Received Oct 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
my alpha gal numbers were up a little bit; Her mouth broke out in blisters, bleeding, gums are swollen.; mouth broke out with blisters; got little split places on my tongue my gums are swollen, my lips are swollen and the corners of mouth is splitting it's getting worse instead of getting better; got little split places on my tongue my gums are swollen, my lips are swollen and the corners of mouth is splitting it's getting worse instead of getting better; got little split places on my tongue my gums are swollen, my lips are swollen & corners of mouth is splitting it's getting worse instead of getting better / has like cracks inside her lips; Her tongue is all swollen; her lips felt like they were on fire, all red and swollen; Gums are starting to get abscesses on them; it was getting a lot worse; got little split places on my tongue my gums are swollen, my lips are swollen and the corners of mouth is splitting it's getting worse instead of getting better; She is having trouble speaking clearly and eating / wasn't really eating anything; She is having trouble speaking clearly and eating; sore; covid; her lips felt like they were on fire, all red and swollen / anything i put in my mouth like food burns in my mouth; it's getting worse instead of getting better/the mouth progressively getting worse/It's worse, not better; This is a spontaneous report and received from Consumer or other non HCPs from medical information team. An 84-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 23Sep2025 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 84 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "I had covid" (unspecified if ongoing), notes: before vaccine, but getting the vaccine she was fine. she was sick 3-4 weeks; "alpha gal numbers", start date: 2021 (ongoing), notes: just got tested again & alpha gal numbers were up a little bit from last year; "aortic dissection", start date: 2014 (unspecified if ongoing), notes: and I was in the ICU for 3 weeks; "blood pressure" (unspecified if ongoing); "shoulder replacement", start date: 17Apr2025 (unspecified if ongoing), notes: Replaced left shoulder & was doing PT 2 days after surgery & it reverse shoulder went wonderful.; "Osteoporosis" (ongoing), notes: supposed to start 2 shots once a month for a year to slow it down; "mouth broke out", start date: 2022 (unspecified if ongoing); "tick bite", start date: 2022 (unspecified if ongoing); "She had breast cancer" (unspecified if ongoing), notes: she had to recover from the radiation. She didn't do chemo; "radiation" (unspecified if ongoing), notes: and it was to the radiation all over upper body, she was in agony; "she was in agony" (unspecified if ongoing), notes: and it was to the radiation all over upper body, she was in agony; "allergies are environmental" (unspecified if ongoing), notes: gives her the runs; "Allergies: gluten" (unspecified if ongoing), notes: gives her the runs; "gives her the runs" (unspecified if ongoing); "ICU", start date: 2014 (unspecified if ongoing), notes: for 3 weeks. Concomitant medication(s) included: LOSARTAN taken for blood pressure measurement, start date: 2014; HYDRALAZINE; NEBIVOLOL; DOXAZOSIN; LEVOTHYROXINE; VITAMIN D3 (ongoing); VITAMIN B12 [VITAMIN B12 NOS] (ongoing). The patient also took other concomitant therapy. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer, got it every year), for Covid-19 immunization; Flu shot, for Covid-19 immunization. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 2025, outcome "unknown", described as "it's getting worse instead of getting better/the mouth progressively getting worse/It's worse, not better"; SPEECH DISORDER (non-serious) with onset 25Sep2025, outcome "not recovered", described as "She is having trouble speaking clearly and eating"; EATING DISORDER (non-serious) with onset 25Sep2025, outcome "not recovered", described as "She is having trouble speaking clearly and eating / wasn't really eating anything"; COVID-19 (non-serious) with onset 25Sep2025, outcome "recovering", described as "covid"; ORAL DISCOMFORT (non-serious) with onset 25Sep2025, outcome "unknown", described as "her lips felt like they were on fire, all red and swollen / anything i put in my mouth like food burns in my mouth"; PAIN (non-serious) with onset 25Sep2025, outcome "unknown", described as "sore"; GINGIVAL ABSCESS (non-serious) with onset 27Sep2025, outcome "not recovered", described as "Gums are starting to get abscesses on them; it was getting a lot worse"; MOUTH HAEMORRHAGE (non-serious) with onset 27Sep2025, outcome "not recovered", described as "Her mouth broke out in blisters, bleeding, gums are swollen."; SWOLLEN TONGUE (non-serious) with onset 27Sep2025, outcome "not recovered", described as "Her tongue is all swollen"; CHAPPED LIPS (non-serious) with onset 27Sep2025, outcome "not recovered", described as "got little split places on my tongue my gums are swollen, my