Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Metrorrhagia, No reaction on previous exposure to drug, Smear cervix, Smear cervix normal, Vaginal haemorrhage
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated intramuscularly with three 0.5ml doses of GARDASIL (lot#, dates and site of administration not reported). Concomitant medication therapy included hormonal contraceptives (unspecified). Subsequently, the patient developed breakthrough vaginal bleeding (date not specified). It was reported that the patient also had "lip swelling" after she had "some dental surgery", it was unknown how long prior to the lip swelling the surgery was performed. The physician stated that the swelling may have been from a food allergy. There was no adverse event (AE) after the first dose, and it was unknown if these AEs happened at the same time or not, and if they occurred after the second or third dose of GARDSIL. Stool cultures had performed with no results reported. Unspecified medical attention was sought. The patient's lip swelling was reported as recovered, the outcome of breakthrough bleeding was unknown. The physician contacted during telephone follow-up could not supply the following information: (patient's name, date of birth, GARDASIL administration dates, lot#, concomitant vaccinations, AE onset dates, stool culture results and patient recovery status). The physician requested a call back in a few days and she needed to be in her office so that she could reference the patient's chart at that time. No further information is available at this time. Follow up information has been received from the physician concerning the 26 year old female with allergy to penicillin, polymycin, neomycin, bacitracin, and late allergies, migraine, temporomandibular joint syndrome, anxiety, back pain, anaemia, attention deficit disorder, abscess and lactose intolerance who on 08-DEC-2008, at 10 a.m., was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot# 0152X) into the left arm. On 09-FEB-2009, at 9 a.m., she was vaccinated intramuscularly with the second dose of GARDASIL (lot# 0152X) into the left arm. On approximately 14-MAR-2009 the patient  developed lip swelling. Her lip swelling was at times part of the lip (mostly upper) but generally not the whole lip. This had continued and no cause had been found (including dental, parasitic, food allergies). On 07-JUL-2009 the patient came to the office and complained of post-coital bleeding for approximately 1 month. She was on birth control pills. Pregnancy test showed negative. Pap test in December 2008 was normal. Chlamydia & gonorrhea DNA test, dental X-ray test, stool culture test and beta-HCG test were all negative. Cervical polyp was seen on exam. There was no illness at the time of vaccination. At the time of reporting the patient was not recovered. On 09-JUN-2009, at 2 p.m., she was vaccinated with third 0.5ml dose of GARDASIL (lot# 661046/0546X) into the left arm. Follow-up information was received on 26-AUG-2009 from the physician's office. On 14-AUG-2009, the physician had an appointment with the patient and the patient had recovered from breakthrough vaginal bleeding and lip swelling. Additional information is not expected.