Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Ear infection, Influenza like illness, Nasopharyngitis, Pneumonia, Pyrexia
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 17 year old female with an allergy to amoxicillin and AUGMENTIN who on 23-JAN-2007 was vaccinated intramuscularly with a first dose of GARDASIL (lot # 654389/0961F). Suspect therapy given intramuscularly included a first dose of VAQTA (lot #656495/1209F). Other concomitant therapy included a first dose of MENACTRA (lot # U2107AA) vaccinated intramuscularly on 23-JAN-2007. On 16-JUL-2007 the patient developed severe case of pneumonia with fever, no cough or cold prior. The patient was sent to hospital for chest X-ray where she was given inhalation therapy and prescribed cefdinir (300 mg) and albuterol (90 mg). In the evening of 16-JUL-2007, the patient went to emergency room when she couldn't breath. The patient received inhalation therapy and Z-PAK. On 18-JUL-2007 the patient was checked at doctor's office for improvement. On 19-JUL-2007 the patient was given additional albuterol (0.83 mg) and told to use one vial every 4 hours. It was reported that in July 2007, the patient was given refill of Z-PAK. On approximately 07-SEP-2007 the patient experienced fever. On 28-SEP-2007 the patient experienced sinus infection and was prescribed Z-PAK. It was also reported that in September 2007, the patient began losing substantial amounts of hair that continued for approximately 4 months. On 07-MAR-2008 the patient was seen for ear and sinus infection and fever and was prescribed Z-PAK. On 19-DEC-2008 the patient developed flu-like symptoms with vomiting, diarrhea and fever. The patient was given PHENERGAN (25 mg) and was sent to hospital when vomiting continued. The patient was given 3 bags of IV fluid and treated for vomiting and diarrhea. On 20-JAN-2009 the patient developed cold symptoms and fever. It was also reported that the patient had chronic bruising. Alopecia, contusion, diarrhoea, ear infection, influenza like illness, nasopharyngitis, pneumonia, pyrexia, respiratory arrest, sinusitis and vomiting were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 338247. A standard lot check investigation was performed. All in-process quality checks for the lot number in question (656495/1209F) 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. No further information is available. Follow-up: Chronic fatigue. Episode of dehydration during stress; cold hands and feet; bronchitis-like symptoms. As soon as patient goes off a specific "diet" (gluten free, diary-free, sugar-free), she gets ill. She is currently on a variety of vitamins to help her maintain good health. She has NEVER fully recovered from the GARDASIL Vaccine. Also, VAERS Shows onset of side effects as 174 days (after 1st shot). But it was only 3 1/2 mons. after 2nd shot that she suffered the severe pneumonia. Also, she was NOT hospitalized because her doctor was afraid she would get an infection in the hospital that would cause her to get more severely ill - and that would be irreversible!