Age: 27.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Facial pain, Facial paralysis, Guillain-Barre syndrome, Headache, Immunoglobulin therapy
Clinical narrative: entire body felt like it was on fire, explosive headache/ pain still intensely burning through body, felt pins and needles in hands and feet/ lost a lot of strength in legs/ not able to move/ eye still won't close/ test confirmed BGS; This report was obtained on request by the Company from the Food and Drug Administration (FDA) under the Freedom of Information Act (VAERS # 799955) on 26-SEP-2019.  This spontaneous report was received from a consumer and refers to an approximately 27-years-old, non pregnant female patient. She had not had any allergies to medications, food or other products. At that time, the patient had no medications, dietary supplements or herbal remedies taken. The patient didn't have any chronic or long-standing health conditions.  On 24-OCT-2018, the patient made an appointment because she felt "flu like symptoms" (which started one day prior the vaccination); she was diagnosed with a viral syndrome (viral infection) and was told the virus would clear within a couple of days. On the same date, her doctor put in an order in the immunization department so she could be vaccinated. On the same date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot number or expiration date not reported), anatomical site of insertion was reported as in the arm, indicated for prophylaxis.  On 26-OCT-2019, the patient went to the emergency room (ER). She felt her entire body "like it was on fire", had explosive headache and her face hurt to touch. There she was told it was the viral infection. On an unknown date, the patient returned to the emergency room with more symptoms. The patient felt "pain intensely burning through her body", had a sensation of pins and needles in hands, feet and head, and her face still hurt. She stated she "could close" her right eye. The patient asked for a magnetic resonance imaging (MRI) but instead of that, she was given a computed tomography (CT) scan  no results were provided); she was told all the symptoms were related to the viral infection. Furthermore, on an unspecified date, the patient went in for a visit with the entire right side of her face paralyzed, and lost strength in her legs and was now diagnosed with Bells Palsy. The rest of the symptoms were attributed to the viral infection. On 01-NOV-2018, the patient went to the office due to worsening of the symptoms. By that time, she asked for an appointment with the neurologist and was told that she had to wait. On an unknown date, between 3 and 5-NOV-2018, the consumer made phone appointments for explosive headaches, pain and not being able to move; by that time, the patient reported she was "stuck in bed most of the day" and she couldn't sit up without assistance. Again, everything was attributed to the viral infection. On an unspecified date, the patient went to the emergency room again because she couldn't sleep. She was given morphine as treatment, throughout the night; although that didn't put all the pain away, she could sleep. It was reported that the ER doctor didn't believe that the patient had Bells Palsy, instead, he believed that the patient had Guillain-Barre Syndrome (GBS). Then, the next morning, the patient had a lumbar puncture and was admitted in the hospital and assigned to a neurologist. She had multiple blood tests and nerve conduction study, and all the tests confirmed Guillain-Barre Syndrome (GBS). Further from that, the patient had an MRI and had a five-day treatment of immunoglobulin therapy (IVig). The patient was hospitalized for 9 days. She lost majority of mobility in legs and had to walk with a cane until an unspecified date of January 2019 (reported as a month ago from the report date). The patient had pregabalin (LYRICA) treatment for the pain, her face was still healing and her eye wouldn't close. The patient was considering surgical procedure for her eye. The outcome of the event Guillain-Barre Syndrome was reported as recovered on an unknown date in 2019.  The causality assessment between Guillain-Barre Syndrome and the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  The event was considered to be life threatening and disability by the reporter and the agency.  Follow up information was received on 18-DEC-2019. On that day, a phone call was placed to immunization coordinator. The phone call was answered by receptionist and transferred to immunization area. Subsequently, the phone call was answered by an admin and could not be completed. Without any patient's identifier it was not possible to assist in obtaining medical information. Additional information was not expected.