Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bladder disorder, Confusional state, Cyanosis, Dyspnoea
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17May2022 as dose 2, single (Lot number: FJ6369) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing), notes: Migraines for 24 years; "Gilbert's liver disease" (unspecified if ongoing), notes: Gilbert's liver disease; "HTN" (unspecified if ongoing), notes: HTN; "Right AV block and left bundle branch block after COVID" (unspecified if ongoing), notes: Right AV block and left bundle branch block after COVID; "Right AV block and left bundle branch block after COVID" (unspecified if ongoing), notes: Right AV block and left bundle branch block after COVID; "COVID" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. Concomitant medication(s) included: ATENOLOL; LOSARTAN; TOPAMAX. Vaccination history included: Pfizer (Dose Number: 1, Batch/Lot No: FJ6369, Location of injection: Arm Left), administration date: 12Apr2022, when the patient was 45-year-old, for COVID-19 immunization; flu (Dose Number: 1, Anatomical Location: Arm Right), administration date: 12Apr2022, when the patient was 45-year-old, for Immunization. The following information was reported: CONFUSIONAL STATE (non-serious) with onset 05Jun2022 at 11:00, outcome "recovered with sequelae" (2022), described as "Confusion"; GENERALISED TONIC-CLONIC SEIZURE (medically significant) with onset 05Jun2022 at 11:00, outcome "recovered with sequelae" (2022), described as "Grand mal seizure on 05Jun2022 less than 5 min long"; BLADDER DISORDER (non-serious) with onset 05Jun2022 at 11:00, outcome "recovered with sequelae" (2022), described as "Loss of bladder, consciousness"; SOMNOLENCE (non-serious) with onset 05Jun2022 at 11:00, outcome "recovered with sequelae" (2022), described as "Sleepiness"; DYSPNOEA (non-serious) with onset 05Jun2022 at 11:00, outcome "recovered with sequelae" (2022), described as "Stopped breathing for 1 minute, turned blue, clonic tonic right sided"; ASTHENIA (non-serious) with onset 05Jun2022 at 11:00, outcome "recovered with sequelae" (2022), described as "Weakness on right side after"; TONIC CLONIC MOVEMENTS (medically significant) with onset 05Jun2022 at 11:00, outcome "recovered with sequelae" (2022), described as "clonic tonic right sided"; LOSS OF CONSCIOUSNESS (medically significant) with onset 05Jun2022 at 11:00, outcome "recovered with sequelae" (2022), described as "consciousness"; PETIT MAL EPILEPSY (medically significant), PARTIAL SEIZURES (medically significant) all with onset 05Jun2022 at 11:00, outcome "recovered with sequelae" (2022) and all described as "focal and absent seizures"; CYANOSIS (non-serious) with onset 05Jun2022 at 11:00, outcome "recovered with sequelae" (2022), described as "turned blue". The events "grand mal seizure on 05jun2022 less than 5 min long", "consciousness", "clonic tonic right sided", "focal and absent seizures", "turned blue", "loss of bladder, consciousness", "stopped breathing for 1 minute, turned blue, clonic tonic right sided", "weakness on right side after", "confusion" and "sleepiness" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Echocardiogram: Unknown results; Electroencephalogram: Unknown results. Therapeutic measures were taken as a result of generalised tonic-clonic seizure, loss of consciousness, tonic clonic movements, petit mal epilepsy, partial seizures, cyanosis, bladder disorder, dyspnoea, asthenia, confusional state, somnolence. Clinical information: Adverse event: loss of bladder, consciousness; stopped breathing for 1 minute, turned blue, clonic tonic right sided, used 2 smelling salts, to start breathing, called 911; post octal for 15+ min weakness on right side after, confusion and sleepiness after, focal and absent seizures since then daily, grand mal monthly, never had seizures before, only migraines. Hospitalization was not prolonged. AE treatment included EEG, echo, carotid Doppler, 1500mg keppra 2x/day. Patient was not tested for Covid post vaccination. Follow-up attempts are completed. No further information is expected.