Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Insomnia, Nuclear magnetic resonance imaging normal, Pain
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of injection arm pain in a 62-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to hydrocodone and smoker. Historic vaccination included pneumonia vaccine (non-gsk); manufacturer unspecified; unknown; unknown given on an unspecified date. Concurrent medications included ADVAIR and COMBIVENT. On 3 October 2011 at 15:15 the subject received a dose of FLUARIX (.5 ml, unknown route, left arm). On 10 October 2011, 7 days after vaccination with FLUARIX, the subject experienced injection arm pain, injection site movement impairment ("loss of range of motion, could not move him, complete loss of mobility"), not sleeping and inability to perform daily activities ("could not dress, cook"). The subject stated that 1 week after the vaccination she developed significant pain in her left arm and loss of motion. She denied any injection site immediate reaction from the vaccination. According to the subject, she continued to worsen to the point of complete loss of mobility in the injected arm. She stated she could not sleep, dress, cook or move her arm. The subject reported that she was only able to get 2 hours of sleep a night for 3 months. The subject saw her physician on 14 December 2011 and again on 12 January 2012 for "continued problems". An X-ray demonstrated no physical damage or tears in her arm. The subject had a magnetic resonance imaging (MRI) on 20 January 2012 and again no injury to the shoulder or arm was seen. The subject saw an orthopedist on 25 January 2012 who treated her with a cortisone injection, pain medications and range of motion exercises. According to the subject, the cortisone injections stopped the pain and the exercises have made a very small improvement in the range of motion. The subject noted that she is not certain if she will ever be able to have full range again like this on the internet and is angry over the loss of function and money". The subject indicated that she has not pursued legal action at this time, but may proceed for reimbursement. The subject stated she reported her events to the FDA. At the time of reporting, the injection site arm pain was resolved as of 25 January 2012 and the injection site movement impairment and not sleeping were improved. The outcome for inability to perform daily activities was unknown. Follow-up information was received via the consumer on 27 March 2012. It was reported that the subject still had ongoing issues following vaccination with FLUARIX. She noted pain in her arm described as severe pain with certain arm movements and "loss of range of motion". The subject noted still not having full use of her arm. She reported that her condition may require additional cortisone shots and therapy. This subject has received ADVAIR concurrently. For details concerning events associated with ADVAIR use, please see case A0912059A.