Sex: F
Vaccine: COVID19
Symptoms: Illness, Rheumatoid arthritis, Visual impairment
Clinical narrative: Losing eyesight; Sick ever since receiving COVID vaccines; Rheumatoid Arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4166746.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at 40 mg (40 mg, every 2 weeks (40mg/0.4ml)), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (caused and prolonged hospitalization, medically significant) with onset Jul2022, outcome "unknown", described as "Rheumatoid Arthritis flare up"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "Losing eyesight"; ILLNESS (non-serious), outcome "unknown", described as "Sick ever since receiving COVID vaccines". The action taken for adalimumab was unknown.  Clinical course: Solicited report from the country by a consumer of a 68 years old female with events of Rheumatoid Arthritis flare up, and non-serious Covid, Losing eyesight, HUMIRA was not working, and Sick ever since receiving COVID vaccines with Single Dose Pen, Adalimumab Solution for Injection. There was no reported medical history. On 2022, the patient experienced Covid. On Jul2022, the patient experienced Rheumatoid Arthritis flare up. On unknown date(s), the patient experienced Sick ever since receiving COVID vaccines, HUMIRA was not working, Losing eyesight. Pfizer/BioNtech covid-19 vaccination was also considered suspect. It was unknown if patient was enrolled in COVID-19-Vaccine Trial. The patient was in hospital in Jul2022 with a flare up. She was having covid as well. HUMIRA was not working. She was losing eyesight and had been sick ever since receiving COVID vaccines. Causalities: The reporters causality for the event(s) of Covid, HUMIRA was not working, losing eyesight, rheumatoid arthritis flare up and sick ever since receiving COVID vaccines with Adalimumab solution for injection was not provided. The reporters causality for the event(s) of Covid, HUMIRA was not working, losing eyesight and rheumatoid arthritis flare up with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was not provided. The reporters causality for the event(s) of sick ever since receiving COVID vaccines with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was reasonable possibility. Agency's opinion was that the causality for the event(s) of Covid, HUMIRA was not working, losing eyesight, rheumatoid arthritis flare up and sick ever since receiving COVID vaccines with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was not provided. Agency's opinion was that the causality for the event(s) of Covid, HUMIRA was not working, rheumatoid arthritis flare up and sick ever since receiving COVID vaccines with Adalimumab solution for injection was no reasonable possibility. Agency's opinion was that the causality for the event(s) of losing eyesight with Adalimumab solution for injection was not assessable. Agency's Alternative Etiology for HUMIRA was not working with Adalimumab Solution for Injection: Desired beneficial effect not observed. Agency's Alternative Etiology for Sick ever since receiving COVID vaccines with Adalimumab Solution for Injection: Most likely related to covid-19 vaccine. Agency's Alternative Etiology for Rheumatoid Arthritis flare up with Adalimumab Solution for Injection: Most likely related to natural course/progression of underlying Rheumatoid arthritis confounded by covid-19 infection and lack of drug effect. Agency's Alternative Etiology for Covid with Adalimumab Solution for Injection: Event more likely related to pandemic outbreak of SARS COV-2 in an elderly patient with underlying Rheumatoid arthritis. Medical history: not reported. Assessment Results: HUMIRA 40MG/0.4ML-Vision decreased, Non-Health Care Professional, Global Introspection, Not Reported. HUMIRA 40MG/0.4ML-COVID-19, Non-Health Care Professional, Global Introspection, Not Reported. HUMIRA 40MG/0.4ML -Rheumatoid arthritis flare up, Non-Health Care Professional, Global Introspection, Not Reported. Pfizer/BioNtech covid-19 vaccination -COVID-19, Market Authorization Holder (MAH). Pfizer/BioNtech covid-19 vaccination -COVID-19, Non-Health Care Professional, Global Introspection, Not Reported. Pfizer/BioNtech covid-19 vaccination -Rheumatoid arthritis flare up, Agency. Pfizer/BioNtech covid-19 vaccination -Rheumatoid arthritis flare up, Non-Health Care Professional, Global Introspection, Not Reported. HUMIRA 40MG/0.4ML -Lack of drug effect, Agency, Global Introspection, No Reasonable Possibility. HUMIRA 40MG/0.4ML -Lack of drug effect, Non-Health Care Professional, Global Introspection, Not Reported. HUMIRA 40MG/0.4ML -Sickness, Agency, Global Introspection, No Reasonable Possibility. HUMIRA 40MG/0.4ML -Sickness, Non-Health Care Professional, Global Introspection, Not Reported - Pfizer/BioNtech covid-19 vaccination -Sickness, Agency. Pfizer/BioNtech covid-19 vaccination -Sickness, Non-Health Care Professional, Global Introspection, Possible. Pfizer/BioNtech covid-19 vaccination -Vision decreased, Agency. Pfizer/BioNtech covid-19 vaccination -Vision decreased, Non-Health Care Professional, Global Introspection, Not Reported. Pfizer/BioNtech covid-19 vaccination -Lack of drug effect, Agency. Pfizer/BioNtech covid-19 vaccination -Lack of drug effect, Non-Health Care Professional, Global Introspection, Not Reported. HUMIRA 40MG/0.4ML -Rheumatoid arthritis flare up, Agency, Global Introspection, No Reasonable Possibility. HUMIRA 40MG/0.4ML -Vision decreased, Agency, Global Introspection, Not assessable. HUMIRA 40MG/0.4ML -COVID-19, Agency, Global Introspection, No Reasonable Possibility.  The reporter's assessment of the causal relationship of "rheumatoid arthritis flare up" and "losing eyesight" with the suspect product(s) 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. The reporter considered "sick ever since receiving covid vaccines" related to BNT162b2. Did reaction abate after stopping drug: N/A; Did reaction reappear after reintroduction: N/A  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events Rheumatoid arthritis, Visual impairment, Illness and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.