Sex: F
Vaccine: COVID19, UNK
Symptoms: Anxiety, Chest pain, Colitis, Immunisation reaction, Investigation
Clinical narrative: Colitis; Colitis; Thyroid nodule; panic attacks; anxiety attacks; reaction to covid vaccine; Chest pain; 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-131-4401114-00.  A 29-year-old female patient received BNT162b2 (BNT162B2), on 13Sep2021 as dose 2, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen since 16Apr2020 (Batch/Lot number: unknown) at 40 mg (40 mg, 1 in 2 wk) and second regimen (ongoing) (Batch/Lot number: unknown) at 1 in 1 wk, all subcutaneous for colitis ulcerative. The patient's relevant medical history included: "Ulcerative Colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, Daily Dose: 1) 1st dose (1 in 1 Once), Route of Admin: 1) Intramuscular), administration date: 23Aug2021, for COVID-19 immunization.   The following information was reported: CHEST PAIN (non-serious) with onset Sep2021, outcome "recovering"; ANXIETY (non-serious) with onset Sep2021, outcome "recovering", described as "anxiety attacks"; PANIC ATTACK (non-serious) with onset Sep2021, outcome "recovering", described as "panic attacks"; IMMUNISATION REACTION (non-serious) with onset Sep2021, outcome "unknown", described as "reaction to covid vaccine"; COLITIS (non-serious) with onset Jan2022, outcome "recovered" (2022), COLITIS (non-serious) with onset Feb2022, outcome "recovered" (2022) and all described as "Colitis"; THYROID MASS (medically significant) with onset 2022, outcome "not recovered", described as "Thyroid nodule". The events "panic attacks" and "anxiety attacks" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: unspecified studies: (2021) good results. The action taken for adalimumab was dosage not changed. Therapeutic measures were taken as a result of panic attack, anxiety.  The reporter's assessment of the causal relationship of "thyroid nodule" and "colitis" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "panic attacks", "anxiety attacks", "reaction to covid vaccine" and "chest pain" related to BNT162b2.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient was treated with Prednisone and Buspar. It was reported that the patient had events of thyroid nodule and non-serious colitis, reaction to covid vaccine, anxiety attacks, panic attacks and chest pain with Humira 40MG/0.4ML (Adalimumab). BNT162B2 (Tozinameran) was also considered suspect. The patient had panic and anxiety attacks after second dose of Covid vaccine, where she had to visit emergency room and had an appointment with endocrinologist, because her disorders might be related to thyroids. She had an appointment with an endocrinologist and all unspecified studies came out with good results. She was using unspecified natural medication for panic attacks and anxiety attacks, and both had diminished greatly.   Causality for Humira 40MG/0.4ML (Adalimumab). The reporter's causality for the event(s) of thyroid nodule, anxiety attacks, panic attacks and chest pain with Humira 40MG/0.4ML(Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of colitis onset in Jan2022 and Colitis onset in Feb2022 with Humira 40MG/0.4ML (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of Reaction to covid vaccine was not provided.  The opinion is that the events of thyroid nodule and chest pain are not assessable. The opinion is that there is no reasonable possibility that the events of colitis onset in Jan2022, colitis onset in Feb2022, reaction to covid vaccine, anxiety attacks and panic attacks are related to Humira 40MG/0.4ML (Adalimumab).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information given in narrative, the causal relationship between the events and the suspect drug 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.