Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Oesophagogastroduodenoscopy, Oral surgery, Palpitations, Reverse tri-iodothyronine increased
Clinical narrative: Like she had a thyroid problem, like hypothyroid/Hypothyroidism/ Lost her hair in the front/ She gained 20lbs/ Heat sensitive / Always been very cold; Felt really tired; The things on her toes have cycles of ballooning out and exploding and bleeding; It literally has caused her broken veins in her legs, now both legs, have broken veins. Has pain in her sternal clavicle; Caused her face to turn red, arms turn red/face gets red, arms get red/Redness; Not feeling well; High elevated reverse T3/ T3 was 25 or 26; Palpitations; She had an oral surgery; Got fluid in her eye; Developed something on her feet/ in Dec got COVID toes/ Mar2022, she had these things on her feet, both second toes and there were big, gel-filled; This is a spontaneous report received from an Other HCP from medical information team.  A 55-year-old female patient received BNT162b2 (BNT162B2), in Jul2021 as dose 2, single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Mmr vaccine, administration date: 2006, for Immunisation; Bnt162b2 (dose 1, single), administration date: Jun2021, when the patient was 53 years old, for COVID-19 immunization, reaction(s): "Vaccine injury". The following information was reported: LIMB INJURY (non-serious) with onset Mar2022, outcome "unknown", described as "Developed something on her feet/ in Dec got COVID toes/ Mar2022, she had these things on her feet, both second toes and there were big, gel-filled"; EYE DISORDER (non-serious) with onset Mar2023, outcome "unknown", described as "Got fluid in her eye"; ORAL SURGERY (medically significant) with onset 27Oct2023, outcome "unknown", described as "She had an oral surgery"; HYPOTHYROIDISM (medically significant), outcome "unknown", described as "Like she had a thyroid problem, like hypothyroid/Hypothyroidism/ Lost her hair in the front/ She gained 20lbs/ Heat sensitive / Always been very cold"; FATIGUE (non-serious), outcome "unknown", described as "Felt really tired"; HAEMORRHAGE (non-serious), outcome "unknown", described as "The things on her toes have cycles of ballooning out and exploding and bleeding"; ANGIOPATHY (non-serious), outcome "unknown", described as "It literally has caused her broken veins in her legs, now both legs, have broken veins. Has pain in her sternal clavicle"; ERYTHEMA (non-serious), outcome "unknown", described as "Caused her face to turn red, arms turn red/face gets red, arms get red/Redness"; MALAISE (non-serious), outcome "unknown", described as "Not feeling well"; REVERSE TRI-IODOTHYRONINE INCREASED (non-serious), outcome "unknown", described as "High elevated reverse T3/ T3 was 25 or 26"; PALPITATIONS (non-serious), outcome "unknown". The event "got fluid in her eye" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: (27Oct2023) Unknow results, notes: She had an oral surgery, it was just a biopsy and it occurred on 27Oct2023; Lab work: (Jun2021) Unknown results, notes: she had lab work done in Jun2021 prior to receiving the vaccine in Jul2021; Lipids: (unspecified date) High, notes: Her lipids were really, abnormally high; Oesophagogastroduodenoscopy: (08Dec2023) Unknown results; SARS-CoV-2 test: (Jul2021) Unknown results, notes: She had a nasal COVID test on 14Jul2021, but does not provide the results of COVID test; Tri-iodothyronine: (unspecified date) 25 or 26, notes: Her T3 was 25 or 26; Weight: (unspecified date) 20 lbs, notes: she gained 20lbs.  Clinical information: Reported as, She had an oral surgery, it was just a biopsy and it occurred on 27Oct2023. After the vaccine, it wasn't immediately, but on the days she received the vaccine, she just felt really tired. Had no negative effect, thought she was fine, but she wasn't. Over time she lost her hair in the front, like she had a thyroid problem, like hypothyroid. It affected her thyroid, she gained 20lbs. States she developed something on her feet. This agent attempted to clarify. Caller became frustrated stating this has nothing to do with the propofol. Informed caller since the details were mentioned, this agent is required to clarify. Clarifies in Dec, she got COVID toes, which is what it was described as by the Pulmonologist. States a pulmonologist would know since they work with people with COVID. It's been a mystery, the things on her feet. She's never had them before. Had the COVID-19 Vaccines in Jul2021. Mar2022, she had these things on her feet, both second toes and there were big, gel-filled. The things on her toes have cycles of ballooning out and exploding and bleeding. It obviously hurts to drain them. She's talked with an orthopedic surgeon whose only advice is to do a surgery, but she would be in a boot for months with a pin in toes. Has always been a healthy person for many, many years. Regrets every getting the COVID-19 Vaccines. It literally has caused her broken veins in her legs, now both legs, have broken veins. Has pain in her sternal clavicle. AE required visit to: Especially since 2022, in this past year, has just seen so many different doctors. Everything from infectious disease, orthopedics, cardiovascular, vascular, primary care. Has been to the doctor multiple times because of what has happened. Got the weird things on her toes in Mar2022. After the COVID-19 Vaccine has become very heat sensitive, never had that in her life, has always been very cold. It caused her face to turn red, arms turn red, never had that ever in her entire life. Made it difficult to work. Used to work in her yard for 12 hours, but physically can't work in her yard, in the dirt and heat. Has something in her sternal clavicle, a heaviness, like something is there or sticking her. It affects the way she lifts her arms up, and then she get hot, face gets red, arms get red, really the last couple years haven't been able to physically do things like walk her dog due to the sensitivity of the heat and not feeling well. Started having weird red flushing and gained a lot of weight. Probably had hypothyroidism at the time. Found out earlier this year that she had high elevated reverse T3. Her T3 was 25 or 26. Caller does not clarify the date of the reverse T3 lab result. In Mar2023, got fluid in her eye, doesn't know, maybe that's thyroid also because it causes the body to build fluid in body. Had fluid in her eye for over 5 months. Had to have an ocular plastic surgeon open the duct to allow it to drain properly. It looked weird. Was sent to different eye doctors and they didn't know. Eye doctors said she didn't have an eye problem, she had some other problem. Obviously because talking to them about how she was feeling after the COVID-19 Vaccine, they were very confused about the eye. They couldn't help her and let her go with fluid in her eye for over 5 months. She was trying to work and struggling with fluid in her eye. Went to withheld for help. Had pain the sternal clavicle area. It was not GERD, had nothing to do with GERD. Had a terrible EGD procedures, clarifies because it was expensive. It doesn't help with her problems. Problems are there. Had to go on armor thyroid to try and address the T3. Had heart palpitations and redness, but is not having that now. States her feet, she still has, but does not complete her sentence. Has gained weight, has broken veins in her legs. Never had that before and needs to have it treated.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events Hypothyroidism and oral surgery and the suspect drug cannot be completely excluded. 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.