Age: 64.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Dyspnoea, Headache, Investigation, Neurological symptom, Tremor
Clinical narrative: Trouble breathing; headaches; shakiness; a neurological effect, when hearing certain sounds; the room was spinning and everything; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EN6201) via an unspecified route of administration on 25Mar2021 (at the age of 64-years-old) as a single dose for COVID-19 immunization and started to receive dapagliflozin propanediol monohydrate (FARXIGA; tablet; strength: 10mg) via an unspecified route of administration from 24Mar2021 to Apr2021 at 10mg, 1x/day (10mg tablet once a day) and via an unspecified route of administration from May2021 to an unspecified date at 10mg 1x/day (10mg tablet once a day) for congestive heart failure. Medical history included heart attacks (2 heart attacks) from an unspecified date and unspecified if ongoing, stroke from an unspecified date and unspecified if ongoing, diabetic from an unspecified date and unspecified if ongoing, pneumonia in Oct2020 ("when that COVID first came out", he had pneumonia and was hospitalized for two weeks with additional time a nursing home. He was tested seven different times during that three-week period, all coming back negative. He also said he was on several different antibiotics during that time), congestive heart failure from 2021 and ongoing and 2 stents put in on an unspecified date. Concomitant medications were not reported; however, the patient stated that he did take several medications. Dapagliflozin propanediol monohydrate was the only one he started at the same time as the Pfizer vaccine. On 26Mar2021, the patient experienced headaches, shakiness, a neurological effect, when hearing certain sounds, the room was spinning and everything and on an unspecified date the patient experienced trouble breathing. The patient stated that he got the 1st Pfizer COVID-19 vaccine on 25Mar2021 and at the same time he got the vaccine, he had congestive heart failure. He was diagnosed before that, he was not sure when, a few weeks to a month, and his cardiologist started him on a new medication, dapagliflozin propanediol monohydrate, and gave him samples. He saw the doctor on Wednesday and on Thursday he got the 1st dose of the vaccine. He started taking the samples of dapagliflozin propanediol monohydrate on 24Mar2021 and took 1 on 25Mar2021 and 1 on 26Mar2021 and that was the day he experienced the side effects, so he only took 3 of them and had the vaccine in the middle. He stated that he got weird side effects, the room was spinning and everything. He tried calling here and we were not open. His cardiologist told him to stop taking the dapagliflozin propanediol monohydrate. He got his 2nd dose of the Pfizer COVID-19 vaccine (Lot Number: EW0153) on 22Apr2021 and was not taking the dapagliflozin propanediol monohydrate and everything was ok with the 2nd vaccine. He had been taking dapagliflozin propanediol monohydrate again since May2021 and in the last month or so, for about 3-4 months now and in the last month he had been getting really bad headaches and when he heard sounds his right side would shake and it was neurological. He tried to get a hold of his neurologist and he said it was the new medication and had been off it for 2 days now. The patient stated that now they were talking about a 3rd vaccine. He was not sure; he did not read the information over really good and was reading now that the vaccine was not even approved. He goes to cardiac rehab as he had a stent put in in May2021 and they wanted him to wear a mask while he was exercising, and he had had 2 vaccines already. In the lecture they wanted him to wear a mask also. He had trouble breathing and would take his mask off and they had not said anything until today at lecture the nurse told him that there were people in the class not vaccinated and to sit out in the hall. He talked to the cardiology nurse and she told him the same thing. He called the heart clinic and left a message. He wanted to see what Pfizer had to say about masking, that he was getting confused. He had health problems before the vaccines came out anyway and did not know if he was able to prove the vaccine had anything to do with it as the neurologist was saying it was the dapagliflozin propanediol monohydrate. His cardiologist put him back on the dapagliflozin propanediol monohydrate in May2021 and the neurologist knew more. He left a message with the heart clinic and the nurse at the cardiac rehab today said the neurologist was a smart guy and said it was the dapagliflozin propanediol monohydrate. All winter he belonged to a gym that was owned by and was part of the hospital, they had a sign to wear a mask when you go in but a big sign that said do not wear it while exercising but when you are done to put it back on and clean the machines and the machines were separated. He told the nurse that the gym was part of the hospital and was told that was their policy, but they own the gym. It seemed like a lot of healthcare providers did not take the vaccine and he did not know what they were so paranoid about it, he guesses they are suspicious. He wanted input. The neurologist wanted him to stop the dapagliflozin propanediol monohydrate for 10 days and get an EEG of his brain and a CT of his head after he had been off it for 10 days. He was wondering with the 3rd vaccine if he should take it. He would be 65 in 2 weeks. He had had 2 heart attacks, a stroke and was diabetic. He had not taken the dapagliflozin propanediol monohydrate for 2 days and was really weird, the noise was bothering him it felt like his head was ready to explode. The neurologist stated that the medication could cause seizures and everything. He did not know why the heart doctor put him on it. He told the cardiologist today he did not usually read side effects anymore because they were about the same with every medication. Now he was wondering if he should take the 3rd vaccine but with his other problems going on, he did not know. He was concerned about dapagliflozin propanediol monohydrate. He saw the neurologist after he saw cardiology on Monday, and he went to the office after cardiac rehab and was told to stop the dapagliflozin propanediol monohydrate. They called him later and he was told the neurologist ordered the EEG and CT scan for 26Aug2021 which would be 10 days from when he stopped taking it and he was thinking that it took that long to get out of his system or that was the earliest he could get it scheduled. He did not know, and they did not tell him. With the neurologist saying that right way, that he did not like it, it was a new drug that just came out and there were commercials on TV and the way he looked he said he did not want to say anything about the cardiologist but they were foolish for giving it to him as it could cause seizures in people and neurological all kinds of problems. He stated that he must have had experience with this. He said that no one was really blaming the vaccine, but they did not know much about it and the healthcare providers do not want to take it and were suspicious of it. The one he called that Friday did not know the side effects, but the room was spinning and when he sat it was okay and he had it like all day Friday. He got the vaccine Thursday and did not notice anything until the next day and he tried to call but it was after 8 at night and he might have called he did not know. He could not think of who to call so he called the cardiologist on call and they called him back within a minute. When he stopped taking the dapagliflozin propanediol monohydrate for the 2nd vaccine he was okay and he did not know what was going on. The patient wanted to know if the symptoms he was experiencing was related to the vaccine or to the medication. He stated that dapagliflozin propanediol monohydrate was a new medication, but it was approved by the FDA. He asked when the vaccine would have approval. He wanted to know our thoughts on a third dose and asked if he should receive the third dose. He also discussed the confusion he had over whether he should wear masks now that he was fully vaccinated. He stated that the mask policy was different at different locations. He asked for our opinion on wearing masks. The action taken in response to the events for dapagliflozin propanediol monohydrate was permanently withdrawn on an unspecified date. The clinical outcomes of the events headaches, shakiness, a neurological effect, when hearing certain sounds, the room was spinning and everything and trouble breathing were unknown.