Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Feeling abnormal, Memory impairment, Nervous system disorder, Systemic lupus erythematosus
Clinical narrative: brain fog; memory, short term especially; attacked central nervous system; lupus flare; MARKETING PROGRAM NAME NOT AVAILBALE  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-163-4312425-00 (Agency).  A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 04Mar2022 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1159243) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant) with onset Mar2022, outcome "recovering", described as "lupus flare"; FEELING ABNORMAL (medically significant), outcome "unknown", described as "brain fog"; MEMORY IMPAIRMENT (medically significant), outcome "unknown", described as "memory, short term especially"; NERVOUS SYSTEM DISORDER (medically significant), outcome "unknown", described as "attacked central nervous system". The action taken for adalimumab was unknown.On unknown dates, the patient experienced brain fog, memory, short term especially and attacked central nervous system. In Mar2022, the patient experienced lupus flare. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient developed lupus flare after covid vaccine. It attacked her central nervous system, bad brain fog, short term memory especially. The physician believed that patient would benefit from increasing frequency of dosing. Action taken with drug was unknown and dechallenge was not applicable. Did Event Abate After Stopping Drug: NA.  The reporter's causality for the event(s) of Lupus flare with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of brain fog, memory, short term especially and attacked central nervous system was not provided. Agency's opinion is that the events of lupus flare, brain fog, memory, short term especially and attacked central nervous system are not assessable.  The reporter's causality for the event(s) SLE flare was Probable and events brain fog, memory, short term especially and attacked central nervous system was not provided with Pfizer BioNTech Covid-19 Vaccine (TOZINAMERAN)(TOZINAMERAN).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events lupus erythematosus, feeling abnormal, memory impairment and nervous system disorder cannot be 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.