Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Auricular swelling, Blood albumin normal, Blood creatinine normal, Blood electrolytes normal, Blood urea normal
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on an unspecified date was vaccinated with her first dose of Gardasil (Lot number unknown). On an unspecified date the patient developed serum sickness after the first dose of Gardasil. The physician also reported that the patient had swelling of the joints and was put on therapy with prednisone (PROMIFEN). At the time of reporting, the outcome was unknown. No additional information was available. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007; 8/17/2007. Information has been received from a physician concerning a 17 year old female with a history of dyslexia, attention deficit disorder, myopia, scoliosis, asthma and joint disorder and a history of rhinitis allergic, sinusitis, pharyngitis streptococcal, viral pharyngitis, wart, plantar warts, pneumonitis, tonsillitis, urticaria and otitis media and myringotomy who on 16-APR-2007 was vaccinated with her first dose of GARDASIL (Lot # 657006/0188U) IM in the left arm. Concomitant therapy includes ADDERALL 15 mg a day. On 14-MAY-2007 the patient developed serum sickness, hives, itching, arthralgia and swelling of joints, low back and the right ear after the first dose of GARDASIL. On 15-MAY-2007 the patient was evaluated by the physician for a chief complaint of sudden swelling of knees, left hip and elbows. There was lesions and swelling on her lower lip. ON her left ear there was a small lesion present on the oracle. The patient stated that her joints are painful and very itchy and swollen. The patients bilateral knees are edematous, red and warm to touch and somewhat tender. She had a full range of motion of the bilateral knees. Her elbows especially her left elbow were edematous, red and warm to touch and somewhat tender. Her chest and lungs are clear. The heart had a regular rate and rhythm, without murmurs. The mother had given her ADVIL 800mg on 14-MAY-2007 to help with the pain. The patient had no fever or chills. The patient was put on therapy with PROMIFEN 50mg down to 10 ng for 7 days. At the time of reporting, the outcome was unknown. The physician feels it was questionable, serum sickness was related to GARDASIL. On 17-MAY-2007 the physician reports the patient is not to receive GARDASIL again. On 18-MAY-2007 the patient woke up in the morning and was very itchy. The patient had no dyspnea, but she had a break out on her face and her arms and had some wheals. The patient's complete cell blood count and erythrocyte sedimentation rate was normal. On 29-MAY-2007 the mother stated that the patient was still breaking out in hives in the evening. The physician also recommended the patient to see allergist/immunologist. Follow-up information was received from the medical records. The patient was evaluated by an allergist/immunologist 30-MAY-2007. The physician reported that the patient was in her usual state of good health and on April 16th of this year she was given the first dose of GARDASIL and approximately a month later she woke up with a swollen ear and later on noticed urticarial lesions on her body. She also had urticarial lesions on her knees and back. The physician doubts if the patient had effusions in her knees, but she actually had hives over her body and she was advised to take MOTRIN. The next day she woke up with what sounded like arthralgias and she also had extensive urticaria. Soon afterwards she was started off on PROMIFEN and she also had been taking antihistamines (therapy unspecified). The patient had extensive swelling of her hands and feet and some swelling of her tongue. No history of tightness in the chest, wheezing or stridor. She has had intermittent nasal congestion. In the last week or 10 days despite being on PROMIFEN and antihistamines (therapy unspecified) she has had hives virtually everyday, although they have more or less subsided by now. The patient has just finished her course of PROMIFEN. There is no history of colicky abdominal pains associated with the above and her above symptoms are not precipitated by a particular food. The question has been raised whether or not this is actually a serum sickness type of reaction related to GARDASIL which is certainly a possibility. The patient has no history of hematemesis, melenas, rectal bleeding, hematuria, photosensitive eruption over her face, neck rigidity, neck stiffness, headaches or visual disturbances. There is no history of pains in the eyes or around the eyes. The patient does have attention deficit hyperactivity disorder for which the mother reports that the patient takes ADDERALL 25 mg a day. In the past she has had bouts of serious otitis media and has had tympanostomy tubes inserted atleast twice, the first time at the age of (?) 1 and 1/2 years, the second time at the age of approximately 3 years. The right tympanostomy tube is still intact and has not fallen out. There is a history suggestive of mild allergic rhinitis. The patient also rides horses and has dogs at home. The patient was placed on ZYRTEC 20mg/day and BENADRYL 50mg a night and 50 mg of BENADRYL for break through hives. On 01-JUN-2007 the patient had recovered from the events. On 25-JUN-2007 the patient was seen for a 6 month check up and the "patient is doing well". All the events were reported as "other important medical events". Additional information has been requested. This is a corrected report, as amended.