Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival erythema, Gingival pain, Gingival swelling, Insomnia, Mass
Clinical narrative: pain in her chin; soft lump/felt like a soft little ball there; Whole mouth became inflamed; Her gums on top were all inflamed; bottom of gums had swelling and pain about a quarter of an inch down to her chin; Gums turned red/gums were beet red and swollen; Bottom of her gums she had swelling /gums were beet red and swollen; she couldn't sleep; mouth was sore; partial and wisdom teeth swelled up then it went down to her chin/her bottom teeth, she has teeth on the bottom, well one got swollen and it went down into her chin; This is a spontaneous report from a contactable Consumer or other non-HCP (patient) communicated to regulatory. A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: not reported), dose 1 via an unspecified route of administration on 01Apr2021 (at the age of 79-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Ongoing diabetes, ongoing pacemaker, ongoing defibrillator, Gum erosion, Tooth loss and sore gums. She was allergic to a lot of things, penicillin, sulfa, and she could not even take pheno (documented medications as provided by the caller) and even with makeup, she has to be careful with what she puts on. She gets hives and itching, and she just did not feel well. Probed for NDC, lot number and expiry date for the previously mentioned products she has experienced an allergy to, and she declined to provide and said that was a long time ago. She was 18 years old when she had the reaction to penicillin, and no one knew what it was and then she passed out from it because she could not sleep for 3 days. They thought it was coca cola and then she saw another doctor and he said that it was penicillin, and he gave her a shot and then she was fine in a few hours. The patient concomitant medications were not reported. On 02Apr2021, the patient experienced pain in her chin, soft lump/felt like a soft little ball there, Whole mouth became inflamed, her gums on top were all inflamed, bottom of her gums she had swelling and pain about a quarter of an inch down to her chin and Gums turned red/gums were beet red and swollen. On an unspecified date in 2021, the patient experienced mouth was sore, she has partial and wisdom teeth swelled up then it went down to her chin/her bottom teeth, she has teeth on the bottom, well one got swollen and it went down into her chin like a line meaning that it was just in one spot and could not sleep. The clinical details of the events as follows: Caller said that on 01Apr2021 she had her first Pfizer COVID shot and she is due to receive her second dose on 22Apr2021, but what happened was she went on Thursday morning at a quarter till 10 for her first COVID vaccine appointment and she got her shot, and she was fine. Then Friday night her mouth, she had a partial and she has lost bone and gums and they could not hold her teeth and she lost teeth, so she has a partial in there, but on Friday night her whole mouth became inflamed. Her gums on top were all inflamed and then her bottom teeth, she has teeth on the bottom, well one got swollen and it went down into her chin like a line meaning that it was just in one spot, and it felt like a soft little ball there and it hurt. They said that she can take Tylenol for this, but it did not do anything for it. She went to the dentist on Monday because this occurred on Easter weekend. She thought that she got an abscess, and she went to the dentist, and they did an x-ray and did not find anything, but they said to go home, and they gave her a medicated rinse to rinse her mouth out with and they sprayed something on her gums, and she went home, and it started to get better. She started to take Motrin and that seemed to take the pain away and help. She was afraid to take Motrin because they said to take Tylenol. She was worried about this happening again tomorrow 22Apr2021. she was asking that if she would get the same reaction and can she use Motrin after the second COVID vaccine. She had her COVID vaccine and was fine and then Friday night it started, and her mouth was sore, and she could not sleep because it was that bad that it had kept her up. Probed if this was ongoing and caller says that she went to the dentist, and they sprayed her gums and did things, but they did not know what was wrong and after that they gave her a prescription mouth rinse and she used that and then she had to use her mouthwash and then it healed. Then on Tuesday she said to try Motrin. Once she took it the pain was going away and she took it a couple of days, maybe 3, and she did not take a whole lot, maybe like one or two tablets a day of 200 mg. Then it started to go away and then just yesterday and today now she feels soreness again that is going down to her chin to that soft little ball that she said she had. She was x-rayed and they did not find anything with that. They saw the redness and the irritation, but they could not find any abscess or anything like that, they were puzzled. She had a past medical history of gum erosion and tooth loss received the first dose of the Pfizer BioNTech Covid 19 vaccine on the morning of 01Apr2021. The next day her gums turned all red and toward the bottom of her gums she had swelling and pain about a quarter of an inch down to her chin and a soft lump there. She went to the dentist on Monday and was X-rayed but there was no abscess but was still given a prescription strength rinse and something was sprayed on her gums. It has started to heal but was still experiencing some pain- aching in the chin. She had taken tylenol and ibuprofen. She was due to receive her second dose of the vaccine but wants to know if she can take any motrin if she develops the pain again. It was reported that She was not blaming the shot, but she never has had this before. She has had sore gums before, but her gums were beet red and swollen. It kept her up for two nights because she could not sleep. Monday 05Apr2021, she went to the dentist, and they did not know and then they were going to send her to see the surgeon, but she goes tomorrow 22Apr2021 for her second COVID vaccine and Friday 23Apr2021, she is going to go to her family doctor for her regular checkup. She does have diabetes, a defibrillator and the pacemaker just in case that has anything to do with it. She did not know. She was not blaming this on the COVID vaccine. Her daughter was there today and said why do not the caller contact Pfizer and see what to do and so that's why she called so last minute when she goes in tomorrow morning at 09:30. Maybe at least she can find out if she can take something. She does not know if Motrin interferes with the injection and that is why they said take Tylenol, but it did not do anything for her. It did not help her. Then on Tuesday or something she started to take Motrin but she did not take it for long, only for a couple days, and then it started bothering her again so she thought to call and see what she can do. She has an endocrinologist (Name) and the endocrinologist and her family doctor are at (Hospital) with the address that is populated in the formal field. Caller provided (City) address even though the provider goes between that address and the (City), (State) address that she does not have to provide at this time. Her heart doctor, Dr. (Name), is at (Hospital name) in (City), (State). This morning she took Motrin at 11:30 and that was it and it cleared up, but she may need more when it wears off or maybe it will last until tomorrow, but she did take one at 11:30. She stated that she did not know if Motrin interferes with the injection and that is why they said take Tylenol, but it did not do anything for her and it did not help her. Investigation Assessment was not provided. The patient outcome of the events pain in her chin, bottom of her gums she had swelling and pain about a quarter of an inch down to her chin, Gums turned red/gums were beet red and swollen, Bottom of her gums she had swelling /gums were beet red and swollen was Resolving and the outcome of the other events was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.