Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Asthenia, Biopsy site unspecified abnormal, Chest X-ray abnormal, Chest pain, Dyspnoea
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 concerning a 12 year old female with a history of asthma and seasonal allergies, who on 25-SEP-2009 was vaccinated with a first dose of GARDASIL (lot # 662229/1497X) intramuscularly in the left arm. Concomitant therapy included doses of MENACTRA (lot # U2932AA) in the left arm and BOOSTRIX (lot # 9C52B033BA) intramuscularly in the right arm. On 26-SEP-2010 the patient developed midsternal chest pain. Evaluation within a short time showed a "black shadow" on chest x ray which was diagnosed as pneumonia and treated with azithromycin. The patient started with vomiting which was continued about 1-2 times per week. She left school feeling weak and pale at the beginning of the vomiting episodes. Fever was intermittent about once a week. This was not documented rather than tactile fever. Her weight was also waxed and waned up and down. She had only once experienced any dyspnoea at PE class. She had one bout of hematemesis. She was seen in the emergency department (July 2010) and was evaluated for pulmonary embolus and the results excluded the embolus but revealed multiple pulmonary nodules. The biopsy (performed in August 2010) showed a vasculitis of the small and medium vessels and a bronchiolitis obliterans. She started taking prednisone and methotrexate in August 2010. She was currently being followed in Pediatric Rheumatology at hospital. The following information was obtained through follow-up and/or provided by the government. On 13-JAN-2011: PCP family medicine office record received for DOS 25-SEP-2009: Assessment: Upper respiratory infection, finger laceration and acne. The patient presented with complaining of finger laceration (cut 3 days ago on branches), acne on face and cough/runny nose for 2-3 days the patient was examined and a small laceration was noted on right 2nd finger, which had no drainage and was healing well. Lungs were clear to auscultation. Acne noted on bilateral cheeks and forehead. Plan was: acne: DUAC GEL applied to face BID; finger laceration: (no signs of infection): continue cleaning and NEOSPORIN, URI: symptomatic treatment. Follow up PRN. On 13-JAN-2011 pediatric pulmonary clinic, ped surgery clinic and ped rheumatology clinic records received for dates from 02-AUG-2010 to 21-OCT-2010. Impression: pulmonary vasculitis of unclear etiology. The patient was seen in pulmonary clinic for initial visit on 02-AUG-2010 complaining of pulmonary nodules. The patient and her parent reported a history of chest pain since September 2009 after GARDASIL first dose. On 01-AUG-2010, chest pain awoke patient from sleep and she was taken to emergency department. The sharp pain was on the left side of chest and increased with breathing. Chest CT showed multiple interpulmonary nodules and the patient was referred for further information. The patient also reported that in the last year, she has had decreased activity, had been tired more often, has had fevers, vomiting every few days and one episode of bloody emesis. The patient was previously diagnosed with pneumonia and was treated. Present examination noted normal air exchange. Diagnosis: Pulmonary nodules; plan: refer to surgery clinic for tissue evaluation. The patient was seen on 04-AUG-2010 in surgery clinic and scheduled for left thoracoscopic pulmonary biopsy. The patient was seen on follow up at rheumatology clinic on 11-AUG-2010 for evaluation of pulmonary vasculitis and bronchitis obliterans revealed at biopsy. The patient noted to be recovering uneventfully from biopsy. Evaluation of lung biopsy noted granulomatous changes really not present and no felt typical of Wegener granulomatosis. Not suggestive of sarcoidosis. No evidence of infection. The possibility of GARDASIL being a putative trigger was discussed and albeit impossible to prove. ANA was nonspecific and the patient was a single organ vasculitis at present time. Assessment: pulmonary vasculitis; cannot classify based on laboratory testing. The patient was seen on 21-OCT-2010 complaining of "cries at the drop of a hat" and not sleeping well. Assessment: emotional lability, probable depression and sleep disorder. Plan; start on amitriptyline, increase methotrexate and taper ORAPRED. The patient's outcome was unknown. The listing indicated that one or more of the events was considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID number is: 414550. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.