Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Overdose, Pancreatic islets hyperplasia, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: Numb in her neck, shoulder; having a stroke; Hyperthyroidism; Sweats; Increased heart rate in the 140's; Shortness of breath; Dizziness; Chest pain; Hyperthyroid/thyroiditis; Capillaries burst (abdomen/chest); Her thyroid count was 0.1; get really sick; I felt hot; skin started peeling in certain areas; Thyroid islets; have a thyroid nodule; it was benign; Difficulty walking/unable to walk without sitting; Slept from around 8 that night until around 2pm the following day; Feverish; basically I overdosed on the first dose; Numb in her neck, shoulder and head; Numb in her neck; Diarrhea; I could not sleep; Spine ("bone") hurting from the cervical area to her tailbone; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (COMIRNATY), administration date 07May2021 (Lot number: EW0173) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pneumonia" (unspecified if ongoing), notes: Verbatim: she was in 3rd grade she was admitted to the hospital for Pneumonia.; "Antibiotic" (unspecified if ongoing), notes: Verbatim: Antibiotics cause her to experience palpitations and chest pain; "Palpitations" (unspecified if ongoing), notes: Verbatim: Antibiotics cause her to experience palpitations and chest pain; "Chest pain" (unspecified if ongoing), notes: Verbatim: Antibiotics cause her to experience palpitations and chest pain; "Goitre" (unspecified if ongoing), notes: Verbatim: She had a partial thyroidectomy at age 17 due to Goitre per caller., then I had part of my thyroid removed when I was 17 due to a goiter; "Stomach issues like IBF" (unspecified if ongoing), notes: I had a few Stomach issues like IBF off and on.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient took concomitant medications. The following information was reported: CEREBROVASCULAR ACCIDENT (Medically significant), outcome "recovered", described as "having a stroke"; HYPERTHYROIDISM (Medically significant), outcome "recovering", described as "Hyperthyroidism"; OVERDOSE (non-serious) with onset 07May2021, outcome "unknown", described as "basically I overdosed on the first dose"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "Numb in her neck, shoulder"; HYPOAESTHESIA (non-serious) with onset 07May2021, outcome "recovering", described as "Numb in her neck, shoulder and head"; HYPOAESTHESIA (non-serious) with onset 07May2021, outcome "recovering", described as "Numb in her neck"; DIARRHOEA (non-serious) with onset 07May2021, outcome "recovering", described as "Diarrhea"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "Sweats"; PYREXIA (non-serious) with onset 07May2021 20:00, outcome "recovering", described as "Feverish"; GAIT DISTURBANCE (non-serious), outcome "recovering", described as "Difficulty walking/unable to walk without sitting"; HYPERSOMNIA (non-serious) with onset 07May2021 20:00, outcome "unknown", described as "Slept from around 8 that night until around 2pm the following day"; SPINAL PAIN (non-serious) with onset May2021, outcome "recovering", described as "Spine ("bone") hurting from the cervical area to her tailbone"; HEART RATE INCREASED (non-serious), outcome "recovering", described as "Increased heart rate in the 140's"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; CHEST PAIN (non-serious), outcome "unknown", described as "Chest pain"; THYROIDITIS (non-serious), outcome "unknown", described as "Hyperthyroid/thyroiditis"; CAPILLARY FRAGILITY (non-serious), outcome "recovering", described as "Capillaries burst (abdomen/chest)"; THYROID DISORDER (non-serious), outcome "recovering", described as "Her thyroid count was 0.1"; INSOMNIA (non-serious) with onset May2021, outcome "recovering", described as "I could not sleep"; ILLNESS (non-serious), outcome "recovering", described as "get really sick"; FEELING HOT (non-serious), outcome "recovering", described as "I felt hot"; SKIN EXFOLIATION (non-serious), outcome "recovering", described as "skin started peeling in certain areas"; PANCREATIC ISLETS HYPERPLASIA (non-serious), outcome "recovering", described as "Thyroid islets"; THYROID MASS (non-serious), outcome "recovering", described as "have a thyroid nodule; it was benign". The patient underwent the following laboratory tests and procedures: heart rate increased: 140's, notes: Increased heart rate in the 140's; investigation: unknown results; sars-cov-2 antibody test: negative; thyroid function test: normal, notes: Labs including thyroid and all labs where normal; 0.1, notes: Thyroid count was 0.1. Therapeutic