Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: had reaction in mouth broke out in tiny sores; Facial flushing; This is a spontaneous report from a contactable consumer reporting for herself. An 82-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration from 08Jan2021 to 08Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included hypertension, blood pressure abnormal, blood cholesterol increased, thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication included triamterene (TRIAMTERENE), verapamil (VERAPAMIL), levothyroxine (LEVOTHYROXINE), atorvastatin (ATORVASTATIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. Caller stated that she had her first Pfizer vaccine on 08Jan and was scheduled for her second one tomorrow. Stated that the next day in the evening that she had a reaction in her mouth that broke out in tiny sores. Stated that she went to her dental appointment and was prescribed Triamcinolone Acetonide paste and it went away. Wanted to know if this is anything that has been reported before she gets the second one. Clarified it as Pfizer Covid 19 vaccine. Is in her 80s. Stated that she also had facial flushing in 15 minutes of the vaccine that went away in 30 minutes. Concomitant Medication: Stated that she was on her regular medication. Littles sores in the roof of my mouth, dentist checked and said that sometimes vaccine can trigger like you have had cold sores or canker sores in the past. Consumer stated, "I spoke with someone earlier today and went through some side effects I had from the first Pfizer vaccine which was 08Jan. And we went through everything and she said I needed to report to someone else, a nurse or something and I decided to get back to that, she said option 3 but when I went to option 3 it was Medical, I don't know if I put the option in too soon or what. All I want to do is just report and I am having my second dose in the morning. When probed for the reference#, consumer stated, She didn't give me a reference number, but I gave her the COVID Vaccine Pfizer LOT and also gave her my email.Role of Pfizer Drug Safety was informed to the consumer. When probed for the adverse reactions, consumer stated, "I had facial flushing at the time. They had me stay for half an hour and check blood pressure and everything and then the following night I had some littles sores in the roof of my mouth and I already had a dental appointment coming up, so I went to the dentist and he checked it and said that sometimes the vaccine can trigger like you have had cold sores or canker sores in the past. Ethnicity: Consumer stated, "(Withheld) with some (withheld). Consumer confirmed vaccine name as COVID-19 Vaccine When probed for the expiration date, consumer stated, "No, but I am having a second one tomorrow. I was given at (Institute name). Other medical conditions: Consumer stated, "I have thyroid." (Not clarified further). When probed for the treatment, consumer stated, "The only treatment I had is the dentist prescribed a paste that I dab on, that I put in my mouth, but it took care of the problem I used it about five days. Consumer further stated, "My main thing was just reassurance that those can be normal because it is not listed in the side effects. I have been on phone now for at least an hour waiting my turn. I think I will go and just tell them tomorrow when I get my shot. Consumer stated, "I spoke with someone earlier today and went through some side effects I had from the first Pfizer vaccine which was 08Jan. And we went through everything and she said I needed to report to someone else, a nurse or something and I decided to get back to that, she said option 3 but when I went to option 3 it was Medical, I don't know if I put the option in too soon or what. All I want to do is just report and I am having my second dose in the morning. When probed for the reference#, consumer stated, "She didn't give me a reference number, but I gave her the COVID Vaccine Pfizer LOT and also gave her my email. Role of Pfizer Drug Safety was informed to the consumer. When probed for the adverse reactions, consumer stated, "I had facial flushing at the time. They had me stay for half an hour and check blood pressure and everything and then the following night I had some littles sores in the roof of my mouth and I already had a dental appointment coming up, so I went to the dentist and he checked it and said that sometimes the vaccine can trigger like you have had cold sores or canker sores in the past. Consumer confirmed vaccine name as COVID-19 Vaccine. Consumer further stated, "My main thing was just reassurance that those can be normal because it is not listed in the side effects. I have been on phone now for at least an hour waiting my turn. I think I will go and just tell them tomorrow when I get my shot. Consumer was provided with Pfizer Medical Information Department's number as (Phone number withheld) and was informed to press option 3 and call from 8 AM to 11 PM, Mon to Sun as per EST. Outcome of the events was recovered. The reporter considered the events as non-serious.