Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Drug-specific antibodies; Fatigue; Cough; Cephalgia; COVID-19 pneumonia; Colitis ulcerative aggravated; This is a solicited report based on the information received by Pfizer. (Manufacturer Control No: 21K163387672000).A contactable consumer (patient) reported.   A 49-years-old female patient received bnt162b2 (Pfizer Covid-19 vaccine, Formulation: Solution for injection, Batch/Lot number was not reported) as), dose 1 intramuscular on 01Mar2021 (Age at vaccination 49-years-old) dose 1, single and dose 2 intramuscular on 01Apr2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Patient received adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) to Jul2021, at unspecified dose for colitis ulcerative, rheumatoid arthritis. The patient medical history was not reported. The patient's concomitant medications were not reported.In Jan2021, the patient had covid, her symptoms were quite severe, and she was hospitalized with pneumonia. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient reported events of COVID-19 with pneumonia and non-serious ulcerative colitis flare, antibodies to Humira and got covid vaccines and had mild covid symptoms such as headache, fatigue, cough with Humira (Adalimumab). On an unknown date, the patient experienced ulcerative colitis flare. In Jan2021, the patient experienced covid-19 with pneumonia. In Mar2021, the patient experienced got covid vaccines and had mild Covid symptoms such as headache, fatigue, cough. In Jul2021, the patient experienced antibodies to Humira. In 2021, the covid-19 with pneumonia and got covid vaccines and had mild covid symptoms such as headache, fatigue, cough resolved. Pfizer Biontech covid-19 vaccine (Tozinameran) was also considered suspect. In Jan2021, the patient had covid, her symptoms were quite severe and she was hospitalized with pneumonia. In Mar and Apr2021, she got her vaccines and had mild covid symptoms such as headache, fatigue, 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 "COVID-19 with pneumonia" was added. 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 events of "antibodies to humira" and "got covid vaccines and had mild covid symptoms such as headache, fatigue, cough" were added. The event of "COVID-19 with pneumonia" is now considered serious. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of covid-19 with pneumonia, 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, got covid vaccines and had mild covid symptoms such as headache, fatigue, cough onset in Mar2021 and got covid vaccines and had mild covid symptoms such as headache, fatigue, cough onset in Mar2021 was not provided. Abbvies opinion is that there is no reasonable possibility that the events of covid-19 with pneumonia, ulcerative colitis flare, got covid vaccines and had mild covid symptoms such as headache, fatigue, cough onset in Mar2021, got covid vaccines and had mild covid symptoms such as headache, fatigue, cough onset in Mar2021 and got covid vaccines and had mild covid symptoms such as headache, fatigue, cough onset in Mar2021 are related to Humira (Adalimumab). Companies opinion is that there is a reasonable possibility that the event of antibodies to Humira is related to Humira (Adalimumab). Adverse reaction was Involved or prolonged inpatient hospitalization. The patient underwent lab tests and procedures which included drug specific antibody: the patient experienced antibodies to humira on Jul2021. The outcome of event covid-19 pneumonia, fatigue, cough and cephalgia was recovered and for drug-specific antibodies was not recovered. The outcome of colitis ulcerative aggravated was unknown.   The lot number for the vaccine, was not provided and will be requested during follow up.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.