Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Myalgia, No reaction on previous exposure to drug, Pain, Pain in extremity
Clinical narrative: Initial report received on 14 November 2008 from a health care professional. A 63 year-old female patient received on 20 October 2008 FLUZONE (lot# U2765AA), Intramuscular into the left deltoid. Within 1 week she could not reach back to buckle the seat belt. No other symptoms were reported. No treatment was given. The patient saw her physician on 14 November 2008. The patient had no illness at vaccination time and had unspecified allergies. She received flu shot previously and no adverse event was reported. Follow-up information received on 11 December 2008 from a physician. At the time of vaccination on 20 October 2008, the patient had pre-existing medical history of very mild allergy to either chicken and/or egg and egg products that is continuing, as well as hypothyroidism, adrenal insufficiency, heart murmur and allergy to BACTRIM and ampicillin. The patient also takes concomitant medication of XANAX (indication not provided). Other concomitant medications include, ARMOUR THYROID (for hypothyroidism) and CORTEF (for adrenal insufficiency). The patient received the FLUZONE on 20 October 2008 at 09:25 AM. The expiration date for the vaccine was reported as 30 June 2009. A copy of a letter from the patient to the physician dated 12 November 2008 was provided. In that letter, the patient stated she called the physician several times over the past several weeks to give the nurse an update on the soreness in her arm after receiving the FLUZONE. The soreness, which was supposed to last a day or two, was still continuing on 12 November 2008, especially when patient rotated her left arm, shoulder and upper arm in certain positions; and when she tries to buckle her seat belt in the car by herself when she is on the passenger side, of which she is unable to do. The patient denied any redness, swelling or tenderness to the left arm. The patient reported that last year and the year before she had taken the flu shot with no problems and a pneumonia shot that caused soreness and aches, but within a week or so it was over. Prior to that, she had received either German measles or measles vaccine in her hip in her mid-thirties and within a week her tail bone and coccyx area began to get sore and she had trouble sitting comfortably for the next two years requiring use of a plastic inflatable ring to sit. The patient had not taken any other vaccinations within 25 years prior to that. The patient expressed concern that she may have some sort of sensitivity to vaccines, but that was not confirmed by a physician. The patient was going to file a VAERS form. On 17 November 2008, the patient was evaluated by her physician for the soreness in the left arm and she reported that she had been self medicating with ibuprofen for this and had relief but the soreness continues. Physical examination that day revealed the patient's left upper arm with no redness or skin changes, and with mild left shoulder impingement, mild frozen shoulder and "ned drop test." Neurovascular examination was "ok." Final assessment was shoulder bursitis/tendonitis with stream of events as follows: flu shot leading to myalgia leading to tight shoulder leading to shoulder tendonitis/bursitis. The patient expressed desire for acupuncture but it was not reported whether this occurred or not. The patient was to return to the physician's office for evaluation as needed. At the time of this report, the patient had not recovered. Documents held by sender: Medical records, doctor letter, copy of patient letter to physician dated 12 November 2008, immunization consent form dated 20 October 2008.