Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder, Swelling face, Swollen tongue, Tearfulness, Tension
Clinical narrative: inability to respond questions; Slow thinking and confusion; Slow thinking and confusion; Electrical sensation/pin pricks/"bursts" across the face; Tingling across the face, including the lips and tongue; Tingling across the face, including the lips and tongue; Facial fullness and swelling; Facial fullness and swelling; throat fullness and swelling; throat fullness and swelling; slurred speech due to swollen tongue; slurred speech due to swollen tongue; flushing in the face; Difficulty breathing once at home; Overall tenseness; Overall weakness; Delayed speech; Loss of ability to speak and formulate clear thoughts; Loss of ability to speak and formulate clear thoughts; Inability to walk due to weakness and shaking; Inability to walk due to weakness and shaking; Involuntary muscle movement; Double vision in the right eye followed by blurred vision; Double vision in the right eye followed by blurred vision; Headache; Clamminess; fever; Increased heart rate; increased blood pressure; Tearfulness; crying; This is a spontaneous report from a non-contactable other healthcare professional. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 46-years-old, intramuscular, administered in Arm Right on 08Sep2021 10:30 (Batch/Lot Number: FC3184) as dose 1, single for COVID-19 immunization. Medical history included vascular malformation in head/neck. There were no concomitant medications. The patient was not pregnant. The patient had no known allergies. The patient had no other vaccine and medication in four weeks. The patient experienced Slow thinking and confusion approximately 5 miles from home, causing dangerous driving, Electrical sensation/pin pricks "bursts" across the face while at a stoplight/exit for home, Tingling across the face, including the lips and tongue, Facial fullness and swelling, throat fullness and swelling, slurred speech due to swollen tongue, Flushing in the face, Difficulty breathing once at home, Overall tenseness , Overall weakness, Delayed speech, and at times, inability to respond to questions, Loss of ability to speak and formulate clear thoughts, Inability to walk due to weakness and shaking, Involuntary muscle movement (jerking of the muscles in a 2-4 second rhythmic pattern that lasted 3-4 hours), Double vision in the right eye followed by blurred vision (with corrective contact lenses, RX unchanged for 2years), Headache, Clamminess (fever?), Increased heart rate up to 85 from typical 50, and increased blood pressure while laying down at 30 degrees tearfulness and crying. The events occurred on 08Sep2021 14:00 and resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment in ED, occupational medicine, ophthalmology, pending speech therapy, optometry neurology, & neurology. Unknown if the patient had prior COVID. Patient was not tested post vaccination. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the mental impairment and other reported events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI, chemistry panel, thyroid function tests and neuropsychiatric examination, counteractive treatment measures and concomitant medications.  This case will be reassessed upon receipt of follow-up information.   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.