Age: 70.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Malaise, Mouth swelling, Musculoskeletal discomfort, Myocardial infarction, Product use issue
Clinical narrative: Booster dose; She had a flu shot given at the same time; Pressure in the neck area very close to the Eustachian tube in the top of the mouth; Hasn't seen a well day since.; He touch the roof of her mouth and said it was swollen; Everything was fine except the BUN.; Have a heart attack.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Oct2021 (Lot number: FF8839) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 07Oct2021 (Batch/Lot number: unknown) for immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing), notes: she has been a diabetic for about 20 years. It isn't great or well controlled. Her A1C was 7.2 from Jul or Aug2021; "asthma" (unspecified if ongoing). Concomitant medication(s) included: NASONEX taken for asthma; FLONASE [FLUTICASONE PROPIONATE]. Past drug history included: Allergic to factin, reaction(s): "allergic to Factin", notes: She is not sure if there would be something in there, but with those reactions she had a physical form and a big break out. That was 10 to 15 years ago. Caller doesn't have NDC, lot, and expiry. One was given in the doctor's office with IV; Allergic to boniva, reaction(s): "muscle aches", notes: Caller states she had a reaction to the Boniva over 20 years ago.; Allergic to boniva, reaction(s): "she couldn't even walk without holding on to stuff throughout the house", notes: she couldn't even walk without holding on to stuff throughout the house; Allergic to boniva, reaction(s): "she had a fine rash on both arms", notes: Caller states she had a reaction to the Boniva over 20 years ago. Vaccination history included: Bnt162b2 (First dose, lot: EL9261), administration date: 22Jan2021, when the patient was 69 years old, for COVID-19 immunization; Bnt162b2 (Second dose, Lot: EN6201), administration date: 12Feb2021, when the patient was 70 years old, for COVID-19 immunization, reaction(s): "Her A1C was 7.2 from Jul or Aug2021". The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 2021, outcome "unknown", described as "Have a heart attack."; PRODUCT USE ISSUE (non-serious) with onset 07Oct2021, outcome "unknown", described as "She had a flu shot given at the same time"; IMMUNISATION (serious) with onset 07Oct2021, outcome "unknown", described as "Booster dose"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "Pressure in the neck area very close to the Eustachian tube in the top of the mouth"; MALAISE (non-serious) with onset 2021, outcome "not recovered", described as "Hasn't seen a well day since."; MOUTH SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "He touch the roof of her mouth and said it was swollen"; BLOOD UREA ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "Everything was fine except the BUN.". The events "have a heart attack.", "pressure in the neck area very close to the eustachian tube in the top of the mouth", "hasn't seen a well day since.", "he touch the roof of her mouth and said it was swollen" and "everything was fine except the bun." were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) 7.2; (2021) fine; blood urea: (2021) normal for her bun to be off; electrocardiogram: (2021) definite problem with the heart at the bottom of; (2021) unknown result; stress: (2021) shook his head and said it is possible but not, notes: shook his head and said it is possible but not probable; thyroid function test: (2021) fine. Therapeutic measures were taken as a result of mouth swelling with Amoxicillin. Clinical course: Reporter stated she had experienced pressure in the neck area very close to the Eustachian tube in the top of the mouth and it comes and last three minutes and then it will slowly dissipate and sometimes it will be followed by another episode immediately. She started experiencing the pressure within a week after the booster. It had been all over the place. It rises and builds. She could feel it in the back of the throat. It builds for a while. Sometimes it isn't so bad. It stays there for a while and slowly dissipated. When it first started she timed it and it lasted 3 minutes. She has had some last more. She would have one then another follows it immediately. She had shrunk an inch. Reporter clarified that she shrunk prior to the vaccines. She had been shrinking for years due to age. She had changed an asthma medication to something like Nasonex or something of that nature. She went back on Flonase and didn't think it was related to the vaccine. It started getting worse and worse. She had to get some help. She went to her family doctor and got an EKG. Her doctor said there was a definite problem with the heart at the bottom of it. The symptoms patient was describing are like women when they have a heart attack. Reporter had been to her cardiologist and had a stress test and EKG. At the request of her family doctor patient went back to cardiologist. The cardiologist shook his head and said it was possible but not probable. Reporter