Age: 83.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cerebrovascular accident, Electroencephalogram, Facial paralysis
Clinical narrative: STROKE; Facial droop; This is a spontaneous report from a contactable physician.  An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscular on 02Mar2021 (Batch/Lot Number: EM9809) as 2ND DOSE, SINGLE for covid-19 immunisation; and carbidopa, levodopa (DUOPA), via percutaneous j-tube from 2018 (Batch/Lot number was not reported) and ongoing, at unspecified dose for advanced parkinson's disease.  Medical history included maternal history of strokes, and paternal history of strokes, both on unspecified dates. Concomitant medication included carbidopa, levodopa taken for an unspecified indication, start and stop date were not reported. Historical vaccination included first dose of BNT162B2 on 20Jan2021, intramuscular, with lot number: EL19261 for covid-19 immunization.  The patient experienced stroke on Apr2021 with outcome of unknown, and facial droop on Apr2021 with outcome of recovering. Details were reported as follows: The patient felt like she experienced a mini stroke in Apr 2021. She had her Peg and J tube replaced on 16Apr2021 because they came completely out. Her husband was not sure if the pump was working states he could not saw the medication. Her husband had the pump disconnected from her. NCM advised her husband to run the pump over paper towels. Her husband did as instructed and could then saw the medication. He then connected patient to the pump and the pump ran without any error codes or alarms. Her husband wanted to make sure patient did not need a new pump since she got new tubing. NCM assured that the current pump seemed to be working fine with the new tubing. She left sided mouth droop in Apr 2021. She was taken to the local hospital via emergency medical services (EMS). She was then transferred to Hospital in for evaluation. She was in the ER awaiting a bed for 20 hours. The primary reporter did not know if any tests or medicine obtained as he did not receive any paperwork. After 20 hours, she was discharged from the ER home. She had a brain waves test a few days later to confirm if stroke had occurred. The primary reporter stated he did not feel the COVID vaccine was related to he events of Mouth droop and possible stroke. The patient underwent lab tests and procedures which included brain waves test: results pending on 21Apr2021.  The action taken in response to the event(s) for bnt162b2 was not applicable, and for carbidopa, levodopa was dose not changed.; Sender's Comments: Based on information provided, considering the age and medical history of the patient, the event stroke is assessed as unrelated to BNT162B2. The event "facial drop" is assessed as symptom of the event stroke, hence not related to BNT162B2 either. 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.