Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cognitive disorder, Drug ineffective, Feeling abnormal, Loss of consciousness
Clinical narrative: Passed out from her migraines; Brain fog; Cognitive issues; Pain; Migraine; COVID-19 breakout /Long term Covid Symptoms; COVID-19 breakout /Long term Covid Symptoms; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out from her migraines), FEELING ABNORMAL (Brain fog), COGNITIVE DISORDER (Cognitive issues), PAIN (Pain) and MIGRAINE (Migraine) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Intercostal neuralgia. Concurrent medical conditions included Asthma and Familial mediterranean fever (Autoinflammatory disease was not specified- familial Mediterranean fever - several years ago.). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jul-2021, the patient experienced COVID-19 (COVID-19 breakout /Long term Covid Symptoms) and DRUG INEFFECTIVE (COVID-19 breakout /Long term Covid Symptoms). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out from her migraines), FEELING ABNORMAL (Brain fog), COGNITIVE DISORDER (Cognitive issues), PAIN (Pain) and MIGRAINE (Migraine). The patient was treated with ATOGEPANT (oral) ongoing from 26-Oct-2021 for Migraine, at an unspecified dose and frequency; PARACETAMOL (TYLENOL [PARACETAMOL]) for Migraine, at an unspecified dose and frequency; SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Migraine, at an unspecified dose and frequency and RIMEGEPANT SULFATE (NURTEC ODT) for Migraine, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out from her migraines), FEELING ABNORMAL (Brain fog), COGNITIVE DISORDER (Cognitive issues), PAIN (Pain), COVID-19 (COVID-19 breakout /Long term Covid Symptoms) and DRUG INEFFECTIVE (COVID-19 breakout /Long term Covid Symptoms) outcome was unknown and MIGRAINE (Migraine) was resolving.            It was reported that, Prior to Qulipta, the consumer had brain fog and cognitive issues because the pain was so intense. Also prior to Qulipta, she passed out from a migraine and had to go to the ER for 2 migraine treatments.   She received the Pfizer Covid-19 booster shot recently. She stated that after taking Qulipta she had some decrease in the intensity of her migraines. She took Tylenol for migraine, and her breakthrough medications, Nurtec and Imitrex. Additionally, she stated that the first week she took Qulipta, she needed Nurtec more frequently, but later she has not needed Nurtec at all.  It was reported that Qulipta was markedly decreased her migraines, and then she felt better. She stated that she had a long list of medications but declined to provide the entire list.  Company Comment: This case concerns a 51-year-old, female patient with medical history of Familial Mediterranean fever, who experienced the unexpected, non-serious and AESI event of COVID-19. Drug ineffective is also reported. The event occurred approximately 4 months and 6 days after second dose of mRNA-1273 vaccine. The rechallenge was not applicable. The medical history of Familial Mediterranean fever remain as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Concomitant Pfizer's COVID-19 vaccine could be considered contributory for the other non-serious events. Event loss of consciousness was automatically upgraded as a Serious event as per IME list. However, based on information available and as per medical criteria was classified as Non-serious.; Sender's Comments: This case concerns a 51-year-old, female patient with medical history of Familial Mediterranean fever, who experienced the unexpected, non-serious and AESI event of COVID-19. Drug ineffective is also reported. The event occurred approximately 4 months and 6 days after second dose of mRNA-1273 vaccine. The rechallenge was not applicable. The medical history of Familial Mediterranean fever remain as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Concomitant Pfizer's COVID-19 vaccine could be considered contributory for the other non-serious events. Event loss of consciousness was automatically upgraded as a Serious event as per IME list. However, based on information available and as per medical criteria was classified as Non-serious.