Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, SARS-CoV-2 test, Sunburn
Clinical narrative: Rheumatoid arthritis; Sun blister; 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-163-4464588-00.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 2 (booster), single (Batch/Lot number: unknown) and on 02May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 72 years, all intramuscular for covid-19 immunization; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 09Apr2021 as dose 1, single (Lot number: 78436735) intramuscular for covid-19 immunization; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, (daily dose: citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "covid-19", start date: Oct2021 (unspecified if ongoing), notes: recovered. Concomitant medication(s) included: HYDROXYCHLOROQUINE; PREDNISONE. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered"; SUNBURN (non-serious), outcome "not recovered", described as "Sun blister". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2021) Positive. The action taken for adalimumab was unknown.  Clinical course: Solicited report by a consumer of a 72-year-old male with events of non-serious blisters due to being out in the sun a lot and rheumatoid arthritis with Humira (Adalimumab). Stated that, there was no reported medical history. On an unknown dates, the patient experienced blisters due to being out in the sun a lot and rheumatoid arthritis. On an unspecified date in Oct2021, the patient experienced covid positive. On an unknown date, Covid positive resolved. Janssen covid-19 vaccine (covid-19 vaccine NRVV AD26 (JNJ 78436735)) and Pfizer Biontech Covid-19 vaccine (TOZINAMERAN) were also considered as suspect. It was unknown whether the patient was enrolled in a COVID-19 Vaccine Trial. Stated that, the primary reporter did not have the lot number information, because the information was not accessible to the physician at his/her clinical setting. Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of blisters due to being out in the sun a lot and rheumatoid arthritis with Humira (Adalimumab) was a reasonable possibility and Causality as per reporter (Drug/Vaccine): Probable. Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran) and JANSEEN COVID-19 Vaccine (COVID-19 Vaccine NRVVV AD26): The reporter's causality for the event(s) of blisters due to being out in the sun a lot and rheumatoid arthritis with Pfizer BioNTech Covid-19 Vaccine (Tozinameran) and JANSEEN COVID-19 Vaccine (COVID-19 Vaccine NRVVV AD26) was reported as Possible.  The reporter's assessment of the causal relationship of "rheumatoid arthritis" and "sun blister" 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.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.