Age: 74.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Loss of consciousness, Magnetic resonance imaging, Magnetic resonance imaging head, Malaise, Nasopharyngitis
Clinical narrative: Booster Dose: collapsed in the hall way and hit is head causing a small abrasion and was out cold; Unconscious; It is a wonder he didn't die; Booster Dose: collapsed in the hall way and hit is head causing a small abrasion and was out cold; Unconscious; It is a wonder he didn't die; Booster Dose: collapsed in the hall way and hit is head causing a small abrasion and was out cold; Unconscious; It is a wonder he didn't die; Booster Dose; Booster Dose: Blood Clots in Both Lungs Pulmonary Embolism, Blood Clot Left Leg; Booster Dose: Blood Clots in Both Lungs Pulmonary Embolism, Blood Clot Left Leg; Booster Dose: Blood Clots in Both Lungs Pulmonary Embolism, Blood Clot Left Leg; Booster Dose: Shortness of Breath; Would Get Winded; Booster Dose: Runny Nose and Cough; Cold Symptoms; Booster Dose: Runny Nose and Cough; Cold Symptoms; Booster Dose: Runny Nose and Cough; Cold Symptoms; Booster Dose: Tiredness; worn down and tired; sleeping a lot; Booster Dose: Tiredness; worn down and tired; sleeping a lot; Booster Dose: hadn't felt good; didn't feel well; Booster Dose: Headaches; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 74-year-old male patient received bnt162b2 (BNT162B2), administration date 15Nov2021 (Batch/Lot number: unknown) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administration date 15Nov2021 (Batch/Lot number: unknown) as dose number unknown, single. Relevant medical history included: "High cholesterol" (ongoing); "High Blood Pressure" (ongoing); "Covid", start date: Oct2020 (unspecified if ongoing), notes: patient had Covid a year ago Oct2020; "Blood clots" (unspecified if ongoing), notes: had Covid and had blood clots at that time and was on Eliquis for 6 months; "starting to get Pneumonia ", start date: 2020 (unspecified if ongoing); "he was going into respiratory failure and had Pulmonary Embolisms", start date: 2020 (unspecified if ongoing); "he was going into respiratory failure and had Pulmonary Embolisms", start date: 2020 (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN (ongoing); AMLODIPINE taken for blood pressure management (ongoing); METOPROLOL (ongoing). Past drug history included: Eliquis, stop date: Apr2021, for blood clot. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (hospitalization, disability, medically significant) with onset 15Nov2021, outcome "unknown", described as "Booster Dose"; THROMBOSIS (hospitalization, disability, medically significant), PULMONARY THROMBOSIS (hospitalization, disability, medically significant), PULMONARY EMBOLISM (hospitalization, disability, medically significant) all with onset 2021, outcome "unknown" and all described as "Booster Dose: Blood Clots in Both Lungs Pulmonary Embolism, Blood Clot Left Leg"; CIRCULATORY COLLAPSE (hospitalization, disability, medically significant), LOSS OF CONSCIOUSNESS (hospitalization, disability, medically significant) all with onset 13Dec2021 22:15, outcome "recovered" (Dec2021) and all described as "Booster Dose: collapsed in the hall way and hit is head causing a small abrasion and was out cold; Unconscious; It is a wonder he didn't die"; SKIN ABRASION (hospitalization, disability), all with onset 13Dec2021, outcome "recovered" (Dec2021) and all described as "Booster Dose: collapsed in the hall way and hit is head causing a small abrasion and was out cold; Unconscious; It is a wonder he didn't die"; DYSPNOEA (hospitalization, medically significant) with onset 2021, outcome "recovering", described as "Booster Dose: Shortness of Breath; Would Get Winded"; MALAISE (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Booster Dose: hadn't felt good; didn't feel well"; COUGH (medically significant), NASOPHARYNGITIS (medically significant), RHINORRHOEA (medically significant) all with onset 10Dec2021, outcome "recovered" (Dec2021) and all described as "Booster Dose: Runny Nose and Cough; Cold Symptoms"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Booster Dose: Headaches"; HYPERSOMNIA (non-serious), FATIGUE (non-serious) all with onset 16Nov2021, outcome "not recovered" and all described as "Booster Dose: Tiredness; worn down and tired; sleeping a lot". The patient was hospitalized for immunisation, thrombosis, pulmonary thrombosis, pulmonary embolism, circulatory collapse, loss of consciousness, skin abrasion, dyspnoea, fall (start date: 13Dec2021, discharge date: 16Dec2021, hospitalization duration: 3 day(s)). The events "booster dose: blood clots in both lungs pulmonary embolism, blood clot left leg", "booster dose: blood clots in both lungs pulmonary embolism, blood clot left leg", "booster dose: blood clots in both lungs pulmonary embolism, blood clot left leg", "booster dose: collapsed in the hall way and hit is head causing a small abrasion and was out cold; unconscious; it is a wonder he didn't die", "booster dose: collapsed in the hall way and hit is head causing a small abrasion and was out cold; unconscious; it is a wonder he didn't die", "booster dose: collapsed in the hall way and hit is head causing a small abrasion and was out cold; unconscious; it is a wonder he didn't die", "booster dose: shortness of breath; would get winded", "booster dose: collapsed in the hall way and hit is head causing a small abrasion and was out cold; unconscious; it is a wonder he didn't die", "booster dose: hadn't felt good; didn't feel well", "booster dose: runny nose and cough; cold symptoms", "booster dose: runny nose and cough; cold symptoms", "booster dose: runny nose and cough; cold symptoms", "booster dose: headaches", "booster dose: tiredness; worn down and tired; sleeping a lot" and "booster dose: tiredness; worn down and tired; sleeping a lot" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood cholesterol: (unspecified date) high; blood pressure measurement: (unspecified date) high; (unspecified date) normal; computerised tomogram: (13Dec2021) blood clots; magnetic resonance imaging: (2021) blood clots in his lungs, notes: Chest; magnetic resonance imaging head: (2021) blood clots in his lungs, notes: Head; ultrasound scan: (2021) clot in his left leg; x-ray: (2021) blood clots in his lungs. Therapeutic measures (Eliquis 10mg 2 tabs twice a day for a week and then will go to 10mg 1 twice a day TPA through port into both lungs to dissolve clots, IV heparin until discharged will be on rest of life.) were taken as a result of thrombosis, pulmonary thrombosis, pulmonary embolism, circulatory collapse, loss of consciousness, skin abrasion, dyspnoea, fall, malaise, cough, nasopharyngitis, rhinorrhoea, hypersomnia, fatigue.  Covid 19 Vaccine: Booster Dose: Tiredness; worn down and tired; sleeping a lot; hadn't felt good; didn't feel well; Runny Nose and Cough; Cold Symptoms; collapsed in the hall way and hit is head causing a small abrasion and was out cold; Unconscious; It is a wonder he didn't die; Headaches; Shortness of Breath; Would Get Winded; Blood Clots in Both Lungs Pulmonary Embolism, Blood Clot Left Leg; all Related.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available ,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely 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.