Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Intensive care, Intracranial pressure increased
Clinical narrative: Information has been received from a physician concerning a 13 years old female patient, one of 28 week preemie twins with asthma and a history of bilateral sinus surgery in December 2011 and no drug reactions/allergies who on 02-NOV-2011, was vaccinated with the first dose of GARDASIL (lot 668261/1397AA) 0.5 ml IM. On 16-JAN-2012, the patient received the second dose of GARDASIL (lot # not reported). Secondary suspect vaccinations included the second dose of VARIVAX (Merck) (lot #, dose and route not reported) given on 16-Jan-2012. Concomitant medications included FLOVENT, ZYRTEC and montelukast sodium (MSD). Physician reported that the patient experienced a 5 inch in diameter injection site reaction in the same arm where the patient had received GARDASIL on 16-JAN-2012. The injection site reaction began the evening of 16-JAN-2012. Physician described the injection site reaction as: red, hot and tender. The patient was treated with clindamycin (manufacturer and dose unspecified) and BENADRYL (dose unspecified), but the injection site reaction did not resolve until 2 weeks after 16-JAN-2012. It was reported that beginning on 16-JAN-2012 in the evening, the patient had experienced persistent headaches which woke her at night. The patient had not had a "headache-free" day since the patient had received GARDASIL on 16-JAN-2012. The patient had not attended school since 16-JAN-2012 (also reported as 18-JAN-2012) and was admitted to the hospital from 05-FEB-2012 to 09-FEB-2012 for a DHE 45 (manufacturer and dose unspecified) trial to treat the patient's headaches. The DHE 45 trial did not effectively treat the patient's headaches. The patient was admitted to the pediatric intensive care unit (ICU) on 27-MAR-2012, so that a "spinal tap" could be completed. The patient was diagnosed with "pseudo tumor" due to elevated intracranial pressure, which was "30". 10 ml of spinal fluid was removed, and the patient's intracranial pressure came down to "17". Spinal tap and serology were negative. The patient was receiving acetazolamide (MSD) and had experienced some relief headache. Physician reported that the patient had been treated by neurologist. Physician also reported that she suspected that the patient might have lyme disease. Magnetic resonance imaging (MRI) and blood work were performed (result not provided). Physician also mentioned that the patient has a twin who received the second dose of GARDASIL on 16-JAN-2012 (WAES # 1203USA04648). At the time of the report, the patient's outcome for headaches, "pseudo tumor" and lyme disease was unknown. Follow up information has been received from the physician who reported that patient had been sent home from the hospital and the lyme test was negative. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source. The patient was admitted to hospital.