Age: 35.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Alopecia, Colitis ulcerative, Headache, Pain, Pyrexia
Clinical narrative: Colitis ulcerative aggravated; Hair loss; Fever; Headache; Ache; 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-163-4525073-00.  A 35-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown), on 01Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 21Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 04Apr2012 (ongoing) (Batch/Lot number: unknown) at 40 mg (40 mg, citrate free), subcutaneous for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Ache"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fever"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021); COLITIS ULCERATIVE (medically significant), outcome "not recovered", described as "Colitis ulcerative aggravated"; ALOPECIA (non-serious), outcome "not recovered", described as "Hair loss". The action taken for adalimumab was dosage not changed.  The reporter considered "colitis ulcerative aggravated", "hair loss", "fever", "headache" and "ache" related to BNT162b2.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of hair loss, fever, headache and achiness with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of ulcerative colitis flare up with Humira (Adalimumab) was a reasonable possibility.  Clinical course: Solicited report from the USA by a consumer of an adult female with events of non-serious hair loss, ulcerative colitis flare up, fever, headache and achiness with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced hair loss and ulcerative colitis flare up. In 2021, the patient experienced fever, headache and achiness. In 2021, the fever, headache and achiness resolved. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was reported that duration of the events fever, headache and ache was 36 hours. It was unknown if patient was enrolled in a covid-19 vaccine trial.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded.   The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.