Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: experienced Covid; experienced Covid; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-ABBVIE-4166746.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at 40 mg 2x/week (40 mg, 2x/week (every 2 weeks)), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 2022, outcome "unknown" and all described as "experienced Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: On 2022, the patient experienced Covid. The action taken for adalimumab was unknown.  clinical course: Solicited report from the female patient with events of non-serious Covid. There was no reported medical history. On 2022, the patient experienced Covid. Pfizer/BioNtech covid-19 vaccination was also considered suspect. It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  Causalities: The reporters causality for the event(s) of Covid, since receiving COVID vaccines with Adalimumab Solution for Injection was Not Provided The reporters causality for the event(s) of Covid with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided the causality for the event(s) of Covid, since receiving COVID vaccines with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided Regulatory Authority opinion was that the causality for the event(s) of Covid since receiving COVID vaccines with Adalimumab Solution for Injection was No Reasonable Possibility. Regulatory Authority 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. Regulatory Authority 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.  Causality Assessment:  Drug: HUMIRA 40MG/0.4ML for the COVID-19 as per Non-Health Care Professional, Global Introspection was Not Reported. Drug: Pfizer/BioNtech covid-19 vaccination for COVID-19 as per Non-Health Care Professional, Global Introspection, Not Reported. Drug: HUMIRA 40MG/0.4ML for the COVID-19 as per Market Authorization Holder (MAH), Global Introspection was No Reasonable Possibility. Drug: Pfizer/BioNtech covid-19 vaccination for COVID-19 as per Market Authorization Holder (MAH), Global Introspection was No Reasonable Possibility.  The reporter's assessment of the causal relationship of "experienced covid" 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 information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to its Lack of efficacy cannot be ruled out.