Sex: F
Vaccine: COVID19, UNK
Symptoms: Anxiety, Blood test, Fatigue, Rheumatoid arthritis
Clinical narrative: Rheumatoid Arthrits; Anxiety; fatigue/tiredness; This is a solicited report from a non-contactable consumer. A 73-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), intramuscular in Feb2021 (Batch/Lot number was not reported) as a single dose (also reported as once) for COVID-19 immunization; and adalimumab (HUMIRA), subcutaneous from 21Oct2020 and ongoing, at 40mg, 1 in 14 days, for rheumatoid arthritis. Medical history included stiffness in shoulders, feet, hand, and finger; urinary tract infection, both hands/knees and spine changes; short ness of breath (hard to breath in cold weather), chronic obstructive pulmonary disease (non-smoker), abstains from alcohol, and sulfa allergy manifestation by rash, all on unknown dates; stiffness in shoulders, feet, hand, finger from 1989 to an unknown date; toes surgery in 2007, hand surgery in 2008, osteoarthritis from 2011, knee surgery in 2015, urinary tract infection from 20Oct2020 to an unknown date; "swollen joints to spine", "tender joints to spine", "stiff joints to spine"; walking was bad but that was bent over/difficulty walking, inability to hold anything or to do hair/washing/dressing/doing usual activities, both hands/knees and spine changes, uterine prolapse, depression for death of ex husband, environmental stress/stress, limb stiffness/stiff right hand, pain in lower back, pain, and pain in ankle/knee/shoulder/painful joints, all in 2020; and headache, bones hurting, and not feeling well at all, all in Jan2021. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Concomitant medications included celecoxib (CELEBREX); hydroxychloroquine; lisinopril taken for blood pressure abnormal; omeprazole taken for gastroesophageal reflux disease; denosumab (PROLIA) taken for osteoporosis; and prednisone taken for inflammation, all start and stop dates were not reported. The patient previously took Xeljanz, Cimzia, sulfa, and Enbrel. The patient experienced rheumatoid arthritis, anxiety, and fatigue/tiredness on an unspecified date. The COVID-19 vaccine was also considered as suspect. In Feb2021, the patient received the first dose of the COVID-19 vaccine manufactured by Pfizer and on 01Mar2021, the second dose of the COVID-19 vaccine also manufactured by Pfizer. The patient underwent lab tests and procedures which included blood work: normal on an unspecified date. Outcome of the event anxiety was not recovered; while for the other events was unknown. The action taken in response to the events for Humira was dose not changed. As reported, per opinion, there was no reasonable possibility that the events of walking was bad but that was bent over/difficulty walking, inability to hold anything or to do hair/washing/dressing/doing usual activities onset in 2020, inability to hold anything or to do hair/washing/dressing/doing usual activities onset in 2020, both hands/knees and spine changes, uterine prolapse, depression for death of ex husband, environmental stress, stiff right hand, pain in lower back, pain, headache, bones hurting, not feeling well at all, anxiety and rheumatoid arthritis are related to Humira 40mg/0.4ml (adalimumab). Causality as per Mfr.(drug/vaccine): no reasonable possibility.  The reporter's assessment of the causal relationship of the event the suspect product was not product at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible. Information on the batch/lot number cannot be obtained.; Sender's Comments: Based on known drug safety profile, there is no reasonable possibility of causal association between the event rheumatoid arthritis and the suspect drugs. Medical history of rheumatic disorder might be the contributing factor. There is a reasonable possibility of causal association between the events anx-iety and fatigue and the suspect drugs.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.