Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injection site induration, Injection site mass, Injection site swelling, Pain in extremity
Clinical narrative: Information has been received from a licensed practical nurse concerning a 25 year old female patient with no medical history and a penicillin allergy who on 01-APR-2008 was vaccinated intramuscularly into the left arm with the first 0.5 ml dose of GARDASIL (Lot # 659962/1740U).  Concomitant therapy included hormonal contraceptives (unspecified), ACIPHEX and minocycline.  On approximately 08-APR-2008, about one week after receiving the vaccination, the patient developed a hardened knot at the injection site.  On 27-APR-2008 the patient reported that the hardened knot had increased by five times.  The patient was examined by the physician on 28-APR-2008 and the adverse injection site reaction was palpable and the size of a marble.  The area was not reddened, painful or swollen, the nurse reported that she did not know if the patient had a hematoma.  The nurse called the patient on 06-MAY-2008 to inquire if the patient recovered.  The patient did not return the nurse's phone call.  It was reported that there are no other symptoms.  No treatment was provided.  No diagnostic laboratory studies were performed.  At the time of this report the patient's outcome had not recovered.  No product quality complaint was involved.  Additional information has been requested.  This is in follow-up to report(s) previously submitted on 5/14/2008.  At the time of this report the patient was much better.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/14/2008. Initial and follow up information has been received from a licensed practical nurse concerning a 25 year old female patient with no medical history and penicillin allergy who on 01-APR-2008 was vaccinated intramusculary into the left arm with the first 0.5 ml dose of GARDASIL (Lot # 659962/1740U). Concomitant therapy included hormonal contracepitives (unspecified), ACIPHEX and ainocycline. On approximately 08-APR-2008, about one week after receiving the vaccination the patient developed a hardened knot at the injection site. On 28-APR-2008 the patient reported via telephone that over the weekend she noticed her arm to be red, sore and the hardened knot had increased by five times. The patient stated that what bothers her the most is the achiness down her arm. The patient was examined bythe physician on 28-APR-2008 and the adverse injection site reaction was palpable and the size of a marble. The area was not reddened, painful or swollen. The nurse reported that she did not know if the patient had a hematoma. The nurse called the patient on 06-MAY-2008 to inquire if the patient recovered. On 07-MAY-2008, the patient returned the nurse's phone call and stated that the knot is smaller now about the size of a pea. It was reported that there are no other symptoms. No treatment was provided. No diagnostic laboratory studies were performed. On 02-JUN-2008 the patient was vaccinated intramuscularly into her right deltoid with a second dose of GARDASIL. Concomitant therapy included Ibuprofen. She was instructed to wait in the office for 15 mintues after the injection to ensure that she was not going to have a reaction. No apparent  reaction was noted. At the time of this report the patient recovered on 07-MAY-2008. No product quality complaint was involved. No further information is available.