Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Atrial fibrillation, Computerised tomogram, Crohn's disease, Dehydration, Heart rate
Clinical narrative: Crohns flare up; Atrial fibrillation; Had 180 bpm; Pain; Vomiting; She lost 7 in a week; Dehydration; FACILITATED COLLECT  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-163-4143193-00 (Agency).  A 71 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 10Feb2021 (Batch/Lot number: unknown) at the age of 70 years as dose 2, single and intramuscular, administration date 20Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (hospitalization, medically significant) with onset Oct2021, outcome "recovered" (2021), described as "Crohns flare up"; ATRIAL FIBRILLATION (medically significant) with onset 22Oct2021, outcome "recovered" (2021), described as "Atrial fibrillation"; TACHYCARDIA (non-serious) with onset 22Oct2021, outcome "unknown", described as "Had 180 bpm"; PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "Pain"; VOMITING (non-serious) with onset Oct2021, outcome "unknown", described as "Vomiting"; DEHYDRATION (non-serious) with onset 2021, outcome "unknown", described as "Dehydration"; WEIGHT DECREASED (non-serious) with onset Oct2021, outcome "unknown", described as "She lost 7 in a week". The patient was hospitalized for crohn's disease (start date: 22Oct2021). The patient underwent the following laboratory tests and procedures: computerised tomogram: (2021) showed ok; heart rate: (2021) 180 bpm; weight: (2021) lost 7. The action taken for adalimumab was unknown.  Primary reporter did not have the lot number information, because the packaging was discarded. The causality of events with bnt162b2 was not provided. The reporter causality for the event(s) of crohns flare up and dehydration with HUMIRA (ADALIMUMAB) was not provided. The reporter causality for the event(s) of atrial fibrillation with HUMIRA (ADALIMUMAB) was no reasonable possibility. Agency's opinion is that there is no reasonable possibility that the events of crohns flare up, atrial fibrillation and dehydration are related to HUMIRA(ADALIMUMAB).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The events of Crohn's aggravated, atrial fibrillation, tachycardia, pain, vomiting, dehydration and weight decreased are related to the suspect product BNT162B2 based on temporal relationship. The confounding factor for the event of Crohn's aggravated is underlying medical condition of Crohn's disease 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.