Age: 10.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MENB, MNQ, TDAP
Symptoms: Respiratory tract congestion
Clinical narrative: headache; lower extremity weakness to the point where she cannot walk; woke unable to move legs; temp 102/fever to 102.9; absent Achilles and patellar reflexes; leg pain; has some knee pain with running but does not have any pain while walking/positive for arthralgias; Positive for dizziness; Positive for activity change; appetite change; fatigue; neck stiffness; eye pain/retro orbital pain when she looks at strong lights; photophobia; constipation; neck pain; dizzy; ears stuffed; headache; nose swelling; whole body soreness; congestion; This report was identified from a line listing obtained on request by the Company from the FDA (Agency # 743303) under the Freedom of Information Act on 14-AUG-2018, concerning an 18 year-old female patient. The patient's other medications included atomoxetine hydrochloride (STRATTERA), beclomethasone dipropionate (QVAR) and albuterol sulfate (PROAIR) inhaler. The patient's current illness included exercise induced bronchospasm (also reported as history condition). The patient's medical history included attention deficit/hyperactivity disorder (ADHD) and depression. Information about lab data and patient's prior vaccinations was not reported.  On 13-MAR-2018, the patient was vaccinated with the fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) ( lot # N019104, expiration date not reported but upon internal validation established as 02-MAR-2020, intramuscular in the left arm; dose was not reported) and the second dose of meningococcal B rfHbp rNadA rNHBA OMV vaccine (E. coli) (BEXSERO) (lot # 165801, intramuscular; dose and expiration date were not reported) for prophylaxis. On 13-MAR-2018, the patient experienced congestion, headache, dizzy, whole body soreness, nose swelling, ears stuffed and was given cough medicine with antihistamine and symptoms resolved by morning. The causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), meningococcal B rfHbp rNadA rNHBA OMV vaccine (E. coli) (BEXSERO) was not reported.  Follow up information has been received from a healthcare professional via FDA on 15-APR-2019 referring to the female patient. Concomitant medication included atomoxetine hydrochloride (STRATTERA), beclomethasone dipropionate (QVAR) and albuterol sulfate (PROAIR) inhaler (previously reported as other medication). The patient was allergic to amoxicillin, tylenol with codeine, prednisone and risperdal. At 16:01 of 13-MAR-2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and meningococcal B rfHbp rNadA rNHBA OMV vaccine (E. coli) (BEXSERO).  Follow up information has been received from the same healthcare professional on 05-JUN-2019. The patient's date of birth was added. The patient's age at vaccination was updated as 10 years old (previously reported as 18 years old). The patient's past surgical history included hx adenoidectomy and hx tonsillectomy. The patient's family history included anesth problems in her maternal grandmother, bleeding problems in her maternal grandfather, brain tumor in her father, cancer in her maternal grandfather, hearing loss in her maternal grandfather, heart disease in her paternal grandfather, negative after reviewed in her mother, osteoarthritis in her paternal grandmother. The patient's concurrent condition included seasonal allergies, nausea, vomiting and loose stools. Concomitant therapies included cetirizine hydrochloride (ZYRTEC) and ondansetron hydrochloride (ZOFRAN). There are no pets in her home. The home's source of water was well water. The patient lived with her parents. Shared custody. The patient's primary caregiver(s) include mom and dad. The patient attended school at 5th grade. There are no concerns with school performance. The patient had not traveled outside her state. On 16-MAY-2019 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose 5(also reported as first dose), lot # 1602281, expiration date not reported but upon internal validation established as 21-JUL-2021, intramuscular in the right arm; dose was not reported), diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (dose 1, lot # U6226AA, intramuscular in the right arm; dose and expiration date were not reported) and the first dose of meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) (lot # U6346AA, intramuscular in the left arm; dose and expiration date were not reported) for prophylaxis. On 17-MAY-2019 the next day after vaccination, the patient experienced lower extremity weakness to the point where she cannot walk, woke unable to move legs, leg pain, lower extremity weakness, headache and fever (body tempature:102.9 fahrenheit (equal to 36.7 degree Celsius) (also reported as102 fahrenheit)). The patient was seen at an emergency department where it was noted that she had absent achilles and patellar reflexes so the decision was made to admit her. The patient was hospitalized due to the above events on 17-MAY 2019. On an unknown date in May 2019, the patient was positive for activity change, appetite change, fatigue, neck stiffness, eye pain and photophobia, constipation, neck pain, arthralgia and dizziness. Magnetic resonance imaging (MRI) of cervical, thoracic and lumbosacraf spine was performed and did not show any evidence of transverse myelitis. On 18-MAY 2019, the patient had return of her reflexes and was subsequently discharged. On an unknown date in May 2019, the patient had good strength in her lower extremities but still got occasional headaches especially when she turned her head to the right, had some retroorbital pain when she looked at strong lights and also had some knee pain with running but does not have any pain while walking. The patient appeared well-developed and well-nourished. The patient was active and had no distress. The nose was normal and no nasal discharge. The mucous membranes were moist and normal. The patient had no dental caries or tonsillar exudate. The patient's oropharynx was clear and pharynx was normal. The patient's conjunctivae, extraocular movement(EOM) and visual tracking were normal. The patient's pupils were equal, round and reactive to light. The patient's right eye and left eye exhibited no discharge. The patient complained of retro-orbital pain when light is shined in her eyes. The patient's neck motion was in normal range. The patient's neck was supple. No neck rigidity or neck adenopathy. The patient's cardiovascular was in normal rate and regular rhythm. The patient had no murmur heard. The outcome of absent Achilles and patellar reflexes, fatigue, neck stiffness, eye pain/retro orbital pain when she looks at strong lights, photophobia, constipation, neck pain, leg pain, has some knee pain with running but does not have any pain while walking/positive for arthralgias, dizziness, activity change and appetite change was recovered. The outcome of eye pain/retro orbital pain when she looks at strong lights was not recovered/not resolved. The outcome of headache, lower extremity weakness to the point where she cannot walk and temp 102/fever to 102.9 was recovering. The causality assessments between all events and all suspect products were not reported by the reporter. It was also found out that her father's house which she stayed in may have had a faulty furnace which may have been leaking carbon monoxide. The patient's mother had stated that she does not want with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) in the future for her daughter.