Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Humira was not effective in relieving symptoms; Humira was not effective in relieving symptoms; 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-4127882.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown), on 01Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, [citrate free], subcutaneous for product used for unknown indication. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Humira was not effective in relieving symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The reporter's assessment of the causal relationship of "humira was not effective in relieving symptoms" 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.  Clinical course: Solicited report by a consumer of a elderly female with an event of and non-serious Humira was not effective in relieving symptoms with Adalimumab Solution for Injection, Single Dose Pen. There was no reported medical history. On unknown date(s), the patient experienced Humira was not effective in relieving symptoms. Pfizer BioNTech COVID-19 vaccine was also considered suspect. It was unknown if patient was enrolled in COVID-19-Vaccine Trial. Therapy Date(s) (from/to): 01Feb2021 to 01Feb2021; 01Mar2021 to 01Mar2021; 01Nov2021 to 01Nov2021. Therapy Duration: 1 days; 1 days; 1 days Causalities: The reporters causality for the event(s) of Humira was not effective in relieving symptoms with Adalimumab Solution for Injection was Reasonable Possibility The reporter's causality for the event(s) of Humira was not effective in relieving symptoms with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided opinion was that the causality for the event(s) of Humira was not effective in relieving symptoms with Adalimumab Solution for Injection was Not Provided opinion was that the causality for the event(s) of Humira was not effective in relieving symptoms with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. Assessment Results HUMIRA: Lack of drug effect, Non-Health Care Professional, Possible HUMIRA: Lack of drug effect,  Pfizer BioNTech COVID-19 vaccine: Lack of drug effect,  Pfizer BioNTech COVID-19 vaccine: Lack of drug effect, Non-Health Care Professional Not Reported  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events "Drug ineffective" and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.