Age: 79.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Incorrect route of product administration, Rheumatoid arthritis, Vaccination site pain
Clinical narrative: Rheumatoid arthritis flare up; achy/arm was sore after COVID-19 vaccine; BNT162B2 via Intra-articular; This is a solicited report based on information received by Pfizer (Mfr. Control No.: 21K-163-4098269-00).   A contactable consumer (patient) reported that a 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose intra-articular on 29Apr2021 (Batch/Lot number was not reported) at age of 79 years old as a single dose, 2nd dose intra-articular on 20May2021 (Batch/Lot number was not reported) at age of 79 years old as a single dose, 3rd dose intra-articular on 22Sep2021 (Batch/Lot number was not reported) at age of 79 years old as a single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for Moderate to severe Rheumatoid arthritis. There were no medical history. The patient's concomitant medications were not reported.  The patient experienced rheumatoid arthritis flare up on an unspecified date, achy/arm was sore after COVID-19 vaccine on 22Sep2021. The action taken in response to the events for adalimumab was unknown. The outcome of rheumatoid arthritis flare up was resolving, achy/arm was sore after COVID-19 vaccine was recovered in Sep2021.   Solicited report by a consumer of a 79 year old female with events of non-serious rheumatoid arthritis flare ups and Achy/arm was sore after COVID-19 Vaccine with HUMIRA (ADALIMUMAB). There was no reported medical history. On an unknown date, the patient experienced rheumatoid arthritis flare ups. On 22Sep2021, the patient experienced Achy/arm was sore after COVID-19 Vaccine. In Sep2021, the Achy/arm was sore after COVID-19 Vaccine resolved. Pfizer BioNTech vaccine (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 29Apr2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer-BioNTech. On 20May2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer-BioNTech. On 22Sep2021, patient received 3rd dose COVID-19 Vaccine manufactured by Pfizer-BioNTech. Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of  rheumatoid arthritis UPS with HUMIRA (ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of Achy/arm was sore after COVID-19 Vaccine was not provided. Causality for BNT162B2: The reporter's causality for the events of Rheumatoid arthritis flare up and Vaccination site pain with BNT162B2 was not reported.   The reporter's assessment of the causal relationship of all events with the suspect product (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 be obtained.; Sender's Comments: Based on the available reported information, the causal association between the events rheumatoid arthritis, vaccination site pain and incorrect route of product administration and the suspect drug BNT162B2 cannot be excluded. 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.