measures were not taken as a result of cerebrovascular accident, hyperthyroidism, hypoaesthesia, hypoaesthesia, diarrhoea, pyrexia, hypersomnia, spinal pain, heart rate increased, capillary fragility, thyroid disorder, insomnia, illness, feeling hot, skin exfoliation, pancreatic islets hyperplasia, thyroid mass. She is scared if she takes the second vaccine she may "die." About 30 minutes after receiving the vaccine she felt ("like a lidocaine injection") for about 30 minutes. Later she experienced the following day. Two days later she was walking around at work and had. She has also experienced, unable to walk without sitting, and skin peeling (when she bumped into something it was like an "abrasion" then would peel. After the vaccine when seeing the Endocrinologist. She had a. She has also been seen by Cardiologist. She is very concerned about her job while she is also afraid of taking a complete dose of the second vaccine. she mentioned that she have a genetic disorder or something like she only had a one enzyme 'this metabolic it is an detox' metabolize medication (Further clarification unknown). So she reported that she got sick after getting the first dose for the Pfizer BioNTech COVID 19 Vaccine. Because before she was running like 6 miles, 13, hiking done all that stuff and when she get the vaccine she could barely walk a mile on the street without feeling like she was going to passed out and she kept having 'sleeping pills'. Prior vaccination (within 4 weeks) was none. Stated, "About 30 minutes after she got shot it was weird because my neck and my head become completely numb and she had already left because they only want me to wait 20 minutes and she was already driving and she was stuck in traffic and  though great. She had a stroke (Further clarification unknown hence event captured as per verbatim) but that subsided after 30 minutes that went away but she felt that was weird because basically it felt like when you go to dentist and someone gives you a lidocaine shot in your mouth and your mouth becomes numb because they are about to do dental work (General statement). Basically that what it felts like the numbness and then she got home and she had severe diarrhea and basically it was about 8 pm she went to sleep and she felt feverish. she went to sleep and she did not wake up until the day till 2 pm and then her spinal cord hurts not back like when she have flu like symptoms but actually her bones, spinal cord and had a hard time walking and then actually she felt better for about two days and then all of sudden she could not sleep. she felt sick and hot. she was walking around at work her heartrate bump into 140 thought she was going to pass out so it ended up because all she had is 'half of' thyroid (Further clarification unknown) so, basically it put her in hyperthyroidism. thyroid level went to like 0.1 and so basically and then when she went in hyperthyroidism and then her thyroid gland was swollen too so they diagnosed her with hyperthyroidism and the Thyroid islets but they did not give me any medicine they said it is not doing good (Further clarification unknown). She had to wait till vaccine gets out of my body so basically she was not in hyperthyroidism more which is wonderful because that was miserable but she stayed in it for about 6 weeks but her skin started peeling in certain areas. she had capillaries that burst. Once again this is due to me not metabolizing medication the way rest of the planet does.  only had one enzyme to metabolize with where everybody else had 'two'." Further stated, "Like she told it is me it is not the vaccine. It is the way she metabolize the medication. That is why she want to talk to someone to figure out if her one dose it is considered a full dose because basically she overdosed on the first dose (Further clarification unknown hence event captured as per verbatim)." Medical condition: Stated, "No she did not take any medicine and actually (Incomplete Sentence). So basically the only thing that she had a few Stomach issues like IBF off and on (Further not clarified) and then had part of her thyroid removed when I was 17 due to a goiter and then I have now. She had a thyroid nodule that had that they have looked at but they tested it and then it was benign and she had certainly went to get all my lab 'storm' before she got the vaccine. All of her lab reports were normal because she had to get her yearly thyroid check so, was normal.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of Cerebrovascular accident and Hyperthyroidism. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.