Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Confusional state, Decreased appetite, Dizziness, Gait disturbance
Clinical narrative: she liked to have die from that Pfizer; she was confused; she was really sick; she didn't have an appetite, she was not hungry or any of that; sick in her chest area; can hardly walk at times/ walks it kind of like off balance; She wasn't even in her right mind; lightheaded/ light and everything is spinning; shaking; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (69-year-old at time of vaccination) as single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as none. Patient says that she liked to have die from that Pfizer, she hasn't been able to function or get around to do stuff for herself and her husband took the vaccine and he isn't no better. She is a nurse but she doesn't think that she is going to be anything else after this. She has been as sick as she has ever been. She is just now halfway to feeling better. How long does it take for this to wear off because she is not getting better. She states that when she had talked to her physician he said that she was referred to Pfizer since this is where she got the shot. She said she just wants to provide the fact she feels better but she has had no changes like this before and she has been in nursing for 30 years. She has talked to her physician and they said this is where she needs to talk to someone. While completing her husband's report she mentioned that they see the same primary healthcare provider. Event Details: She states that she was out of it, she was confused, she was really sick and she didn't have an appetite, she was not hungry or any of that. They began the day after she took the shot; she couldn't tell it exactly but it was right after that on the same day that she took the shot. She wasn't even in her right mind. Inquired if her side effects were ongoing and she says that some of them are but not all of them. She had stopped taking the Pfizer medicine and she hasn't had none, she has just been out of it. Her husband was no better and he couldn't take the Pfizer and she doesn't know what it was. Inquired on what side effects the patient is still having and she says that the ones that she is still having is that she is sick in her chest area, she can hardly walk at times and she is a little on the confused side. Inquired for outcome and she states that it is a little bit better but she isn't back where she was. When she walks it kind of like off balance and she is not functioning. A lady had told her to call and check with Pfizer first because that's where she got the shot from. Seriousness: She thinks that it is serious because before they got this they didn't have that. Causality: She didn't have any problems before then, she only went to get the vaccine because her doctor said that everyone was going to have to get the vaccine. She states that she didn't have any symptoms like she wasn't sick or in pain or none of those things but she hasn't been right since then. Inquired again if she believes that her side effects are related to the COVID vaccine and she says that they are related to something because she has not been right since then. The nurse told her that the patient hasn't been right since then, not at all. She has had plenty shots and she has never dealt with this. If she takes a regular shot, it is okay, but this here, no ma'am. She is not going to try and take the other part of the shot. If her reaction came from one she might not live with next one. Patient mentioned that she has never had these side effects before and it is unusual. She states she did not want to provide further information because she is feeling a little lightheaded. She says that she could call back later but she can't do it now, the light and everything is spinning. When she was informed that this DSU agent is unable to call her back she said that she needs to finish this and it is awful. With her, she had the worst of it. She was lightheaded and confused and shaking and she has never had that before. She took the 1st Pfizer dose but she is not going to take the other one because she was so sick by it and she doesn't know what Pfizer is doing for her. She was able to function and do a lot of things but then her doctor had to talk to her because she thought that death was the better off. She states in her case she was sick and hasn't been able to provide nothing and she wasn't able to go and take care of herself. She did have a great reaction to it and it was quick as can. She wants to know why no one and say anything, she was sick flat on her back ad had to work part time. She had to have her grandchildren come over and take care of her and she has never had that before. Patient provided some information that may have contradicted itself regarding her side effects, documented as was provided and confirmed by patient. Patient assessed events "she liked to have die from that Pfizer", "she was confused", "she was really sick", "she didn't have an appetite, she was not hungry or any of that", "sick in her chest area", "can hardly walk at times" as medically significant. The outcome of "she was confused", "sick in her chest area", "can hardly walk at times/ walks it kind of like off balance" was not recovered; outcome of "she liked to have die from that Pfizer", "she was really sick", "she didn't have an appetite, she was not hungry or any of that", "she wasn't even in her right mind" was recovering; outcome of "lightheaded/ light and everything is spinning" and shaking was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events 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.