Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscle twitching, Neurological examination normal, Rash, Rectal haemorrhage, Red blood cell count normal
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative regarding a 17 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date the patient completed full series of GARDASIL (lot, dosage regimen unknown) by "injection" route. Concomitant medications were not reported. On an unknown date the patient was diagnosed with mononucleosis. After post-mononucleosis diagnosis several months later, the patient's mother complained to the nurse practitioner that the GARDASIL caused the patient to experience an unspecified rash and fatigue (onset date unknown). The patient did not sought medical attention and no treatment was given for the adverse events. The outcome of the events was unknown. Product quality complaint (PQC) was not filed. Causality assessment for the event of mononucleosis was not provided. Follow up information has been received from the nurse practitioner on 06-JUN-2016. The patient was a non-smoker with no known allergy. The patient was vaccinated with three doses of GARDASIL on 29-OCT-2014 09:18 (lot# K006124, in left deltoid), 08-JAN-2015 09:01 (lot# K009482, in right deltoid) and 15-JUN-2015 15:21 (lot# K014191, in right deltoid) via intramuscular respectively. On an unknown date the patient experienced Attention-Deficit Hyperactivity Disorder (ADHD), dysuria (recovered on 15-JUN-2015), left breast mass (recovered on 15-JUN-2015) and underwent ear tube insertion. The patient also complained of vertigo intermittently, always being tired, headache, wired rashes on different spots (2-3 months) lasting only a couple hours and episodes of facial twitching to her right cheek by her nose lasted for 4 days (only felt it, not visible). The patient had episodes of abdominal pain and constipation and diarrhea and celiac disease. On 30-NOV-2015, the patient tested positive for Epstein-Barr virus (EBV) and the white blood cell (WBC) was decreased at that time. Blood in toilet was noticed 2-3 weeks ago (February 2016), initially after stool. The patient had episode of blood in toilet and on paper without bowel movement in the night on 06-MAR-2016. The patient was on period but did not feel it is related to that. The patient's mother was concerned that it was related to the 3rd dose of vaccine along with multiple other health related concerns. On 07-MAR-2016, physical examination of the patient was normal. Complete blood count (CBC) and urinalysis were normal. WBC was 5.7, red blood cell count was 4.91 and hemoglobin was 13.8. The rectal bleeding was suspected to be related with constipation by the reporter. The causality between the events except rash and fatigue was not provided. The outcome of the other events that was not mentioned above was unknown. Upon internal review, rectal bleeding was determined to be medically significant. Additional information is not expected as all correspondence was received. Patient information, product, event, narrative and serious criteria were all updated.