computerised tomogram head normal, Depression, Electrocardiogram normal
Clinical narrative: Initial report received on 14 August 2013 from an investigator participating in a study. A 58-year-old female subject had attempted suicide on 03 August 2013 i.e. 18 days after receiving fifth intramuscular dose of the Purified Vero Rabies Vaccine - Serum Free (VRVg) in the left deltoid on 16 July 2013 (Batch number not reported). The subject received first dose of the Purified Vero Rabies Vaccine - Serum Free (VRVg) on 18 June 2013, second dose on 21 June 2013, third dose on 25 June 2013 and fourth dose on 02 July 2013. The subject had no relevant medical history. The subject had concomitant therapies with ATIVAN on 03 August 2013, per OS, dosage: unknown, indicated for suicide attempt. During Visit 7 performed on 13 August 2013 at 11:30am, the subject reported that she was admitted to the hospital on 03 August 2013 because she attempted suicide by taking 29 ATIVAN pills, all at once on that same day. She had depression on 03 August 2013. It was pending to receive medical records in order to provide more information including that on lab investigations. The subject was prescribed LEXAPRO 20mg PO QD. The subject had not started taking this medication because she does not have any medical insurance at that moment. It was pending to receive medical records in order to provide more information. The subject was discharged from the hospital on 09 August 2013. The event of attempted suicide along with associated symptom of depression were ongoing at the time of report. The event of attempted suicide was not related to the study vaccine or to the trial procedure. 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 17 September 2013 and 18 September 2013: The subject was admitted to the hospital on 04 August 2013 and not on 03 August 2013 as reported earlier. Medical records were received on 17 September 2013. The subject was treated with intravenous fluids and oxygen. She was administered LOVENOX x1, LEXAPRO and TYLENOL x1. The subject started taking LEXAPRO 20 mg PO QD to treat her depression since 15 August 2013. ECG showed normal sinus rhythm, lab results were not clinically significant, CT brain- negative, chest x-ray- showed cardiomegaly. The event of attempted suicide was resolved on 03 August 2013. Follow-up information received on 24 September 2013: It was reported that the subject was admitted to the hospital on 04 August 2013 because she attempted suicide by taking 29 ATIVAN pills at once on the previous day. The subject had corrective treatment with PROTONIX. Follow-up information received on 12 October 2013: It was reported that the subject was first diagnosed with depression on the day of the suicidal attempt. Follow-up information received on 25 November 2013: The investigator reported that after medical records were reviewed, it was confirmed that the subject attempted suicide on 03 August 2013. Subject was diagnosed with depression. Unblinding information received on 09 December 2013: The subject received IMOVAX Rabies on 16 July 2013. Upon second medical examination of case at time of internal review the unblinding information received date was modified to correct date 20 December 2013. Follow up information received on 05 February 2014: The symptom of depression was resolved on an unknown date in December 2013.