Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic aneurysm, Deep vein thrombosis, Diplopia, Fatigue, SARS-CoV-2 test
Clinical narrative: Deep Vein Thrombosis; Chronic Fatigue for months; Diplopia; Aneurysm in Ascending Aorta; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "BPH" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN; DUTASTERIDE. Vaccination history included: bnt162b2 (Prev dose product: COVID 19 , Prev dose brand: Pfizer , Prev dose brand unknown: False , is bivalent: False , Prev dose lot number: Not Available , Prev dose lot unknown: False , Prev dose administration date: 23Jan2021 , Prev dose dose number: 1 , Prev dose vaccine location: Left arm), administration date: 23Jan2021, when the patient was 66-year-old, for COVID-19 immunization; bnt162b2 (Previous dose details, Prev dose product: COVID 19 , Prev dose brand: Pfizer , Prev dose brand unknown: False , is bivalent: False , Prev dose lot number: Not Available , Prev dose lot unknown: False , Prev dose administration date: 13Feb2021, Prev dose dose number: 2 , Prev dose vaccine location: Left arm), administration date: 13Feb2021, when the patient was 66-year-old, for COVID-19 immunization, reaction(s): "Deep Vein Thrombosis", "Chronic Fatigue for months", "Diplopia", "Aneurysm in Ascending Aorta". The following information was reported: AORTIC ANEURYSM (disability, life threatening) with onset 20Sep2021 at 12:45, outcome "recovered with sequelae", described as "Aneurysm in Ascending Aorta"; DIPLOPIA (disability, life threatening) with onset 20Sep2021 at 12:45, outcome "recovered with sequelae"; DEEP VEIN THROMBOSIS (disability, medically significant, life threatening), outcome "recovered with sequelae"; FATIGUE (disability, life threatening), outcome "recovered with sequelae", described as "Chronic Fatigue for months". The events "deep vein thrombosis", "chronic fatigue for months", "diplopia" and "aneurysm in ascending aorta" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Dec2021) Negative; Ultrasound scan: (unspecified date) Unknown Results. Therapeutic measures were taken as a result of deep vein thrombosis, fatigue, diplopia, aortic aneurysm and included Referral to Ultrasound/PCP and was put on Eliquis.  Clinical course: Deep Vein Thrombosis, both legs (ankle) causing permanent damage to right leg, Chronic Fatigue for months, Diplopia, Aneurysm in Ascending Aorta. No previous health issues. AE resulted in: [Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event), Disability or permanent damage].  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: All serious events including Deep Vein Thrombosis, Chronic Fatigue, Diplopia and Aneurysm in Ascending Aorta most likely represent intercurrent medical conditions associated with the older patient underlying predisposing factors unlikely related to BNT162B2 use.  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,Linked Report(s) : US-PFIZER INC-202300296283 Same patient/events, different dose;