Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Heart rate increased, Immediate post-injection reaction, Injection site pain, Insomnia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 21 years old female patient was vaccinated on left arm with the first dose GARDASIL on 14-AUG-2009. No other co-suspects were reported. No concomitant medications were reported. On 14-AUG-2009 the patient experienced Activities of daily living impaired, Alopecia, Constipation, Decreased appetite, Diarrhoea, Diplopia, Dizziness, Dyskinesia, Fatigue, Feeling abnormal, Gait disturbance, Headache, Heart rate increased, Injection site pain, Insomnia, Malaise, Muscle spasms, Muscle tightness, Nausea, Paraesthesia, Pyrexia, Thirst, Tremor, Vertigo, Vomiting, Weight decreased. The patient experience nerve jerks and insomnia for first six months and muscle spasms, fever when active, extreme fatigue, muscle tension, loss of appetite, extreme thirst, weight loss still to date. The patient severally visited to emergency room (E.R.) for saline IV's to re-hydrate and lower high pulse. Treatment has been lots of water, have rest, low cholesterol, low sodium, low sugar diet with lots of rest. On 01-JUN-2012 emergency room (ER) records received for DOS 9/23-28/2009 with differential diagnosis (Dx): severe GARDASIL reaction with neuro component as has been described infrequently vital signs (vs) new mental status (MS) vital signs (vs) doubt Guillain Barre Syndrome (GBS) as no further progression since last evaluation (eval), normal (nl) reflexes vs doubt stroke by physical exam (PE) and symptoms (sx). Patient complained of (c/o) feeling unwell since 09-AUG-2009 status post (s/p) vaccination. Immediately after vaccination patient complained of (c/o) vertiginous/dizzy feelings followed by fevers (resolved), fatigue, "groggy in the head", variable tingling in fingers/toes, muscle cramps & tremor, weight loss, constipation/diarrhea, hair loss, headaches, difficulty walking, double vision. Patient unable to participate in usual activities. Physical exam (PE): tremor lt hand > rt at rest. Patient returned for follow up (f/u). Labs, neuro exam unremarkable. The patient did Magnetic Resonance Imaging (MRI) and blood tests. On 01-JUN-2012 lab/diagnostic records received for DOS (23-SEP-2009 to 28-SEP-2009). MRI brain: multiple tiny foci of increased signal intensity in both hemispheres. Chest X Ray (CXR) within normal limits (WNL). The results of HIV, Antinuclear antibody (ANA), RF, monospot, pregnancy test were negative (-). Urinalysis (UA): white blood cell (WBC) 6-20 (High), RBC >50 (High), leukocyte esterase (+). Blood: white blood cell (WBC) 10.7 K/mcL (High), Plt 460 K/mcL (High), Mean platelet volume (MPV) 6.4 fL (Low), neutros 52.4% (Low), lymphs 40.8% (High), blood urea nitrogen (BUN) 7 mg/dL (Low), protein 9.1 g/dL (High). The patient required an emergency room visit and the reporter considered the events were serious. The adverse events were considered to be immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS ID# is 456264.