Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Spinal pain, X-ray
Clinical narrative: Case number PHHY2013US146758 is an initial report received from the vaccine adverse event reporting system (VAERS reference number: 509830) website on 16 Dec 2013, with the follow-up received on 20 Jan 2014 and a follow-up information was received from Quality Assurance Department (reference number: 302067) on 25 Jun 2014. This report refers to an 11-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M11033, expiry date: Jan 2014) intramuscularly in the left arm and GARDASIL (other manufacturer, batch number: 1435AA) intramuscularly in the left arm on 02 Feb 2012. She was also vaccinated with VAQTA (other manufacturer, batch number: 1288A) and ADACEL (other manufacturer, batch number: C4015AA), both vaccines administered intramuscularly in the right arm on 02 Feb 2012. On an unknown date, she had severe nose bleeds and headaches which continued for the next few weeks. She developed a rash which was not raised (livedo reticularis) on her thighs in the mid of Mar 2012. She received second dose of the GARDASIL (other manufacturer, batch number: not reported) on 03 Mar 2012 and she passed out at the check-out counter at the physician's office. She also had pain in her hips, tailbone, legs and pelvic region on 17 Apr 2012. She was hospitalized on 20 Apr 2012 for excruciating pain in her hips. She could not walk for those 6 days in the hospital. Her C-reactive protein level when she reached the hospital was 166 (units and normal values were not reported). She was hospitalized for 11 days. She was administered clindamycin and vancomycin via intravenous route as well as morphine, TORADOL and oxycodone for pain and what was believed to be an infection deep in her hip muscles and tissue. She was discharged only with a follow up to her pediatrician. It was reported that 18 months later, she still had debilitating pain in her hips. She was forced to stop playing soccer with her school team as the pain was too great. She was in physician therapy for 2 weeks. Her orthopedic doctor recently did a magnetic resonance imaging (MRI) of her pelvic region which did not show any infection, however it showed that she had 3 ovarian cysts. She also had X-rays and multiple blood tests and the results were not reported. The outcome of the events reported as condition unchanged. The seriousness and causality of the event were not reported. No additional information was available. Batch review report (reference number: 302067) received from quality assurance department 25 Jun 2014. Based on the batch review performed, it was stated that MENVEO (batch number: M11033) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from the VAERS (reference number: 509830) website on 20 Jan 2014: Suspect vaccines are recoded and updated batch numbers of MENVEO (batch number: M11033), VAQTA (batch number: 1288A), GARDASIL (batch number: 1435AA), and ADACEL (batch number: C4015AA), and the patient was hospitalized for 11 days (not 10 days). Follow up received from Quality Assurance Department (reference number: 302067) on 25 Jun 2014: Updated batch review report and expiry date of vaccine.