Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Stress echocardiogram abnormal, Vaccination failure
Clinical narrative: Stroke; Blockage/Clogged two arteries; Not normal electrocardiogram/Abnormal nuclear stress test; Low energy; COVID; COVID; 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-163-4396809-00 (AbbVie).  A 59-year-old male patient received BNT162b2 (BNT162B2), on 01Jan2021 as dose 1, single (Batch/Lot number: unknown), on 28Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 01Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1159670), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "COVID"; ASTHENIA (non-serious) with onset 2022, outcome "unknown", described as "Low energy"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "recovered", described as "Stroke"; ARTERIAL OCCLUSIVE DISEASE (medically significant), outcome "not recovered", described as "Blockage/Clogged two arteries"; STRESS ECHOCARDIOGRAM ABNORMAL (non-serious), outcome "not recovered", described as "Not normal electrocardiogram/Abnormal nuclear stress test". The patient underwent the following laboratory tests and procedures: Cardiac stress test: Abnormal, notes: Nuclear stress test; Electrocardiogram: Not normal. The action taken for adalimumab was unknown.  AbbVie's opinion is that the events of stroke, blockage/clogged two arteries and not normal  electrocardiogram/abnormal nuclear stress test are not assessable. AbbVie's opinion is that there is no reasonable possibility that the events of COVID with sequela and low energy are related to Humira(Adalimumab).    The reporter's assessment of the causal relationship of "stroke", "blockage/clogged two arteries", "low energy" and "not normal electrocardiogram/abnormal nuclear stress test" 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 "covid" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded.   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.