Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Aphasia, Computerised tomogram, Confusional state, Dizziness
Clinical narrative: suffered paralysis on her whole right side; suffered a hemiplegic migraine; aphasia; dizziness / acute on chronic dizziness / increased dizziness; confusion; This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient.  A 41 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscular, administered in arm left, administration date 21Dec2021 (Lot number: FD7218) at the age of 41 years as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "Migraines" (unspecified if ongoing), notes: normally had traditional migraines that were not complicated by any auras; "Acne" (unspecified if ongoing); "OAB" (unspecified if ongoing). The patient had no known allergies. Concomitant medications included: ALDACTONE [SPIRONOLACTONE]; AJOVY [FREMANEZUMAB]; ATARAX [ALPRAZOLAM]; EXCEDRIN MIGRAINE; FLONASE ALLERGY RELIEF. Vaccination history included: BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (DOSE 2, SINGLE, Lot number: ER8732, Location of injection: left arm, route of administration: intramuscular), administration date: 27Mar2021, when the patient was 41 years old, for COVID-19 immunization; BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (DOSE 1, SINGLE, Lot number: EN6198, Location of injection: left arm, route of administration: intramuscular), administration date: 03Mar2021, when the patient was 41 years old, for COVID-19 immunization. The vaccination facility type was reported as the hospital. The patient had no COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. The following information was reported: HEMIPLEGIA (hospitalization, medically significant) with onset 09Feb2022 18:15, outcome "recovered with sequelae," described as "suffered paralysis on her whole right side"; HEMIPLEGIC MIGRAINE (hospitalization) with onset 09Feb2022 18:15, outcome "recovered with sequelae," described as "suffered a hemiplegic migraine"; APHASIA (hospitalization) with onset 09Feb2022 18:15, outcome "recovered with sequelae," described as "aphasia"; DIZZINESS (hospitalization) with onset 09Feb2022 18:15, outcome "recovered with sequelae," described as "dizziness / acute on chronic dizziness / increased dizziness"; CONFUSIONAL STATE (hospitalization) with onset 09Feb2022 18:15, outcome "recovered with sequelae," described as "confusion." The patient was hospitalized for hemiplegia, hemiplegic migraine, aphasia, dizziness, confusional state (start date: 09Feb2022, discharge date: 11Feb2022, hospitalization duration: 2 days). The event "dizziness / acute on chronic dizziness / increased dizziness" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: angiogram (CTA): unknown result; computerised tomogram (CT): unknown result; echocardiogram (TEE): unknown result; laboratory test (basic work-up): normal; magnetic resonance imaging (MRI): unknown result; neurological examination (full neuro workup): all normal. Therapeutic measures were taken as a result of hemiplegia, hemiplegic migraine, aphasia, dizziness, confusional state, which included Plavix and aspirin. Clinical course: The doctors believed the patient suffered a hemiplegic migraine. She suffered paralysis on her whole right side, aphasia, dizziness, and confusion. The hospital did a full neuro workup, which was all normal. The patient had never experienced this type of migraine before, ever. She was also currently experiencing acute on chronic dizziness since the hemiplegic migraine attack. All of these symptoms started a few weeks after her 3rd Pfizer dose. In addition, the patient went to the ER for increased dizziness on 17Mar2022. The hospital did a basic work-up which was normal. She was to follow up with ENT and was prescribed Meclizine. The patient had never experienced any of this in her life.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully 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.