Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal discomfort, Condition aggravated, Drug ineffective, Hepatitis C test negative, Inappropriate schedule of drug administration
Clinical narrative: This is a spontaneous report based on the information received by Abbvie, Reference: 15P-163-1477635-00. A contactable 65-years-old female consumer reported that: Spontaneous report by consumer of a female with the event of pneumonia and non-serious HUMIRA did not work, she had so many flare ups, methotrexate caused stomach upset, took HUMIRA without taking methotrexate along with it, doctor said patient probably developed Rheumatoid arthritis lungs and HUMIRA did not slow down the progression of rheumatoid arthritis with HUMIRA. She was diagnosed with Rheumatoid arthritis in 2006 and she started taking ENBREL right away. She was prescribed to take methotrexate with her ENBREL regime about four year ago. She could not tolerate taking the Methotrexate because it tore up her stomach. She took Methotrexate for about two years. The product stated building up in her stomach. She started on XELJANZ because of how the Methotrexate affected her stomach. She did not recall the dosage of the Methotrexate. She started taking XELJANZ about 1 or years ago. It worked well for her. She didn't have any pain. She stopped taking XELJANZ about two years ago because her insurance would not cover it. The doctor put her on HUMIRA because of this. The HUMIRA did not work because she was not able to take the recommended Methotrexate along with it. The HUMIRA worked a little bit, but she had so many flare ups. HUMIRA did not stop the progression of her rheumatoid arthritis. The doctor prescribed her to take a 40 mg injection twice a month, or every two weeks. The written instructions provided with the product stated that the product could be taken once a week. The doctor told her that he did not want her to take the product once a week. She started taking HUMIRA about 2 years ago. She stopped taking HUMIRA on 21Sep2015 when she was able to start back on XELJANZ. On unknown dates the patient experienced Pneumonia, methotrexate caused stomach upset, took HUMIRA without taking Methotrexate along with it, Doctor said she probably developed rheumatoid arthritis lungs and HUMIRA did not slow down the progression of rheumatoid arthritis. She received a pneumonia vaccine about three to four years ago, but got pneumonia about two years ago after she received the vaccine. Her doctor said that she was probably developing rheumatoid arthritis lungs. She did not know the manufacturer or the dose that was given. It was given at her doctor's office. She was in the intensive care unit for two days and was hospitalised for a total of five days. She completely recovered from this experience. On 21Sep2015, the patient experienced HUMIRA did not work. She had so many flare ups. On unknown dates, Pneumonia and Methotrexate caused stomach upset resolved. XELJANZ, Methotrexate, Pneumonia vaccine, Prednisone, Cortisone shot and ENBREL were also considered suspect. Causality for HUMIRA: The reporter's statement of causality for the events of Pneumonia, Methotrexate caused stomach upset, took HUMIRA without taking Methotrexate along with it and doctor said she probably developed rheumatoid arthritis lungs was not provided. The reporter stated that there is a reasonable possibility that the events of HUMIRA did not work, she had so many flare ups and HUMIRA did not slow down the progression of rheumatoid arthritis are related to HUMIRA. Change History: On 27Oct2015 received updates to suspect drug information. Check all appropriate to adverse reaction: Involved or prolonged inpatient hospitalization. Causality assessment for Pneumonia, Stomach upset, Inappropriate schedule of drug administration and Rheumatoid arthritis causality as per reporter was not reported; for Drug effect lack of and Drug effect lack of was Probable. Pfizer is Marketing Authorization Holder of cortisone acetate, Pneumococcal vac in the reporter's country. This may be duplicate report in situations where another Marketing Authorization Holder of cortisone acetate, Pneumococcal vac has submitted the same report to the regulatory authority.