Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Rheumatoid arthritis, Therapeutic response shortened
Clinical narrative: rheumatoid arthritis breaking through; rheumatoid arthritis breaking through; Feeling a little slower; This is a solicited report based on the information received by Pfizer. A non-contactable consumer (patient) reported that a 60-year-old female patient received first dose of bnt162b2 (Batch/Lot number was not reported), intramuscularly on an unspecified date as single dose, received second dose intramuscularly in 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneously, start and stop date, batch/lot number and dose were not reported for moderate to severe rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. The patient experienced rheumatoid arthritis breaking through on an unspecified date, feeling a little slower in 2021. Solicited report from by a consumer of a 60-year-old female with events of non-serious feeling a little slower and at the end of Humira cycle felt the rheumatoid arthritis breaking through before her next injection with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced at the end of Humira cycle felt the rheumatoid arthritis breaking through before her next injection. In 2021, the patient experienced feeling a little slower. Covid-19 vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unknown date, patient received 1st dose COVID-19 Vaccine manufactured by unknown, lot number unknown, expiration date unknown. In 2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer, lot number unknown, expiration date unknown.  The action taken in response to the events for adalimumab was unknown. The outcome of events for feeling a little slower was resolving, for other events was not resolved. Causality of Humira (Adalimumab): The reporter's causality for the events of feeling a little slower and at the end of Humira cycle felt the rheumatoid arthritis breaking through before her next injection unknown onset was not provided. Causality as per reporter (Drug/Vaccine) for all events was not reported.  The reporter's assessment of the causal relationship of all events with the suspect product 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 possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, Rheumatoid arthritis cannot be completely ruled out. The impact of this report on 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, Ethic committees, and Investigators, as appropriate.