Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Interchange of vaccine products, Magnetic resonance imaging, X-ray
Clinical narrative: She had 3 Pfizer doses previously and then had a Moderna dose, and her last booster dose was Pfizer; Caller reports a stroke 4 days after receiving; developed high blood pressure; high cholesterol; mild narrowing of her carotid artery; but her handwriting was a little messy; 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 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 5 (booster), single (Lot number: 656738, Expiration Date: 31Jul2023) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diverticulitis" (unspecified if ongoing), notes: She also had diverticulitis. The patient's family history included: "stroke" (unspecified if ongoing), notes: her 102-year-old grandmother has had a stroke. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EN5318, Expiry Date: Unknown, Manufacturer Pfizer, Site: Left arm), administration date: 28Jan2021, when the patient was 64-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot: EN6200, Expiry: Unknown, Manufacturer: Pfizer, Site: Left arm), administration date: 19Feb2021, when the patient was 64-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot: 30145BA, Expiry: Unknown, Manufacturer: Pfizer, Site: Left arm), administration date: 24Oct2021, when the patient was 65-year-old, for COVID-19 immunization; moderna (DOSE 4 (BOOSTER), SINGLE, Lot: 002M21A, Expiry: Unknown, Manufacturer: Moderna, Site: Left arm), administration date: 14Apr2022, when the patient was 65-year-old, for COVID-19 immunization; Flu vaccine (Thinks she got it in Sep2022), administration date: Sep2022, for Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant) with onset 14Nov2022, outcome "unknown", described as "She had 3 Pfizer doses previously and then had a Moderna dose, and her last booster dose was Pfizer"; CEREBROVASCULAR ACCIDENT (hospitalization, medically significant) with onset 18Nov2022, outcome "unknown", described as "Caller reports a stroke 4 days after receiving"; HYPERTENSION (medically significant), outcome "not recovered", described as "developed high blood pressure"; BLOOD CHOLESTEROL INCREASED (medically significant), outcome "unknown", described as "high cholesterol"; CAROTID ARTERY STENOSIS (medically significant), outcome "unknown", described as "mild narrowing of her carotid artery"; DYSGRAPHIA (non-serious), outcome "unknown", described as "but her handwriting was a little messy". The patient was hospitalized for cerebrovascular accident (start date: 18Nov2022, discharge date: 19Nov2022, hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: Blood cholesterol: (unspecified date) high cholesterol; Blood pressure abnormal: (unspecified date) 140/68; (13Jan2023) 180/90, notes: 190/80 or 90; Blood test: (unspecified date) numbers went wonky; (18Nov2022) Unknown results; (19Nov2022) Unknown results; Computerised tomogram: (18Nov2022) Unknown results, notes: CT scan of her head/they also did a CT scan of her stomach; Echocardiogram: (18Nov2022) Unknown results; (19Nov2022) Unknown results; Electrocardiogram: (18Nov2022) Unknown results; Magnetic resonance imaging: (18Nov2022) damage to her brain, notes: MRI showed damage to her brain from the stroke; X-ray: (18Nov2022) Unknown results. Therapeutic measures were taken as a result of hypertension.  Clinical Information: The caller was a consumer that reported that she got the last booster shot and she would like to report a possible bad outcome from it. Caller clarified that it was the Pfizer Covid-19 booster shot. The patient had no problems after the injection, but 4 days later she had a stroke. She had no occluded arteries and no blood clots. The doctors could not figure out why she had the stroke. She read some reports that some people have had this after the injection. No further details provided. She got the injection on 14Nov2022 and had the stroke on 18Nov2022. She has no deficits. Her ability to write came back on her left side, but her handwriting was a little messy. Her blood pressure was higher than it has ever been. She was placed on blood pressure medications after they waited a month to see if her blood pressure would come down on its own, but it did not. She has been on blood pressure medications now for 3 weeks and had her blood pressure checked yesterday and her blood pressure was higher. Her doctor increased the dose of her blood pressure medication for the 2nd time. Her blood pressure has not come down yet, but it has only been a day. Caller clarified the name of the blood pressure medication as Losartan Potassium, no NDC, lot, or expiration to provide. The medication is in a pharmacy vial. Losartan Potassium dose was increased to 75mg from 50mg. She is taking 25mg 3 tablets once a day. She is increasing the dose until it lowers her blood pressure per her doctor's orders. She clarified that she started taking Losartan Potassium 25mg, then increased to 50mg, then increased it to 75mg. They are going to determine if that is the best medication for her. The patient also reports that her BP was 140/68 and then it was 190/80 or 90. The patient clarified the name of the booster dose she received as the Covid-19 Bival (12y) Booster shot. Caller said that she cannot read the entire NDC number on her vaccination card as the pharmacy placed a sticker over it that is covering some of the NDC. Concomitant medications: When she was in the hospital, she was given her medications. She was not taking any blood pressure medication and no cholesterol medications before the incident and now she takes them. She said that her medication she was taking prior to the stroke are not relevant. She was admitted in the hospital for 24 hours. Testing/ Investigations: She had a CT scan of her head, chest x-ray, EKG, Heart Ultrasound, Blood work and they also did a CT scan of her stomach (She also had diverticulitis and they were just checking that for abscess or anything and she was placed on a antibiotic prophylactically to avoid any possible complications). The CT scan, EKG, blood work, and chest x-ray were done on 18Nov2022, MRI was done around midnight. On 19Nov2022 they did more blood work and the heart Ultrasound. MRI showed damage to her brain from the stroke, it was small, but they saw the stroke on the MRI. Everything else was negative, they saw that she had mild narrowing of her carotid artery, but it was not enough to cause a stroke. She received her Covid-19 Bival (12y) Booster shot dose between 1315-1330 on the 14Nov2022. She had 3 Pfizer doses previously and then had a Moderna dose, and her last booster dose was Pfizer. When queried about if a 3rd or Subsequent dose was administered her husband had diabetes and thought it was good idea and the right thing to do. 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): Unknown, she cannot remember when she got her flu vaccine. Thinks she got it in Sep2022. Family Medical History Relevant to Adverse Events (AEs): none. No one in her family except her 102-year-old grandmother has had a stroke. Her father's side of the family has a history of obesity and diabetes, but she is the healthy one. Specific Relevant Test: The patient was anxious to know if her blood pressure would return to what it was. Was very lucky it was a mild stroke. Her blood pressure is terrifying her, it was 180/90 when she wakes up while on medication. She has seen in the literature that mostly women have had strokes. Did not have high blood pressure or cholesterol and had blood work done like 3 weeks prior to receiving the injection with no issues. Her blood pressure has gone up 30 points and cholesterol went up 10 points over night. Saw one study about the stroke, but it did not follow their blood pressure. The patient was taking Losartan Potassium. She was placed on blood pressure medications after they waited a month to see if her blood pressure would come down on its own, but it did not. Her doctor increased the dose of her blood pressure medication for the 2nd time. Her blood pressure has not come down yet, but it has only been a day. She clarified that she started taking Losartan Potassium 25mg, then increased to 50mg, then increased it to 75mg. No NDC, lot, or expiration to provide. The medication is in a pharmacy vial. Product strength and count size dispensed: Losartan 25mg, 90 tablets Additional lot numbers: Not applicable. The sample of the product available to be returned was not provided. Packaging sealed and was in a pharmacy vial. The report is not related to a study or programme.