Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Cough, Fatigue, Headache
Clinical narrative: Headache/Cephalgia; Fatigue; Cough; Colitis ulcerative aggravated; This is a solicited report facilitated collect (marketing program name not available) from a contactable consumer (patient), based on the information received by Pfizer. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE (Tozinameran); Solution for injection, batch/lot number: unknown, expiration date Unknown), via intramuscular route of administration on 01Mar2021 (at the age of 49-years-old) as dose 1, single and received second dose via intramuscular route of administration on 01Apr2021 (at the age of 49-years-old) as single both were taken for COVID-19 immunization and adalimumab (HUMIRA, Solution for Injection In Pre-Filled Pen), via subcutaneous route of administration on an unspecified date at an unknown dose (citrate free) and frequency for moderate to severe ulcerative colitis and moderate to severe rheumatoid arthritis and stopped on an unspecified date in Jul2021. Primary reporter did not have the lot number information, because the packaging was discarded. The patient's medical history included COVID-19 with pneumonia from an unknown date in Jan2021 was recovered on an unknown date in 2021. In Jan2021, she had COVID, her symptoms were quite severe, and she was hospitalized with pneumonia, recovered in 2021. The patient had Colitis ulcerative. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Concomitant medications were not reported. In 2021, the patient experienced colitis ulcerative aggravated. In Mar2021, she got COVID vaccines and had mild covid symptoms such as experienced cephalgia or headache, fatigue and cough for four to days. In Jul2021, it was discovered that she was building antibodies to the Humira and she stopped taking it. On 25Jun2021, received updates to event information, reporter opinion of causality, suspect drug information and narrative description. The event of "Blood in stool" was amended to "Ulcerative Colitis Flare". On 28Aug2021, received updates to patient demographics, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The event of "Got COVID vaccines and had mild COVID symptoms such as headache, fatigue, cough " were added. The action taken in response to the events for adalimumab was Permanently withdrawn. The outcome of the event "Colitis ulcerative aggravated" was unknown, while the outcome of the remaining events was recovered in 2021.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of, ulcerative colitis flare and Antibodies to Humira With Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of got COVID vaccines and had mild COVID symptoms such as headache, fatigue, cough onset in Mar2021 was not provided.  Opinion was that there was no reasonable possibility that the events of, ulcerative colitis flare, got COVID vaccines and had mild COVID symptoms such as headache, fatigue, cough onset in Mar2021, are related to Humira (adalimumab). Abbvie's opinion was that there was a reasonable possibility that the event of antibodies to Humira was related to Humira (adalimumab).  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided the causal association between the events ulcerative colitis flare, headache, fatigue and cough with the vaccine BNT162B2 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 RAs, Ethics Committees, and Investigators, as appropriate.