Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Laboratory test normal, Muscular weakness, Myalgia, Mycoplasma test positive, Myositis
Clinical narrative: Abnormal loss of weight; Antibody test negative; Antineutrophil cytoplasmic antibody negative; Antinuclear antibody negative; Antiphospholipid antibodies negative; Blood creatine phosphokinase increased; Blood lactate dehydrogenase increased; C-reactive protein increased; CSF test normal; Endoscopy upper gastrointestinal tract abnormal; gastritis; laboratory test normal; muscular weakness; myalgia; mycoplasma test positive; nuclear magnetic imaging brain normal; oropharyngeal pain; pyrexia; red blood cell sedimentation rate increased; respiratory viral panel; Rheumatoid factor negative; streptococcus test negative; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA# 702780) refers to a 16 year old male patient. Patient's current illnesses and other medications were reported as none. On 06-JUN-2017 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # M043731 dose 1, intramuscularly for prophylaxis. Other suspect therapy included vaccination with meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) on 06-JUN-2017, dose 2, lot# u5462aa, intramuscularly for prophylaxis. On 07-JUN-2017, starting the day after vaccination, patient developed sore throat, muscle aches and weakness. He was seen in the Emergency Department on day 5 following vaccination with fever and myalgia. He was hospitalized on day 13-15 following vaccination with myosistis and weight loss with CPK elevated to 583 at it's peak. He was again hospitalized with progressive unintentional weight loss and continued muscle pain on day 23-28 following vaccine (15-20 pound unintentional loss). Following his first admission, he was treated with 10 days of Doxycylcine (as recommended by pediatric ID consultant) which did not seem to alter his course. He was also seen by Rheumatology consultant on his second admission. Lab tests included Lactate dehydrogenase (LDH) and Creatine phosphokinase (CPK) were followed on each admission. The CPK was not elevated 6/19, peaked at 583 on 6/21, and then fell back to normal range by  the time of second admission 6/29. LDH was elevated in ti 300+ range at the time of both admissions. Erythrocyte sedimentation rate(ESR) was 58 on 6/11, rose to a peak of 113 on 6/28. CRP was 70.6 on 6/11, was 96 on 6/19, fell some in the next few days and then peaked again on 6/28 at 95 with fall toward  normal range by 7/2. Antinuclear Antibody, Sjogren's ab, deoxyribonuclease, myeloperoxidase, ASO, Proteinase 3, Rheumatoid factor and other autoimmune/Lupus studies were negative. ID studies/serologies including respiratory pathogen panel were negative with the exception of IGM and IGG for Mycoplasma on 6/18 (IGM 2.77, igg 4.98). CSF studies were negative as was MRI of the brain. Upper endoscopy did show gastritis. The outcome of the events were reported as not recovered/not resolved. Causality assessment was not provided. The agency considered the events to be serious due to hospitalization and disability. Follow up information has been from a physician via FDA (HA# 702780) on 15-APR-2019. There was no prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination. The patient was not allergic to medication, food and other products. There were no other illnesses at the time of vaccination and up to one month prior. There were no chronic and long-standing health conditions. The patient didn't experience an adverse event following any previous vaccine. The duration of hospitalization was 8 days.  Follow-up information was received from a registered nurse on 02-JUL-2019. The nurse was unable to assist in obtaining any information. Records from long ago were not available and there were no patient identifiers.