Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis acneiform, Lymphadenopathy, Rash, Rheumatoid arthritis
Clinical narrative: 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-163-4453620-00. A 53-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), since 21Mar2022 (ongoing) (Lot number: 1165105) at 15 mg 1x/day, oral for rheumatoid arthritis. The patient's relevant medical history included: "Lupus-related facial rashes" (unspecified if ongoing), notes: Lupus-related facial rashes; "Lupus-related facial rashes" (unspecified if ongoing), notes: Lupus-related facial rashes. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single; Intramuscular), administration date: 01Dec2020, when the patient was 52-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Single; Intramuscular), administration date: 02Jan2021, when the patient was 52-year-old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 01Apr2022, outcome "not recovered", described as "Localised rash"; DERMATITIS ACNEIFORM (non-serious) with onset 01Apr2022, outcome "not recovered", described as "Rash acneiform"; RHEUMATOID ARTHRITIS (medically significant) with onset 2022, outcome "not recovered", described as "Rheumatoid arthritis flare up"; LYMPHADENOPATHY (non-serious) with onset 2022, outcome "unknown", described as "Swollen lymph nodes". The action taken for upadacitinib was dosage not changed. The reporter considered "rheumatoid arthritis flare up", "localised rash" and "rash acneiform" not related to BNT162b2. The reporter considered "swollen lymph nodes" related to BNT162b2. Clinical course: The patient reported events of non-serious Pfizer vaccine caused swollen lymph nodes, rash on face/like acne bumpy red/stippled across t-zone and eyelids and rheumatoid arthritis flare up with Rinvoq (upadacitinib). The patient had a relevant medical history of lupus-related facial rashes. In 2022, the patient experienced Pfizer vaccine caused swollen lymph nodes and rheumatoid arthritis flare up. On 01Apr2022, the patient experienced rash on face/like acne bumpy red/stippled across t-zone and eyelids. Pfizer BioNTech covid-19 vaccine (tozinameran) was also considered suspect. The patient had a rash on her face since starting RINVOQ. She also stated it was like acne, bumpy and red and stippled across her T-zone and eyelids. She had not spoken to her doctor regarding that situation yet but she intends to. She had a history of lupus-related face rashes but that was not like those rashes. She had rheumatoid arthritis flare and had knee swelling. Her Pfizer vaccine caused swollen lymph nodes. On 01Sep2022, received updates to event information, reporter opinion of causality, suspect drug information and narrative description. The events of "Pfizer vaccine caused swollen lymph nodes" and "rheumatoid arthritis flare up" were added. The patient did not agree to had physician contacted. She reported that no concomitant drugs were taken. 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 Pfizer vaccine caused swollen lymph nodes with Rinvoq (upadacitinib) was no reasonable possibility. The reporter's causality for the event(s) of rash on face/like acne bumpy red/stippled across t-zone and eyelids onset 01Apr2022 and rash on face/like acne bumpy red/stippled across t-zone and eyelids onset 01Apr2022 was not provided. The reporter's causality for the event(s) of Rheumatoid arthritis flare up with RINVOQ (UPADACITINIB) was a reasonable possibility. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the events Rheumatoid arthritis, rash, dermatitis acneiform and lymphadenopathy with the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.