Age: 64.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Animal bite, Cellulitis, Erythema, Incisional drainage, Pain
Clinical narrative: Initial report received from an investigator on 08 march 2010 under the reference number FUF14. A 64 year-old female subject with a history of occasional heart palpitations, hyperlipidemia, urinary incontinence, sciatica, back pain, dry skin, depression, seasonal allergy to penicillin, spinal stenosis, dysthymia, skin tag, sleep apnea, osteopenia, and hypertension developed cellulitis of the left ankle secondary to a cat bite 36 days after receiving a second injection of H1N1 (7.5 ug HA, lot number UD12414) on 28 August 2009. The first dose was administered on 06 August 2009. On 29 September 2009 the subject was bitten by her cat on her left ankle. As a result, the subject developed swelling, redness, and pain. She went to an urgent care center on 02 October 2009 and was given tetracycline and keflex without improvement. On 03 October 2009 she was admitted to the hospital. An incision and drainage were performed. She was given fentanyl during the procedure and CIPRO and clindamycin at a later time. She was discharged on 04 October 2009. The subject continued participation in the study and recovered from the event. According to the investigator, the event of cellulitis was not related to the study product. Follow-up information was received from the investigator on 23 March2010. The event began on 29 September 2009 was considered to be fully recovered on 04 October 2009. The subject was taking CELEXA 20 mg per os since 2006. No additional information was reported. Follow-up information was received from the investigator on 26 March 2010. The event was updated to "Cellulitis left lower extremity secondary to a cat bite"; redness, swelling, and pain were added as symptoms, beginning 29 September 2009 and resolving 04 October 2009. Study vaccine was administered intramuscularly in the right deltoid. Treatment medications tetracycline and keflex were started on an unknown date. Fentanyl 500mcg was taken x1 on 03 October 2009; ciprofloxacin 500mg was taken 03 October 2009 - 12 October 2009; clindamycin 300mg was taken 03 October 2009 through 12 October 2009.In addition, the patient also received ZOFRAN 4mg x1 on 03 October 2009 and PERCOCET 1 tab on 03 October 2009. The outcome was updated from "recovered; to "recovered with sequelae". Follow-up information received from the investigator on 31 March 2010. The subject had received additional treatment for the serious adverse event of bacitracin topical (Start date 03 October 2009, stop date unknown). The dose for fentanyl treatment was 50mcg times one dose (not 500mcg as previously reported). The stop date of 04 October 2009 was removed by the investigator from the symptoms of redness and swelling as the subject was evaluated by her primary care physician on 07 October 2009 for follow-up and the wound was healing, but was still swollen and red. At that time, the subject was still taking antibiotics. Per investigator, the subject has not followed-up with them since that time. Recovery status remains "recovered with sequelae." This study was unblinded on 25 October 2009. Documents held by sender: None