Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Swollen tongue, Throat tightness, Tongue disorder
Clinical narrative: chills; nausea; She had a lot of oral issues as well, I had a lot of oral issues, I can't even open my mouth; she did not feel well due to Covid vaccine; It was like someone switched the saliva switch off; yeast infection; mouth was burning/burning pain in her mouth; dry mouth/strange reaction with her mouth. It started off very dry and gradually got worse/dryness. It was acute for at least 8 weeks; dry mouth/strange reaction with her mouth. It started off very dry and gradually got worse/dryness. It was acute for at least 8 weeks; alterations in tongue texture/tongue changed, she had smooth areas on her tongue; feelings that her throat was closing up; difficulty swallowing; hard to eat/difficulty swallowing and eating; Her tongue and throat were swelling; Her tongue and throat were swelling/tongue was swelling; sore tender spot at the base of the neck.; loose some sleep; This is a spontaneous report from contactable consumer (patient) received from Pfizer Sponsored program. This report is related to a study or programme. A 61-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, lot number: EWO171, NDC: unknown, Expiry: unknown) via an unspecified route of administration administered in arm right (aslo reported as right shoulder) on 12May2021 as dose 2, single for COVID-19 immunization. The patient's medical history included major surgery with hip replacement on unspecified date (reported as the year before). She would say she wasn't feeling well on unspecified date reported as around Christmas, but she was recovering from major surgery. Patient was treated as Xerostomia which is dry mouth from unspecified date. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, lot number: ER8735, NDC: unknown and expiration date: unknown) via an unspecified route of administration administered in right shoulder on 20Ap2021 (at the age of 61 years old) for COVID-19 immunization; previously received INFLUENZA (flu shot) for immunisation and experienced flu like symptoms; previously took ibuprofen ("the year prior to this happening she had been taking a lot of Ibuprofen"; she can't say that she has the ibuprofen from a year ago because she had taken so much of it. She had to stop taking it towards the surgery because she was tired of taking it); naproxen (stated "which was another anti-inflammatory") and experienced dry throat (the summer of 2019), reported she stopped taking it and stated it was not near this condition, further stated it was just a dry mouth and as soon as she stopped taking it, it went away. Prior vaccinations: One time she got flu like symptoms after a flu shot, but that is it as far as vaccines. As far as medicines she was wary because she has had some reactions. Usually she is not as wary with vaccines. She had long term illness after taking some medications in the past so she was careful with what she takes. She was weary of new medication. Patient clarified it was something that happened in 1990's and the medication was metronidazole. It was a neurological thing. She had tingling flu like symptoms, muscle cramps, and intense feeling of being unwell. It lasted 6 months. She still has information for the metronidazole because of the reaction and she didn't want to be prescribed it again. She clarified the metronidazole was METROGEL for bacterial vaginosis. Strength: gel .75, expired in 1997 or 1998, Lot: stated that when she opened the tab there is the number P0017795, NDC: she doesn't see that on the package, Manufacturer: Curatek. The patient experienced chills, nausea, she had a lot of oral issues as well, she had a lot of oral issues, she can't even open her mouth and she did not feel well due to COVID vaccine on an unspecified date. It was reported that, patient received both doses of the COVID vaccine, and that was around 'May'. Patient had her second Pfizer shot on 16th, Monday for the COVID-19 and she had the usual chills and nausea within the 24 hours after the second dose that came and went, both of it, she got over it but, then three four days after getting second dose she had a lot of oral issues, she couldn't even open her mouth and she did not feel well due to Covid vaccine. She was concerned about this because it lasted about 8-9 weeks and she was trying to figure it out. Patient just wanted to understand whether if she should go ahead and might have the booster and wanted to know if this was something, she should try different brand or maybe that didn't suit her. As of 26Aug2021, the patient wanted to know if she should get the booster if offered to her given her possible side effects. She was nervous about having oral side effects recur. It was stated that the patient received two doses of the Pfizer COVID vaccine. Four days after receiving the second vaccine dose she developed dry mouth, burning pain in her mouth, alterations in tongue texture, feelings that her throat was closing up and difficulty swallowing and eating. She