Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Insomnia, Laboratory test abnormal, Lyme disease, Menstrual disorder, Metabolic disorder
Clinical narrative: This spontaneous report was received from the patient's mother via website concerning her daughter an 11 year old (currently 15 years old) female patient with corrective lens user. The patient's medical history included oophorectomy on 20-FEB-2011. It was reported that her recovery was smooth and she was released and referred to the adolescent doctor for follow-up care. On 30-MAR-2011, the patient was vaccinated with the first dose of GARDASIL, (strength, dose, route and anatomical location were not reported), (lot# reported as 1437Z). Concomitant therapy included unspecified oral contraceptive. It was reported that after the paediatrician's office the patient felt sick of her stomach and when she got home she was nauseous and bloated. The reporter called the doctor and was told it all stemmed back to the surgery because she had removed her left ovary and probably she was having side effects from the anaesthesia that was used during the surgery. The following four months she continued to have severe abdominal pain, bloating, nausea and felt full after just a few bites of food. The reporter called again to the physician and she was told that because of the removal of patient's left ovary removal "she was feeling her body adjusted to what her insides were adapting to with more room" and that was normal and was no cause of concern. On 08-AUG-2011, the patient was vaccinated with the second dose of GARDASIL, (strength, dose, route and anatomical location were not reported), (lot# reported as 1271Z). It was reported that they did not indicated the symptoms the patient already have because they already had knowledge of them. For the next four months the symptoms did not improve. Every time the patient ate she felt sick and also she was always nauseous and her stomach was already bloated. On 12-DEC-2011, the patient was vaccinated with the third dose of GARDASIL, (strength, dose, route and anatomical location were not reported), (lot# reported as 1261AA). The patient continued to have the severe abdominal pain, bloating, nausea, feeling full, headaches came and went and on 12-DEC-2011, she was not sleeping well. The reporter consulted again with the doctor and a computerized tomogram (CAT scan) was performed in order to verify if the right ovary was right, the reporter also requested to the doctor to perform a CA 125 blood test which detect early signs of ovarian cancer however, the physician indicated that it was not accurate due to the patient's recent oophorectomy. The result of the computerized tomogram was normal and every looked fine then, they were told to hydrate and made sure the patient moved her bowels. Additionally, they changed the oral contraceptives thinking that would help to relieve some of the patient's symptoms. All of 2012, the patient continued with the symptoms. The patient constantly complaint about aches and pains in arms and legs and also she was feeling abnormal. At the end of 2012, they consulted an Obstetrics and Gynecology because the patient kept complaining with all of the symptoms all of the last year. The new physician and ordered a magnetic resonance imaging (MRI) and double check that everything was okay. The reporter also stated that to that date the patient had never had a Pap screening concerning her cervix or uterus. The MRI was normal and the physician put her on another new contraceptive and said that low oestrogen would help with the pain and headaches. On the other hand, it was reported that since the oophorectomy the patient did not have a normal cycle and she would bleed maybe a day and it was always black blood. The physician said it was normal due to the contraceptives and always reassured her that everything was fine. The whole year of 2013, the patient continued with the pain and the physician's said to them to keep the patient hydrated, that her bowels moved and that was the contraceptives or normal teenage hormones. Her medication was changed several times trying to see if the symptoms improved however it never did. By the end of 2013, the patient complaint about her vision, due she wore prescription glasses the reporter made an appointment to have her eyes checked out. On an unspecified date in January 2014, it was reported that the patient's vision changed and a new contact and glasses were prescribed by the optometrist who never questioning anything out of the norm when examining the patient. On an unknown date in 2014, the patient's headaches were increasing and not leaving her at all and she also still suffered from the severe abdominal pain, bloating, feeling full and nausea. Moreover, she was now having blurred vision even with her new prescription. They consulted with physicians on an unknown date and they were told that contraceptives would cause eye issues and it was nothing they could do. On the other hand, on an unknown date in 2014, the patient experienced bladder spasms and felt like she always had a bladder infection. A physician's sample her urine and they were told that just traces of white blood count and that the patient did not have an infection. The patient also experienced sharp shooting pains down through her groin and her right hip was always hurting. On an unspecified date in February 2014, the patient experienced a feeling as though she wanted to pass out, was not able to keep her breaths regulated and the reporter was told to keep the patient hydrated. On an unknown date in 2014, the patient's headaches and her other symptoms became more severe, also she started acting like she was afraid to do anything by herself. The headaches got so severe that on an unknown date in 2014 they were to the emergency room. Right away they saw the patient's optic nerves were swollen and they called to the ophthalmologist who confirmed it. They performed a computerised tomogram (CT) of head which was normal so they were told to go to the office the next day for more abrasive testing. Next day (unspecified date) all test were normal. Then, they were told to go back in a month for a re-check and if the optic nerves were still swollen and the tests were normal, it was birth defect. On an unknown date in 2014, the patient was sleeping more and she acted like she was still afraid of everything, she won't even walk by herself from the car to a friend's front door, she was becoming anxious and having lucid dreams. Furthermore, she was having trouble to sleep, pain was all over her body and could not support her own weight, she had tremors in her hands, legs and face, her hands and feet kept going numb, she was having low grade fevers and all the symptoms she had had for the last three years had increased. The patient came from the school exhausted, she fell asleep right away and woke up in more pain than before. The patient indicated that it was so hurting so bad at school that she had a hard time concentrating and understanding what the teachers was saying. As she walked to each class she said she felt as though she was going to pass out. She was still having severe back pain and new pain going down into her legs. Additionally, lights hurt her eyes while inside and when she stepped outside that pain shoots through her head making it difficult to see, lights were too bright all over and the sun was a torture. Her legs were having more spasms and her heart kept racing even when she sitting still. She started to just stare off into the space and writing words over and over in her school work like she was stuttering, not realizing it until she read her work. On an unknown date, the patient was diagnosed with Lyme disease, metabolic disorder, immunodeficiency and encephalopathy, chronic gastritis with pre-cancerous cells throughout her stomach and colon, and ovarian failure. It was also reported she had several active virus within her system which included Bartonella, Babesia, Coxsackie B, Francisella tularensis, and human papilloma virus (HPV) -6. Moreover, it was reported that the patient was "heavily toxin" with heavy metals that did not want to left her body and she was receiving treatment and trying to detox her body. The outcome of Lyme disease, metabolic disorder, immunodeficiency and encephalopathy, chronic gastritis with pre-cancerous cells throughout her stomach and colon, ovarian failure, several active virus within her system and pain in hip was unknown. The outcome of metal poisoning, bladder spasm, she was not sleeping well, abnormal behaviour, optic nerves were swollen and lights hurt eyes was reported as not recovered/not resolved. The reporter considered the events described above to be related to GARDASIL. Upon internal review, encephalopathy was determined to be medically significant. Additional information has been requested.