Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Behcet's syndrome, Malaise, Pyrexia, Rash
Clinical narrative: Behcet's disease; Fever; Felt like a bus hit all for a day; Rash over arms; This is a solicited report based on the information received by Pfizer from a company. (MFR Control No. #21K-163-4151162-00).   A contactable consumer (patient) reported that a 64 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Solution for injection), dose 1 intramuscular on 20Aug2021 (Batch/Lot number was not reported), dose 2 intramuscular on 10Sep2021 (Batch/Lot number was not reported) both as a single dose for covid-19 immunisation at age of 63 years old at vaccination. Medical history included ankylosing spondylitis, moderate to severe rheumatoid arthritis. The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Solicited report by a consumer of a 64 year old female with events of non-serious Behcet's Disease, with covid-19 vaccine had fever/felt like a bus hit all for a day and rash on arm with HUMIRA (ADALIMUMAB). On an unknown date, the patient experienced Behcet's Disease. In 2021, the patient experienced with covid-19 vaccine had fever/felt like a bus hit all for a day, rash on arm and with covid-19 vaccine had fever/felt like a bus hit all for a day. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The action taken in response to the events for adalimumab was unknown. The outcome of event Ill feeling was unknown, outcome of event Behcet's disease was not recovered, outcome of Fever, Rash over arms was recovered in 2021.  The reporter's assessment of the causal relationship of the event Behcet's Disease with the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was not provided at the time of this report. Since no determination has been received, the case was managed based on the company causality assessment.  Causality for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN): The reporter's causality for the event(s) of Behcet's Disease was not reported, for events "Ill Feeling, Rash over arms , Fever" was reported as Possible.  Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of Behcet's Disease, with covid-19 vaccine had fever/felt like a bus hit all for a day onset in 2021 and rash on arm was not provided. The reporter's causality for the event(s) of WITH COVID-19 VACCINE had fever/felt like a bus hit all for a day onset in 2021 with Humira (Adalimumab) was no reasonable possibility.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: There is a reasonable possibility that the events fever, malaise, and rash were related to Bnt162b2 based on known drug safety profile. Based on the temporal relationship, the association between the event Behcet's disease with Bnt162b2 can not be completely 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.