Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Nerve conduction studies normal, Neuropathy peripheral, Pain in extremity, Sleep disorder
Clinical narrative: Initial case received from a health care professional on 13 August 2010. A 46-year-old female patient received a left arm injection of ADACEL (sanofi pasteur inc lot number UF544CA, sanofi pasteur ltd lot number C3109) on 29 June 2010. She had no previous medical conditions, and no illness at the time of vaccination. Per the reporter, "since getting vaccinated" (exact date not reported) the patient had experienced severe, constant left arm pain. She had been seen by a physician, and at the time of the report she was being treated for ongoing left arm pain; specific treatment was not noted. The reporter denied redness or swelling. Seriousness criteria: Other - medically significant. Follow-up information received from a health care professional on 27 August 2010 provided information that has determined this case to serious. The patient had a history of smoking, tonsils removed as a child, appendectomy at age 8 years and carpal tunnel syndrome (CTS) in 1987. She has no known drug allergy (NKDA) and takes no medications. On 14 July 2010 the patient complained of a left painful arm where she received an injection 2 weeks ago. She has had constant pain since then, and went to Urgent Care. The patient was given a steroid but the steroid did not do anything. The patient had stated that the pain wakes her up in the middle of the night. She was feeling sick all over and at one point thought she was going to pass out. On examination of the left shoulder and upper arm on 17 July 2010, there was no swelling or redness and the patient was able to hold arm close to body. Upon palpation to the left arm, tenderness of the deltoid and bicep was found. She had restricted rotations and abduction above 90 degrees with decreased strength. Sensation was intact. The assessment was pain in limb. The plan of treatment was to start the patient on oral tablets of doxycycline, hyclate 100 milligrams (mg) 1 tablet twice daily (bid) for 10 days, prednisone taper 9 day of 20 mg one tablet three times daily (tid) for 3 days, 1 tablet bid for 3 days then 1 daily (qd) for 3 days. A diagnostic imaging of the left shoulder x-ray and left electromyography (EMG)/nerve conduction study (NCT) was ordered. On the 14 July 2010, the patient had left shoulder x-ray which was normal. The nerve conduction study of the left axillary to deltoid done on 16 July 2010 showed no evidence of abnormality and was reported as normal. The EMG of the upper extremity performed on 16 July 2010 showed mild but reproducible denervation acute of medial deltoid greater than anterior. No denervation noted in the posterior. This was consistent with probable local nerve irritation secondary to immunization preservative. The impression was probable local axillary neuritis secondary to immunization preservative. The patient called the doctor on 10 August 2010 to complain that she was unable to sleep due to the pain in the arm. The patient was prescribed oral ELAVIL tablet 10 mg one tablet at bedtime. At this time the recommended patient treatment was ELAVIL 10 mg qhs after steroid, occupational therapy (OT) 4-6 visits if necessary and follow-up if worse. The outcome remained not recovered. Documents held by sender: Medical records.