Sex: F
Vaccine: COVID19
Symptoms: Blood test, Butterfly rash, Fatigue, Pain, Pain assessment
Clinical narrative: hives/ welts/itching on right thigh, hives/ welts/ itching on left thigh; welts; itching on left thigh/itching on right thigh; pain/burning pain; butterfly shaped rash on face hurting and burning like on fire; fatigue/exhausted all time; butterfly shaped rash on face hurting and burning like on fire; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 1, single and intramuscular (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous since 30Jul2021 (ongoing) (Batch/Lot number: unknown) at 40 mg (40 mg, 1 in 14 d) for psoriatic arthropathy. Relevant medical history included: "difficulty with dressing self/cutting food/wash/dry body/taking tub bath/run errands/lifting full cup to mouth, difficulty standing from straight chair/getting in/out of bed/climbing five steps/bending to pick items from floor, difficulty opening jars/ope" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (medically significant) with onset 2021, outcome "recovering", described as "fatigue/exhausted all time"; SKIN BURNING SENSATION (medically significant), BUTTERFLY RASH (medically significant) all with onset 2021, outcome "unknown" and all described as "butterfly shaped rash on face hurting and burning like on fire"; URTICARIA (medically significant) with onset 30Jul2021, outcome "unknown", described as "hives/ welts/itching on right thigh, hives/ welts/ itching on left thigh"; PAIN (medically significant) with onset 2021, outcome "unknown", described as "pain/burning pain"; URTICARIA (medically significant) with onset 30Jul2021, outcome "unknown", described as "welts"; PRURITUS (medically significant) with onset 30Jul2021, outcome "unknown", described as "itching on left thigh/itching on right thigh". The patient underwent the following laboratory tests and procedures: blood test: (2021) something was off; pain assessment: (2021) 50 out of 100. The action taken for adalimumab was dosage not changed. Therapeutic measures were taken as a result of fatigue, skin burning sensation, urticaria, pain, butterfly rash, urticaria, pruritus.  Clinical course: Psoriasis gotten worse became more intense and in new areas with HUMIRA 40MG/0.4ML (ADALIMUMAB). In Aug2021, the patient experienced hives/ welts/ itching on thigh. In Nov2021, the patient experienced body pain and sore throat. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB) The reporters causality for the event(s) of FATIGUE/EXHAUSTED ALL TIME, BUTTERFLY SHAPED rash on face hurting and burning like on fire onset in 2021, blood work showed something was off, hives/ welts/ itching on right thigh, hives/ welts/ itching on left thigh, pain/burning pain, butterfly shaped rash on face hurting and burning like on fire onset in 2021, body pain, sore throat and psoriasis gotten worse became more intense and in new areas was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient was treated with BENADRYL. Patient received first dose of COVID-19 Vaccine manufactured by Pfizer biontech. Patient received second dose of COVID-19 Vaccine manufactured by Pfizer biontech. On 22Nov2021, patient received booster dose of COVID-19 Vaccine manufactured by Pfizer biontech. Change History: On 11Oct2021, received updates to event information, reporter opinion of causality, suspect drug information, concomitant drug information and narrative description. The event of "butterfly shaped rash on face hurting and burning like on fire" was added. On 24Nov2021, received updates to event information, reporter opinion of causality, suspect drug information, concomitant drug information, laboratory/diagnostic procedures and narrative description. The events of "blood work showed something was off", "body pain", "sore throat" and "psoriasis gotten worse became more intense and in new areas" were added. the event of "pain" was amended to "pain/burning pain".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible temporal relationship the causal role of the BNT162B2 Vaccination cannot be excluded for reported events.