A cluster of 2 patients who received DECAVAC, lot number U2865BA, and developed local reactions at the injection site. Initial report received on 14 August 2009 from a healthcare professional. A 59 year old female patient, with an allergy to aminoglycosides, received a left deltoid 0.5 ml intramuscular injection of DECAVAC (lot number U2865BA) on 10 August 2009. The patient had a burn at the time of vaccination. On 14 August 2009, the patient had a local reaction at the injection site described as larger than a softball, hard to touch, and red. The patient required a doctor visit. Corrective treatment was not reported. At the time of the report, the patient had not recovered. Follow up information received on 03 September 2009 from a health care professional who reported that the patient had a history of hyperlipidemia, migraines, anxiety, urinary tract infectious disease, allergy to minocycline, and insomnia. No previous administration of tetanus was noted in the patient's medical record. On 14 August 2009, the patient presented with increased redness and tenderness over the left deltoid area receiving a DECAVAC 5 days prior, when she was seen for a left forearm burn. She was treated with KEFLEX and SILVADENE cream. She was noted to have a fever, chills, body aches. She also had a sore throat. Upon assessment, the patient had a loss of appetite and fatigue. Vital signs were 126/64, pulse 71, respirations 16, temperature 98.2. Impression included fever, arthralgia, fatigue, and reaction to DECAVAX injection. Plan included ALEVE 1-2 tabs twice a day, BENADRYL 25 mg every 6 hrs as needed for redness in the left arm, increase fluids, rest, avoid Td injections in the future, monitor for worsening of redness and pain, and continue KEFLEX 500 mg one tablet four times a day for ten days. No further information was provided. Follow-up information was received from the health care professional on 09 November 2009. Based upon this new information, it was determined that the event should be considered serious. Additional medical history included osteoporosis, and the patient was taking AMBIEN, FOSAMAX, and LIPITOR concomitantly. Four days post vaccination, the patient developed cellulitis of the arm, fever, and muscle and joint pain. ESR was 58 at that time, and the patient was treated with ADVIL. She was seen by her physician on 29 September 2009, at which time she complained of ongoing joint pain in the hands, wrists, fingers, and knuckles. Her knees and hips also had some mild swelling. She also reported worsening problems sleeping, and noted that she was getting up at night due to the pain in her joints. She denied any fevers. A physical exam revealed slightly tender hands with no redness or swelling. Her physician ordered testing, including a CBC, ESR, CPK, and testing for rheumatoid arthritis, antinuclear antibody, and lupus (test results were not reported). She was instructed to take ibuprofen 600 mg four times daily as needed as needed for pain, and was to follow-up if her symptoms increased. No additional information was provided. Case 2009-03537 with the same reporter and same DECAVAC lot number was created for the other patient. List of documents held by Sender: office visit notes.