Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Respiratory tract infection, Rheumatoid arthritis, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Rheumatoid arthritis flare up; Recurrent respiratory tract infections; Covid-19; Covid-19; This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4305965-00 (RA).  A 54-year-old female patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown), on 16Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 21Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 28Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 28Jan2022, outcome "recovered" (2022) and all described as "Covid-19"; RHEUMATOID ARTHRITIS (medically significant), outcome "recovering", described as "Rheumatoid arthritis flare up"; RESPIRATORY TRACT INFECTION (non-serious), outcome "recovered", described as "Recurrent respiratory tract infections". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jan2022) Positive, notes: the patient experienced COVID-19. The action taken for adalimumab was unknown.  Additional information: Solicited report by a consumer of a 54-year-old female with event of non-serious Rheumatoid arthritis flare up, COVID-19 and upper Respiratory infections often with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced Rheumatoid arthritis flare up and upper Respiratory infections often. On 28Jan2022, the patient experienced COVID-19. In 2022, the COVID-19 resolved. on an unknown date, upper respiratory infections often resolved. PFIZER BIONTECH COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packing was discarded. Change History: On 25Apr2022, received updates to patient demographics, event information, reporter opinion of causality, suspect drug information, concomitant drug information and narrative description. The event of "Upper Respiratory Infections Often" was added. The event of "COVID" was amended to "COVID-19".   Causality for Humira (Adalimumab) The reporter's causality for the event(s) of Rheumatoid Arthritis Flare Up with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of COVID-19 and Upper Respiratory Infections Often was not provided.  The reporter considered "covid-19", "rheumatoid arthritis flare up" and "recurrent respiratory tract infections" related to BNT162b2.  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 possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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