Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Feeling abnormal, Hyperaesthesia, Myalgia, Pain of skin
Clinical narrative: This report is a solicited report received via Abbott (manufacturer control no. 12P-163-0969278-00). The report was originally reported by a health professional and refers to a 23 years old female patient. The patient's current conditions include alopecia, arthritis, chronic bowel problems, irritable bowel syndrome, drug allergy for REGLAN and REMICADE (resulting in skin crawling), and rheumatoid arthritis. On an unknown date in 2012 the patient was vaccinated with GARDASIL to treat Human Papilloma Virus (HPV). Dose, route and lot number were not reported. Other suspect therapies included HUMIRA with dose information as (40 mg, qow), started "4 months ago" (estimated start date April 2012) for rheumatoid arthritis. No concomitant medications were reported. In 2012, the patient experienced HPV. On an unknown date in 2012 the patient developed the HPV virus. She stopped the HUMIRA for two weeks and then was treated with GARDASIL. After getting the GARDASIL, she felt like her body was attacking itself, her skin was sensitive to touch, and she had cold spots on her skin. She went to the emergency room and was sent home. In April 2012, the patient experienced kidney infection and bladder infection. The patient reported that she had a kidney infection, bladder infection, and lung infection since starting HUMIRA pen 4 months ago. The patient did not provide treatment, just stated that they had resolved. In May 2012, the patient experienced upper respiratory infection. The patient held the HUMIRA injection for an unknown amount of time because she received the HPV vaccine. On the day of the event she was seen in the emergency room. The reporter stated she declined to be admitted to the hospital. Treatment and testing were unknown. No further information was available. The patient received a GARDASIL vaccination on 13-AUG-2012 and was "now experiencing burning in her back muscles and a sensation like her jaw was locking up. The patient stated that her muscles and skin ached and were tender to touch. The patient contacted her primary care physician who advised her to visit the emergency room. The patient planned to go to the emergency room now. In August 2012, the patient experienced burning pain in muscles of back, and sensation like her jaw is locking up and muscles and skin ache and are tender to touch. On 15-AUG-2012, the patient seemed to be locking up and experienced delayed reaction to medication. The mother thought it was a delayed reaction because it occurred after the dose was given. The physician did not believe that was an event. In 2012, the bladder infection and upper respiratory infection had resolved. The patient was treated with unknown antibiotics (not specified for which event antibiotics were given). The physician stated he did not believe the GARDASIL or HUMIRA were related to the feeling her body was attacking itself, skin sensitive to touch, and cold spots on her skin. No causality assessment between GARDASIL and the other events was provided. The events burning pain in muscles of back, sensation like her jaw is locking up, seemed to be locking up and delayed reaction to medication were reported to be medically significant ("required intervention"). Additional information is not expected.