Age: 32.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Alopecia, Antibody test, Heavy menstrual bleeding, Lupus-like syndrome, Pyrexia
Clinical narrative: Fever; Hair loss; Heavy menstrual bleeding; Drug-induced lupus erythematosus; 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-163-4296597-00 (Agency).  A 32-year-old female patient received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Batch/Lot number: unknown), on 04May2021 as dose 2, single (Batch/Lot number: unknown) and on 27Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), from Feb2021 (Lot number: 1155992) to Feb2021 at 40 mg (unk, (cf 40 mg, 1 in 2 week)), subcutaneous for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LUPUS-LIKE SYNDROME (medically significant) with onset Dec2021, outcome "not recovered", described as "Drug-induced lupus erythematosus"; PYREXIA (non-serious), outcome "recovering", described as "Fever"; ALOPECIA (non-serious), outcome "unknown", described as "Hair loss"; HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Antibody test: Unknown results. The action taken for adalimumab was dosage permanently withdrawn in Feb2021.  The reporter's assessment of the causal relationship of "drug-induced lupus erythematosus", "hair loss" and "heavy menstrual bleeding" 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. The reporter considered "fever" not associated to BNT162b2.  Clinical information: The patient was diagnosed with drug induced Lupus, symptoms started two months ago (Dec2021) and include severe rash itching and scaling on arms, back and legs. She was diagnosed with the drug Indus Lupus and the doctor said that she could not take Humira. However, a test was performed to test for antibodies and it turned out that she was at a therapeutic level. Since she could not take it, her hair was falling out, had issues with my menstrual cycle, and had small clots. When she got her Covid Vaccine, she had a fever for a while. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (ADALIMUMAB), the reporter's causality for the event (s) of drug induced lupus, fever after covid vaccine, hair falling out and issues with menstrual cycle and been having small clots was not provided. Agency's opinion is that there is a reasonable possibility that the event of drug induced lupus is related to Humira. Agency's opinion is that there is no reasonable possibility that the events of fever after covid vaccine, hair falling out and issues with menstrual cycle and been having small clots are related to Humira (Adalimumab).  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 currently available information and onset latency the causal association between the reported events and the suspect drug BNT162B2  is assessed unelated . The case will be reassessed once new information is available.