Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Product dose omission issue, Seizure, Thyroid function test, Visual impairment
Clinical narrative: CONVULSIONS/SEIZURES; HYPERTHYROIDISM; DRUG INTERACTION; FLUCTUATING HEART RATE; NUMBNESS DOWN FACE; NUMBNESS AND TINGLING IN ARM; ABNORMAL VISION; SKIPPED DOSES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included neurological issues related to covid, and seizures. On 19-MAR-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency once total, administered for prophylactic vaccination. The patient received Topiramate (capsule, hard, oral, batch number was not reported) 100 mg, 1 time every 1 day, from OCT-2020, 100 mg, 1 time every 1 day, from 08-MAY-2021, and 200 mg, frequency, and therapy dates were not reported for neurological issues related to covid. The batch number was not reported and has been requested. Concomitant medications included thyroid.  On an unspecified date in 2021, the patient experienced hyperthyroidism, and was hospitalized (date unspecified) and experienced convulsions/seizures, numbness down face, abnormal vision, fluctuating heart rate, numbness and tingling in arm and had skipped doses (coded as drug dose omission). Patient went to the hospital where she had stopped Topamax for 6 days to check whether electroencephalogram (EEG) would show up, and thyroid function test (NR: not provided) high (hyperthyroid). levels had dropped. The hospital ultimately could not found anything. But she went back to a different hospital for more neurological testing and was taken off of Topamax again. She had another thyroid test and her levels had dropped. On, 07-May-2021, the patient was discharged and started taking it again from the night of 08-May-2021.The numbness had came back. She saw online that Topamax and Armour Thyroid should not be combined. She mentioned that at some point her dose was increased to 200 mg a day and she had experienced more seizures. On an unspecified date in 2021, the patient experienced drug interaction The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with Topiramate was not reported. The patient recovered from hyperthyroidism, had not recovered from numbness down face, and abnormal vision, convulsions/seizures, fluctuating heart rate and numbness drug interaction and tingling in arm was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint 90000179114.; Sender's Comments: V0. 20210522141-COVID-19 VACCINE AD26.COV2.S -Convulsions/Seizures, Hyperthyroidism, Drug interaction. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210522141-TOPOMAX-Convulsions/Seizures. This event(s) is labeled per RSI and is therefore considered potentially related.  20210522141-TOPOMAX-Hyperthyroidism, Drug interaction. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).