Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, White matter lesion
Clinical narrative: Had symptoms consistent with stroke; Headache on the right side of her head that was 10/10 in intensity, attributed it to migraine; left sided weakness.; She could not move; Numbness/weakness on left side of face, left arm, and left leg that started; Numbness/weakness on left side of face, left arm, and left leg that started; Numbness/weakness on left side of face, left arm, and left leg that started; This is a spontaneous report from a contactable physician and consumer (patient). A 32-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8734), via an unspecified route of administration, administered in Arm Right on 09Apr2021 12:00 as 2nd dose, single for COVID-19 immunization in a workplace clinic. Medical history included migraine, depression, asthma, and known allergy: sulfa from an unknown date. No COVID-19 prior to vaccination. Concomitant medications included fluoxetine hydrochloride (PROZAC); omeprazole (PROTONIX); ibuprofen all taken for an unspecified indication, start and stop date were not reported and an unspecified birth control medication. The patient previously took Tylenol, erythromycin, Levaquin, and Flagyl and experienced drug allergy. The patient previously received the first dose of bnt162b2 (lot number: EP7534) on 19Mar2021 12:00 PM on the left arm for COVID-19 immunization. On 09Apr2021, on the same day after receiving the vaccine, the patient had numbness/weakness on left side of face, left arm, and left leg. On 10Apr2021 20:30 the patient woke up with a headache on the right side of her head that was 10/10 in intensity attributed it to migraine and left sided weakness. Her symptoms persisted and she could not move, so she called her mother and had symptoms consistent with stroke called 911 and went to the hospital emergency room then was admitted to the stroke unit. The patient was hospitalized for 2 days from 10Apr2021 to 12Apr2021. The patient received TPA and supportive treatment in ICU Stroke Unit. The events were considered serious for hospitalization and life threatening condition by the reporter. The patient underwent lab tests and procedures which included computerised tomogram and magnetic resonance imaging both did not show ischemia or brain bleed on unspecified dates, headache pain assessment: 10/10 on 10Apr2021, Aptima SARS-CoV-2 assay via Nasal Swab: negative on 11Apr2021, COVID-19 PCR test via Nasal Swab: negative on 06May2021. The outcome of the events was recovered.; Sender's Comments: Based on information provided, the reported events more likely represent intercurrent medical conditions which are unlikely related to bnt162b2. The case will be reassessed once more information become available. 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.