Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Immediate post-injection reaction, Oral herpes, Pyrexia, Respiratory disorder
Clinical narrative: Information has been received from a health care worker at a physician's office and from emergency room (ER) records (patient education materials) concerning a 24 year old white female student who on 17-JUN-2008 was vaccinated into left deltoid with a first dose of GARDASIL vaccine (yeast) (lot # 660553/0070X). There was no illness at the time of vaccination. The health care worker reported that on 23-JUN-2008, the patient called the office and complained of nasal and above upper mouth lip sores since receiving the GARDASIL vaccine (yeast) (also reported as "immediately post injection"). The patient also reported that she had been febrile and feeling worse everyday. She was asked about having a history of herpes and denied having a history of herpes. She was asked to stop by the office for an evaluation. The reporter stated that when the patient visited the office and visual exam was done, she had sores that looked 100% herpetic. She was reassured that the outbreak was not due to GARDASIL vaccine (yeast), and she was sent to the emergency room for a second opinion and documentation of incident. The patient education materials from the emergency room for the patient, referred to the patient's injury and illness as viral respiratory illness, "she had an upper respiratory illness caused by a virus". Home care education for the viral respiratory illness included : rest for severe symptoms, avoid exposure to cigarette smoke, TYLENOL or ADVIL or MOTRIN for fever, muscle aching, headache. Also to avoid dehydration by drinking 6-8 glasses of fluids daily, and to return promptly or contact physician if any cough with lots of colored sputum occurs (mucus or blood), chest pain, shortness of breath, wheezing, or having trouble breathing, severe headache, face, neck or ear pain and any fever over 1200.4 degrees F (38.0 degrees) for more than three days. The education materials also noted the patient's cold sore-herpes labials, HSV; type 1. Home care information for the cold sore included: the patient's use of TYLENOL or ADVIL or MOTRIN to relieve pain and fever and not to use aspirin. She could use over the counter remedies such as bacitracin zinc (+) lidocaine hydrochloride (+) neomycin sulfate (+) polymyxin B sulfate (CAMPO-PHENIQUE) or benzocaine (+) phenol (ANBESOL) to help to relieve pain. Ice cube could be applied on blisters to relieve severe pain. The patient was informed not to touch the cold sore and to avoid touching her eyes to avoid spreading the virus to the eyes. She was to wash her hands often during a flare-up and avoid kissing or sharing of utensils to avoid spreading the virus to others, and to use zinc oxide or sun block on her lips before spending time in the sun. She was to contact the physician or return promptly for any eye pain, redness or drainage, headache, fever or stiff neck. The patient was given prescriptions for sulfamethoxazole (+) trimethoprim (BACTRIM DS tablet) 1 tab orally twice a day for 7 days. The patient was to follow up with her physician within 1 day. The patient returned to the physician's office after the ER visit to inform the office that the ER concurred a viral outbreak. On 25-JUN-2008 the patient called the physician's office requesting acyclovir (ZOVIRAX) changing to acyclovir (ZOVIRAX) 5% #1 tube "AAA 6-7 1R/F". The patient's outcome was not reported. Additional information is not expected.