Age: 13.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP, FLUN3, HPV4, MEN, TD
Symptoms: Myalgia, Pyrexia, Scar, Skin disorder, Ultrasound abdomen
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. A 13 year old very healthy and athletic female patient, allergic to the fruit formula given before having a CAT scan, was vaccinated in the left arm with the first dose of GARDASIL (Lot # 659435/1265U). Concomitantly, the first dose of influenza virus vaccine (unspecified) (manufacturer unknown) (Lot # 500487P) was given. It was reported that the patient experienced fever, severe abdominal pain and muscle aches. The patient was lethargic and had asthma. The patient also developed skin indentations (tissue break down up underneath the skin). The indentations were circular in size, starting around the injection site and had spread throughout entire body. A specialist stated that had never seen anything like it. The patient was referred for further testing. The indentations were not going away but permanently scarring the patient. The patient was also experiencing vertigo. Records received on 23-MAR-2009 from date of Service of 10-NOV-2008 presented a patient complaining of lesions to trunk and extremities. Records received on 30-MAR-2009 from Emergency Department visit on 02-NOV-2008 showed a patient complaining of abdominal pain and a diagnosis of ruptured ovarian cyst. Doctor's office records showed two other shots of Td adult vaccine given on 17-OCT-2008 (Lot # C2778AP) and also MONOTZ (Lot # U2426AA) given on 18-OCT-2007. Several biopsies were performed by two dermatologist (specialist) and regular dermatologist with unreported results. The patient did several regular doctor visits. An ultrasound and CAT scan of abdomen-biopsy were performed, which records were received on 23-MAR-2009, with unreported results. The listing indicated that one or more of the events required hospitalization. No further information is available. The original reporting source was not provided. The VAERS ID # 342045. Follow up information was received on 01-MAY-2009 via a senator's office, from a constituent who is the patient's mother. The reporter stated that the patient received GARDASIL , nasal flu, meningitis and tetanus shot "all on the same day", and now has asthma, skin tissue (fibers breaking down) in a pox like formation, sweating, hospitalized for severe abdominal pain, fever, and more symptoms. The reporter noted that GARDASIL has not been tested with the nasal flu, meningitis, or tetanus shots, and that the most severe side effects occur when you combine it with the meningitis shot. The patient's mother stated that her daughter had over seventy pox like formations on her body, scarring her body and never going away. The patient had skin biopsies taken (results not reported). The patient has been reviewed by several dermatologist specialists and all of the doctors have never seen anything like this. She was also taken to see an immunologist and rheumatologist and they've never seen this before. Her case is currently being reviewed by a vaccine side effect specialist. No further information is available. This report was filed with the FDA. The ISR number is 342045.