Initial case received from a consumer, non-healthcare professional, on 05 March 2012. A 36-year-old female patient received dose one of a left arm intramuscular injection of ADACEL, sanofi pasteur Ltd., lot number unknown, on 20 February 2012. The patient's past medical history was not reported; however, she did report multiple allergies: codeine, SUDAFED, pollen, grass, and some foods. She took no concomitant medications, other than vitamins and denied illness at time of vaccination. The patient denied any adverse event following prior vaccinations. On 20 February 2012, right after injection, the patient's left arm became sore and the next day, was in "severe pain", which has gradually improved. She also experienced muscle stiffness in left deltoid and there were a few "red lines" on the upper arm. The patient did seek a doctor visit. The patient's outcome is not recovered. Follow-up information and medical records were received 07 May 2012 from a health care professional. Based upon new information received, it was determined this case now meets seriousness criteria, and this case has been upgraded from non-serious to serious. According to medical records, on 20 February 2012, the day of vaccination with ADACEL, the patient felt well. Medical records noted the patient had been going to PT (reason not specified). In addition to previously reported allergies, she had additional allergies to nuts, red peppers, barley, trees; seasonal allergies; and she experienced facial flushing from codeine, and migraines from SUDAFED. Past medical history consisted of tonsillectomy and adenoidectomy (T+A), back symptoms, eye symptoms (glasses 2011), depression and anxiety 1983, GERD caused by peppers and decreased right hearing loss x five years. She was a non-smoker, rarely used alcohol, slept 6-8 hours daily and exercised regularly. The patient had previously received a Td vaccination (date not reported). Family history included her mother with increased cholesterol and anxiety, father with pancreatic cancer at 58 yrs of age and sister with mitochondrial disease. Review of findings noted decreased right hearing loss and sleep habits with normal findings. Assessment was GERD and asthma with instructions to exercise daily. The patient also received ADACEL, (sanofi pasteur, Inc. lot number U4304BA; sanofi pasteur, Ltd. lot number C4068) during this office visit. On 05 March 2012, the patient returned for evaluation. According to medical records, weight was 116.4, blood pressure 100/80, pulse 80, temperature 98.5. Interval history: the patient complained of a sore left arm after receiving TdaP vaccine. General assessment "NAD". Evaluation findings noted "(illegible) arm nontender without red or without swelling, no local reaction noted in deltoid area, pain in L flex external rotation of Lt shoulder; 4 "linear streaks". Pain was reported as 7/10 originally with no pain with movement; pain now 4/10, increased with movement. Heat applied twice daily over weekend, and MOTRIN two tablets taken. The patient complained of pain moving arm only at present, no pain at rest. Assessment was left arm pain and dermatitis. Corrective treatments consisted of MOTRIN 400 mg 1 tab q8h prn for pain with food # 90, ALLEGRA 180 mg daily for seven days; "call if one week", ice / warm packs alternating, and a return office visit in two weeks. On 23 April 2012; the patient returned for re-evaluation. Assessment: weight 112.4, blood pressure 104/60, apical pulse 80, respirations 16, temperature 98.3 with no fever or chills. The patient had a cold the week prior to this visit that improved with Vitamins, tea and OTC medications. Interval history noted physical therapy for the left shoulder and weekly chiropractor visits. The patient claimed her left shoulder pain was a result of her TdaP vaccination. Upon examination, the patient was able to sit comfortably, speech was fluent, "NAD". Throat showed no erythema or exudate; chest clear to auscultation bilaterally with no chest pain and no shortness of breath; heart rate and rhythm regular; ears revealed visible tympanic membranes, landmark intact; nose was clear; no nausea, vomiting or diarrhea. Musculoskeletal system revealed full range of motion (FROM) with + "TTP" over acromion L shoulder, strength normal 5/5. At the time of examination, the patient had completed one session of PT "last week" and noticed approximately 60% improvement. She had been receiving laser therapy once weekly at the chiropractor and she had been taking oral medications (unspecified) once a week for pain. Assessment: Shoulder bursitis, Biceps tendonitis, Asthma - stable. The patient was to continue PT for four weeks and follow-up one month to re-evaluate. Outcome was reported as "to be determined". Documents held by sender: None.