Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Palpitations
Clinical narrative: Heart racing; Felt flushed and warm; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 22Dec2020, this case now contains all required information to be considered valid.  This is a spontaneous report from two contactable nurses. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right deltoid on 21Dec2020 18:30 at single dose for Covid-19 immunisation. Medical history included Graves disease, hypothyroidism and radiation from an unknown date and unknown if ongoing (all diagnosed about 12 years ago), dental infection (root canal that failed and said she had an infection) and teeth cleaning from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID) taking for many years for hypothyroidism, amoxicillin (500 mg tablet) from 21Dec2020 for dental infection. Prior vaccinations within 4 week was none. The patient experienced felt flushed and warm (non-serious) on 21Dec2020, heart racing (medical significant) on 22Dec2020. The patient received the COVID vaccine yesterday (21Dec2020). She called Pfizer Drug Safety yesterday and asked about if she could take amoxicillin with it for a dental infection. She got the vaccine last night (21Dec2020 18:30) and felt a little flushed and warm after receiving it, so they kept her for 15 minutes. Today (22Dec2020), her heart had been racing at 09:00. She was at rest and had not been exercising. Her heat felt like it will beat out of her chest. She had no history of anxiety. She was a little concerned since she got it at around 6pm yesterday and it has been about 18 hours ago. She would like to know if there have been any reports of any elevated heart rates issues occurring the day after. She called her doctor, but he did not have any information. She did start the amoxicillin yesterday before the vaccine. She got a teeth cleaning and had a previous root canal that failed and said she had an infection. She is not symptomatic. They said she needed another one root canal and crown. It is encapsulated and is not causing any issues, but it could down the line. Regarding the feeling warm and flushed, she said the room was warm and there were a lot of people in it, even though they were socially distanced. She said there was just some angst in the room. She did not have a history of getting anxiety. There was also no Air Conditioning on in the room. It subsided and she did not feel like it was alarming. At the facility, they were not documenting it. That went away within 15 minutes. Regarding the racing heart, she does not know how long it could go on. She did have thyroid issues. She had not done thyroid labs. It could be her thyroid meds too. She took her Synthroid first thing when she woke up so it could be that too. She did not have a lot or expiration to provide. No emergency room or physician's office required. The outcome of felt a little flushed and warm was recovered on 21Dec2020 at 18:45, heart racing was not recovered.  Information about lot and batch was requested.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine.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.