Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Blisters; Fever; Muscle pain; not able to stand up from the back; it harmed her system and she wondered if the vaccine altered her immune system; diarrhea; she was not tolerating insulin anymore; she was swelling; her belly was growing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 04Jan2022 as dose 3 (booster), single (Lot number: FL3209) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "diabetes" (ongoing), notes: diabetic and had been taking her medications and injecting insulin, without issues; "Raynaud disease" (unspecified if ongoing); "cancer" (ongoing), notes: she has been on the cancer medication for 4 years; "Gluten allergy" (unspecified if ongoing), notes: She got tested because she's allergic to Gluten. Concomitant medication(s) included: AROMASIN taken for neoplasm malignant. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for COVID-19 immunization, reaction(s): "Pyrexia", "Vaccination site discomfort", "Vaccination site pain"; Bnt162b2 (DOSE 2, SINGLE), administration date: 2021, for COVID-19 immunization, reaction(s): "Pyrexia", "Injection site discomfort". The following information was reported: BLISTER (medically significant), outcome "not recovered", described as "Blisters"; PYREXIA (medically significant), outcome "not recovered", described as "Fever"; MYALGIA (medically significant), outcome "not recovered", described as "Muscle pain"; DYSSTASIA (medically significant), outcome "not recovered", described as "not able to stand up from the back"; IMMUNE SYSTEM DISORDER (medically significant), outcome "not recovered", described as "it harmed her system and she wondered if the vaccine altered her immune system"; DIARRHOEA (medically significant), outcome "not recovered", described as "diarrhea"; INSULIN RESISTANCE (non-serious), outcome "unknown", described as "she was not tolerating insulin anymore"; SWELLING (non-serious), outcome "unknown", described as "she was swelling"; ABDOMINAL DISTENSION (non-serious), outcome "unknown", described as "her belly was growing". The events "blisters", "fever", "muscle pain", "not able to stand up from the back", "it harmed her system and she wondered if the vaccine altered her immune system", "diarrhea", "she was not tolerating insulin anymore", "she was swelling" and "her belly was growing" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Biopsy: (2022) Unknown results; Influenza virus test: (2022) Unknown results; Monkeypox: (2022) Unknown results; SARS-CoV-2 test: (Dec2021) Negative, notes: In Dec2021, she had all the symptoms of COVID- 19 but she tested negative for COVID-19 with the test kits that she purchased; (2022) Unknown results. Therapeutic measures were taken as a result of blister, pyrexia, myalgia, dysstasia, immune system disorder, diarrhoea.  Clinical course: Patient called about booster shot for the covid 19 vaccine. She received the first and second doses in 2021. The booster shot was received on 04Jan2022, when taking care of a relative and they were offering vaccines to older people. She was informed she had to take care of her family that was older. She decided to take a covid test at home and knew how to do it. When she went to (Withheld), the results were negative. This was 24 or 48 hours traveling. Before going to take care of her brother, she decided to take the booster shot in 2022. Since her brother was getting surgery, decided to get the vaccine. After receiving the booster dose, patient was bedridden for three days. It seemed like she had covid. Got blisters, fever, muscle pain and not able to stand up from the back. Her brother just continued his normal life and recovered very well. In her case, she has been dragging this situation since January. Visited her primary care doctor since she was getting worse and she decided to do a biopsy. She heard that when receiving a vaccine, if there's any allergic or any reaction, it has to be reported to primary care doctor and that's what she did. She has been receiving a cancer treatment for 5 years and it's produced by Pfizer, Aromasin. She never had any type of side effects with Aromasin. She's sure that it's the booster shot. She even went to the emergency room and they tell her there's nothing wrong with her. She's sure it's the third vaccine she received. Confirmed her side effects with the booster dose since started. Patient has lupus, fibromyalgia, diabetes, Raynaud disease, and cancer, she has been on the cancer medication for 4 years with which she only had nausea and headache, she asked her doctor if she could take it at night, and she did so, to avoid those symptoms during the day and be an active person. Pfizer has supplied to her the medication Aromasin exemestane 25 mg tablets, for 4 years, and she has an appointment scheduled for October at the cancer institute. In Dec2021, she had all the symptoms of COVID- 19 but she tested negative for COVID-19 with the test kits that she purchased. She's diabetic and had been taking her medications and injecting insulin, without issues, until the day after she received the booster dose of Pfizer COVID-19 vaccine (lot number FL3209 on 04Jan2022). Since then, she stated that she fell in bed, and she still has symptoms to this day 11Aug2022, the booster messed up her life, it's still the same, it harmed her system and she wondered if the vaccine altered her immune system. The same booster dose was given to her and her brother, on the same day in the same place, the same injection from the same nurse. Since they were vaccinated, she stated that she fell in bed along with her brother. They were in bed for 4 days, they woke up to go to the bathroom because they had diarrhea, they had fever. Her brother got up and continued to do his daily life, with his back condition, but he was able to get up and she was not. His brother had surgery on his spine, he was merged from L1 to sacral S1, S2, S3, S4, he has screws and cannot bend, he does not like to take medicines so the doctor gave him the option to use medical cannabis. Patient made an appointment with her brother's doctor to get medical cannabis and that was what got her out of bed. Patient went to her doctor in February, gave her some medications to put on and if she didn't get better, she had to come back for a biopsy. Her primary care physician sent her to the endocrinologist to check that it's not a reaction to her other diabetes medications. She went to her internist and endocrinologist because her body was reacting differently, she was not tolerating insulin anymore, she was swelling, and her belly was growing. She got tested because she's allergic to Gluten. She was taken off the Insulin and she followed instructions, she continued taking the other two diabetes medications. She was taken off the Insulin because the medical plan originally did not want to pay for the insulin recommended by her endocrinologist due to high cost and they gave her another insulin alternative which was less expensive, but her endocrinologist did not want to use that, however, patient accepted it and she had been injecting that insulin for almost a year, until it caused her a reaction and they took her off that insulin. She has an appointment with her endocrinologist on 16Aug2022. She went to the emergency room in July because she continued to have symptoms and got filled with blisters. In July, they told her she had nothing. Before going to the emergency room, she had gone to her primary care physician who tested her for COVID, Influenza, and the Monkeypox because she had blisters, her primary care physician ordered to do a biopsy for that.