Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9
Symptoms: Ear pain, Gait inability, Headache, Lumbar puncture normal, Malaise
Clinical narrative: This initial spontaneous report was received on 20-FEB-2018 from the mother of an 11 year old female patient. The patient had no drug reactions/allergies. She was diagnosed with asthma when she was six years old and used albuterol inhaler as needed (but had not used it in three years). On 28-JUN-2017, the patient received her first dose of GARDASIL 9 intramuscularly, given by a physician for the indication of "vaccination" (lot # N043731; expiration 22-JUN-2019) along with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer not specified) and MENACTRA.  Her daughter reported stomach pain after receiving the vaccine but no treatment was given. The patient received a flu vaccine (manufacturer not specified) on 13-OCT-2017. Then, on 29-DEC-2017, she received her second dose of GARDASIL 9 (lot # N021475; expiration 31-JAN-2020). On 21-JAN-2018, the patient experienced pain in the ear and head, nausea, and dizziness. The reporter took her daughter to a pediatric and adolescent urgent care and was told she had swimmer's ear and was given unspecified ear drops. On 23-JAN-2018, the patient followed up with the physician who administered the vaccine and was told she had a sinus infection. AUGMENTIN was prescribed but no treatment was observed. On 26-JAN-2018, her daughter's condition got worse and she couldn't walk anymore. On 29-JAN-2018, she was seen by the physician again and was told she failed the unspecified neurology test and was told to go to the Emergency Room (ER). The patient was admitted. A computerized tomography (CT) scan, magnetic resonance imagining (MRI), urine and blood work call came back negative. The mother stated "they think she has acute cerebellar ataxia." Meclizine was prescribed for her dizziness. The patient was discharged on 31-JAN-2018. On 06-FEB-2018, she was admitted to the hospital ER due to low blood sugar and slurred speech but was discharged the same day without any treatment. On 12-FEB-2018, her daughter saw a neurologist at a hospital. An unspecified spine test came out normal and no treatment was ordered. The patient has an appointment with another neurologist on 21-FEB-2018 (the mother wanted all follow up questions directed to this physician). The mother reported that up to this point, her daughter had been healthy, other than asthma diagnosed at age 6. She added that her daughter was currently experiencing headache, nausea, vertigo, dizziness, sensitivity to both hot and cold water (described as burning sensation), can't feel both legs and feet starting with the knee caps down, numbness and tingling in legs and feet, pain in the neck, feet, ear, and jaw, fatigue, blood in the stool, and constipation. She believed her daughter's condition was due to a viral infections because that's what most of the doctors and nurses she spoke to stated could be the cause. Therefore, she thinks GARDASIL 9 is the reason her daughter cannot walk and now she is in a wheelchair. The mother also stated that if her daughter does not get better in six months, and Merck does not provide any type of compensation, she will sue Merck. The outcomes of stomach pain, slurred speech, low blood sugar and sinus infection were unknown. The outcomes of the other events were not recovered/not resolved.  The mother felt all the events were related to GARDASIL 9. On 23-FEB-2018, it was determined that lot # N043731 is not valid for GARDASIL 9. The events couldn't walk anymore, acute cerebellar ataxia, numbness of extremities, and viral infection were considered disabling at the patient was now in a wheelchair. Upon internal review, blood in stool was considered medically significant. Additional information has been requested.