Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Bradycardia, Disturbance in attention, Dizziness, Feeling hot
Clinical narrative: got very sick; lightheaded; her blood pressure was extremely high/Blood pressure goes up; Passed out and what she would call a loss of consciousness; Syncope; feels a heat rush like she is about to pass out; made a rash; skin has a different texture where they injected the shot; lots of little bumps; Bradycardia; Sore Arm; affecting her memory, she can't concentrate or focus, something is happening neurological with her thinking; affecting her memory, she can't concentrate or focus, something is happening neurological with her thinking; affecting her memory, she can't concentrate or focus, something is happening neurological with her thinking; This is a spontaneous report received from a contactable Nurse. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; 50-year age at time of vaccination), via an unspecified route of administration on 13Jan2021 (Batch/Lot Number: EL1284) as second dose at unknown dose single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported patient had, Passed out and what she would call a loss of consciousness on 24Feb2021; Syncope in 2021; lots of little bumps in 2021; Bradycardia in 2021. she was hospitalized for them back in April, and she was still having side effects. She states one of them dizziness and she feels a heat rush like she is about to pass out (in 2021). She states her doctor told her to report the side effects. She states she does need to talk about it, because any time, even if she is sitting, she feels like she can pass out. She states she did pass out her very first time, the day she went to the hospital. and she has had 3 today. Syncope AE: She states if she was not somewhere where she can catch herself or where she can sit, she knows she will pass out and has to take deep breaths until she can get herself together. Fainting AE: She states her biggest problem is the fainting. She states it is not just when she was walking, it was a at any time, sitting or lying too. She states at some point in time she thought she had orthostatic hypotension but it can't be because she can be sitting and get dizzy like she was fixing to pass out. She states she actually did the very first time. She states she thought she was just nervous but it happened in less than 3 minutes after getting the first vaccine. She states her side effects come and go. Memory AE: She states it is almost to the point where it is affecting her memory because she didn't have memory problems before. She states it is affecting her memory (in 2021), she can't concentrate or focus, something was happening neurological with her thinking. Skin had a Different Texture at the Injection Site AE: She states it made a rash (in 2021), the skin has a different texture where they injected the shot (in 2021), and she can see and feel the bump there. She states she knows it is where the injection went in with the first one and she believes that is the one that made the mark. She states is actually turned red but it didn't swell. She states right there were it was injected, it has improved because it is no longer red, but she just has an area of different skin texture there, like how when a person gets burned and the skin feels different, it feels like a lot of little bumps (in2021). She states she had no other side effects. She states no drowsiness, no fatigue. She states she did have a sore arm, but she took Aleve and it was gone in 2-3 days. She states the episode of dizziness came back 2 days later and then it went away for a week and then came back and one at a time until she started getting 2-3 episodes back to back at a time. She states that is what concerned her and prompted her to go to the doctors office. She states she was on the phone and she said oh, she doesn't feel good and all she remembers was sitting up right and she had fell over to the side, she considers that a loss of consciousness, because she doesn't remember. She states that was on 24FEB2021, the day of her admission when she went the hospital. She states she went to see her doctor and she got an order for a direct admission to the hospital and the ER was so busy and she got very sick, dizzy, and lightheaded, and when she got there, her blood pressure was extremely high (Blood pressure goes up). Treatment: Aleve, Hydralazine, Amlodipine. She states the put a Heart Monitor on her. Heart Monitor: She states they put a heart monitor on her and the leads broke her out and she had to turn that back in early because she had an allergic reaction to the leads. She states she knows she was off of work for 13 days and she wants to say she had the heart monitor put on that Monday after she was discharged. The outcome of the events Passed out was recovered on 24-FEB-2021; Blood pressure high was recovered in 2021; Syncope, Feeling hot was not recovered; Rash, Vaccination site discomfort, Vaccination site mass was Recovering, Bradycardia was recovered in 2021. Rest of the events was unknown.   Reporter causality: Syncope and Fainting - Related Covid Vaccine: Blood Pressure Goes Up - Related Covid Vaccine: feels a heat rush like she is about to pass out - Related Covid Vaccine: affecting her memory, she can't concentrate or focus, something is happening neurological with her thinking; - Related Covid Vaccine: Sore Arm - Related Covid Vaccine: made a rash, the skin has a different texture where they injected the shot, can see and feel the bump there; like how when a person gets burned and the skin feels different, lots of little bumps - Related Covid Vaccine: got very sick, dizzy,and lightheaded, and when she got there, her blood pressure was extremely high Related.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of loss of consciousness,syncope,illness,dizziness,hypertension,feeling hot,rash,vaccinationsite discomfort,vaccination site mass,bradycardia,pain in extremity,Thinking abnormal,memory impairment,disturbance in attention cannot be excluded.But also consider relevant medical history and concomittant drugs. 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.