Age: 39.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Oedema peripheral, Pain, Pyrexia, Renal failure acute
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. This was reporting a 39 year old male. The patient had attention deficit/hyperactivity disorder (ADHD); anxiety; multiple drug allergies to BACTRIM DS (serum sickness), DURICEF, EMBEDA (nausea), FLAGYL (syncope), LAMICTAL (hypomania), TOPAMAX (mania), ULTRAM, gabapentin (slurred speech) and vancomycin (red man); contrast Dye; chronic low back pain; gastritis; drug abuse; chronic sinusitis; costochondritis and a history of shingles, right knee surgery and abdominal pain and hospitalization for abdominal pain. There was no pre-existing illness. On 14-FEB-2011 the patient was vaccinated IM on the left arm with the second dose of GARDASIL (lot # 667866/1437Z). Concomitant therapy included DURICEF, BACTRIM, vancomycin and "all anti-epileptic drugs". The patient was starting a low grade fever. The bilateral hand/knuckle joints were sore and swollen. The right knee was the size of a softball and the right foot was swollen with pitting edema around 2+. The patient had seen the doctor with this earlier in the week and the doctor had prescribed a 100 mg prednisone taper along with pain medications. Later the next day or so the patient called the doctor's cover, and upon explaining his first recent bout with serum sickness from antibiotics (abx) and the size of swelling when he described his right knee, the doctor told the patient to waste no time and go to hospital which he did. In the meantime the patient had ace wrapped his knee. Upon arriving at hospital the patient was seen promptly but had noticed that his swelling had gone down sufficiently along with his hands and right lower leg. The physicians did not know why this would happen and agreed he needed to see an immunologist, rheumatologist in case his right knee needed draining again, and a pain consult since this was continuing to be a pain problem. The ER doctor thought that since all his lands had not come back out of range the patient was safe to go home and have this all done outpatient despite the fact the patient explained he was on limited COBRA. The patient knew he had what seemed to be chronic joint pain and had to wear a special medical alert band because any drug you put in him could most likely have a reaction too. He also lost a lucrative nursing contract over this disease because he was too sick to show up for work. The following information was obtained through follow-up and/or provided by the government on 06-APR-2011. PCP internal medicine office note record received for DOS 01-APR-2011. Assessment: Edema and joint pain. Patient presented with complaint of right shoulder and both knees, legs swollen. Patient's temperature was 99.0 Fahrenheit. No rash. Assessment: edema and joint pain. Plan: Pred taper and OXYCONTIN PRN. Record noted 01-APR-2011: not convinced that GARDASIL caused acute recurrence of patient. The patient   [Due to memory limitations, the remainder of this text could not be compared.]  ient stated belief that this reactivated his serum sickness. On 06-APR-2011 vaccination record received for DOS 14-FEB-2011. Report updated. 08-APR-2011 ER, lab records received from DOS 05-MAR-2011 and 26-MAR-2011. The diagnosis was Polyarthritis. Patient presented to ER on 05-MAR-2011 for complaint of leg pain, redness. Patient reported hitting leg while moving 3 days ago. Exam noted wound on shin with surrounding erythema and warmth. Impression: Cellulitis right leg. Patient presented to ER on 26-MAR-2011 with complaint of joint pain in knees, ankles, hands and elbows. Impression: diffuse joint pain. The patient reported past a hospitalization this past month with serum sickness and related his pain to serum sickness. The patient was seen on 02-APR-2011 with complaint of pain and swelling of right knee and swelling down to the foot. Exam noted min. effusion to right knee and min. swelling to shin and foot. The diagnosis was polyarthritis. On 14-APR-2011 hospital discharge summary was received for DOS 13-MAR-2011 to 16-MAR-2011. Primary diagnosis was Polyarthralgia secondary to drug reaction. The patient presented with complaint of acute onset of joint pain (right shoulder, fingers, wrists, feet, toes). The patient had a history of recent treatment for lower extremity cellulitis with IV vancomycin and then a 5 day course of cephalosporin and BACTRIM. The patient underwent joint aspiration, which revealed acute infection or septic joint and so antibiotics were held due to concern that patient was having reactive arthritis versus eruptive polyarthralgias from drug reaction. Rheumatology was consulted and the patient was started on IV SOLU-MEDROL and within 24 hours, polyarthralgias improved. It was also noted that upon admission, the patient was significantly drowsy (presumably from taking too much narcotics). On day of discharged, it was recommended that patient took no further narcotics. The patient was discharged home on prednisone taper. Patient would follow up with PCP. The patient developed acute renal failure and associated lab tests were performed which revealed low CBC (hematocrit), chronic pain and many others. On 08-APR-2011 the records received revealed chest X-ray was negative (no active disease). The line listing indicated that one or more events was caused hospitalization and extended hospital stay and considered to be immediately life threatening and permanent disability. 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. The original reporting source was not provided. The VAERS ID # is 420232-1. No further information is available.