lips are swollen & corners of mouth is splitting it's getting worse instead of getting better / has like cracks inside her lips"; TONGUE DISORDER (non-serious), GINGIVAL SWELLING (non-serious), LIP SWELLING (non-serious) all with onset 27Sep2025, outcome "not recovered" and all described as "got little split places on my tongue my gums are swollen, my lips are swollen and the corners of mouth is splitting it's getting worse instead of getting better"; LIP ERYTHEMA (non-serious) with onset 27Sep2025, outcome "not recovered", described as "her lips felt like they were on fire, all red and swollen"; ORAL MUCOSAL BLISTERING (non-serious) with onset 27Sep2025, outcome "not recovered", described as "mouth broke out with blisters"; FOOD ALLERGY (non-serious) with onset Oct2025, outcome "unknown", described as "my alpha gal numbers were up a little bit". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter stated, she took it on 23Sep2025 and she had a bad, she has taken it ever since it came out and she never had a reaction to it, she had covid before the vaccine, but getting the vaccine she has been fine, she never had a reaction or anything else but this time when she took it, she was, the next morning she took it in the afternoon, but the next morning she had it about lunch time she guess or something like that, on 25Sep2025, she cannot get out of bed she was sick, she was sore, she got covid, and from it, that was fine, a few days later she was okay by the middle of the week she was okay but then her mouth broke out with blisters and she got little split places on her tongue her gums are swollen, her lips are swollen and the corners of mouth was splitting it was getting worse instead of getting better, that started when she was still feeling kind of sick covid the next Saturday, she think it was a Thursday when she got the vaccine but she started feeling better from the feeling she had covid, the mouth progressively getting worse, she called her allergist, first she called the pharmacist and she said this was probably a reaction, they had this type of reaction from it, but she figured this will go away but it was getting worse instead of going away and we're into Oct2025 now anything she put in her mouth like food burns in her mouth, it was terrible so she thought, well then she also called her allergist because she just got tested again and her alpha gal numbers were up a little bit from last year, so she ended up in the emergency room 4 years ago because of alpha gal. So, the mouth was getting worse instead of getting better, so she just wondering, her allergist said we don't know what was in it that patient was allergic to. So, she decided to call to see what she can do or what was going on, she gets it every year and she never had a reaction to it at all, this year her arm didn't even hurt. She has been getting this so long and did not bother her, finally something she can tolerate. Confirmed inquiry, if after taking the vaccine she had problems with her mouth, reporter confirmed. Reporter added, she had something similar to this years ago when she developed, she has been taking losartan, she had aortic dissection in 2014 and she was in the ICU for 3 weeks Covid shots, she has been taking blood pressure medications since then, she developed after many years same thing that was going on now to the losartan that she was taking for a number of years that's not how you get allergic to this things right away so she stopped that and they put her in a different blood pressure medication and that went away but this was not going away this time so she was not sure. All the pharmacy all the you know called the companies there was nothing in the things she taking in. On 23Sep2025, she got the Pfizer Covid vaccine. She has been getting Pfizer ever since they came out. She had Covid before the vaccine came out and she did ok, she was sick 3-4 weeks. She was 84 years old now. On 23Sep2025, she got the vaccine. She had to hold off getting it, it was due in Jul or Aug2025, but she had shoulder replacement, and the surgeon told her to wait. Never really had a reaction, maybe sore spot on the arm but not even as bad as a flu shot just you know you had it. It never bothered her. States with this she couldn't get out of bed for 2 days. After 5 days that was gone. Her mouth broke out in blisters, bleeding, gums are swollen. It was worse, not better. Her pharmacist said probably a reaction to the vaccine. There was nothing else new she has done that can cause this. She talked to her allergist because she has allergies. He said there was no real way to test something new in vaccine. She was having trouble speaking clearly and eating, it was not getting better. She can't trace this to anything else but the vaccine at this point. She was worried because she wants to get it, it was important. She has been getting it every year and never had a reaction; she was kind of concerned. Wants it to go away but doesn't seem to be