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Life Threatening? No Write-up: Stiff person; eyeballs raise upward; fell down from the chair; This is a spontaneous report from a contactable pharmacist received via COVID-19 Vaccine Adverse Event Reporting System (COVAES). The patient was a 22-year-old female and didn''t know whether she was pregnant or not. Whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Prior to vaccination, whether the patient was diagnosed with COVID-19 was unknown. The patient had allergy to shrimp, crab and peanuts. Other medical history included Epilepsy. Concomitant medications were not reported. On 25Jun2021 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EW0207, Expiration date 30Sep2021) via an unspecified route of administration for COVID-19 immunization. On 25Jun2021, the patient experienced fell down from the chair, and was lying face down. The patient was experienced Stiff person and eyeballs raise upward. After one minute, the patient recovered the consciousness level and got up by herself and moved to the stretcher. The reporter stated the events result in Doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown and whether got treatment was either unknown. Since the vaccination, whether the patient has been tested for COVID-19 was unknown. No follow up attempts are needed. No further information is expected.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Stiff person syndrome, Gaze palsy, Fall and the suspect drug BNT162B2. 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. | ||||||||||||||||
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