Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neuralgia, Oedema peripheral, Petechiae
Clinical narrative: Stroke; Left sided weakness and numbness; Muscle in left arm is hard, swollen; Marks on arms and back/Little red dots; Muscle in left arm is hard, swollen; A lot of pain and bone growth in that area, it is causing pain to her cranial nerve; A lot of pain and bone growth in that area, it is causing pain to her cranial nerve; A lot of pain and bone growth in that area, it is causing pain to her cranial nerve; Covid Vaccines her health was down mentally and physically/she had a lot of medical problems; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [13Mar2023], this case now contains serious adverse reaction(s). Information processed together.  This is a spontaneous report received from contactable reporter(s) (Nurse), Program ID:. The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 24Nov2021 as dose 3 (booster), single (Lot number: FF841) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "for water" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "Heart rate" (unspecified if ongoing). Concomitant medication(s) included: CARVEDILOL taken for blood pressure measurement; LASIX [FUROSEMIDE] taken for fluid retention; FOLIC ACID; VITAMIN D1; LEVOTHYROXINE taken for thyroid disorder; METOPROLOL taken for heart rate. Vaccination history included: BNT162b2 (dose 1, single; left arm, lot number: Pfizer 9899), administration date: 21Dec2020, when the patient was 58-year-old, for COVID-19 immunization, reaction(s): "They were ready to send her for a liver transplant", "Extreme fever"; BNT162b2 (Dose 2, Single, Lot Number: Pfizer 421 with 9231 in front of it, left arm.), administration date: 12Jan2021, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "Blood sugar of 700", "Bleeding". The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant) with onset Mar2023, outcome "unknown", described as "Stroke"; HEMIPARESIS (medically significant), outcome "unknown", described as "Left sided weakness and numbness"; OEDEMA PERIPHERAL (non-serious), outcome "unknown", PETECHIAE (non-serious), outcome "unknown" and all described as "Marks on arms and back/Little red dots"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "not recovered", described as "Muscle in left arm is hard, swollen"; EXOSTOSIS (non-serious), MAXILLOFACIAL PAIN (non-serious), NEURALGIA (non-serious), outcome "unknown" and all described as "A lot of pain and bone growth in that area, it is causing pain to her cranial nerve"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "Covid Vaccines her health was down mentally and physically/she had a lot of medical problems". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 3 day(s)).  Clinical Course: No other conditions and investigations. The caller states that the adverse events started in 2020. Caller stated that currently she was 61 years old. Caller stated that her doctor was out of [Institution name withheld].  Caller also states that she has had care at [Hospital name withheld]. Caller denied any other medical conditions relevant to these events. Caller mentions that she has taken Carvedilol for blood pressure, Lasix for water, Folic Acid, Vitamin D1, and Levothyroxine for her thyroid.  When prompted related to time frames for starting these medications caller states that these medications all changed after 2020.  States that she never had medical problems before 2020 other than she was taking Metoprolol for her heart rate, but it was discontinued for her. No further information provided by the caller related to any of these mentioned medications. Caller also stated that they were ready to send her for a liver transplant then all of the sudden her liver started working again.  Caller states that this event took place in 2020. Extreme fever: Caller states that this began for her with the shot in 2020. Stated that it still occured on and off. Bleeding: Caller mentioned that she was hospitalized last year, then states it was 2021, for bleeding from her rectal area and her mouth. Caller verified that this occurred in 2021.  States she missed a lot of work.  She was hospitalized for 2 weeks and had to have blood transfusions.  Caller states that they never did find where the blood was coming from.  She lost a lot of blood. Blood sugar of 700: When prompted related to concomitant medications the caller mentioned that in 2021 her blood sugar was 700.  States that they put her on unspecified insulin at that time.  Caller states that suddenly her blood sugar went down to normal.  States it was normal at that time and she was not using those medications anymore. Left sided weakness and numbness: Caller states that this was ongoing for her because she just had a stroke 2 weeks ago. Stroke: Caller stated that this occurred about 2 weeks ago and got confused about the date of this event.  Verifies that this occurred for her in Mar2023.  Caller stated that she was hospitalized for three days. Muscle in left arm is hard, swollen: Caller states that this issue is ongoing for her.  Caller mentioned that she had the vaccines in her left arm, and it was still swollen.  Her son had to get her outside because she was falling, and he had to hold her. Marks on arms and back: Caller stated that the marks were like little mosquito bite looking marks, like little blood stuff.  Caller stated that they were on her arms and back. Caller mentioned that she hasn't been the same since her stroke, in the hospital they were wondering about her marks, her little red dots. She got the 3 Pfizer covid-19 vaccines from them and after getting that she had a lot of medical problems. Investigations: When prompted related to any labs, testing, or treatments relevant to these events the caller stated yes.  Stated that at the time of report, she would have to have maxillofacial surgery because of a lot of pain and bone growth in that area, it was causing pain to her cranial nerve. Caller states that she was scared. The last two weeks when she woke up with the numbness in her left arm and left feet, she thought it was a stroke, but they could not find anything.  Her tests had been normal.  Caller mentions that since the Covid Vaccines her health was down mentally and physically.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported events cerebrovascular accident, hemiparesis. 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.