Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Ataxia, Confusional state, Dizziness, Headache, Lethargy
Clinical narrative: ataxia; not able to think straight; extremely dizzy; Lethargic; headache to the back of her neck to her head; This is a spontaneous report from a contactable other health care professional. A 26-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration at left arm on 05Feb2021 11:00 as single dose for COVID-19 immunization. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246). Medical history included high functioning autism; reporter mentioned that this was diagnosed when her daughter was 16, but she suspected it since she was a child, polio; reporter mentioned that her daughter had polio as a baby, she was adopted from out of the country and got polio, high cholesterol; reporter mentioned that this was diagnosed when she was a baby, she came to this country when she was 16 months old and had it then and ADD; reporter mentioned that this was diagnosed when she was 16, but started before that somewhere in her teenager years. Patient concomitant medications were not reported. On an unspecified date in Feb2021, patient has been extremely dizzy, lethargic, and has a headache to the back of her neck to her head, not able to think straight and not be able to move around. Reporter said that patient said that the dizziness is getting worse, and patient did try to work one day last week, then tried again, and couldn't, reporter would say it is getting worse. Reporter mentioned that she gave her daughter a 24 hours allergy pill, nasal spray, and some over the counter Bonine, but all it did was put her to sleep. 24 hours allergy pill was clarified to being generic Value Med Allergy Relief, the ingredient Cetirizine 10mg. UPC: 68925-3, LOT S200197, EXP Oct2021. Reporter also mentioned that Bonine was also over the counter, with LOT 173146C, EXP August 2019. Dosage: 25mg took one last night and one this morning, the product other name is Meclizine. Reporter mentioned that the generic nasal spray is over the counter Mometasone furoate made by Apotex Corporation. LOT: RG4324, EXP: June 2021. Reporter mentioned that she doesn't know what to do for her, and she was supposed to see her doctor today, but due to the snowstorm her appointment was cancelled until tomorrow, the ENT. Reporter mentioned that the doctor said that there was nothing they could do for dizziness. Reporter also mentioned that her daughter got both doses of the vaccine, and it was the second one that really made her sick. Reporter thought that it is serious because her daughter was not getting better and she was in tears because patient does not feel good, and she did not know what was wrong with patient. Reporter wanted to know whether this is something that has been reported or that they had heard of happening before. Outcome of the events was unknown. Reporter thought that it is serious because her daughter was not getting better and she was in tears because patient does not feel good, and she did not know what was wrong with patient. Reporter wanted to know whether this is something that has been reported or that they had heard of happening before. Outcome of the events was unknown. Reporter thought that it is serious because her daughter was not getting better and she was in tears because patient does not feel good, and she did not know what was wrong with patient. Reporter wanted to know whether this is something that has been reported or that they had heard of happening before. Outcome of the events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. However, the concomitant medication of allergy pill may provide a plausible alternative explanation for the events.   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.