wanted to know if those things were reported with the vaccine. She also stated that on the day of receiving the second vaccine, she experienced severe nausea and chills. She stated that she was still experiencing dry mouth though it's lessened in severity. Her doctors have no idea what was causing her issues and tried treating it as a yeast infection and prescribed magic mouthwash, but it made things worse. Also stated that she was recovering from surgery when she received the vaccine. It was asked if it would make sense to switch to the Moderna vaccine for the third dose and asked if it was mRNA as well. The patient wanted to know if her immunity to the vaccine would be compromised if she became ill in the 2 weeks after receiving the second vaccination. Height was reported as 163 cm or 5 feet, 4 inches. It was stated that a couple of weeks ago she called to report a side effect she had after the second shot. Stated she was not sure if it was the shot or not. Clarified product as Pfizer COVID shot, it was after the second one. She spoke to someone initially and then was put through to someone else and she couldn't hear, she rescheduled the phone conversation and didn't hear back. When she called before, she was going through the details of what happened. Weight was about 150 pounds. She was asking questions because she was going to have the booster shot with her age. She was not saying it was a side effect but it did happen 4 days after. She was looking for that kind of information. Further reported that what she experienced was a strange reaction with her mouth. It started off very dry and gradually got worse. It was like someone switched the saliva switch off. Her tongue changed, she had smooth areas on her tongue. It was hard to eat properly. Her mouth was burning. It got worse and worse and lasted 9 to 10 weeks. She dealt with the dryness. It was mostly dryness. It was acute for at least 8 weeks. She would eat only things like cucumbers, things that were easy. Her tongue and throat were swelling. She had 6 visits to doctor, ENT, and dentist; stated that everyone shrugs their shoulders when she asked. Date of adverse event was reported as around 16May2021. One other thing she experienced was a sore tender spot at the base of the neck on unspecified date in May2021 (started a week after her symptoms started) and went away after a week (unspecified date in 2021). It wasn't something she could see visually, it was just tender. She had COVID test once after the initial reaction. The COVID test was a month after the fact. Nobody mentioned testing for COVID. A month in the patient requested it, and it was negative. It was reported that patient went to dentist. The patient did a yeast test and bacteria test when she went in for COVID-19 Virus test, stated they did it all. All of these tests were done in Jun2021. Mentioned that no additional vaccines administered on same date of the Pfizer suspect. AE(s) did not require a visit to the Emergency Room, at a certain point she wanted to go because the tongue was swelling, but it was so far into the symptoms and she had gone to the doctor and the doctor wasn't concerned about it being life threatening. She waited for it to pass, but she did loose some sleep on unspecified date in 2021.; AE(s) did require a visit to Physician Office, she went to the doctor, ENT, and dentist. Prior Vaccinations (within 4 weeks) was not provided. It was stated that she has to go overseas for a few months and will be out of the country until January. She will be leaving in about a month. That is one of the reason she wanted information. That will be at her eight months. She was not sure if she should get the vaccine over there and stated that "if that happened she would want to be here". Patient asked questions because she was going to have the booster shot with her age. She was not saying it was a side effect but it did happen 4 days after. She was looking for that kind of information. The outcome of the event sore tender spot at the base of the neck was recovered on unspecified date in 2021 while unknown for the other events.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (26Aug2021): New information from the same contactable consumer (patient) includes: Case was upgraded to serious. Patient's details (birthdate, age, height and weight), medical history and past medications, lab data, vaccination details (dose 1 and dose 2 regimen), reaction details ("mouth was burning/burning pain in her mouth", "dry mouth/strange reaction with her mouth. It started off very dry and gradually got worse/dryness. It was acute for at least 8 weeks", "hard to eat/difficulty swallowing and eating", "Her tongue and throat were swelling", "sore tender spot at the base of the neck", "alterations in tongue texture/tongue changed, she had smooth areas on her tongue", "feelings that her throat was closing up", "difficulty swallowing", "It was like someone switched the saliva switch off", "yeast infection", "loose some sleep" were added as events) and clinical course details.