Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain, Pulmonary calcification
Clinical narrative: Initial report received from a healthcare professional on 27 December 2012. 10 patients of unspecified demographics, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (Lot number U4496AA, dose number and site of administration were not reported) on unspecified date. On an unspecified date, the patients developed pain and lump formation at the injection site. Corrective treatments were not reported. No laboratory investigations were done. On an unspecified date, the patients had recovered from the events. Follow-up information was received from a health care professional on 20 May 2013. Based upon the new information provided, this case has been upgraded to serious. A 67-year-old female patient received an intramuscular injection in the left arm of FLUZONE HD (Lot number U4496AA, dose number not reported) on 04 October 2012. One day post-vaccination, on 05 October 2012, the patient experienced adverse event onset. The patient had a previous history of the "same problem, still hurting" after receiving FLUZONE HD on 23 September 2011 (Lot number UH452AC, Expiration date 04 April 2012, route and site of administration were not reported). The patient had a history of arthritis, spinal stenosis in cervical region, hypertension, obesity, goiter, scoliosis, meningioma (2011), "P2G2", and hyperlipidemia. In the procedure history, the patient had arthrocentesis of the left shoulder acromioclavicular bursa, hernia repair (2005), trigger point injections, hemorrhoidectomy, and bone spur (2008). The patient's family history included aortic stent (brother), hypothyroid (Family), goiter (maternal aunt), arthritis (mother), hyperlipidemia (mother), hypertension (mother), hypothyroidism (mother), CAD, Diabetes, hypertension, atherosclerosis (sister), goiter (sister), and Parkinson's disease (sister). The patient's allergies included codeine, amoxicillin, acetaminophen and oxycodone. The patient was a non-smoker and not pregnant. Based on the office visit on 18 January 2013, the patient had nothing abnormal in the physical exam except positive for bone/joint symptoms. The left shoulder was tender to palpation and motion with slight limitation to range of motion. An MRI revealed a partial tear of the supraspinatus and subscapularis. The patient also had a diagnostic "shoulder min 2 views" on 29 November 2012 and results showed arthritis, hilar calcifications, and LLL calcification. An MRI of the brain with and without contrast was ordered 18 October 2012 and an MRI of the upper extremities not joint was ordered 27 December 2012. The medical assessment made on 18 January 2013 was tendinitis of left rotator cuff. The site was prepped and draped using sterile technique. An injection was performed on the left shoulder acromioclavicular bursa. Anesthetics included Lidocaine 2% plain 1 mL. Injected medications included 1 mL of Celestone SOLUSPAN 10mg. Patient tolerated the procedure well. The patient was instructed on shoulder exercises. The patient's concomitant medications included FLEXERIL, methylprednisolone, XERESE, ADIPHEX-P, omeprazole, LIPITOR, and BUTALBITAL COMPOUND. The patient's outcome was reported as not recovered (previously reported as recovered). This case is linked to cases 2013-06234, 2013-06243, and 2013-06244. List of documents held by sender: none.