Age: 32.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Immunodeficiency, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Immunocompromised; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (Not Available). The reporter is the patient. Other Case identifier(s): 22K-163-4418834-00 (AbbVie).  A 32-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Lot number: 1160069), oral for rheumatoid arthritis. 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) all with onset May2022, outcome "recovering" and all described as "COVID-19"; IMMUNODEFICIENCY (medically significant) with onset May2022, outcome "unknown", described as "Immunocompromised". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. The action taken for upadacitinib was unknown. Patient with events of non-serious caught COVID-19 and patient immune-compromised with RINVOQ (UPADACITINIB). There was no reported medical history. In May2022, the patient experienced caught COVID and patient immune-compromised. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for RINVOQ (UPADACITINIB). The reporter's causality for the event(s) of CAUGHT COVID with RINVOQ (UPADACITINIB) was no reasonable possibility. The reporter's causality for the event(s) of patient immune-compromised was not provided. Indications for use was reported as moderate to severe rheumatoid arthritis for upadacitinib and COVID-19 vaccination for BNT162b2. The causality assessment for the drug RINVOQ (UPADACITINIB) with COVID-19 included actions taken with drug was unknown, causality as per reporter (Drug/Vaccine) was not reported and dechallenge was  N/A, with immunocompromised (Immunodeficiency) actions taken with drug was unknown, causality as per reporter (Drug/Vaccine) was not reported and dechallenge was N/A. The causality assessment for the drug PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) for COVID-19 (COVID-19) with actions taken with drug as unknown, causality as per reporter (Drug/Vaccine) was  possible and dechallenge was N/A, Immunocompromised (Immunodeficiency) with actions taken with drug: was unknown, causality as per reporter (Drug/Vaccine) was possible and dechallenge was N/A. Event abating after stopping drug was NA.   The reporter's assessment of the causal relationship of "covid-19" and "immunocompromised" 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: Based on the Limited information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events.