Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Psoriasis, Respiratory disorder, SARS-CoV-2 test
Clinical narrative: Upper respiratory disorder; Plaque psoriasis; COVID-19 virus test positive; COVID-19 virus test positive; 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-163-4471065-00.  A 53-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown) and in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient had no relevant medical history. Concomitant medication(s) included: METHOTREXATE oral. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jul2022, outcome "recovered" (Jul2022) and all described as "COVID-19 virus test positive"; RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "Upper respiratory disorder"; PSORIASIS (non-serious), outcome "unknown", described as "Plaque psoriasis". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jul2022) Positive; (09Jul2022) Negative. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "covid-19 virus test positive" and "upper respiratory disorder" 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 "plaque psoriasis" related to BNT162b2.  Clinical Course: Solicited report by a consumer of a 53-year-old female with events of non-serious tested positive for covid, reaction to the booster from plaque psoriasis/patches all over body on shines, hands, back and legs and upper respiratory problem with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced reaction to the booster from plaque psoriasis/patches all over body on shines, hands, back and legs and upper respiratory problem. On 04Jul2022, the patient experienced tested positive for covid. In Jul2022, the tested positive for covid resolved. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient took Humira (Solution for injection in pre-filled pen) (Adalimumab) with daily dose: Citrate free via Subcutaneous route for moderate to severe rheumatoid arthritis. Patient had no known allergies and no relevant medical history. Concomitant medication were reported. Relevant Laboratory & Other Diagnostic Tests were reported. Causality for Pfizer BioNTech Covid-19 vaccine (Tozinameran): The reporter's causality for the event(s) of COVID-19 virus test positive, Upper respiratory disorder was not Reported. For event Plaque psoriasis was possible. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of tested positive for covid and reaction to the booster from plaque psoriasis/patches all over body on shines, hands, back and legs with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of upper respiratory problem was not provided.  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 the available information in the case, the causal association between the events drug ineffective, COVID-19, respiratory disorder, psoriasis and the suspect drug cannot be excluded.