Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Electroencephalogram, Influenza virus test, Magnetic resonance imaging head, Malaise
Clinical narrative: Developed regularly  fits which progressed to seizure like activity; Had fever briefly; loss of smell; loss of taste; conversion disorder; Diagnosed with pseudoseirves; feeling ill; cough; sore throat; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 17 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 19Aug2021 (Lot number: FA7484) at the age of 17 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PROZAC; TRI-LO-SPRINTEC taken for contraception. The following information was reported: SEIZURE (medically significant), outcome "recovered", described as "Developed regularly  fits which progressed to seizure like activity"; PSYCHOGENIC SEIZURE (medically significant) with onset Oct2021, outcome "recovered", described as "Diagnosed with pseudoseirves"; MALAISE (non-serious) with onset 23Aug2021, outcome "recovered", described as "feeling ill"; COUGH (non-serious) with onset 23Aug2021, outcome "recovered", described as "cough"; OROPHARYNGEAL PAIN (non-serious) with onset 23Aug2021, outcome "recovered", described as "sore throat"; PYREXIA (non-serious), outcome "recovered", described as "Had fever briefly"; CONVERSION DISORDER (non-serious) with onset Oct2021, outcome "recovered", described as "conversion disorder"; ANOSMIA (non-serious), outcome "recovered", described as "loss of smell"; AGEUSIA (non-serious), outcome "recovered", described as "loss of taste". The events "feeling ill", "cough" and "sore throat" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram head: (09Jan2022) negative; electrocardiogram: (31Aug2021) negative; electroencephalogram: (09Jan2022) negative; influenza virus test: (31Aug2021) negative; magnetic resonance imaging head: (09Jan2022) negative; sars-cov-2 test: (23Aug2021) negative; (31Aug2021) negative; (09Jan2022) negative, notes: Nasal Swab; sleep study: (20Jan2022) borderline; x-ray: (31Aug2021) negative. Therapeutic measures were not taken as a result of malaise, cough, oropharyngeal pain. Additional information: The patient provided information regarding the reported adverse event(s) with the use of the product and did not consider the Pfizer product had a causal effect to the adverse event. Prior Vaccinations (within 4 weeks) was reported as none.; Sender's Comments: Based on information provided, the company concurs with the reporter that the reported events are inter-current or underlying medical conditions, thus unrelated to the suspect drug. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.