Sex: M
Vaccine: HEPA, HPV4
Symptoms: Asphyxia, Completed suicide, Hanging, Toxicologic test normal
Clinical narrative: Respiratory failure; Acute central respiratory depression; Hostility; Aggression; committed suicide; asphyxiation by hanging; Information has been received from a physician concerning an 18 year old male patient with acne and no drug allergy or reaction who on 16-MAY-2011 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot number 668554/0306AA; Expired date: 10-MAY-2013) and a dose of hepatitis A vaccine (inactive) (MSD) (Lot number: 670377/0126AA; Expired date: 07-DEC-2013, dose in series unknown). On 22-JUL-2011, the patient received the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot number 668262/0841AA; Expired date: 18-APR-2013). Concomitant therapy included sulfamethoxazole/trimethoprim (SEPTRA).   Follow up phone call from the physician was received. The physician reported that the patient had no medical history. The last time he saw the patient was on 22-JUL-2011, when the patient received his second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The physician also reported that there was no indication from the patient that he was troubled. On 27-JUL-2011  the patient committed suicide. The cause of death was asphyxiation by hanging. The death report that the physician received was that the patient had a normal examination. The Toxic screen indicated that there were no medications involved in the patient's death. The patient's mother had asked the physician if HPV rL1 6 11 16 18 VLP vaccine (yeast) could have caused her son to commit suicide. The physician reported to the patient's mother that he did not feel that HPV rL1 6 11 16 18 VLP vaccine (yeast) was the cause of her son's suicide. The physician stated that he was not aware of any reported deaths by suicide that were related to HPV rL1 6 11 16 18 VLP vaccine (yeast).   A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question (670377/0126AA, hepatitis A vaccine (inactive) (MSD)) were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to  release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.  A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question (668262/0841AA, HPV rL1 6 11 16 18 VLP vaccine (yeast)) were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.  A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question (668554/0306AA, HPV rL1 6 11 16 18 VLP vaccine (yeast)) were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and  Research and was released.  Additional information received from the nurse practitioner who reported the patient was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) intramuscularly, 0.5 ml, second dose. It was also reported that it was "2 days after patient was given his second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) ", patient committed suicide. The reporting nurse considered "committed suicide" to be immediately life-threatening and disabling.  Addittional information has been received from a physician through a social media. The reported said that the standardized MedRa Queries (SMQ) were Suicide/Self-injury (Narrow), acute central respiratory depression (broad), hostility/aggression (broad), respiratory failure (broad). At the time of his death, the outcome of the events of acute central respiratory depression, hostility/aggression, and respiratory failure were unknown.   The causality assessment between the suspect vaccines and acute central respiratory depression, hostility/aggression and respiratory failure were not reported.; Sender's Comments: , MERCK1110USA00917:Mfr number; Reported Cause(s) of Death: asphyxiation by hanging; committed suicide