Sex: F
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: Lupus erythematosus; Tiredness; Elevated liver enzymes; Blood pressure increased; 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-163-4233032-00.  A 51 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for psoriatic arthropathy, rheumatoid arthritis. Relevant medical history included: "Stroke" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (dose 1), for COVID-19 immunization; Janssen covid-19 vaccine (dose 2), for COVID-19 immunization. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (non-serious), outcome "unknown", described as "Lupus erythematosus"; IMMUNISATION (non-serious), outcome "unknown", described as "booster"; FATIGUE (non-serious), outcome "recovering", described as "Tiredness"; HEPATIC ENZYME INCREASED (non-serious), outcome "recovering", described as "Elevated liver enzymes"; BLOOD PRESSURE INCREASED (non-serious), outcome "recovering", described as "Blood pressure increased". The patient underwent the following laboratory tests and procedures: blood pressure measurement: 160/109; liver function test: elavated. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of blood pressure increased. Clinical course: The patient took shot around 4 pm and felt tired next day. Her liver enzymes were elevated but she thought it  was because of another medication. If liver enzymes were remain elevated then she will do scan of liver. She also had elevated blood pressure 160/109 which had come down. She was put on new blood pressure medicine on 04Jan. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. She received 1st dose COVID-19 Vaccine manufactured by Johnson & Johnson. She received 2nd dose COVID-19 Vaccine manufactured by Johnson & Johnson.   The reporter's causality for PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) Booster dose: The reporter's causality for the event(s) of Lupus erythematosus, Tiredness, Elevated liver enzymes, Blood pressure increased was Possible.  The reporter's causality for the event(s) of LUPUS was not provided. The reporter's causality for the events of felt tired, liver enzymes elevated and elevated blood pressure with HUMIRA (ADALIMUMA) was no reasonable possibility. Company's opinion is that the events of lupus, felt tired, liver enzymes elevated and elevated BLOOD PRESSURE are not assessable.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Systemic lupus erythematosus, Fatigue, Hepatic enzymes increased, and Blood pressure in-creased 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.