Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ankle fracture, Drug ineffective, Foot fracture, Muscle fatigue, Pain
Clinical narrative: Muscle fatigue; Ankle fracture; Foot fracture; pain; covid 19; covid 19; Rheumatoid arthritis flare up; FACILITATED COLLECT  This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP), Program ID: (not available). The reporter is the patient. Other Case identifier(s): 22K-163-4421501-00.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 02Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 63 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "not recovered", described as "Rheumatoid arthritis flare up"; SUSPECTED COVID-19 (medically significant) with onset Nov2021, outcome "recovered", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "covid 19"; MUSCLE FATIGUE (non-serious), outcome "unknown"; ANKLE FRACTURE (non-serious), outcome "unknown"; FOOT FRACTURE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown". The action taken for adalimumab was unknown. solicited report by a consumer of a 64 year old female with events of non-serious hands got tired quickly, right foot and ankle were fractured, which was causing pain, covid and rheumatoid arthritis flare with humira (adalimumab). there was no reported medical history. on unknown dates, the patient experienced hands got tired quickly and rifht foot and ankle were fractured, which was acusing pain, in 2021, the patient experienced rheumatoid arthritis flare. in november 2021, the patient experienced covid. on and unknown date, covid resolved. pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB) Causality: Muscle fatigue, Ankle fracture, COVID-19, Rheumatoid arthritis flare up, Pain was not related, Foot fracture was not reported.  PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(Injection)Causality: Muscle fatigue, Ankle fracture, Foot fracture,COVID-19, Pain Causality as per reporter was not reported and Rheumatoid arthritis flare up was probable.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective, suspected COVID-19, rheumatoid arthritis and the suspect drug cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.