Age: 42.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Arthralgia, Discomfort, Inflammation, Injection site pain, Limb mass
Clinical narrative: Initial unsolicited report received from a consumer on 27 Jan 2017. This case involves 42 year old female patient who was vaccinated with a dose of ADACEL (batch number, expiry date, dose in series was not reported) via intramuscularly in left deltoid on 12 Sep 2016, a dose of INFLUENZA VACCINE (batch number, expiry date, dose in series was not reported) via intramuscularly in left deltoid on an unknown date. (Reported as 10 days later). The patient had no illness at time of vaccination, the patient has an autoimmune syndrome that has been in remission for 1 year. The patient concomitant medications were not reported. On 13 Sep 2016, within 24 hours after the vaccination with ADACEL, the patient developed pain at the injection site, that woke her up at night and her whole body ached. On an unknown date, few days after the vaccination with influenza vaccine and ADACEL the patient had lymph node swelling and a fever of 103 F, on an unknown date the patient was seen by her MD (medical doctor), blood work showed an elevated rheumatoid factor and the patient was diagnosed as inflammatory reaction to vaccine, on 09 Nov 2016, 1 month 28 days after the vaccination with ADACEL the patient Thumb swelled on left hand and left foot swelling. Seen by MD rheumatoid factor was 24, again on 20 Dec 2016, the patient Left thumb and foot had swelling, on 26 Dec 2016, the patient top of the left foot very swollen and a lump about the size of two peas developed, causing her pinky toe to be pushed away from her other toes, on 29 Dec 2016, the patient was seen by a rheumatologist and put on high dose of steroids. Rheumatoid factor was 38, and diagnosed as Early Rheumatoid arthritis. On an unspecified date, following vaccination, the patient had swelling in her right hand to the middle index finger, and left hand the thumb was swollen. She is also experiencing pain in her joints and uncomfortable feeling. The patient other lab tests were not reported. The patient had corrective treatment with Prednisone, Zovalax 35 mg 2 times per day and a steroid daily. The outcome of the events were reported as not recovered. Upon internal review the company decided to consider the events serious because of important medical events Rheumatoid arthritis, Peripheral swelling, inflammatory reaction to vaccine, joints a painful, fever of 103F, uncomfortable feeling, lymph node swelling. List of documents held by sender: none. Sender's Comments: Patient was vaccinated with ADACEL and presented with vaccination site pain and whole body ache with 24 hours and 10 days later she was vaccinated with influenza after both vaccine she presented Rheumatoid arthritis and associated symptoms. Time to onset is compatible, in this case patient has been positive for RA factor, rheumatoid arthritis is autoimmune disease which has genetic correlation and idiopathic in nature, past vaccination status, any similar complain are needed to further assess the case. Based on available information the role of vaccine in rheumatoid arthritis is unlikely, but for vaccination site pain and whole body ache cannot be ruled out.