Sex: F
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product discontinuation
Clinical narrative: Colitis ulcerative aggravated; Colitis ulcerative aggravated; Tiredness; Fatigue; Shortness of breath; Heart rate increased; Inappropriate schedule of product discontinuation; 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-163-4526755-00.  A 43-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen since 2016 (Batch/Lot number: unknown) at citrate free (40 mg,1 in 2 wk), second regimen (Batch/Lot number: unknown) at citrate free (40 mg,1 in 2 wk) and third regimen (Batch/Lot number: unknown) at citrate free (40 mg,1 in 2 wk), all subcutaneous for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "Tiredness"; FATIGUE (non-serious), outcome "recovered"; DYSPNOEA (non-serious), outcome "recovered", described as "Shortness of breath"; COLITIS ULCERATIVE (non-serious), outcome "recovered", HEART RATE INCREASED (non-serious), outcome "not recovered" and all described as "Heart rate increased"; INAPPROPRIATE SCHEDULE OF PRODUCT DISCONTINUATION (non-serious), outcome "unknown"; COLITIS ULCERATIVE (non-serious), outcome "unknown", described as "Colitis ulcerative aggravated". The patient underwent the following laboratory tests and procedures: Heart rate: Unknown results. The action taken for adalimumab was dosage permanently withdrawn. Additional information: On unknown dates, the patient experienced fatigue, shortness of breath, increased ulcerative colitis symptoms, fast heart rate when tired or in the early morning, stopped Humira for eight to nine months at start of covid until patient was able to get first covid vaccine/again stopped Humira for two weeks prior to second covid vaccine and ulcerative colitis flare.  The reporter's assessment of the causal relationship of "tiredness", "fatigue", "shortness of breath", "colitis ulcerative aggravated", "heart rate increased" and "inappropriate schedule of product discontinuation" with the suspect product(s) BNT162b2 was not reported by the reporter. Since no determination has been received, the case is managed based on the company causality assessment.  Causality for Humira(Adalimumab): The reporter's causality for the event(s) of fatigue, shortness of breath and increased ulcerative colitis symptoms with Humira(Adalimumab) was a reasonable possibility. the reporter's causality for the event(s) of fast heart rate when tired or in the early morning unknown onset with Humira(Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of stopped Humira for eight to nine months at start of covid until patient was able to get first covid vaccine/again stopped Humira for two weeks prior to second covid vaccine, ulcerative colitis flare and fast heart rate when tired or in the early morning unknown onset was not provided.  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 in the case report, a possible causal relationship between the reported events and the suspect drug BNT162B2 cannot be completely 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.