Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Pyrexia, SARS-CoV-2 test, Seizure
Clinical narrative: Fever and seizure resulting in hospitalization; Fever and seizure resulting in hospitalization; Fever and seizure resulting in hospitalization; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 10 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Dec2021 (Lot number: FFF8839) at the age of 10 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hunter syndrome" (unspecified if ongoing); "OSA" (unspecified if ongoing); "Mitral and Aortic regurgitation" (unspecified if ongoing); "Mitral and Aortic regurgitation" (unspecified if ongoing); "Constipation" (unspecified if ongoing); "B/L carpal tunnel syndrome" (unspecified if ongoing); "seizures" (unspecified if ongoing); "global developmental delay" (unspecified if ongoing); "Alcohol (topical)" (unspecified if ongoing), notes: known allergies: Alcohol (topical). Concomitant medication(s) included: DIVALPROEX SODIUM; OXCARBAZEPINE; TYLENOL; LARONIDASE. Past drug history included: Benzodiazepines, reaction(s): "Allergy: Benzodiazepines", notes: known allergies: Benzodiazepines; Amoxicillin, reaction(s): "Allergy: Amoxicillin", notes: known allergies: Amoxicillin; Diphenhydramine-zinc acetate, reaction(s): "Allergy: Diphenhydramine-Zinc Acetate", notes: known allergies: Diphenhydramine-Zinc Acetate; Benadryl, reaction(s): "Allergy: Benadryl", notes: known allergies: Benadryl; Camphor, reaction(s): "Allergy: Camphor", notes: known allergies: Camphor. The following information was reported: SEIZURE (hospitalization, medically significant), CONDITION AGGRAVATED (hospitalization, medically significant), PYREXIA (hospitalization) all with onset 31Dec2021, outcome "recovered" and all described as "Fever and seizure resulting in hospitalization". The patient was hospitalized for condition aggravated, pyrexia (hospitalization duration: 2 day(s)); the patient was hospitalized for seizure (hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of seizure, condition aggravated, pyrexia. Additional Information: Keppra was received as treatment for the adverse event. Prior to vaccination, patient was not diagnosed with COVID-19, Since the vaccination, patient has not been tested for COVID-19. Device Date was 25Feb2022  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. 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