Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunodeficiency common variable, Infection, Lymphadenopathy
Clinical narrative: COVID-19; COVID-19; Common variable immunodeficiency; Swollen lymph nodes; Infection; 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-163-4442896-00.  A 56-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 56 years intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Lot number: 1163244), 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), outcome "recovered" and all described as "COVID-19"; IMMUNODEFICIENCY COMMON VARIABLE (medically significant), outcome "recovering", described as "Common variable immunodeficiency"; LYMPHADENOPATHY (non-serious), outcome "recovered", described as "Swollen lymph nodes"; INFECTION (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. The action taken for upadacitinib was dosage permanently withdrawn. Clinical course: There was no booster vaccine received other evishield. Pfizer biontech covid-19 vaccine (Tozinameran) was also considered suspect. The patient was doing well on Rinvoq. She had to stop drug intermittently due to infection. She had common variable immunodeficiency, an autoimmune disease. She was not able to be tested during this exposure due to a lack of testing availability. She was not hospitalized. She had been taken Evishield as directed by her physician. She developed swollen lymph nodes with Pfizer vaccination under the left arm. Her physician had directed her to no longer take this vaccination but took Evishield as directed in the future for protection against covid. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's assessment of the causal relationship of "covid-19", "common variable immunodeficiency", "swollen lymph nodes" and "infection" 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.  Causality for Rinvoq (Updadacitinib): The reporter's causality for the event(s) of common variable immunodeficiency, an autoimmune disease and infections was not provided. The reporter's causality for the event(s) of covid and developed swollen lymph nodes with pfizer vaccination under left arm with Rinvoq (Updadacitinib) was no reasonable possibility.  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 information provided there is a reasonable possibility of causal association between the events with the suspect product bnt162b2.  The impact of this report on the benefit/risk profile of the Pfizer product 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 RAs, Ethics Committees, and Investigators, as appropriate.