Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Full blood count normal, Helicobacter test negative, Immunology test, Infectious mononucleosis, Mental status changes
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Agency number 785121) under the Freedom of Information Act on 07-FEB-2019, referring to a 14-year-old female patient. The patient did not have any other medication or medical history. On 07-OCT-2018, the Complete Blood Count (CBC), complete metabolic panel (CMP), Lipid panel and Vitamin D labs were performed, and results were all normal. The patient had no other illnesses at the time of the visit. No information was provided regarding to the patient's prior vaccinations. On 12-OCT-2018, the patient was vaccinated with the second dose of GARDASIL 9 (lot # R011628 and with expiration date auto-populated as 11-DEC-2020; strength, dose detail and frequency were not reported) by intramuscular route, in the left arm, and the second dose of FLUARIX QUADRIVALENT (lot # YZ7TR; strength, dose detail, frequency and expiration date were not reported) by intramuscular route, in the right arm for prophylaxis. On 24-OCT-2018 (also reported as since the patient received the GARDASIL 9 vaccine), the patient's father reported the patient had not been herself and her sleeping pattern changed first and she complained that she was not feeling quite like herself (onset date also reported as in October). On approximately 26-OCT-2018 (reported as two weeks after the vaccine was given), the patient started with vomiting and mild diarrhea. Those symptoms resolved but again at the time the patient's father expressed his concern that this was due to the vaccine despite discussions of viral illnesses that could be present. On approximately 29-OCT-2018 (reported as three days later), she started complaining about a sore throat, she was seen at emergency room (ER) and diagnosed with mononucleosis and strep throat. Despite treatment for strep throat, her sleep pattern and behavior continued to worsen, so she was seen again in ER. At that time she was admitted for altered mental status for two days, while tests were performed: H. pylori Stool antigen (Ag), enzyme immunoassay (EIA) Negative; CBC, CMP, thyroid stimulating hormone (TSH), Urinalysis (UA) - were negative; Magnatic Resonance Imaging (MRI) - Negative; Cerebrospinal Fluid (CSF) - Negative; Abdominal Ultrasound - Negative; Antistreptolysin O (ASO) - Positive; Monospot  Positive. The patient had been referred to psychologist in October and had continued in counseling. At the hospital, she was referred to a neurologist for continued care as well. The outcome of the event diarrhea and vomiting was recovered. The outcome of all the other events was not recovered. The patient's father was extremely concerned that the vaccine could have contributed to the patient's symptoms. An investigation into the manufacture of lot R011628 was completed and confirmed that all in-process quality checks were satisfactory. The results indicated that the lot was manufactured in accordance with manufacturing site standard operating procedures. The lot was confirmed to have met the requirements for market release. Following medical review of the AE report and the Quality investigation, there were no identified concerns related to quality within the results of the investigation.