Age: 59.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Injection site pain, Joint range of motion decreased, Joint stiffness, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received FLULAVAL QUADRIVALENT. Previously administered products included Influenza Vaccine (the patient had never experienced any reaction in the past after vaccination with flu shots).  Concurrent medical conditions included knee arthritis. Concomitant products included ALDACTONE, SINGULAIR, progesterone, estradiol and ADVAIR DISKUS. On 22nd September 2015, the patient received FLULAVAL QUADRIVALENT. On 24th September 2015, 2 days after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site pain, stiffness, arthralgia, stiff joint and joint range of motion decreased. On 25th September 2015, the patient experienced pain in hand. On 27th September 2015, the patient experienced shoulder pain. The patient was treated with CELEBREX. On 29th September 2015, the outcome of the injection site pain, stiffness, arthralgia, stiff joint, pain in hand, shoulder pain and joint range of motion decreased were recovered/resolved. It was unknown if the reporter considered the injection site pain, stiffness, arthralgia, stiff joint, pain in hand, shoulder pain and joint range of motion decreased to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The patient was a employee. The reported injection site was right arm. The patient did not experience any adverse reaction following previous vaccination. On 24th September 2015, 2 days after receiving FLULAVAL QIV, the patient experienced pain and stiffness in her right hand and wrist pain. The pain and stiffness really resulted in a decrease range of motion when performing certain activities. The decreased range of motion was similar to someone who suffered from chronic arthritis. After one day the symptoms started to dissipate with little residual pain. On 25th September 2015, 3 days after the vaccination, the patient experienced pain in the left hand and wrist. The pain and stiffness lessened after one day but with residual pain. After almost complete resolution, the pain and stiffness returned to both hands and wrists on 27th September 2015. On 27th September 2015, 5 days after the vaccination, the patient also experienced quite significant pain and stiffness in her left shoulder and was very painful that she was unable to sleep that following night. Throughout the entire course of pain, the patient was taking CELEBREX 200 mg with little relief. She normally takes this medication. The patient also added that she experienced increase pain in right and left knees, but has a history of arthritis. She noted that the pain was more severe than it normally is with just her arthritis. The pain was particularly in the left knee. The patient could not recall when the pain started following the vaccination. The batch number and expiry date of the vaccine were unknown. Medical attention was not required. The patient did not consult a physician regarding the events. The patient was not hospitalised because of the reaction. Follow-up information received on 6th November 2015: This case was upgraded to serious due to psoriatic arthritis (GSK medically significant). The reporter called back to provide additional details to the previous report. The reporter stated that her symptoms (pain) had not resolved and they do return primary in her hands and knees. For several weeks the patient ADVIL 600mg twice a day. She scheduled an appointment with a rheumatologists just to make sure it was not a joint related problem. According to her blood work, the patient stated her lab work came back negative for lupus. The rheumatologist diagnosed her with post vaccination inflammation. The reporter stated she was recently diagnosed with psoriatic arthritis and the doctor believed the symptoms she was having was related to the vaccine. The patient continued to take ADVIL on a daily basis (1-600mg a day).