Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mental status changes, Nausea, Renal failure, Vomiting
Clinical narrative: She confirms she passed out.; She ended up in the hospital with lots of vomiting and nausea.; She ended up in the hospital with lots of vomiting and nausea.; her heart started with Afib; her kidneys shut down; her lungs were affected; This is a spontaneous report from a contactable consumer (patient) via sponsored program. A 64-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiration date was not reported), dose 1 via an unspecified route of administration on 30Mar2021 (at the age of 64-year-old) as DOSE 1, SINGLE for covid-19 immunisation; morphine (MORPHINE), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; gabapentin (GABAPENTIN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications was not reported. The patient experienced she confirms she passed out. (medically significant) on 31Mar2021, she ended up in the hospital with lots of vomiting and nausea. She had to get rehydrated. On 30Mar2021, she ended up in the hospital with lots of vomiting and nausea. on 30Mar2021, her heart started with afib (medically significant) in 2021, her kidneys shut down in 2021, her lungs were affected in 2021. The patient was hospitalized for she confirms she passed out and she ended up in the hospital with lots of vomiting and nausea from 31Mar2021 to 07Apr2021. The reporter also stated that her kidneys shut down, her lungs were affected, her heart started with Afib.  She takes lots of medications and wasn't getting them because of the vomiting. She states she takes Gabapentin and when she suddenly stops it she goes into a coma.  She says that did not happen however she was "in an altered state of consciousness for 5 days and then in a couple of days I got to go home."  She was in the hospital for a week.  She also takes Morphine, and "this relates to the stopping of the gabapentin":  "it looks like you've taken more morphine that you have" since the kidney's stopped working.  She says the doctors feel that's what happened.  She says its not an allergic reaction.  If she can stop the nausea and vomiting "is it too risky to take the second dose?"  Her doctor said she is "lucky to be alive" and not to take the second dose.  Caller states she filed a VAERS report but the report number is not handy. She said she takes a lot of different medications and because of all of the vomiting, she really wasn't getting all of those medications, 2 of which were Gabapentin and Morphine. She said when she stops the Gabapentin suddenly, she goes into a coma. However, that didn't happen while she was in the hospital, but she says she was in an altered state of consciousness for 5 days while being in the hospital. She was in the hospital for a week, and for 5 days, she was in that altered state of consciousness, and then a couple of days later, she got to go home. In regards to the Morphine, she stated because of the vomiting, which she believes is also related to the stopping of the Gabapentin, it looked like she had taken more Morphine than she actually had because of her kidneys not working properly. The doctors feel that is what happened. Her question for the agent was that she knows it is not an allergic reaction but, if she can't stop the nausea and vomiting, is it too risky to get the second dose? She said that her doctor told her she was lucky to be alive and should not take the second dose.  She also filed a report through VAERS but does not have the report number handy. Agent states that the agent stated she was going to fax an AE report to the regulatory authority.  Agent stated that she told the caller to talk to her physician because Pfizer cannot determine if she should take the next dose or make a recommendation to stop the nausea and vomiting- this all has to be discussed with the physician. States that she put him down on the report she filed. She was very surprised the doctors at the hospital were all about the Morphine and it wasn't about the Morphine. States that she filed a report with VAERS but this is the first time speaking with Pfizer. The only reason she called Pfizer is that her doctor said that its up to her if she wanted to get the second shot. The vaccine would give her protection but he couldn't guarantee that the kidneys wouldn't shut down just because of the vomiting. She thought maybe there was an injection they could give her if she went to the hospital to have the vaccine. She confirms she passed out. They made her wait an hour after the shot because of her history. After about 2 hours of getting home, she started throwing up. She thought well the paperwork said nausea, and it did not occur that it would get as bad it did. She states she didn't realized it was that bad, and when she doesn't get Gabapentin after so many hours, her brain starts getting fuzzy, and she was saying she was fine, but wasn't. She has had comas before because she didn't keep her Gabapentin down. She clarifies she has been in a coma 3 times be before in the hospital because she was not keeping the Gabapentin down. That is why she felt that it was more from the Gabapentin and not from the morphine. She mentions she was given her Narcan 3 times and it didn't do anything. She mentions she wrote this all down in the report and didn't hide the fact had that she took Morphine. They counted the pills and the pills were all there, but it turns out, when her kidneys shuts down and she stopped taking certain drugs, the morphine elevates she guesses. She confirms she was in an altered state for 5 days. Clarified that it was 30Mar2021 that she got the vaccine and has this reaction. Her breathing shut down, her lungs were bad and she started going into A-fib which she never had A-fib before. Clarified that the vaccine facility had kept her there for one hour and then 2 hours later, she started throwing up. The next morning 31Mar2021, she passed out and she was taken to the hospital. She got out of the hospital on 07Apr2021. She states she was out of it for 5 days. She confirms she takes many medications. She knows that she didn't keep anything down on 30Mar2021, but she does not know what she kept down on 31Mar2021. Obviously, she kept the Morphine down otherwise it wouldn't have been in her system, but she was just out of it. That is how bad the nausea and vomiting was. The paperwork said nausea, but she wasn't warned about extreme vomiting. She states she was taken off of everything. The only thing she knows she was given was Narcan. She was told until she could wake up and swallow, they wouldn't give her any medication. She had to go cold turkey on everything. She was on IV's, but she really doesn't know what they were doing because she was unconscious. Caller states that she has another call and requests someone to call her back. Caller advised that Pfizer would contact her if in need of further information. She states she is on many medications, including Gabapentin and Morphine.  She was told until she could wake up and swallow, they wouldn't give her any medication. No further details were provided or obtained. The action taken for morphine and gabapentin was unknown. Therapeutic measures were taken as a result of she confirms she passed out, she ended up in the hospital with lots of vomiting and nausea, her heart started with afib, her kidneys shut down, her lungs were affected. The outcome of the events was unknown.  Information on the Batch/lot number has been requested.