Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: DNA antibody negative, Decreased appetite, Diplopia, Enterovirus test negative, Epstein-Barr virus test negative
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 11 years old female patient with asthma, functional murmur, sinusitis, viral syndrome and no pre-existing illness at the time of vaccination. The patient was vaccinated with lot # (668261/1397AA) dose 1 GARDASIL (dose and route not reported) on 10-FEB-2012. No other co-suspects were reported. Concomitant medications include dose 1 of MENVEO (lot # X10125) and dose 1 of HAVRIX (lot # AHAVB549BA). It was reported that the patient complained for days that her arm hurt. On 24-FEB-2012 the patient had been complaining for a couple of days now saying that she had a headache and was tired. She came straight home and went to bed. On 25-FEB-2012 the patient had a severe headache and color was really pale. She could barely stay awake and started throwing up. The patient was taken to the pediatrician. The Doctor saw the patient and said that she had some junk draining and thought it was a sinus infection. The doctor prescribed her a Z-PAK. Patient's complaints were her headache and her stomach felt "queasy". On 28-FEB-2012 she was not any better at all if anything getting worse. The patient was seen again by the doctor and thought that the medicine still had not had enough time to get in her system completely. She said it was five pills but would continue to work for a total of 10 days. The patient was complaining of headache, nausea, sore arm muscles and the back of her neck hurting. The patient said her vision was blurry and double. The doctor thought patient was putting pressure on her eyes rubbing her head. On 06-MAR-2012 the patient's pupils were huge in the evening could not see what color her eyes were. The patient was very tired and still not feeling well, not eating or drinking. On 07-MAR-2012 the patient was still not any better and her eyes were moving differently. She was having trouble walking and trouble seeing. She was very tired and not wanting to eat or drink very much. The doctor saw her and did a bunch of exercises on her. The doctor scheduled an MRI thinking a possibility of a tumor. Patient's MRI was schedule for 7:30p.m. on 07-MAR-2012. On 08-MAR-2012 the patient's MRI came back normal per doctor. He thought the patient looked pretty good but the patient still could not see and was having trouble walking. The doctor set her up with an eye specialist and he sent the patient home. On 09-MAR-2012 the doctor saw the patient and knew right away something was wrong. He had a visual field done and several other tests. He looked at patient's MRI. The doctor sent the patient to hospital to have her admitted and a lumbar puncture was done. The lumbar puncture was done around 5:00. Patient stated immediate relief of her headache, but still trouble seeing (not nearly as bad though). Patient had 35 ml around her brain and normal levels were 20 ml or less. Patient was rated a 4 on the pseudotumor Cerebri scale. On 10-MAR-2012 the patient was released from hospital at approximately 8:00p.m. The patient was prescribed acetazolamide 250mg three times a day since patient still had a little headache and nausea. On 14-MAR-2012 the patient saw the eye specialist who said the patient's eyes looked so much better but still had a ways to go. All in all impressed with how her eyes were doing. On 15-MAR-2012 the patient left school early sick. By the time the patient went to pediatrician, she was throwing up everywhere. The doctor saw the patient and spoke to the Neurologist. They increased patient's meds from 250mg three times a day to 500mg three times a day. On 16-MAR-2012 the patient saw the doctor as a follow up. On 28-MAR-2012 the patient had been complaining of being cold and nausea since 24-MAR-2012. Took her to see again, the doctor said patient looked fine but did mention that there was a case where an 18 yr. old Pseudotumor Cerebri and it was linked to this child taking the vaccine and said he would need to look into that. The following information was obtained through follow-up and/or provided by the government. On 02-APR-2012 consultant records received for Date of sampling 12-MAR-2012 with assessment: idiopathic intracranial hypertension, patient with initial complaints of frontal headache, runny nose, not feeling well on 25-FEB-2012. Treated for sinusitis. Progressed to neck pain, tiredness, dilated eyes, vomiting, double vision, difficulty walking. Lab diagnostic tests included MRI; Lumbar puncture; Blood work. The following information was obtained through follow-up and/or provided by the government. 02-APR-2012 lab diagnostic records received for date of sampling DOS 23-FEB-2012 and 24-FEB-2012. MRI brain unremarkable. CSF: pressure 35 (H), RBC 4 (H). Lupus anticoag screen 42.6 sec (H). ANA, anticardiolipin, anti-DNA, monospot, EBV, adenovirus, enterovirus, influenza, RSV, blood ex, CSF ex (-). Blood: WBC 11.5 K/mm3 (H), LDH 383 U/L (H), uric acid 5.9 mg/dL (H), protein 8.5 g/dL (H). The outcome of trouble seeing was reported as recovering. The outcome of the remaining events was unknown. The relatedness for the reported events was not provided for GARDASIL. The patient required an emergency room visit. This report considered serious by the agency. The original reporting source was not provided. The VAERS ID# is 452670-1. No further information is available.