Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, HPV9, MNQ
Symptoms: Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging spinal normal, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: She can't see and eyes hurt./ headaches. dizzy./ Postural Orthostatic Tachycardia Syndrome; stomach ache, nausea and vomiting, has no appetite./ gastro paresis; Ankle pain./ small ganglion cyst./ CRPS; a pop in right hip area./ right anterior iliac spine avulsion fracture; This information was obtained on request by the Company from the FDA (Agency#803689) under the Freedom of Information Act on 26-SEP-2019.  This spontaneous report was received from the parent/guardian or caregiver and refers to a 11 year old white female patient. The patient's concurrent conditions included allergy to cefalexin (KEFLEX) and amoxicillin (+) clavulanic acid (AUGMENTIN). The patient's concomitant therapies included desmopressin, amphetamine aspartate (+) amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate(ADDERALL XR), fluticasone propionate(FLONASE), unspecified multivitamins, ibuprofen and acetaminophen(TYLENOL).   On 29-FEB-2016, at 11:15, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # L007560 with expiration date on 15-JUN-2017 and meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) with lot# U5179AA; both  intramuscular for prophylaxis. On the morning of 22-MAY-2016, the patient stated to her mother "I forgot to tell you, I hurt my ankle yesterday" (complex regional pain syndrome); and on the top of the right foot and ankle area was bruised and swollen; however, she didn't remember what she did while actively playing with her cousins outdoors. At the time, they elevated the right foot, applied ice and gave her ibuprofen.  On an unknown date, in 2016, the patient was seen by a doctor, since pain was getting worse. X-rays were completed and were normal and a splint was placed in the ankle with an advised for a week on crutches for non-weight bearing for the ankle sprain.  On 28-JUN-2016, the patient was seen because of the continued ankle pain and placed on a walking boot and a recommendation of a Magnetic Resonance Imaging (MRI). On 13-JUL-2016, the patient was seen for continued ankle pain and steroids injections were done with pain relief for 2 days and then, pain returned. On an unknown date, in 2016, MRI  was completed, and the report read a small ganglion cyst with the sinus tarsi arising from the anterior subtalar joint. On an unknown date, in 2016, ultrasound therapy and kinesio taping were performed for the swelling in the right ankle. On 15-AUG-2016, the patient had a physical therapy appointment and the physician assessed that pain was in the area of the typical sock area of the right foot and discontinued ultrasound therapy as it was not benefit for her. The patient was treated with a graston instrument and commented the concern about needing to get blood flow to the foot as was wearing the boot since June. On an unknown date, in 2016, the patient loses her footing on a playground equipment ladder and falls down about 4 feet and her right hip lands on the lip of a slide and then she tumbles down the slide with a heard pop in the right hip area and instant terrible pain (ilium fracture). Emergency Room (ER) visit with a x-ray completed showed a right anterior iliac spine avulsion fracture and was unable to extend leg or bear weight due to pain was put on a wheelchair. On an unknown date in 2016, the patient was seen by a pediatric orthopedic and another right ankle x-ray was completed. The physician did not feel she had a ganglion cyst and recommended a Computed Tomography (CT) and also wanted to wait for the avulsion fracture to heal before assessing further. The patient was left in a horrible unexplained pain in right ankle-foot and right hip area. On 03-SEP-2016, the patient saw a sports therapist who helped her out of the wheelchair and thought her to walk with crutches. On 06-SEP-2019, on her first day of school, the patient attended the whole day but was exhausted, in pain and tears when she was picked up from school. On an unknown date, in 2016, a CT scan right foot-ankle was completed. On 19-SEP-2016, the patient was home sick from school with stomach ache, nausea, vomiting and no appetite. On 20-SEP-2016, a letter was received from the physician, were CT was normal and would see her back again for ankle pain when the avulsion fracture healed. On 23-SEP-2016, the patient had a eye "Dr" appointment as she had been complaining that she couldn't see and the eyes hurt since April 2016. From 10-OCT-2016 to 14-OCT-2016, the patient was not able to participate in normal activities as she was on crutches and struggling with continued pain in right ankle and right hip area. On 31-OCT-2016, the patient had a follow up of the right ankle pain and when she was asked to walk without crutches, she dragged her right leg like someone who had a stroke. The physician noticed weakness and possible nerve involvement in right lower leg and was discussed as a possible a Complex Regional Pain Syndrome (CRPS). On 02-NOV-2016, physical therapy was started for the right leg weakness and pain with continuation 2-3 times a week for the next 2 months. On 03-NOV-2016, the patient arrived from school sobbing that her pain was not tolerable and complaining of pain in her right ankle, right hip and back. On an unknown date, in November 2016, MRI of lumbar spine was completed and an Electromyography (EMG) was completed under sedation. On 23-NOV-2016, a call informed them that all test were normal as a good new, however, as a bad new, they felt they had exhausted all they could do and recommended seeing a pain doctor for diagnosis of CRPS. From 27-NOV-2016 to 29-NOV-2016, the patient arrived from school with nausea, stomach pain and vomiting. On 03-DEC-2019, the patient was "again" up during the night with vomiting. The patient was unable to attend the competition with her team to support them. The patient spent most of the day in a chair with ear buds in place and she wanted her room quite and dim as started to not tolerate any light or noise as her head hurt with also pain in the back, right hip and right ankle-foot.   From 05-DEC-2016 to 07-DEC-2016, the patient arrived home again from school with nausea, vomiting, pain and headaches that seemed migraine like in nature. On an unknown date, a last minute appointment became available for a pain specialist and he disguised her with CRPS and the patient started to attend a pain program. On 14-DEC-2016, blood test for iron, vitamin D and feratin were performed with unspecified results. On 11-JUN-2017, a blood test for comprehensive metabolic panel and Creatin Kinase (CK) were performed with unspecified results. Over the next few months, the patient was able to regain function of her right foot-ankle and was able to get off crutches. The pain continued and struggled with nausea, vomiting, headaches and started to have issues with dizzy spells and ringing in the ears with 50 days of school missed between physicians appointments, test, physical therapy and ill days. On an unknown date, the patient was seen by a pediatrician gastroenterologist (GI), and after tilt table test, the patient was diagnosed with Postural Orthostatic Tachycardia Syndrome (POTS) and after a gastric empty test was diagnosed with gastroparesis. From January to May 2018, the patient had unknown treatments. The reporter stated, that before vaccination, the patient was a vibrant and healthy 11 year old, she was part of a competition at school, with many friends that she enjoyed spending time with. On unknowns dates, the following test were performed with not reported results; Blood test for Lyme serology, Antinuclear Antibodies (ANA), sedimentation rate, Complete Blood Cell Count (CBC), C-reative protein, Rheumatoid Arthritis (RA) factor.  At the reporting time, the patient suffered daily debilitating pain that spread all over her body with nausea, vomiting, dizziness, ringing in ears, lack of energy and difficulty sleeping were all part of her daily life with the outcome of the events as not recovered. The patient was no longer able to attend school and rarely saw friends and her life as she knew it had changed due to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and meningococcal acyw conj vaccine (dip toxoid)(MENACTRA); being the related the causal relationship between the events and vaccines. All the events were considered disability events.  Follow-up information has been received from a registered nurse on 16-OCT-2019.The reporter was unable to determine who the patient was and had no further patient identifiers. The nurse was provided the date of vaccination as well as the date of the events which was no further help. No further information was available.