Age: 61.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Off label use, SARS-CoV-2 test, Skin disorder
Clinical narrative: 1st 2nd dose manufactured by Moderna/ booster dose manufactured by Pfizer; off label use; COVID-19; Skin disorder; Energy decreased; COVID-19;  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4240399-00 (AbbVie).  A 61 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 24Nov2021 (Batch/Lot number: unknown) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) till 2021 at 40 mg (cf (40 mg,1 in 7 d)) for rheumatoid arthritis. Relevant medical history included: "RIGHT HIP SURGERY", start date: Jun2021 (unspecified if ongoing), notes: RIGHT HIP SURGERY; "LEFT HIP SURGERY", start date: Sep2021 (unspecified if ongoing), notes: LEFT HIP SURGERY. The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose:2), administration date: 09Apr2021, when the patient was 61 years old, for Covid-19 Vaccination; Moderna covid-19 vaccine (Dose:1), administration date: 11Mar2021, when the patient was 60 years old, for Covid-19 Vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Nov2021, outcome "unknown", described as "1st 2nd dose manufactured by Moderna/ booster dose manufactured by Pfizer"; OFF LABEL USE (medically significant) with onset 24Nov2021, outcome "unknown", described as "off label use"; SKIN DISORDER (medically significant) with onset 2021, outcome "unknown", described as "Skin disorder"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "Energy decreased". The patient underwent the following laboratory tests and procedures: investigation: (2021) unknown; sars-cov-2 test: (2021) positive. The action taken for adalimumab was unknown. The reporter's assessment of the causal relationship of the event with the suspect product 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 lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded.   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.