Age: 13.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Endotracheal intubation, Gait inability, Lung disorder, Malaise, Mechanical ventilation
Clinical narrative: Information has been received from an unspecified person via a company employee referring to a male patient of unknown age, who was perfectly healthy. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, lot #, expiration date and route not reported). On an unknown date, the patient was paralyzed after getting the GARDASIL shot. The patient was hospitalized for 88 days and had to be intubated. The patient's spinal cord remained inflamed and he needed to wear 15 pounds (lbs) breathing apparatus at all times. The outcome of the events was unknown. The doctors at the hospital had reported the events to vaccine adverse event reporting system (VAERS). The reporter considered the GARDASIL caused the events. Upon internal review, the events of "paralyzed and spinal cord remained inflamed" were considered to be medically significant. This is one of several reports received from the same reporter. Follow up information has been received via a company representative from a researcher who obtained the information from the web site on 16-JAN-2018. It was unspecified how many doses of the vaccine were administered. On an unknown date, the patient was hospitalized due to due to loss of some bodily functions (adverse event); the patient lost the ability to walk on an unknown date and had to learn to walk again. It was reported, that the patient never regained full function of his lungs, neck and right arm. It was unknown if the patient received any treatment or had any laboratory diagnostic tests performed for the events. On 08-JAN-2018, the patient died from an unknown cause. It was unknown if an autopsy was performed. The outcome of adverse event was unknown, the outcome of gait inability was reported as resolving and the outcome of lung disorder and musculoskeletal disorder was reported as not resolved. The causality between the events and GARDASIL was not reported. The events loss of some bodily functions, musculoskeletal disorder, lung disorder, and gait inability were considered as disability. Upon internal review, the death was considered as medically significant. Follow up information has been received from a consumer from a web site article referring to a 13 years old male patient on 23-JAN-2018. The patient was healthy, active and not sick before he received GARDASIL. The third dose of GARDASIL was administered on 01-FEB-2014. Approximately on 15-FEB-2014 (reported as about two weeks after), he experienced painful neck following the vaccine and was given TYLENOL to alleviate the pain. On the next day (16-FEB-2014), the patient after a motor-cross riding started to feel nauseous, become pale, and was not well that evening; he expressed that he could not use his right arm. On 17-FEB-2017, the patient was brought to the urgent care at hospital and the patient was almost completely paralyzed. The patient was hospitalized during 88 days. The patient was diagnosed with acute longitudinal transverse myelitis that affected vertebrae C1 (cervical-1) through T-12 (thoracic-12), which was a substantial portion of the entire length of the spinal column. Initially, the TM caused paralysis in patient's neck and right arm. Eventually, he lost function in his left arm and became paralyzed. The patient eventually had lost the ability to breathe easily, so he was intubated and a ventilator was connected to allow him to breathe. Over time, the paralysis spread through his body, and he eventually lost the ability to speak. The patient required therapy to avoid infections and pneumonia, hot and cold packs to help regulate body temperature and connection to a 7 kg (15 lb) ventilator. On 08-JAN-2018, the patient died from transverse myelitis and according to his parents from suicide, nausea, become pale and was not well. The reporter considered the event transverse myelitis to be not related to GARDASIL, besides the causality with the event suicide was not reported. It has been determined that case # US-009507513-1801USA006187 is a duplicate of case # US-009507513-1609USA002149 Therefore, case # US-009507513-1801USA006187 is being deleted from our files and the cases are consolidated into case # US-009507513-1609USA002149.; Sender's Comments: US-009507513-1609USA002304:, MERCK 1609USA002149:Mfr number; Reported Cause(s) of Death: Myelitis transverse; from suicide.