Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Dysarthria, Gait disturbance
Clinical narrative: stroke; stumbling at work; when she started talking she was slurring; This is a spontaneous report from a contactable consumer (patient herself). A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: ER8732), dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 in the morning (at the age of 70 years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included heart palpitations (about 6 weeks before receiving the Covid 19 vaccine) and heart rate abnormal both from an unknown date and unknown if ongoing. She had long heart beats also. She also had a history of anaphylaxis to a sulfa medication. She reported, Sulfa medication was prescribed for a urinary tract infection about 7 years ago. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start date was not reported and was ongoing, 300mg once daily. The patient previously took sulfonamide for urinary tract infection and sulfonamide for anaphylactic reaction. Patient history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was none. any other vaccinations within four weeks prior to the first administration date of the suspect vaccine and AE(s) following prior vaccinations were none. On 04Apr2021, about 3 days after the first Covid 19 vaccine the patient experienced stroke, stumbling at work and when she started talking, she was slurring. The patient was hospitalized for stroke from 04Apr2021 to 07Apr2021. It was reported that, Patient received her first Covid 19 vaccine on 03Apr2021 and on 07Apr2021 the Patient had a stroke. The caller's doctor was not certain her stroke was caused by the Covid 19 vaccine or not. The caller's cardiologist said the stroke came from the caller's heart because 6 weeks prior the caller had experienced palpitations. The caller went to the hospital to get her second Covid 19 vaccine but the staff at the hospital would not give her the vaccine requiring the caller's neurologist to sign off on her being able to receive the second vaccine. The caller is well outside the 42-day window to receive the second Covid 19 vaccine. The caller also has a history of anaphylaxis to a sulfa medication. The caller did not mention a specific sulfa medication. She was in the hospital when she took the sulfa medication and now carries an epi-pen. The caller reports she received her first Covid 19 vaccine on 01Apr2021 and had the stroke on 04Apr2021. The caller does not recall the name of the Sulfa medication. She reports it was prescribed for a urinary tract infection about 7 years ago. She does not have the NDC/Lot/Expiry. The caller reported her neurologist told her the staff at the hospital should have allowed her to receive her second Covid 19 vaccine. The caller felt like the neurologist was short with her and quick with his answer about whether she could get the Covid 19 vaccine. He did not outright say that it was ok for her to receive the second Covid 19 vaccine. When probing for details related to the caller's stroke she reports she didn't notice it at the time but looking back she was stumbling a little at work. The first real symptom was she felt like something was coming on. She sat down and tried to put her right arm on the arm rest of the chair but her right arm had a mind of its own. Her right arm was not weak it just wouldn't go on the arm rest. She was sitting in a high chair and she was trying to put her right foot on the rail of the chair and her right leg just wouldn't do what she wanted it to do. She called for help and a girl came over to help her and when she started talking, she was slurring. 911 was called. She was taken to the emergency department and had a CT scan to make sure she didn't have a brain bleed. She did not have a brain bleed, so she was given TPA which is a major clot buster. She had another CT scan after that. She was admitted to the hospital to the Neuro-ICU. She thinks around the second day she had an MRI scan. She had blood work also, but nothing looked abnormal. She was admitted on 04Apr2021 to the hospital and discharged on 07Apr2021. She spent 3 nights in the Neuro-ICU and one night on the regular floor. When probing medical history, she reports about 6 weeks before she had the stroke, prior to receiving the Covid 19 vaccine, she had been having severe palpitations. It felt like her heart was doing cart wheels. She had long heart beats also. She did not report this to her doctor. While she was in the hospital it was determined that her heart caused her stroke. Now she is on heart medicine and has an EKG monitor in her chest. Medtronic Reveal LINQ was placed in her chest on 24May2021. The device doesn't do anything to her heart it sends a constant EKG to her doctor and it picks up more information than a regular EKG. Clarified with patient that her heart palpitations began before she received her first Covid 19 vaccine. She was now taking Aspirin 325mg daily, Atorvastatin 10mg daily, Metoprolol 25mg daily. The only prescription medication she was taking prior to the Covid 19 vaccine was Wellbutrin 300mg daily because her husband passed away a few months ago. She reported she had her Covid 19 vaccine in the hospital because she wanted to be in a hospital setting because of her anaphylactic reaction to the sulfa medication. Upon follow up, she reported that, she received first dose April 3rd and had a stroke on April 7th she stated that she was in good health and even her doctors did not know what caused it. She wanted to know what was Pfizer recommendation for her to receive the second dose because she already past the 21 days timeline. Events required a visit to, Emergency Room and Physician Office. Patient was hospitalized for 4 days. On an unspecified date, the patient underwent lab tests and procedures which included unknown blood test in which Nothing looked abnormal, computerised tomogram and magnetic resonance imaging both with unknown results. Therapeutic measures were taken as a result of stroke. Outcome of the events were unknown.