Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Seizure, Syncope, Vision blurred, Visual impairment
Clinical narrative: looks like fainting but she begin to convulse in her legs in her arms; seizure event; looks like fainting but she begin to convulse in her legs in her arms; seizure event; She couldn't see that her vision was blurry and she was seeing spots in front of her eyes; Dizzy; She couldn't see that her vision was blurry and she was seeing spots in front of her eyes; This is a spontaneous report received from a contactable pharmacist. An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0185 and expiration date 31Aug2021), on 07Jun2021 (at the age of 18-year-old) as 1st dose, single dose (reported as first COVID vaccine) for COVID-19 immunization. The patient's medical history was reported as no appointment history. The patient's concomitant medications were not reported. It was unknown if patient was taking concomitant medications, reporter believed they said like birth control pills. The pharmacist stated that he/she did not believe that patient received other vaccine within 4 weeks, he/she did not know, they did not report that. Pharmacist stated that he/she administered the vaccine to the patient, about he/she would say less than 5 minutes later she said she had been having the reaction to the vaccine she said that she could not see that her vision was blurry and she was seeing spots in front of her eyes. Pharmacist saw, wanted step down and he/she asked her if she was having any signs of the anaphylactic reactions like swelling of the face or top of the lip or tongue if she could swallow correctly, If she felt that she could breath and all of those things were normal however she said that she felt very dizzy so he/she suggested to lay her on the floor because he/she assumed that she was like she was going to faint and then started to, like her eyes sort of curl she looks like fainting. Pharmacist also stated that so, he/she would asking for questions about how she felt and then she said she felt dizzy and he/she suggested that they potentially put her on the floor in case she might faint and then she started to looks like fainting but she began to convulse in her legs in her arms and he/she would say that it happened for roughly he/she did not know 5 seconds only the mom and his/herself the mom really pulled her on the floor urgently and once she was on floor all of all of it stopped and she regained consciousness and the mom was not it was just normal thought she was fainted or she had a seizure event. The mom said that this was not something that ever happened to her daughter before with the vaccination. Pharmacist stated that the event was resolved but she was going to the hospital for a neurological (as reported). Pharmacist did not know if lab data were performed. Pharmacist stated that as he/she know of no treatment due to the event was administered. Reporter's seriousness was not specified. The outcome of the events was resolved.; 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 events Seizure  and Fainting cannot be excluded.  The case will be reassessed if additional information becomes 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.