Age: 16.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MNQ
Symptoms: Hypersomnia, Insomnia, Lipase normal, Loss of personal independence in daily activities, Metabolic function test normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA # 674435) under the Freedom of Information Act on 10-MAY-2017 referring to a 16 years old male patient. The patient's medical histories included asthma and prior vaccinations. There was no current illnesses. Concomitant therapies included VENTOLIN INHALER (reported as VENTOLIN HFA INHALER), triamcinolone and MIRALAX. On 10-OCT-2016 the patient was seen for 16 year old physical and received GARDASIL 9 (lot # M013636, 1st dose, intramuscularly in the left arm, for prophylaxis), HAVRIX (lot # NT9K2, 1st dose, intramuscularly in the left arm), FLUZONE (lot# UT5629JA, intramuscularly in the right arm), and the second dose of MENACTRA lot # U5410AA (dose not provided) intramuscularly in the right arm. On 11-OCT-2016, the patient was seen at the emergency room (ER) with right (RT) flank pain. On 14-OCT-2016, follow up information was received from the ER: the patient was seen with RT flank pain on 11-OCT-2016. The patient felt warm and was sweating. Kidney-Ureter-Bladder X-Ray (KUB) showed stool and no other significant finding. Urine Analysis (UA) was normal. The patient was sent home on MIRALAX and COLACE. The child denied constipation. The patient also had runny stool since taking medication. The patient still had pain. No vomiting or urinary symptoms at that time. Complete Blood Count (CBC) performed in the office was normal, and UA in the office was also normal. CBC/UA was reassuring, but the child was still in pain. Symptoms had not changed, waking him up at night. The patient was referred to ER for further evaluation. On 14-OCT-2016, the patient was admitted and had extensive workup including blood test, urine test, and ultrasound. On 19-OCT-2016, Follow-up information Admission (14-OCT-2016 to 16-OCT-2016): the patient was admitted for RT flank pain. All lab results normal (CBC, Comprehensive Metabolic Panel (CMP), C-Reactive Protein (CRP), Erythrocyte Sedimentation rate (ESR), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transferase (GGT), Lipase, and UA). Computerized tomography (CT) scan, Ultrasound (US), Xray of the pelvis were also performed and revealed no abnormality. The patient had neuro, pain, and physical therapy (PT) consultations while hospitalized but was unable to determine etiology. The patient was sent home on muscle relaxant, MOTRIN, and lidocaine (manufacturer unknown) patch for symptomatic relief. The child still complained pain and was unable to sleep secondary to pain. No fever or urinary symptoms. No limping or hip pain. The patient was referred to PT and was advised to gradually wean off pain medication and muscle relaxant. The patient was told to call if not better or worsening pain. On 31-OCT-2016: the patient was unable to return to school, tried stopping muscle relaxant but pain returned and stayed up all night with pain. No hip pain or urinary symptoms. The patient was hurt on RT side in flank on changing position. No vomiting or fever. The patient also had no appetite. The patient was just drinking fluids and smoothies. Creatine Kinase Total, CBC with Differential/ Plate, Sed Rate, and UA were ordered. UA was within normal limits. CPK elevated, CBC, ESR and CMP normal. Xray of the lumbar spine was ordered, the patient was referred to orthopedics for further evaluation. On 06-DEC-2016, Follow-up information was received from ER (05-DEC-2016- Shortness of Breath (SOB)). The patient started having breathing problems at school the week before. The mom thought it was because of the brace he was wearing for myositis so the patient stopped wearing brace. Breathing problem did not get any better. The child was unable to catch his breath and went to ER the day before. No cough or fever. Electrocardiogram (EKG) was normal. The child had been seeing orthopedics, a brace was prescribed and MOBIC was prescribed. Probable musculoskeletal pain versus (VS) Gastric Esophageal Reflux Disease (GERD), reassure parent, the patient was advised to get CPK rechecked as recommended by orthopedics. Repeat CPK was normal. On 09-DEC-2016, the mother called the office and stated the patient was having chest pain to the touch and the mother instructed the patient to take off the brace due to the chest pain. Chest X-ray (CXR) was ordered. On 16-DEC-2016: Follow-up information showed normal CXR. Chest and back was hurting, it was hard for him to breathe and to take deep breaths. The patient was unable to stay in school and had been there only for 3 hours all week. The patient was barely able to stay awake, no appetite, food sometimes came in his throat, and the patient was very tired. The patient had been sleeping a lot, symptoms were getting worse, RT flank pain still present. The parent thought symptoms were secondary to of GARDASIL 9. The parents were requesting neurologist referral. The patient had been to orthopedics and was unable to find answer. The child seemed too drowsy. The patient was seen in ER, had normal lab results except positive Mononucleosis heterophile (Mono) (Epstein-Barr virus (EBV) within normal limits). Thyroid Stimulating Hormone (TSH) was borderline elevated with normal T4. The patient was still very drowsy and was barely able to keep his eyes open, complained pain on changing position. The patient was referred to neurologist on the mom's request. The mom was requesting records to further pursue on GARDASIL 9 reaction. Copies of all labs were given to the mom. The outcomes of all the events were not recovered. The Agency considered all the events serious and checked hospitalized as serious criteria. The causality was not provided by the Agency. Additional information is not expected as information was from the Agency.