Age: 67.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Condition aggravated, Crohn's disease, Feeling abnormal, Immunisation, Inflammation
Clinical narrative: crohns disease flare up; Flair up; Inflammation; flu like symptoms; Felt horrible due to pfizer booster vaccine; off label use; Booster;   This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4169555-00, 21K-163-4203053-00.  A 68 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 09Mar2021 (Batch/Lot number: unknown) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for crohn's disease; doxycycline hyclate (DOXYCYCLINE HYCLATE) (Batch/Lot number: unknown) for inflammation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 01, Route of administration; Intramuscular, Event outcome; Unknown), administration date: 22Jan2021, when the patient was 67 years old, for COVID-19 immunization, reaction(s): "Flair up", "Inflammation", "flu like symptoms", "Crohn's disease flare up"; Bnt162b2 (Dose 02, Route of administration; Intramuscular, Event out come; Unknown), administration date: 12Feb2021, when the patient was 67 years old, for COVID-19 immunization, reaction(s): "Flair up", "Inflammation", "flu like symptoms", "Crohn's disease flare up". The following information was reported: OFF LABEL USE (medically significant) with onset 09Mar2021, outcome "unknown", described as "off label use"; IMMUNISATION (medically significant) with onset 09Mar2021, outcome "unknown", described as "Booster"; CROHN'S DISEASE (medically significant), outcome "not recovered", described as "crohns disease flare up"; FEELING ABNORMAL (non-serious) with onset 03Sep2021, outcome "recovered" (03Sep2021), described as "Felt horrible due to pfizer booster vaccine"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Flair up"; INFLAMMATION (non-serious), outcome "not recovered", described as "Inflammation"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu like symptoms". The action taken for adalimumab and doxycycline hyclate was unknown.  The reporter considered "booster" and "felt horrible due to pfizer booster vaccine" related to bnt162b2.  Clinical course: It was unknown if patient was enrolled in a COVID 19 Vaccine Trial. Causality for HUMIRA(ADALIMUMAB)The reporter's causality for the event(s) of FLAIR UP DUE TO ANTIBIOTICS and FELT HORRIBLE DUE TO PFIZER BOOSTER VACCINE was not provided. The reporter's causality for the event(s) of INFLAMMATION with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's assessment of the causal relationship of the event with the suspect product BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment. On 20Dec2021, it was reported that no known allergies and it was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of crohns disease flare up with Humira(adalimumab) was a reasonable possibility and for flu like symptoms was no reasonable possibility. The reporter's causality for the event(s) of crohns disease flare up with BNT162B2 was not Related and for flu like symptoms was no reasonable possibility. The reporter considered "felt horrible due to pfizer booster vaccine" related to bnt162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (20Dec2021): This is a follow-up solicited report based on the information received by Pfizer from a company. (MFR Control No. 21K-163-4203053-00). A contactable 68-Year-old female consumer (patient) reported for herself that:  Updated information: New event flu like symptoms and Crohn's disease aggravated. Historical Vaccine event: flu like symptoms, Crohn's disease aggravated and casuality.  No follow-up attempts are needed; information about Lot/Batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events off label use, immunization, crohn's disease, feeling abnormal, condition aggravated, inflammation, influenza like illness and the suspect drug BNT162B2 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.