Sex: M
Vaccine: COVID19
Symptoms: Blood culture, Blood pressure measurement, Body temperature, CSF test, Chest X-ray
Clinical narrative: Generalized tonicclonic seizure; This is a literature report for the following literature source(s):   A 62 year-old male patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; clozapine (CLOZAPINE) (Batch/Lot number: unknown) at 400 mg 1x/day (400 mg, 1x/day (for over 2 years, nightly)) for schizophrenia. Relevant medical history included: "TRS" (ongoing); "Hypertension" (ongoing); "Peripheral neuropathy" (ongoing); "former smoker" (unspecified if ongoing), notes: quit smoking 2 years prior. Concomitant medication(s) included: RISPERIDONE; GABAPENTIN; GLYCOPYRROLATE; TRAZODONE; LORAZEPAM. The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (hospitalization, medically significant) with onset Jan2021, outcome "recovered", described as "Generalized tonicclonic seizure". The patient was hospitalized for generalised tonic-clonic seizure (start date: Jan2021). The event "generalized tonicclonic seizure" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood culture: (Jan2021) unrevealing, notes: with no evidence of systemic infection; blood pressure measurement: (Jan2021) 116/700 mmHg, notes: normotensive; body temperature: (Jan2021) 98.6 Fahrenheit, notes: afebrile; (Jan2021) 104.5 Fahrenheit, notes: fever; chest x-ray: (Jan2021) unrevealing, notes: with no evidence of systemic infection; csf test: (Jan2021) unrevealing, notes: with no evidence of systemic infection; drug level: (unspecified date) 380 ng/ml, notes: in the year preceding hospitalization; (unspecified date) 384 ng/ml, notes: in the year preceding hospitalization; (Jan2021) 247 ng/ml, notes: on hospital day 2 (after missing 1 dose on hospital day 1); (Feb2021) 218 ng/ml, notes: 5 days before vaccination; (unspecified date) 389 ng/ml, notes: in the year preceding hospitalization; (unspecified date) 505 ng/ml, notes: in the year preceding hospitalization; (Jan2021) 274 ng/ml, notes: on hospital day 2 (after missing 1 dose on hospital day 1); (Feb2021) 400 ng/ml; drug screen: (Jan2021) negative; electroencephalogram: (Jan2021) revealed nonspecific diffuse slowing without, notes: any evidence of epileptic discharges or seizures; heart rate: (Jan2021) 91, notes: beats per minute; magnetic resonance imaging head: (Jan2021) revealed flair hyperintensity and mildly, notes: restricted diffusion in the left hippocampus consistent with the postictal state but was otherwise unremarkable; physical examination: (Jan2021) there was no evidence of rigidity or hyperreflexia, notes: on examination, lowering suspicion for neuroleptic malignant syndrome; urine analysis: (Jan2021) unrevealing, notes: with no evidence of systemic infection. The action taken for clozapine was unknown. Therapeutic measures were taken as a result of generalised tonic-clonic seizure.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the event generalized tonic-clonic seizure and the 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.