Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: throat was hurting; Cholesterol was a tad off; sugar was a tad off; losing her hair; She has lost 20-30 lbs; her heart is racing very fast; feeling like crud; Couldn't walk; Graves' disease; thyroid was way off; TSH wasn't even reading it was so low; feeling bad; shaking; 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 65-year-old female patient received BNT162b2 (BNT162B2), on 27May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "Just has a reaction to sulfa" (unspecified if ongoing); "Parkinson" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Bactrim, reaction(s): "Just has a reaction to sulfa and Bactrim medications". Vaccination history included: BNT162b2 (Dose: 01, Lot: EN6202), administration date: 23Feb2021, when the patient was 64-year-old, for Covid-19 immunization; BNT162b2 (Dose: 02, Lot: EN6204), administration date: 16Mar2021, when the patient was 64-year-old, for Covid-19 immunization; BNT162b2 (Dose: 03, Lot: FF2593), administration date: 16Dec2021, when the patient was 65-year-old, for Covid-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset Jun2022, outcome "recovering", described as "feeling bad"; TREMOR (non-serious) with onset Jun2022, outcome "recovering", described as "shaking"; GAIT DISTURBANCE (non-serious) with onset Jul2022, outcome "recovering", described as "Couldn't walk"; BASEDOW'S DISEASE (medically significant) with onset Jul2022, outcome "recovering", described as "Graves' disease"; BLOOD THYROID STIMULATING HORMONE DECREASED (non-serious) with onset Jul2022, outcome "recovering", described as "TSH wasn't even reading it was so low"; FEELING ABNORMAL (non-serious) with onset Jul2022, outcome "recovering", described as "feeling like crud"; HYPOTHYROIDISM (medically significant) with onset Jul2022, outcome "recovering", described as "thyroid was way off"; OROPHARYNGEAL PAIN (non-serious), outcome "recovering", described as "throat was hurting"; BLOOD CHOLESTEROL DECREASED (non-serious), outcome "recovering", described as "Cholesterol was a tad off"; BLOOD GLUCOSE DECREASED (non-serious), outcome "recovering", described as "sugar was a tad off"; ALOPECIA (non-serious), outcome "recovering", described as "losing her hair"; WEIGHT DECREASED (non-serious), outcome "recovering", described as "She has lost 20-30 lbs"; HEART RATE INCREASED (non-serious), outcome "recovering", described as "her heart is racing very fast". The event "her heart is racing very fast" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood cholesterol: (13Apr2022) was a tad, notes: was a tad off and sugar was a tad off, but not a lot; Blood thyroid stimulating hormone: (unspecified date) TSH is still off the, notes: TSH is still off the charts at 0.005 and some of her levels are coming around a little bit now; (13Apr2022) her levels were perfect, notes: her levels were perfect and her thyroid was okay; (Jul2022) Low, notes: it was so low; Food craving: (13Apr2022) tad off, notes: was a tad off and sugar was a tad off, but not a lot; Heart rate: (unspecified date) 142-143, notes: heart rate was 142-143; Weight decreased: (unspecified date) She has lost 20-30 lbs. Therapeutic measures were taken as a result of basedow's disease, hypothyroidism, heart rate increased.  Clinical Information:  Patient went to get lab work on 13Apr2022 and all her levels were perfect and her thyroid was okay. Cholesterol was a tad off and sugar was a tad off, but not a lot. Took the booster dose and by Jun2022 she was feeling bad, shaking, thought Patient had Parkinson. It was going to be her bday in Jul, and she was feeling like crud. Couldn't walk, had to have a friend help her. Made an appointment with her doctor and she ran a bunch of tests in Jul2022 and found her thyroid was way off. Her TSH wasn't even reading it was so low. Didn't understand what was causing that. Three months ago, her levels were fine. Took all these tests and has been seeing endocrinoglist for about a month and endocrinoglist diagnosed her with graves disease. Cant figure out how she got it because everything was good in April. Takes methimazole now and is feeling better. TSH is still off the charts at 0.005 and some of her levels are coming around a little bit now, but still the TSH wasn't even at 1. Calling because she was nervous to take the Covid booster shot with the medication she is one now. Wanted to make sure there weren't going to be any side effects or reactions because of the methimazole she is on. She has no idea that thyroid issues could be a side effect of the vaccine. She has had a total of 4 vaccines now. Doctor was floored. Thought she had Parkinson. She was going to be 66 and other than car accidents, has been pretty healthy up until this happened. Height: Caller was 5ft 2inches. She's shrunk, but she doesn't know what from. Because, with graves disease her heart is racing very fast and her heart rate was 142-143 when she went to the doctor. The methimazole has bought the heart rate down though. It effects her bones and calcium and everything and her liver. Keeping a close eye on that. She was shocked to hear that she has shrunk. Before she knows it, they'll have to scrape her little body off the ground. She is the same height now that person was. Weight: She has lost 20-30 lbs. She is losing her hair and going crazy. Didn't realize that little butter-fly organ could mess up her whole life. In Jun2022, she started to feel really bad. Doesn't know exactly the date. Called to make an appointment to see (name), the nurse practitioner. Thought she was starting with Parkinson's be-cause her body was shaking, she was having panic attacks, everything worried her, her hair was affected, she would get very hot. It just throws her whole body off tilt. Nurse practitioner looked at her levels and saw it was the thyroid. Prior to this, she had had a little granular thyroid because she had got-ten her thyroid checked because her throat was hurting. Everything was okay with her thyroid then and her levels were great. Never would've thought that it could've been the vaccine. Now, she is leery to get the booster shot tomorrow. Doesn't think its safe for her to take the next booster dose.She wasn't even putting the whole thing together with the vaccine and the Grave's disease.Just takes a Vitamin D supplement. Prior to this, she didn't take medications at all.Just has a reaction to sulfa and Bactrim medications.She was calling because she wanted to know if the composition of the vaccine would interact with the medication she is taking. She doesn't know if the methimazole and the ingredients in the bivalent booster is made out of would react somehow. She didn't know that the thyroid could have been a side effect of the vaccine. The agent said that it could be a side effect of the booster shot. Did have granular thyroid, but her levels have always been fine. Is that something Pfizer has been getting reports about with the thyroid symptoms and the Covid-19 vaccine.Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. She is not a firm believer in vaccines and didn't even want to get her flu shot, but she did get the flu shot at the beginning of this month.AE require visit to: Emergency room: the nurse practitioner wanted to send her to the Emergency room because her heart rate was so high at 142-145. There was a product complaint to report. Description of Product Complaint: Description of complaint: She is leery to get the Covid-19 boost-er shot tomorrow. Doesn't think its safe for her to take the next booster dose due to AE that occurred after most recent COvid-19 booster. A patient is calling about the Pfizer COVID-19 Bivalent Vaccine. She mentioned that she was diagnosed with thyroid and was prescribed with Methimazole 5MG. She wonders if the shot has any side effects or contraindications with methimazole. -Submitted a manual AE form as precautionary since she did not mention if she took the primary series. Before she got her third vaccine, the bivalent. I´m taking 5 mg of Methimazole and I was wondering if there are any side effects that would react with the medications she was taking and the vaccine. She take Methimazole for her thyroid. She took her other two shots (boosters) but she wasn't on this medication, She was diagnosed with Graves disease maybe like four months ago. That was way after she got her vaccines, it´s been a while. She took her last vaccine on 27May2022.