Age: 82.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site pain, Mobility decreased, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Mobility decreased/could hardly get out of bed; Injection site pain/soreness at the injection site with Humira; This is a solicited report based on information received by Pfizer from a company (MFR no.: 21K-163-4117449-00). A contactable 82-year-old female consumer (patient) reported for herself that:  Solicited report by a consumer of an 82 year old female with events of non-serious had second dose of covid vaccine, it triggered rheumatoid  Arthritis and could hardly get out of bed and soreness at the injection site with Humira (adalimumab). There was no reported medical history. On an unknown date in 2021, the patient experienced soreness at the injection site. In 2021, the patient had second dose of covid vaccine, it triggered  Rheumatoid arthritis and could hardly get out of bed. Pfizer biontech covid-19  Vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 30Jan2021, patient received 1st dose  COVID-19 Vaccine manufactured by Pfizer/BioNTech, lot number unknown, expiration date unknown. On 20Feb2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech, lot number unknown, expiration date unknown. The patient's past medications include:Prednisone for unknown indication.  Causality for humira(adalimumab): The reporter's causality for the event(s) of had second dose of covid vaccine, it triggered rheumatoid Arthritis and could hardly get out of bed onset in 2021 and had second dose of covid vaccine, it triggered Rheumatoid arthritis and could hardly get out of bed onset in 2021 with humira (adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of soreness at the injection site with humira (adalimumab) was a reasonable possibility. The reporter's assessment of the causal relationship of the events with BNT162B2 was not provided 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 needed. Information about lot/batch number cannot been obtained. No further information is expected.; Sender's Comments: The information provided is limited and does not allow a meaningful medical assessment of the case. However, based on the available information in the case, a possible contributory role of the suspect product BNT162B2 to the development of reported events of Rheumatoid arthritis flare up and Mobility decreased cannot be completely excluded. However, the reported event of Injection site pain/soreness at the injection site with Humira was consider as unrelated to vaccine and more plausibly explained by concomitant HUMIRA. 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.