was scheduled for another stress test on 02Dec2021. Reporter clarified that she was on Flonase and she was changed to something different, like Nasonex. She was on that for about a week and then went back to Flonase because she was having these symptoms. At first reporter thought it was due to the medication change. Some days it happens every 20 to 30 minuets. She has had three days with nothing happening. She mentioned it to her cardiologist and his nurse. They were not together when she mentioned it and they raised their eyes and said oh. Reporter was not sure if they have had other people come in with it or not. She got the feeling they knew something about the COVID shot. He touch the roof of her mouth and said it was swollen. He felt nodules in there. He gave her antibiotic. Reporter has been on Amoxicillin and it is not helping. Amoxicillin: it is in an amber colored pharmacy vial. 500mg strength. Dose: one capsules by mouth three times a day for 10 days. She started taking it on 19Nov2021. Additional Vaccines administered on same date of the Pfizer Suspect was reported as she had a flu shot given at the same time. The flu shot wasn't in a vial, but it was in a plastic syringe. It was a blue piece where the medication was being stored in the syringe and it broke. Part of the vaccine went running down the arm. They couldn't give her more because that would have been an over dose. Reporter doesn't have the NDC, lot, and expiry for the flu shot. It was given in the right arm which is the same arm the booster shot was given in. No prior Vaccinations (within 4 weeks) was reported. She had a flu shot given at the same time. The flu shot wasn't in a vial, but it was in a plastic syringe. It was a blue piece where the medication was being stored in the syringe and it broke. Part of the vaccine went running down the arm. They couldn't give her more because that would have been an over dose. Reporter didn't have the NDC, lot, and expiry for the flu shot.  No follow-up attempts are needed. No further information is expected. This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Oct2021 (Lot number: FF8839) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 07Oct2021 (Batch/Lot number: unknown) for immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing), notes: she has been a diabetic for about 20 years. It isn't great or well controlled.; "asthma" (unspecified if ongoing). Concomitant medication(s) included: NASONEX taken for asthma; FLONASE [FLUTICASONE PROPIONATE]. Past drug history included: Allergic to factin, reaction(s): "allergic to Factin", notes: She is not sure if there would be something in there, but with those reactions she had a physical form and a big break out. That was 10 to 15 years ago.; Allergic to boniva, reaction(s): "muscle aches", notes: Caller states she had a reaction to the Boniva over 20 years ago.; Allergic to boniva, reaction(s): "she couldn't even walk without holding on to stuff throughout the house", notes: she couldn't even walk without holding on to stuff throughout the house; Allergic to boniva, reaction(s): "she had a fine rash on both arms", notes: Caller states she had a reaction to the Boniva over 20 years ago. Vaccination history included: Bnt162b2 (First dose, lot: EL9261), administration date: 22Jan2021, when the patient was 69 years old, for COVID-19 immunization; Bnt162b2 (Second dose, Lot: EN6201), administration date: 12Feb2021, when the patient was 70 years old, for COVID-19 immunization, reaction(s): "Her A1C was 7.2 from Jul or Aug2021". The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 2021, outcome "unknown", described as "Have a heart attack."; IMMUNISATION (medically significant) with onset 07Oct2021, outcome "unknown", described as "Booster dose"; PRODUCT USE ISSUE (non-serious) with onset 07Oct2021, outcome "unknown", described as "She had a flu shot given at the same time"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "Pressure in the neck area very close to the Eustachian tube in the top of the mouth"; MALAISE (non-serious) with onset 2021, outcome "not recovered", described as "Hasn't seen a well day since."; MOUTH SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "He touch the roof of her mouth and said it was swollen"; BLOOD UREA ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "Everything was fine except the BUN.". The events "have a heart attack.", "pressure in the neck area very close to the eustachian tube in the top of the mouth", "hasn't seen a well day since.", "he touch the roof of her mouth and said it was swollen" and "everything was fine except the bun." were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) 7.2; (2021) fine; blood urea: (2021) normal for her bun to be off; electrocardiogram: (2021) definite problem with the heart at the bottom of; (2021) unknown result; stress: (2021) shook his head and said it is possible but not, notes: shook his head and said it is possible but not probable; thyroid function test: (2021) fine. Therapeutic measures were taken as a result of mouth swelling.