Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Neurological symptom, Seizure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2229872US. A 44-year-old female patient received BNT162b2 (BNT162B2), on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation; ubrogepant (UBRELVY), (Lot number: 1155142, Expiration Date: 31Dec2022) at 100 mg for migraine; erenumab aooe (AIMOVIG), (Batch/Lot number: unknown) for 1 day for migraine. The patient's relevant medical history included: "break-through migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 2, Batch/Lot number: unknown), administration date: 01Jan2021, when the patient was 42-year-old, for Covid-19 immunization; BNT162b2 (dose 1, Batch/Lot number: unknown), administration date: 01Dec2020, when the patient was 42-year-old, for COVID-19 immunization. The following information was reported: SEIZURE (medically significant), outcome "recovering", described as "seizures"; NEUROLOGICAL SYMPTOM (medically significant), outcome "recovered", described as "neurological symptoms"; MIGRAINE WITH AURA (medically significant), outcome "recovered with sequelae", described as "aura with migraines"; HYPERTENSION (medically significant), outcome "not recovered", described as "high blood pressure"; CONSTIPATION (medically significant), outcome "not recovered"; INFLAMMATION (medically significant), outcome "not recovered"; NEURALGIA (medically significant), outcome "unknown", described as "neuropathic pain". The action taken for ubrogepant and erenumab aooe was unknown. Therapeutic measures were taken as a result of inflammation, neuralgia. The clinical course was as follows: A patient experienced seizure, neurological symptom, hypertension, constipation, covid-19, therapy interrupted, inflammation, neuralgia, migraine, and aura following the administration of ubrogepant (UBRELVY) for "break-through migraines". Co-suspect drugs included: erenumab aooe (AIMOVIG) (also "Im ivig (SP)") for "break-through migraines"; Pfizer Biontech Covid-19 Vaccine (tozinameran) for "covid-19 immunisation". Patient was in the process of starting atogepant (QUILIPTA) on 12Sep2022. Reported taking ubrogepant for break-through migraines and Im ivig (SP) injections. She reported having interruption in therapy due to changes in insurance earlier this year. She said she was currently having some episodes again. She reported having higher blood pressure and constipation with the Im ivig (SP) and by week three her migraines start seeping in and she takes ubrogepant. She was hopeful the atogepant would work more efficiently that the Im ivig (SP). She stated she was also prescribed medical Cannabis due to inflammation and neuropathic pain and takes it in pill and tincture form. She stated no side effects related to Cannabis. She stated five days after her last COVID-19 shot she started having aura with her migraines, neurological symptoms, and seizures that she never had before. The reporter assessed the relationship between ubrogepant and the event of migraine as probable. The reporter assessed the relationship between ubrogepant and the events of seizure, neurological symptom, hypertension, constipation, COVID-19, and aura as not related. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-PV202200065163 same patient/drug, different vaccine dose/AE.