getting better. She has pretty bad Osteoporosis and was supposed to start 2 shots once a month for a year to slow it down, but she was scared to start that. She has alpha gal and that number went up this year. This was from tick bite 5 years ago. She has been very, very careful. If it has any mammal in it that could be what was going on. Clarifies she has like cracks inside her lips and when she opens her mouth wide the corners are splitting. Her tongue was all swollen and has little cracks in it. Her gums are swollen. Started feeling sick immediately that night, she got the vaccine in the afternoon. For the gum thing she thinks she was so sick she wasn't really eating anything. States it was not the next day but the next day after that, 25Sep2025. States it started with tongue swelling and the inside of her lips felt like they were on fire, all red and swollen. Her coffee has to be cold because it hurts. Gums are starting to get abscesses on them; it was getting a lot worse. She has a paper from (withheld). It says Pfizer Covid vaccine 2025/2026 0.3ml Liquid. White. Does not see lot or expiry. She called her allergist and was told it was so new there was no way to test what would be in it to see if she might be allergic to that with all her allergies. Doesn't know if what was in it was different. States she didn't even feel the shot at all, there was no pain in her arm at all. States she gets it every year, she started in Sep. Does not have dates of previous vaccine to provide. Does not have NDC, lot or expiry to provide for previous vaccines. She was hoping this doesn't prevent her getting this in the future. Shoulder replacement was 17Apr2025. Concomitant Medication: States she was taking blood pressure medication since 2014 after the aortic dissection. Hydralazine 10mg tablet 3 times a day has been taking for a long time. Nebivolol 10mg twice a day for a few years. Doxazosin 1mg twice a day for a few years. Levothyroxine she has taking many years a low dose that has never changed. Taking since menopause. She developed an allergy similar to this when she was taking Losartan for years since her episode and guesses it's been 3 years ago all of a sudden, her mouth broke out like this and turned out to be Losartan and another medication she was taking. She doesn't recall the name of it. Manufacturer and lot unknown. She got the tick bite around the same time. They had to change her blood pressure medications. With 1st shoulder replacement she had a bad reaction. She had breast cancer, and it was to the radiation all over upper body, she was in agony. They delayed her first should surgery back like 3 years ago. Her left shoulder. They discovered breast cancer, and she had to recover from the radiation. She didn't do chemo. Replaced her left shoulder and was doing PT 2 days after surgery and it was a reverse shoulder that went wonderful. This shoulder because the osteoporosis was worse didn't go as smoothly because the osteoporosis was worse. She broke out from the antiseptic they paint your shoulder with and the tape. She was a bloody mess there and had to keep it on for a few weeks. When her mouth broke out after the pharmacist said they were pretty sure it was a reaction to the Covid vaccine because they are getting more of those with this vaccine. The allergist said her alpha gal number was up. If there was any mammal in the covid vaccine that could be what was going on. Has to find out so she knows. Takes Vitamin D3 and Vitamin B12 and are all vegan and she has been taking for years. Most of her allergies are environmental, and gluten issue gives her the runs. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
Alpha-gal allergy (just got tested again & alpha gal numbers were up a little bit from last year); Osteoporosis (supposed to start 2 shots once a month for a year to slow it down)
Medical History/Concurrent Conditions: Aortic dissection (and I was in the ICU for 3 weeks); Blood pressure; Breast cancer female (she had to recover from the radiation. She didn't do chemo); COVID-19 (before vaccine, but getting the vaccine she was fine. she was sick 3-4 weeks); Diarrhea; Environmental allergy (gives her the runs); Gluten intolerance (gives her the runs); Hospitalization (for 3 weeks); Mouth broke out; Pain (and it was to the radiation all over upper body, she was in agony); Radiation therapy (and it was to the radiation all over upper body, she was in agony); Shoulder replacement (Replaced left shoulder & was doing PT 2 days after surgery & it reverse shoulder went wonderful.); Tick bite
LOSARTAN; HYDRALAZINE; NEBIVOLOL; DOXAZOSIN; LEVOTHYROXINE; VITAMIN D3; VITAMIN B12 [VITAMIN B12 NOS]
Test Date: 2024; Test Name: alpha gal numbers; Result Unstructured Data: Test Result:Unknown results; Test Date: 202510; Test Name: alpha gal numbers; Result Unstructured Data: Test Result:numbers were up a little bit; Comments: She just got tested again and her alpha gal numbers were up a little bit from last year