Age: 49.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Feeling of body temperature change, Hyperhidrosis, Insomnia, Mental disorder, Migraine
Clinical narrative: Hot and cold, sweating profusely; Hot and cold, sweating profusely; Raspiness, and coughing; Lack of Appetite; Chantix: Very emotional and snaps or cries in a moment.; Chantix: not sleeping well at all and only getting an hour at a time; She talks to herself a lot; would not breathe; mental problems; her balance is a hot mess; Migraine; Chantix:  Ran out of medication; This is a spontaneous report from a contactable consumer (patient herself).  A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Patient had also received varenicline tartrate (CHANTIX), oral from May2021 (Batch/Lot number was not reported) on an unspecified date, at starter pack; one tablet daily and oral from May2021 (Batch/Lot number was not reported) to an unspecified date, at ended up taking twice daily by mouth for smoking cessation therapy. Medical history included speech rehabilitation, physiotherapy, pneumonia, migraine suffered since she was 9 years old, neck injury from unknown date and unknown if ongoing, she broke her neck at 14 years. Concomitant medications included zolmitriptan (ZOLMITRIPTAN), butalbital, caffeine, paracetamol (FIORICET) taken for an unspecified indication. Patient had not any history other products. It was reported that, she was a long haul COVID patient. She was going through speech therapy and physical therapy all because of the COVID. She had really good results taking the Pfizer COVID vaccine, especially, the second dose. It helped her a lot. She had Chantix starter kit. She could hear she was having difficulty breathing. She had a migraine. She did not want her to relapse. Patient clarified information above. The COVID diagnosis occurred prior to receiving the Pfizer COVID Vaccine and before taking Chantix. The second shot was only a week and a half ago. She was slowly starting to feel like a human being again. She was still having the mental problems and her balance was a hot mess. She really wanted to get off from smoking. Chantix had just been in the last month. Her daughter was coming back from college and she has pneumonia and she cannot smoke around her. She had double pneumonia herself during COVID. The first time she got COVID virus was 26Dec2020 and they cleared her to go back to work. She made it back for 2 days and passed out and went to hospital. That was when she found out she had double pneumonia and may have caught COVID-19 again. She had side effects from first Pfizer COVID vaccine. But, she was still dealing with the post COVID. She did have to postpone first dose for a week or two because of times available. She started Chantix when she went to long term clinic after that. They were the ones that put her in physical therapy and speech therapy and helped her get on Chantix. She was still having the hot and cold and sweating profusely when she went in to get the vaccine, so it just continued. She really did not know a start date. It was getting better but has started again in the last 3 days. The raspiness and coughing had persisted through when she had COVID, but it is not near as bad. She had been a severe migraine sufferer since she was 9 years old. he had weird COVID migraines, but it was not the same. The migraine medications somewhat helped but not really. They really have gotten better. She just got one after the second dose. Before the last couple of days it had gotten better, but the last couple of days it had come back. Her brain just races and she forgot what she was saying. Her short term memory a joke. This happened before the vaccine and before the Chantix. It was still continuing. She broke her neck at 14 years old and got migraines from that. Lack of appetite was after the vaccine but more specifically after the Chantix. She just noticed it in the last week. It has persisted because she does not eat much when she has migraines. She was very emotional and snaps or cries in a moment. It could just be from the migraine or that she lost her healthcare. She is very overwhelmed right now and just noticed it in the past couple of days. She got mad at her cat and never does that. The angry part was within a week or two of starting Chantix. That was a side effect and they pointed it out to her so she is really working on that. She said it will get better since she was out of medication. Within first week of starting Chantix, she was not sleeping well. She had thrown away the Chantix container. She was ran out of Chantix from 30My2021.But again, she had the migraine so she cannot 100% say it was the Chantix. She talked to herself a lot. She honestly thought it may have started right before she got second dose of Pfizer COVID vaccine. She was trying to do too many things at one time and she cannot do it. A friend noticed she would not breathe and get herself worked up and told her to calm down and think of one thing at a time and it does seem to help a little bit. Even though she had double pneumonia, she was still craving smoking. That was why she started Chantix. Description of complaint: The migraine medications somewhat help but not really. They really have gotten better. She just got one after the second dose. Before the last couple of days it had gotten better, but the last couple of days it has come back. The medication they originally gave her is Zolmitriptan dose of 5mg, Manufacturer (Name). She took one and it did not work, so she did not take any more. The next medication was generic for Fiorcet, butalbacetamincass, 50-300-40. This one did work if it was a migraine triggered where she broke her neck, but not for the kind behind her eyes. The reporter seriousness for the adverse events was unspecified. The patient underwent lab tests and procedures which included SARS-COV-2 test which was positive on 26Dec2020. The outcome of event Chantix: Ran out of medication, hot and cold, sweating profusely, raspiness, coughing, migraine, lack of appetite, Chantix: not sleeping well at all and only getting an hour at a time was not recovered while outcome of Chantix: Very emotional and snaps or cries in a moment was recovering and the outcome for she talks to herself a lot, would not breathe, mental problems and her balance is a hot mess was unknown.  Information about lot/batch no has been requested.